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| Name | Class |
|---|---|
| Palmer College of Chiropractic | OTHER |
| Samueli Institute for Information Biology | OTHER |
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The purpose of this study is to evaluate the effectiveness of chiropractic manipulative therapy for pain management and improved function in active duty service members with low back pain that do not require surgery. The study will also measure the impact of a tobacco cessation program delivered to participants allocated to the chiropractic arm.
Low back pain (LBP) is the most common cause of disability worldwide, but it is even more prevalent in active duty military personnel; more than 50% of all diagnoses resulting in disability discharges from the military across all branches are due to musculoskeletal conditions. LBP has been characterized as "The Silent Military Threat" because of its negative impact on mission readiness and the degree to which it compromises a fit fighting force. For these reasons, military personnel with LBP need a practical and effective treatment that relieves their pain and allows them to return to duty quickly, but also one that preserves function and military readiness, addresses the underlying causes of the episode and protects against re-injury. Currently a clear "gold standard" medical treatment for low back pain does not exist and studies show that evidence-based guidelines are rarely used in general practice. Thus, there is a need to consider innovative treatment options for chronic diseases such as LBP. Therefore the primary purpose of this study is to assess the effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved function in active duty service members with orthopedic injuries or disorders of the low back that do not require surgery. This multi-site Phase II Clinical Comparative Effectiveness Trial is designed to rigorously compare the outcomes of CMT and conventional medical care (CMC) to CMC alone. Chiropractic treatment will include CMT plus ancillary physiotherapeutic interventions. CMC will be delivered following current standards of medical practice at each site. At each of the four participating sites, active military personnel, ages 18-50, who present with acute, sub-acute or chronic low back pain that does not require surgery will be randomized to one of the two treatment groups. Outcome measures include the Numerical Rating Scale for pain, the Roland-Morris Low Back Pain and Disability questionnaire, the Back Pain Functional Scale for assessing function, and the Global Improvement questionnaire for patient perception regarding improvement in function. Patient Expectation and Patient Satisfaction questionnaires will be used to examine volunteer expectations toward care and perceptions of that care. Pharmaceutical use and duty status data will also be collected. The PROMIS-29 will be utilized to compare the general health component and quality of life of the sample at baseline. In addition, doctors of chiropractic are well positioned to provide information to support tobacco cessation. Thus this clinical trial will include a nested study designed to measure the impact of a tobacco cessation program delivered by a doctor of chiropractic. The results from this randomized clinical trial, with a nested tobacco cessation intervention, will provide critical information regarding the health and mission-support benefits of chiropractic health care delivery for active duty service members in the military
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Care + Chiropractic Care | Active Comparator | Medical care plus chiropractic manipulative therapy |
|
| Conventional Medical Care Only | Active Comparator | Conventional medical care only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Care + Chiropractic Care | Other | Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) for Prior Week | Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. | Baseline, week 6, week 12 |
| Roland Morris Disability Questionnaire (RMDQ) | We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability). | Baseline, week 6, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Bothersomeness of Symptoms | The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica. Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian D. Coulter, Ph.D. | RAND | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134-5000 | United States | ||
| Naval Hospital Pensacola |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26857706 | Background | Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8. | |
| 30646047 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Medical Care + Chiropractic Care | Medical care plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| FG001 | Conventional Medical Care Only | Conventional medical care only Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Site: WRNMMC - UMC | Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| 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 | Numerical Rating Scale (NRS) for Prior Week | Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, week 6, week 12 |
|
12 weeks
Any untoward medical occurence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
*The total number of Adverse Events (AEs) may exceed the total # of people affected because some people experienced multiple AEs.
AEs were monitored via self-report AE collected at Week 2, Week 4, and Week 6 assessments or via self-report to the study physician or site project manager directly during the 12 week period.
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 Medical Care | Conventional medical care only/usual medical care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spine-related pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cyndy Long | Palmer Center for Chiropractic Research | 563-884-5157 | LONG_C@palmer.edu |
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Conventional Medical Care Only | Other | Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
|
| Baseline, week 6, week 12 |
| Numerical Pain Rating Scale (NRS) for Past 24 Hours | Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours. | Baseline, week 6, week 12 |
| Healthcare Utilization & Medication Use | Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use. | week 6, week 12 |
| Global Improvement Scale | This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse. | Week 6 |
| Patient Satisfaction | A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied]. | Week 6 |
| Patient Expectation | Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect. The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful). | Baseline only |
| Back Pain Functional Scale (BPFS) | The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits. | Baseline and all endpoint visits (week 2, week 4, week 6, week 12) |
| Pensacola |
| Florida |
| 32508-5141 |
| United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889-5600 | United States |
| Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105. |
| 41992252 | Derived | Shannon ZK, Long CR, Vining RD, Walter JA, Coulter ID, Goertz CM. Mediators of the effect of chiropractic care on 12- and 52-week outcomes for U.S. active-duty military personnel with low back pain: secondary analysis of a clinical trial. Chiropr Man Therap. 2026 Apr 16;34(1):12. doi: 10.1186/s12998-026-00628-0. |
| 41947115 | Derived | Shannon ZK, Long CR, Vining RD, McCarey J, Walter JA, Coulter ID, Goertz CM. Longer-term chiropractic care outcomes for US active-duty military personnel with low back pain: secondary analysis of a pragmatic clinical trial. BMC Complement Med Ther. 2026 Apr 7;26(1):185. doi: 10.1186/s12906-026-05347-w. |
| 39566948 | Derived | Shannon ZK, Long CR, Chrischilles E, Goertz C, Wallace R, Casteel C, Carnahan RM. Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity. BMJ Open. 2024 Nov 19;14(11):e083509. doi: 10.1136/bmjopen-2023-083509. |
| BG001 | Site: WRNMMC - UMC + Chiropractic Care | Site: Walter Reed National Military Medical Center (WR) Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| BG002 | Site: NHP - UMC | Site: Naval Hospital Pensacola Conventional medical care only/Usual Medical Care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| BG003 | Site: NHP - UMC + Chiropractic Care | Site: Naval Hospital Pensacola Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| BG004 | Site: NMCSD - UMC | Site: Naval Medical Center San Diego Conventional medical care only/Usual Medical Care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| BG005 | Site: NMCSD - UMC + Chiropractic Care | Site: Naval Medical Center San Diego Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Site: WRNMMC - UMC + Chiropractic Care | Site: Walter Reed National Military Medical Center (WR) Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| OG002 | Site: NHP - UMC | Site: Naval Hospital Pensacola Conventional medical care only/Usual Medical Care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| OG003 | Site: NHP - UMC + Chiropractic Care | Site: Naval Hospital Pensacola Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| OG004 | Site: NMCSD - UMC | Site: Naval Medical Center San Diego Conventional medical care only/Usual Medical Care (UMC) Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
| OG005 | Site: NMCSD - UMC + Chiropractic Care | Site: Naval Medical Center San Diego Medical care (UMC) plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. |
|
|
|
| Primary | Roland Morris Disability Questionnaire (RMDQ) | We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, week 6, week 12 |
|
|
|
|
| Secondary | Bothersomeness of Symptoms | The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica. Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome). | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, week 6, week 12 |
|
|
|
|
| Secondary | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, week 6, week 12 |
|
|
|
|
| Secondary | Healthcare Utilization & Medication Use | Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use. | Posted | Count of Participants | Participants | week 6, week 12 |
|
|
|
|
| Secondary | Global Improvement Scale | This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
|
| Secondary | Patient Satisfaction | A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied]. | Posted | Mean | 95% Confidence Interval | units on a scale | Week 6 |
|
|
|
|
| Secondary | Patient Expectation | Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect. The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful). | Posted | Mean | Standard Deviation | units on a scale | Baseline only |
|
|
|
| Secondary | Back Pain Functional Scale (BPFS) | The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and all endpoint visits (week 2, week 4, week 6, week 12) |
|
|
|
| 0 |
| 375 |
| 0 |
| 375 |
| 13 |
| 375 |
| EG001 | UMC + Chiropractic Care | Medical care plus chiropractic manipulative therapy Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic. | 0 | 375 | 0 | 375 | 33 | 375 |
| Spine-related pain with radiation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Extremity pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| General stiffness/tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle spasm/cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| Week 6 |
|
| Week 12 |
|
All sites combined (week 12) - RMDQ Between-Group Differences in Disability |
| Mean Difference (Final Values) |
| -2.0 |
| 2-Sided |
| 95 |
| -3.0 |
| -1.0 |
| Superiority |
| Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -1.8 | 2-Sided | 95 | -3.4 | -0.2 | Superiority |
| Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -3.2 | 0.2 | Superiority |
| Pensacola site (week 6) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -2.1 | 2-Sided | 95 | -3.8 | -0.4 | Superiority |
| Pensacola site (week 12) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -1.9 | 2-Sided | 95 | -3.7 | -0.2 | Superiority |
| San Diego site (week 6) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -2.7 | 2-Sided | 95 | -4.3 | -1.1 | Superiority |
| San Diego site (week 12) - RMDQ Between-Group Differences in Disability | Mean Difference (Final Values) | -2.7 | 2-Sided | 95 | -4.4 | -1.1 | Superiority |
| Week 6 |
|
| Week 12 |
|
All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP |
| Mean Difference (Final Values) |
| -0.4 |
| 2-Sided |
| 95 |
| -0.6 |
| -0.2 |
| Superiority |
| Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.5 | 0.1 | Superiority |
| Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.5 | 0.1 | Superiority |
| Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.8 | -0.2 | Superiority |
| Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.8 | -0.2 | Superiority |
| San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.5 | 2-Sided | 95 | -0.7 | -0.2 | Superiority |
| San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP | Mean Difference (Final Values) | -0.4 | 2-Sided | 95 | -0.7 | -0.1 | Superiority |
| Week 6 |
|
| Week 12 |
|
All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean |
| Mean Difference (Final Values) |
| -1.1 |
| 2-Sided |
| 95 |
| -1.6 |
| -0.7 |
| Superiority |
| Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -0.7 | 2-Sided | 95 | -1.3 | -0.02 | Superiority |
| Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -0.8 | 2-Sided | 95 | -1.5 | -0.1 | Superiority |
| Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -1.3 | 2-Sided | 95 | -2.0 | -0.7 | Superiority |
| Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -1.5 | 2-Sided | 95 | -2.3 | -0.8 | Superiority |
| San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -1.6 | 2-Sided | 95 | -2.3 | -1.0 | Superiority |
| San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean | Mean Difference (Final Values) | -1.2 | 2-Sided | 95 | -1.9 | -0.5 | Superiority |
| 1-2 days |
|
| 3-4 days |
|
| 5-6 days |
|
| 7 days |
|
| missing |
|
| Week 12 Med Frequency |
|
Week 12: All 3 sites combined
| Odds Ratio (OR) |
| 0.76 |
| 2-Sided |
| 95 |
| 0.58 |
| 1.0 |
| Superiority |
| Much better |
|
| Moderately better |
|
| A little better |
|
| About the same |
|
| A little worse |
|
| Much worse |
|
| missing |
|
| Odds Ratio (OR) |
| 0.26 |
| 2-Sided |
| 95 |
| 0.16 |
| 0.42 |
| Superiority |
| Naval Hospital Pensacola site: 6 weeks | Odds Ratio (OR) | 0.18 | 2-Sided | 95 | 0.10 | 0.33 | Superiority |
| Naval Medical Center San Diego site: 6 weeks | Odds Ratio (OR) | 0.13 | 2-Sided | 95 | 0.08 | 0.21 | Superiority |
| Mean Difference (Final Values) |
| 2.0 |
| 2-Sided |
| 95 |
| 1.4 |
| 2.6 |
| Superiority |
| Naval Hospital Pensacola site: 6 weeks | Mean Difference (Final Values) | 2.3 | 2-Sided | 95 | 1.6 | 3.0 | Superiority |
| Naval Medical Center San Diego site: 6 weeks | Mean Difference (Final Values) | 3.1 | 2-Sided | 95 | 2.5 | 3.7 | Superiority |
| Expectation UMC |
|
| Week 2 |
|
| Week 4 |
|
| Week 6 |
|
| Week 12 |
|