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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3AT010621-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.
The research will be conducted with three health care system (HCS) sites: Boston Medical Center (BMC), Massachusetts (MA), a safety net health system; University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania (PA), a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill.
As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site.
Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Pain Program + Usual PCP Care | Experimental | Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. |
|
| Usual PCP Care | Active Comparator | Participants will receive usual PCP care for chronic lower back pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group medical visits with mindfulness-based stress reduction | Other | Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score | The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10. | Baseline, 8 weeks, 6 months (primary timepoint), 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months | Physical function will be assessed using the 4 items Patient Reported Outcome Measurement Information System (PROMIS) at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back). For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 22.5 to 57. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 21 to 59. Higher scores are more favorable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia Morone, MD, MS | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42371634 | Derived | Morone NE, Faurot KR, Weinberg J, McTigue K, Roth I, Barnhill J, Gardiner P, Thomas HN, Lathren CR, Castro MG, Baez J, Lawrence S, Harr E, Elhadidy N, White AM, Nguyen PT, Dore G, Rodriguez R, Gaylord SA, Greco CM. Mindfulness-Based Group Medical Visits for Persons With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 29. doi: 10.1001/jamainternmed.2026.2186. Online ahead of print. | |
| 40891220 | Derived | Miller VE, Barnhill J, Greco CM, Castro G, Nguyen TP, Gardiner P, Faurot KR, Gaylord S, Weinberg JM, Thomas HN, Sariahmed K, Morone NE. Prevalence of Chronic Overlapping Pain Conditions in Participants With Chronic Low Back Pain Enrolled in a Pragmatic Trial of Mindfulness-Based Stress Reduction. Eur J Pain. 2025 Oct;29(9):e70119. doi: 10.1002/ejp.70119. |
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Of 451 enrolled participants, 224 were assigned to the intervention and 227 to the control group.
Participants were recruited from the Internal Medicine Clinic at Boston Medical Center (BMC), University of Pittsburgh, University of North Carolina (UNC) at Chapel Hill in partnership with Piedmont Health and UNC HealthCare by trained and Institutional Review board (IRB)-approved staff. Ways for recruiting included flyers throughout the clinics, provider referral, automated electronic medical record review, clinic sign-up sheet, and website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Pain Program + Usual Primary Care Provider (PCP) Care | Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual Primary Care Provider (PCP) care for chronic lower back pain. |
| FG001 | Usual PCP Care | Participants will receive usual PCP care for chronic lower back pain. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Pain Program + Usual PCP Care | Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. |
| BG001 | Usual PCP Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score | The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 8 weeks, 6 months (primary timepoint), 12 months |
|
Adverse events were collected from participants over a 12-month period, which corresponded to the duration of their participation in the study.
Adverse Event: any untoward medical occurrence (whether physical or psychological) associated with the use of meditation or mind and body methods, or breach of confidentiality and which may have a causal relationship with the study procedures.
This definition is more specific to breach of confidentiality and any issues related to meditation practices.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Pain Program + Usual PCP Care | Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. Group medical visits with mindfulness-based stress reduction: Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits Usual PCP care: Usual one on one PCP care for chronic lower back pain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | The subject reported experiencing increased neck pain, headaches, and nausea, which they attributed to the chair yoga and stretching from a previous session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalia Morone, MD, MS | Boston Medical Center | 617-414-6652 | natalia.morone@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2020 | Sep 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2024 | Dec 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Usual PCP care | Other | Usual one on one PCP care for chronic lower back pain |
|
| Baseline, 8 weeks, 6 months, 12 months |
| Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months | Sleep disturbance will be assessed using the 4 items PROMIS at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 32 to 73.3. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 31.7 to 76.1. Higher scores indicate worsen sleep disturbance. | Baseline, 8 weeks, 6 months, 12 months |
| Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months | The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse. | Baseline, 8 weeks, 6 months, 12 months |
| Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months | Mindfulness will be assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). 12-item questionnaire with a total score range of 12 to 48 that measures everyday mindfulness, and focuses on the degree to which respondents experience their thoughts and feelings. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness. | Baseline, 8 weeks, 6 months,12 months |
| Mindfulness at 12 Months | Mindfulness will be assessed by the Global Mindfulness Measure at 12 months. Items are rated on a 5-point Likert scale from 1 (rarely/not at all) to 5 (very much). Scores on the scale are summed and converted to a t-score, with a total t-score range of 23 to 75.7. The scale provides T-scores that standardize results to a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher scores reflect greater mindfulness. | 12 months |
| Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months | Patient impression of change is assessed by the self-report measure Patient Global Impression of Change (PGIC) reflects a respondent's belief about the efficacy of treatment to their pain. This single-item scale is rated on a 6-point Likert scale from 0 (very much improved) to 6 (very much worse). | 8 weeks, 6 months,12 months |
| Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months | Pain catastrophizing will be assessed by the Pain Catastrophizing Scale short form, a 6-item self-report questionnaire that assesses how catastrophic thinking about low back pain affects respondents. Respondents are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is ranged from 0-24, and the higher score indicates greater pain catastrophizing. | Baseline, 8 weeks, 6 months, 12 months |
| Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months | The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS-1) Tool consists of a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). If any item in the TAPS-1 has a response other than "Never" then score this item as positive screening. | Baseline and 12 months |
| Comorbidity at Baseline | Comorbidity will be assessed by the Charlson Co-Morbidity Index (CCI) with 20 items about different health conditions. The CCI ranges from 0 to 37, with higher scores indicating a higher burden of comorbidity. | Baseline |
| Anxiety at Baseline, 6 Months, & 12 Months | Anxiety will be assessed by the Generalized Anxiety Disorder 2-item (GAD-2), a brief screening tool for generalized anxiety disorder (GAD) and other common anxiety disorders, such as panic disorder, social anxiety disorder, and posttraumatic stress disorder. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The total GAD-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the GAD-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population. | Baseline, 6 Months, 12 Months |
| Depression at Baseline, 6 Months, & 12 Months | Depression will be assessed by the Patient Health Questionnaire 2-item (PHQ-2), a brief screening tool for depression. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The PHQ-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the PHQ-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population. | Baseline, 6 Months, 12 Months |
| Sleep Duration at Baseline and 6 Months | Sleep duration will be assessed by a single-item survey asking the amount of actual sleep the respondent got at night per night in the last month in hours and minutes. | Baseline, 6 months |
| 40162193 | Derived | Barnhill JL, Castro G, Lathren C, Harr E, Roth I, Baez JE, Rodriguez R, Lawrence S, Gardiner P, Greco CM, Thomas HN, Gaylord SA, Dore G, Bengert A, Morone NE. The Hidden Complexity of Virtual Mindfulness-Based Group Medical Visits: Comfort, Challenge, and the Influence of Social Determinants of Health. Glob Adv Integr Med Health. 2025 Mar 27;14:27536130251326938. doi: 10.1177/27536130251326938. eCollection 2025 Jan-Dec. |
| 34455111 | Derived | Greco CM, Gaylord SA, Faurot K, Weinberg JM, Gardiner P, Roth I, Barnhill JL, Thomas HN, Dhamne SC, Lathren C, Baez JE, Lawrence S, Neogi T, Lasser KE, Castro MG, White AM, Simmons SJ, Ferrao C, Binda DD, Elhadidy N, Eason KM, McTigue KM, Morone NE. The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. Contemp Clin Trials. 2021 Oct;109:106545. doi: 10.1016/j.cct.2021.106545. Epub 2021 Aug 27. |
| Work Family Obligations |
|
| Other |
|
Participants will receive usual PCP care for chronic lower back pain.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual PCP Care | Participants will receive usual PCP care for chronic lower back pain. |
|
|
| Secondary | Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months | Physical function will be assessed using the 4 items Patient Reported Outcome Measurement Information System (PROMIS) at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back). For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 22.5 to 57. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 21 to 59. Higher scores are more favorable. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | T-score | Baseline, 8 weeks, 6 months, 12 months |
|
|
|
| Secondary | Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months | Sleep disturbance will be assessed using the 4 items PROMIS at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 32 to 73.3. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 31.7 to 76.1. Higher scores indicate worsen sleep disturbance. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | T-score | Baseline, 8 weeks, 6 months, 12 months |
|
|
|
| Secondary | Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months | The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse. | Persons with chronic low back pain 18 years old or older. Only participants who reported opioid use completed the current opioid misuse measure at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 6 months, 12 months |
|
|
|
| Secondary | Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months | Mindfulness will be assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). 12-item questionnaire with a total score range of 12 to 48 that measures everyday mindfulness, and focuses on the degree to which respondents experience their thoughts and feelings. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 6 months,12 months |
|
|
|
| Secondary | Mindfulness at 12 Months | Mindfulness will be assessed by the Global Mindfulness Measure at 12 months. Items are rated on a 5-point Likert scale from 1 (rarely/not at all) to 5 (very much). Scores on the scale are summed and converted to a t-score, with a total t-score range of 23 to 75.7. The scale provides T-scores that standardize results to a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher scores reflect greater mindfulness. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | T-score | 12 months |
|
|
|
| Secondary | Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months | Patient impression of change is assessed by the self-report measure Patient Global Impression of Change (PGIC) reflects a respondent's belief about the efficacy of treatment to their pain. This single-item scale is rated on a 6-point Likert scale from 0 (very much improved) to 6 (very much worse). | Persons with chronic low back pain 18 years old or older. Only participants at week 8, month 6, and month 12 were asked to report this outcome measure. | Posted | Count of Participants | Participants | 8 weeks, 6 months,12 months |
|
|
|
| Secondary | Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months | Pain catastrophizing will be assessed by the Pain Catastrophizing Scale short form, a 6-item self-report questionnaire that assesses how catastrophic thinking about low back pain affects respondents. Respondents are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is ranged from 0-24, and the higher score indicates greater pain catastrophizing. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8 weeks, 6 months, 12 months |
|
|
|
| Secondary | Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months | The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS-1) Tool consists of a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). If any item in the TAPS-1 has a response other than "Never" then score this item as positive screening. | Persons with chronic low back pain 18 years old or older. | Posted | Count of Participants | Participants | Baseline and 12 months |
|
|
|
| Secondary | Comorbidity at Baseline | Comorbidity will be assessed by the Charlson Co-Morbidity Index (CCI) with 20 items about different health conditions. The CCI ranges from 0 to 37, with higher scores indicating a higher burden of comorbidity. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Anxiety at Baseline, 6 Months, & 12 Months | Anxiety will be assessed by the Generalized Anxiety Disorder 2-item (GAD-2), a brief screening tool for generalized anxiety disorder (GAD) and other common anxiety disorders, such as panic disorder, social anxiety disorder, and posttraumatic stress disorder. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The total GAD-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the GAD-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population. | Persons with chronic low back pain 18 years old or older. | Posted | Count of Participants | Participants | Baseline, 6 Months, 12 Months |
|
|
|
| Secondary | Depression at Baseline, 6 Months, & 12 Months | Depression will be assessed by the Patient Health Questionnaire 2-item (PHQ-2), a brief screening tool for depression. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The PHQ-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the PHQ-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population. | Persons with chronic low back pain 18 years old or older. | Posted | Count of Participants | Participants | Baseline, 6 Months, 12 Months |
|
|
|
| Secondary | Sleep Duration at Baseline and 6 Months | Sleep duration will be assessed by a single-item survey asking the amount of actual sleep the respondent got at night per night in the last month in hours and minutes. | Persons with chronic low back pain 18 years old or older. | Posted | Mean | Standard Deviation | Hours | Baseline, 6 months |
|
|
|
| 0 |
| 224 |
| 0 |
| 224 |
| 4 |
| 224 |
| EG001 | Usual PCP Care | Participants will receive usual PCP care for chronic lower back pain. Usual PCP care: Usual one on one PCP care for chronic lower back pain | 0 | 227 | 0 | 227 | 0 | 227 |
|
| Anxiety | Nervous system disorders | Non-systematic Assessment | The participant felt anxious when lying down regularly. |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | The participant experienced severe nausea during meditation, which also occurred in previous sessions. |
|
| Sciatic Pain | Nervous system disorders | Non-systematic Assessment | The subject stated that they experienced a sciatic flare that began after a meditation session. They complained of pain attributed to the sitting position during the session. |
|
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| D004191 |
| Behavioral Disciplines and Activities |
| 8 Weeks |
|
|
| 6 Months |
|
|
| 12 Months |
|
|
| 8 Weeks |
|
|
| 6 Months |
|
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| 12 Months |
|
|
| Week 8 |
|
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| Month 6 |
|
|
| Month 12 |
|
|
| 8 Weeks |
|
|
| 6 Months |
|
|
| 12 Months |
|
|
| Much improved |
|
| Minimally improved |
|
| No change |
|
| Minimally worse |
|
| Much worse |
|
| Very much worse |
|
| Month 6 |
|
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| Month 12 |
|
|
| 8 Weeks |
|
|
| 6 Months |
|
|
| 12 Months |
|
|
| Yes (Possible substance use) |
|
| Month 12 |
|
|
| Yes (Clinically significant anxiety symptom) |
|
| Month 6 |
|
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| Month 12 |
|
|
| Yes (Clinically significant depressive symptom) |
|
| Month 6 |
|
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| Month 12 |
|
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| Month 6 |
|
|