Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UH3AT010739 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
The main goal of the BackInAction research study is to determine the effectiveness of a standard course of acupuncture (15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults (65+ years) with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
Background: A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults (65+ years) with chronic low back pain. Acupuncture has been found to be effective in treating chronic low back pain in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction has been designed to address this gap.
Purpose: The main goal of BackInAction is to evaluate the effectiveness of a standard course of acupuncture (up to 15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (up to an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
Design and Outcomes: In this pragmatic, three-arm parallel groups multi-site randomized controlled trial, the investigators will recruit and randomize at least 789 adults ≥ 65 years of age with chronic low back to standard acupuncture, enhanced acupuncture, or usual medical care alone in four health-care systems. These include two integrated health care systems, a fee-for-service system and a network of federally qualified health centers. Primary outcome data will be collected by questionnaire at 3-, 6-, and 12-months post-randomization. In addition, short monthly surveys will capture data on physical function and a composite score of pain intensity and pain interference.
Interventions and Duration: Standard acupuncture will consist of 3 months (90 days) of acupuncture needling, with a proposed minimum of 8 treatments and a maximum of 15. Enhanced acupuncture will include the standard acupuncture plus an additional 3-month maintenance period, with a maximum of six additional treatments. Usual medical care will consist of the care that individuals receive according to their insurance benefits plus anything else they pay for out of pocket. The investigators will ask those assigned to usual medical care to avoid acupuncture for the year they are enrolled in the study. Both active treatment arms will also have access to usual medical care. Participants will be enrolled in the study for 12 months.
Sample Size and Population: BackInAction will include patients at least 65 years of age with uncomplicated chronic low back pain with or without radiculopathy. The investigators plan to enroll at least 789 participants (263 per study arm). Participants will be recruited from four health plans, with varying numbers of participants from each site. Randomization will be stratified by health care system, age category and gender. The investigators expect the racial and ethnic mix will roughly parallel that of the older Medicare population.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Acupuncture | Experimental | Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. |
|
| Enhanced Acupuncture | Experimental | Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. |
|
| Usual Care | No Intervention | Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Acupuncture | Procedure | The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Back-related Disability at 6-month Post Randomization (Continuous) | Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement. | Baseline to 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Back-related Disability at 3-, and 12-month (Continuous) | Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Sleep Quality | Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring\_Manual\_Only/PROMIS\_Sleep\_Scoring\_Manual\_03June2022.pdf |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lynn L DeBar, PhD, MPH | Kaiser Permanente | Principal Investigator |
| Andrea J Cook, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Division of Research | Oakland | California | 94612 | United States | ||
| Sutter Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40938602 | Derived | DeBar LL, Wellman RD, Justice M, Avins AL, Beyrouty M, Eng CM, Herman PM, Nielsen A, Pressman A, Stone KL, Teets RY, Cook AJ. Acupuncture for Chronic Low Back Pain in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2531348. doi: 10.1001/jamanetworkopen.2025.31348. | |
| 40484274 | Derived | Justice M, Piccorelli A, Avins AL, Cook AJ, Eng CM, Nielsen A, Pressman A, Stone KL, Teets RY, Wellman R, DeBar LL. Baseline sample characteristics for the BackInAction pragmatic trial of acupuncture for chronic low back pain in older adults. Contemp Clin Trials. 2025 Aug;155:107981. doi: 10.1016/j.cct.2025.107981. Epub 2025 Jun 6. |
Not provided
Not provided
The Kaiser Permanente Washington-based data coordinating center will produce a releasable de-identified database corresponding to the primary outcomes manuscript that can be used by research investigators outside of the study. This dataset will also include the NIH HEAL (Helping to End Addiction Long-term) Initiative common data elements collected from study participants. The dataset will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act and in accordance to the standards set forth in the Department of Health and Human Services Regulations for the Protection of Human Subjects. All identifiers specified in HIPAA will be recoded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional or healthcare system identifiers.
The de-identified dataset will be released within 12 months of the publication of the primary manuscript.
Access to the de-identified database housed in an NIH-assigned repository will be in accordance with procedures and regulations of the NIH HEAL Initiative and the project funder (NCCIH). The project team does not plan to provide any support for investigators using the HEAL releasable database.
Of 12,438 participants screened for eligibility, 800 were randomized and enrolled in the study.
Participants with chronic low back pain that had persisted for >3 months were recruited from four different health systems. The first participant was enrolled in August 2021 and the last participant was enrolled October 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. |
| FG001 | Standard Acupuncture | Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
| FG002 | Enhanced Acupuncture | Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants with chronic low back pain that had persisted for >3 months were recruited from four different health systems. The first participant was enrolled in August 2021 and the last participant was enrolled October 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. |
| BG001 | Standard Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Back-related Disability at 6-month Post Randomization (Continuous) | Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in score from baseline on scale | Baseline to 6-month |
|
Adverse event data was collected during the one-year period of enrollment for each study participant.
Adverse events were identified by acupuncturists, follow-up mailers and ad-hoc participant reports.
Serious adverse events, defined as hospitalizations and deaths, were assessed monthly from the electronic health record (EHR) and medical-record abstraction conduction by physician monitors at each site to determine relatedness.
We collected only potentially treatment-related non-serious adverse events in the acupuncture arms (not in usual care).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Encephalopathy | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Limitations: UMC control group precludes assessment of attention or other nonspecific effects on outcomes; results may be affected by subjectivity in PROs; treatment impact on medication changes unattainable due to limited robust medication-dispensing data at 2 sites; even after imputation and non-response weighting, residual bias may remain, potentially due to differential loss to follow-up by arm; significant findings for secondary outcomes should be interpreted cautiously.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Cook, PhD - Principal Investigator | Kaiser Permanente Washington | 206-287-4257 | andrea.j.cook@kp.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2024 | Jul 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2023 | Jul 18, 2025 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Enhanced Acupuncture | Procedure | The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
|
| Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement. | Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months |
| Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care). | SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews. |
| Study primary outcome timepoint: Baseline to 6 months (sleep quality) |
| Change in Sleep Duration at 3-, 6- and 12-month | Change in 1-item sleep duration scale for sleep duration. | Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only) |
| Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Change in Fatigue at 3-, 6- and 12-month (Continuous) | Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles. | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
| Walnut Creek |
| California |
| 94596 |
| United States |
| Institute for Family Health | New York | New York | 10035 | United States |
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98103 | United States |
| 38765784 | Derived | Wang PZ, Pressman A, Sanchez G, Aparicio C, Nielsen A, Avins A. Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials. Integr Med Res. 2024 Jun;13(2):101042. doi: 10.1016/j.imr.2024.101042. Epub 2024 Apr 17. |
| 36990274 | Derived | DeBar LL, Justice M, Avins AL, Cook A, Eng CM, Herman PM, Hsu C, Nielsen A, Pressman A, Stone KL, Teets RY, Wellman R. Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial. Contemp Clin Trials. 2023 May;128:107166. doi: 10.1016/j.cct.2023.107166. Epub 2023 Mar 27. |
| Withdrawal by Subject |
|
| Dealing with health/life issues |
|
| Privacy concerns |
|
| Withdrawal by research team |
|
Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months.
Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
| BG002 | Enhanced Acupuncture | Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Formal education background | Missing data for 2 participants | Count of Participants | Participants |
|
| Clinical Site | Research project clinical site. | Count of Participants | Participants |
|
| Household Income | Missing data for 38 participants. | Count of Participants | Participants |
|
| Received Disability for Lower Back Pain | Count of Participants | Participants |
|
| Married or Domestic Partnered | Count of Participants | Participants |
|
| Pain Limits Work | Missing data for 2 participants | Count of Participants | Participants |
|
| BMI | Missing data for 12 participants | Count of Participants | Participants |
|
| BMI Mean | Missing BMI data for 12 participants | Mean | Standard Deviation | kg/m^2 |
|
| Frailty | The frailty scale used a modified version of the 5-item questionnaire by Morley, et al. Participants were asked four yes-no questions pertaining to fatigue, difficulty climbing stairs, difficulty walking and weight loss of more than 5% in the last year. The fifth item used EHR data to indicate the present of five of eleven predefined illnesses. Each item was coded as 1 for yes and 0 for no. The frailty score was calculated as the sum of the five items, yielding a range of 0 (best) to 5 (worst). Frailty scores correspond to the following categories: 0=Robust health, 1-2=Pre-frail, 3-5=Frail. | Missing complete data for 33 participants | Count of Participants | Participants |
|
| Frailty Mean | Mean of Frailty (description above). The frailty score was calculated as the sum of the five items, yielding a range of 0 (best) to 5 (worst). Frailty scores correspond to the following categories: 0=Robust health, 1-2=Pre-frail, 3-5=Frail. | Missing data for 33 participants. | Mean | Standard Deviation | units on a scale |
|
| Medical Morbidity (Elixhauser) | Scale range from 0-13; a higher score always indicates a greater comorbidity burden. | Missing data for 2 participants | Mean | Standard Deviation | units on a scale |
|
| Any Opioid in Prior 3 Months | Count of Participants | Participants |
|
| Long-term Opioid Therapy | Long-term opioid therapy (60-day supply in the last 3 months) | Count of Participants | Participants |
|
| Multiple Musculoskeletal Pain Conditions | Musculoskeletal conditions include following ICD diagnostic codes within last year: back pain; neck pain; fibromyalgia; limb/extremity, joint, and non-systematic noninflammatory pain; muculoskeletal chest pain, headache, jaw pain, and general pain. (from the EHR) | Count of Participants | Participants |
|
| Number of Musculoskeletal Pain Conditions | Number of Musculoskeletal Pain Conditions (from the EHR) | Mean | Standard Deviation | Number of conditions |
|
| Types of Painful Conditions | Types of Painful Conditions (from the EHR) | Count of Participants | Participants |
|
| Substance Use Disorder Diagnosis | Substance Use Disorder Diagnosis (from the EHR) | Count of Participants | Participants |
|
| Mental Health Mood Disorder Diagnosis | Mental health mood disorder diagnoses (anxiety, depression) from the EHR | Count of Participants | Participants |
|
| General Anxiety Disorder Subscale of PHQ-4 (GAD 3+) | General Anxiety Disorder (GAD) subscale of the Personalized Health Question (PHQ-4) in which higher values represent worst anxiety (range 0-6) and we categorize into having anxiety symptoms >=3 vs not having anxiety symptoms. | Count of Participants | Participants |
|
| Personalized Health Questionnaire-2 (PHQ-2) (depression threshold of 3+) | Personalized Health Question-2 (PHQ-2) in which higher values represent worst depression (range 0-6) and we categorize into having depression symptoms >=3 vs not having depression symptoms. | Count of Participants | Participants |
|
| Roland Morris Disability Questionnaire-Revised | Roland Morris Disability Questionnaire Revised (RMDQ-R) assesses how low back pain affects functional activity. Higher scores indicate worst functional activity. Roland: Scale Range 0-24. | Mean | Standard Deviation | units on a scale |
|
| Pain (PEG) | The PEG is a measure of pain (3-item composite score of P (pain intensity), E (pain interference with enjoyment in life), and G (pain interference with general activity). Higher scores indicate worse pain. PEG Scale Range: 0-10. | Mean | Standard Deviation | units on a scale |
|
| Pain Intensity | Characteristic of Pain Intensity (single item in rating scale over last week 0-10) | Mean | Standard Deviation | units on a scale |
|
| PROMIS Physical Function Subscale | Subscale that assesses physical function through a grading scale of activities of daily living. The PROMIS Physical Function scale is not a direct 0-100 scale; it uses a T-score scale with a population mean of 50 and a standard deviation of 10, where a higher score indicates better physical function. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Sleep Disturbance Subscale | Subscale that evaluates sleep quality and disturbances. The PROMIS Sleep Disturbance scale uses a T-score metric, not a 0-100 scale. A T-score of 50 represents the average sleep disturbance level for the U.S. general population, with a standard deviation of 10. A higher T-score indicates greater sleep disturbance. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Fatigue Subscale | Subscale that measures fatigue experience and impact. PROMIS Fatigue does not use a 0-100 scale for its T-score, but a T-score metric where 50 is the average for the U.S. general population. Scores above 50 indicate more fatigue than average. | Mean | Standard Deviation | units on a scale |
|
| PROMIS Engagement in Social Roles Subscale | Measures ability to engage in social roles. A PROMIS T-score has a standardized mean of 50 and a standard deviation (SD) of 10. For measures related to social function, higher scores indicate better function and fewer limitations. | Mean | Standard Deviation | units on a scale |
|
| Pain Catastrophizing | 13-item scale (0-52) in which higher scores indicate more pain catastrophizing. | Mean | Standard Deviation | units on a scale |
|
| High Impact Chronic Pain | Count of Participants | Participants |
|
| Sciatica | Count of Participants | Participants |
|
| Expectations of Acupuncture | Measure of acupuncture expectation (1-10) in which higher scores indicate higher expectation. | Mean | Standard Deviation | units on a scale |
|
| Sleep Duration | Sleep duration (number of hours per night). | Mean | Standard Deviation | hours |
|
| Fear Avoidance | Fear avoidance of acupuncture. | Count of Participants | Participants |
|
| Tobacco, Alcohol, Prescription Medication, and Other Substance User (TAPS) Tool | Count of Participants | Participants |
|
| Self-Management Program | Use of self-management program for back pain or other needs. | Count of Participants | Participants |
|
| Use of Mind-Body Techniques | Use of mind-body techniques for back pain or other needs. | Missing data for 9 participants. | Count of Participants | Participants |
|
| Use of Online Pain Management Program | Use of online pain management program for back pain or other needs. | Missing data for 7 participants. | Count of Participants | Participants |
|
| Psychological Counseling | Use of psychological counseling for back pain or other needs. | Missing data for 4 participants | Count of Participants | Participants |
|
| How has COVID affected your ability to get healthcare in the last 3 months? | Missing data for 5 participants | Count of Participants | Participants |
|
| How has COVID affected your overall health in the last 3 months? | Missing data for 9 participants | Count of Participants | Participants |
|
| Use of various types of pain relievers for Back Pain | User of various types of pain relievers (NSAIDS, acetaminophen, cannabis, CBD only, herbal/nutritional supplements) for back pain. | Count of Participants | Participants |
|
| Weekly Exercise | Exercise (active, low back, other movement) at least weekly. | Count of Participants | Participants |
|
| Weekly Exercise (number of days) | Number of days of weekly exercise (active, low back, other movement). | Mean | Standard Deviation | Days |
|
| 3+ Days/Week of Exercise | 3 or more days per week of exercise (active, low back, other movement). | Count of Participants | Participants |
|
| Roland Morris Disability Questionnaire Revised (RMDQ-R) - Back-Related Dysfunction (>=18 score) | RMDQ-R assesses how low back pain affects functional activities. Higher scores indicate worst functional activity. Roland: Scale Range 0-24. This is a count of participants with back-related dysfunction score >=18 and participants with a score <18. This is a dichotomous variable to indicate high RDMQ scores. Scores generally indicate increasing severity, with 15-24 often considered moderate to severe, and scores above 18 (e.g., 19+) moving towards extreme disability or maximal impairment. | Count of Participants | Participants |
|
| Usual Care |
Participants assigned to the usual care arm will not receive acupuncture and will be asked to not get acupuncture over the one-year course of the study. |
| OG001 | Standard Acupuncture | Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
| OG002 | Enhanced Acupuncture | Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. |
|
|
|
| Secondary | Change in Back-related Disability at 3-, and 12-month (Continuous) | Change in back-related disability is defined as score change in RMDQ, a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 3-months or 12-months would indicate greater improvement. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | score change from baseline on a scale | Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Secondary | Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary) | The MCID is measured by a 30% improvement (reduction) on the Roland Morris Disability Questionnaire Revised (RMDQ-R). The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Mean | 95% Confidence Interval | adjusted percentage of participants | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Secondary | Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous) | Change in pain intensity and pain interference with enjoyment of life and general activity will be measured by PEG, a 3-item pain-intensity and pain-related interference composite measure assessing pain intensity, and pain interference with enjoyment of life and general activity. Each item is measured by a 0 to 10 scale with 10 indicating greater pain intensity or pain interference. The scores are then averaged with a higher average score indicating greater pain interference/intensity. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change of score from baseline on a scale | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Secondary | Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary) | The MCID is measured by a 30% improvement (reduction) on the PEG. The MCID reflects clinical improvement and estimates the percentage of individuals with a 30% improvement by intervention arm and 95% confidence intervals are adjusted means of a binary variables estimated using modified Poisson regression. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702-6. doi: 10.1093/aje/kwh090. PMID: 15033648. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Mean | 95% Confidence Interval | adjusted percentage of participants | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Secondary | Change in Physical Functioning at 3-, 6- and 12-month (Continuous) | Change in the Patient-Reported Outcomes Measurement and Information System (PROMIS) Physical functioning short form 6b from the PROMIS-29 (6 items). The 6-item Physical function scale measures self-reported ability to perform activities rather than the actual performance of those activities. Each question has five response options, ranging from one to five. Raw scores range from 6 to 30, with higher scores indicating greater ability. The scores are then standardized using a T-score metric in which 50 is the reference mean and 10 is the standard deviation (SD) of that population. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in score from baseline on a scale | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months | Patient Global Impression of Change in Overall Pain (1 item). This is a 0 to 6 scale ranging from much worse to much better, with higher scores indicating more improvement. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | Change in score from baseline on a scale | Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months |
|
|
|
|
| Secondary | Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE) | Serious adverse events were defined as hospitalizations and deaths. Only potentially treatment-related non-serious adverse events were reported in the acupuncture arms (not usual care). | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Number | events | SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews. |
|
|
|
| Other Pre-specified | Change in Sleep Quality | Change in sleep quality is measured by the six-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Sleep Disturbance Short Form 6a. The raw computed score has a range of 6-30 with higher scores indicating more sleep disturbance. The raw score is converted to a T-score with mean of 50, standard deviation of 10. Higher T-scores indicate worse sleep quality. PROMIS Sleep Scoring Manual. Published online June 3, 2022. https://www.healthmeasures.net/images/PROMIS/manuals/Scoring\_Manual\_Only/PROMIS\_Sleep\_Scoring\_Manual\_03June2022.pdf | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | Change in T-score from baseline | Study primary outcome timepoint: Baseline to 6 months (sleep quality) |
|
|
|
|
| Other Pre-specified | Change in Sleep Duration at 3-, 6- and 12-month | Change in 1-item sleep duration scale for sleep duration. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in hours from baseline | Study primary outcome timepoint: Baseline to 6 months (sleep duration); Test of Standard Acupuncture: Baseline to 3 months (sleep duration only); Test of Maintenance effect: Baseline to 12 months (sleep duration only) |
|
|
|
|
| Other Pre-specified | Change in Symptoms Suggesting Clinically Relevant Anxiety at 3-, 6- and 12-month (Continuous) | Change in PRO scores about the frequency of being anxious or having uncontrollable worry over the past two weeks from the GAD-2, which is part of the PHQ-4. Each item is measured by a 0 to 3 scale with 3 indicating greater anxiety. GAD-2 range is 0-6, with 6 being greater anxiety symptoms. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in score from baseline on a scale | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Other Pre-specified | Change in Symptoms Suggesting Depression at 3-, 6- and 12-month (Continuous) | Change in PRO scores about the frequency of depressed mood and anhedonia over the past two weeks from the PHQ-2. Each item is measured by a 0 to 3 scale with 3 indicating greater depression. Total score is 0-6, with 6 indicating greater depression. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in score from baseline on a scale | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Other Pre-specified | Change in Fatigue at 3-, 6- and 12-month (Continuous) | Change in fatigue will be measured by a change in T-score of the 4-item Patient-Reported Outcomes Measurement and Information System (PROMIS) Fatigue Subscale - SF 4a. This PROMIS measure has a T-score with a mean of 50 and a standard deviation of 10, meaning a score of 50 is average. Higher T-scores indicates greater fatigue. PROMIS Fatigue Scoring Manual. Published online November 4, 2016. https://www.fda.gov/media/137977/download | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in T-score from baseline | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| Other Pre-specified | Change in Ability to Engage in Social Roles at 3-, 6- and 12-month (Continuous) | Change in ability to engage in social roles will be measured by the 4-item subscale for ability to participate in social roles in PROMIS. PROMIS measures are standard T-score range of 20-80, with higher scores indicating greater ability to engage in social roles. | Participants were individuals >= 65 years of age with non-specific chronic low back pain (cLMP) persisting for >=3 months with pain-related interference (>= on general activity item from PEG) recruited from four different health systems. After baseline assessment, participants were randomized in equal proportions to the three arms. Participants completed follow-up assessments at 3-, 6-, and 12- months post-enrollment. | Posted | Least Squares Mean | 95% Confidence Interval | change in score from baseline on a scale | Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months |
|
|
|
|
| 2 |
| 266 |
| 18 |
| 266 |
| 0 |
| 266 |
| EG001 | Standard Acupuncture | Participants randomized to standard acupuncture will receive 8-15 acupuncture treatments over 3 months. Standard Acupuncture: The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. | 0 | 265 | 24 | 265 | 24 | 265 |
| EG002 | Enhanced Acupuncture | Participants randomized to enhanced acupuncture will receive 12-21 acupuncture treatments over 6 months. Enhanced Acupuncture: The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices. | 1 | 269 | 24 | 269 | 27 | 269 |
| Anemia | Gastrointestinal disorders | Systematic Assessment |
|
| Arrythmia | Cardiac disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Bacteremia | Infections and infestations | Systematic Assessment |
|
| Bladder Infection | Infections and infestations | Systematic Assessment |
|
| Bradycardia and syncope | Cardiac disorders | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Car Accident | General disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Collapsed Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID | Cardiac disorders | Systematic Assessment |
|
| COVID | Infections and infestations | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Death | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Death | Vascular disorders | Systematic Assessment |
|
| Difficulty passing food | Gastrointestinal disorders | Systematic Assessment |
|
| Dysautonomia | Nervous system disorders | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | Systematic Assessment |
|
| Gastritis and Duodenitis | Gastrointestinal disorders | Systematic Assessment |
|
| Heart Attack | Cardiac disorders | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Hip Fracture | General disorders | Systematic Assessment |
|
| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intestinal Infection | Gastrointestinal disorders | Systematic Assessment |
|
| Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Medication Poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Myasthenia Gravis | Immune system disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | Systematic Assessment |
|
| Pinched Nerve | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Renal and urinary disorder | Renal and urinary disorders | Systematic Assessment |
|
| Rib and cervical spine fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment | Includes sepsis, septic arthritis, and septic shock |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Spinal fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spinal surgery | Surgical and medical procedures | Systematic Assessment |
|
| Stomach ulcer | Gastrointestinal disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Surgical procedure | Surgical and medical procedures | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Low Back Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lower Extremity Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain at Needle Insertion Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Swelling at Needle Insertion Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Broken Ribs | General disorders | Systematic Assessment |
|
| Bruising at Needle Injection Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Falling | General disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Generalized Pain | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Headache | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| High Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Low Back Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower Extremity Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower Extremity Numbness | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Lower Extremity Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle Spasm at Needle Insertion Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Neck Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nerve Pain | Nervous system disorders | Systematic Assessment |
|
| Nerve Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Periorbital Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postural Instability | Nervous system disorders | Systematic Assessment |
|
| Sciatica | Nervous system disorders | Systematic Assessment |
|
| Spinal Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Spinal Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Warmth at Needle Insertion Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
|
|
| Title | Measurements |
|---|---|
|
|
|
Difference in change from baseline at 12 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .008 |
| Mean Difference (Final Values) |
| -1.2 |
| 2-Sided |
| 95 |
| -2.1 |
| -0.3 |
| Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | -1.7 | 2-Sided | 95 | -2.6 | -0.7 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .27 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -1.4 | .4 | Superiority |
|
| 12 Months |
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. |
| .022 |
| Risk Ratio (RR) |
| 1.33 |
| 2-Sided |
| 95 |
| 1.04 |
| 1.70 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | <.001 | Risk Ratio (RR) | 1.49 | 2-Sided | 95 | 1.19 | 1.86 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .36 | Risk Ratio (RR) | 1.12 | 2-Sided | 95 | .88 | 1.43 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .012 | Risk Ratio (RR) | 1.33 | 2-Sided | 95 | 1.06 | 1.66 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | <.001 | Risk Ratio (RR) | 1.54 | 2-Sided | 95 | 1.25 | 1.91 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .076 | Risk Ratio (RR) | 1.16 | 2-Sided | 95 | .98 | 1.37 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .019 |
| Mean Difference (Final Values) |
| -0.4 |
| 2-Sided |
| 95 |
| -0.8 |
| -0.1 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | -0.9 | 2-Sided | 95 | -1.3 | -0.6 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .02 | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.9 | -0.1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .02 | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.8 | -0.1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | -0.6 | 2-Sided | 95 | -1 | -0.3 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .22 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.6 | 0.1 | Superiority |
|
| 12 Months |
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. |
| .14 |
| Risk Ratio (RR) |
| 1.19 |
| 2-Sided |
| 95 |
| .94 |
| 1.50 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .006 | Risk Ratio (RR) | 1.38 | 2-Sided | 95 | 1.10 | 1.73 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .167 | Risk Ratio (RR) | 1.16 | 2-Sided | 95 | .94 | 1.42 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .089 | Risk Ratio (RR) | 1.22 | 2-Sided | 95 | .97 | 1.52 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .12 | Risk Ratio (RR) | 1.21 | 2-Sided | 95 | .95 | 1.55 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Estimation performed with adjusted modified Poisson regression model with binary outcome, 30% improvement from baseline, fit with GEE. | .99 | Risk Ratio (RR) | 1.00 | 2-Sided | 95 | .80 | 1.25 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .747 |
| Mean Difference (Final Values) |
| .2 |
| 2-Sided |
| 95 |
| -0.8 |
| 1.1 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .1 | Mean Difference (Final Values) | .8 | 2-Sided | 95 | -.1 | 1.7 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .22 | Mean Difference (Final Values) | .6 | 2-Sided | 95 | -.4 | 1.6 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .162 | Mean Difference (Final Values) | .7 | 2-Sided | 95 | -.3 | 1.6 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .277 | Mean Difference (Final Values) | .5 | 2-Sided | 95 | -.4 | 1.4 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .68 | Mean Difference (Final Values) | -.2 | 2-Sided | 95 | -1 | .7 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| 0 |
| Mean Difference (Final Values) |
| .7 |
| 2-Sided |
| 95 |
| .4 |
| 1 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | 1.3 | 2-Sided | 95 | 1 | 1.5 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | .6 | 2-Sided | 95 | .3 | .9 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | .5 | 2-Sided | 95 | .2 | .8 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | .8 | 2-Sided | 95 | .5 | 1.1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .06 | Mean Difference (Final Values) | .3 | 2-Sided | 95 | 0 | 0.5 | Superiority |
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| -.15 |
| Mean Difference (Final Values) |
| -1 |
| 2-Sided |
| 95 |
| -2.4 |
| .3 |
| Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .387 | Mean Difference (Final Values) | -.6 | 2-Sided | 95 | -1.9 | .7 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .272 |
| Mean Difference (Final Values) |
| .1 |
| 2-Sided |
| 95 |
| -.1 |
| .3 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .049 | Mean Difference (Final Values) | .2 | 2-Sided | 95 | 0 | 0.4 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .409 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | -.1 | .3 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .62 | Mean Difference (Final Values) | 0 | 2-Sided | 95 | -.1 | .2 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .121 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | 0 | .3 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .27 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | -.1 | .2 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .013 |
| Mean Difference (Final Values) |
| -.3 |
| 2-Sided |
| 95 |
| -.6 |
| -.1 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .043 | Mean Difference (Final Values) | -.3 | 2-Sided | 95 | -.5 | -.1 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .629 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | -.2 | .3 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .001 | Mean Difference (Final Values) | -.4 | 2-Sided | 95 | -.6 | -.2 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .019 | Mean Difference (Final Values) | -.3 | 2-Sided | 95 | -.5 | -.05 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .271 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | -.1 | .3 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .038 |
| Mean Difference (Final Values) |
| -.3 |
| 2-Sided |
| 95 |
| -.5 |
| -.01 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .019 | Mean Difference (Final Values) | -.3 | 2-Sided | 95 | -.5 | -.05 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .803 | Mean Difference (Final Values) | -.03 | 2-Sided | 95 | -.2 | .2 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .163 | Mean Difference (Final Values) | -.2 | 2-Sided | 95 | -.4 | .1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .625 | Mean Difference (Final Values) | -.05 | 2-Sided | 95 | -.2 | .1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .198 | Mean Difference (Final Values) | .1 | 2-Sided | 95 | -.1 | .3 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .51 |
| Mean Difference (Final Values) |
| -.5 |
| 2-Sided |
| 95 |
| -2 |
| 1 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .218 | Mean Difference (Final Values) | -1 | 2-Sided | 95 | -2.5 | .6 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .62 | Mean Difference (Final Values) | -.5 | 2-Sided | 95 | -2.3 | 1.4 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .07 | Mean Difference (Final Values) | -1.3 | 2-Sided | 95 | -2.7 | .1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | 0 | Mean Difference (Final Values) | -2.3 | 2-Sided | 95 | -3.6 | -1 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .086 | Mean Difference (Final Values) | -1 | 2-Sided | 95 | -2.2 | .1 | Superiority |
|
| 12 Months |
|
|
Difference in change from baseline at 6 months |
| Wald Test, 2-sided |
Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. |
| .186 |
| Mean Difference (Final Values) |
| .8 |
| 2-Sided |
| 95 |
| -.4 |
| 2 |
| Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .107 | Mean Difference (Final Values) | 1.1 | 2-Sided | 95 | -.2 | 2.5 | Superiority |
| Difference in change from baseline at 6 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .651 | Mean Difference (Final Values) | .3 | 2-Sided | 95 | -1 | 1.7 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .001 | Mean Difference (Final Values) | 1.8 | 2-Sided | 95 | .7 | 2.9 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .007 | Mean Difference (Final Values) | 1.6 | 2-Sided | 95 | .4 | 2.7 | Superiority |
| Difference in change from baseline at 12 months | Wald Test, 2-sided | Adjusted ANCOVA model for change from baseline fit with generalized estimating equations (GEE) with 3-, 6-, and 12-month in same model. | .656 | Mean Difference (Final Values) | -.2 | 2-Sided | 95 | -1.2 | .8 | Superiority |