Lower Back Pain
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERMedical 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.
OTHERConventional 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.
Sponsors
Palmer College of Chiropractic
Samueli Institute for Information Biology
RAND
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-50 (Inclusive) * Diagnosis of acute, subacute or chronic low back pain * Ability to provide voluntary written informed consent * Active duty at one of the three participating military sites
Exclusion criteria
* LBP from other than somatic tissues as determined by history, examination and course (i.e., pain referred from visceral conditions) * Co-morbid pathology or poor health conditions that may directly impact spinal pain * Volunteers who have case histories and physical examination findings indicating other than average good health * Bone and joint pathology contraindicating CMT (Chiropractic Manipulative Therapy) * Volunteers with recent spinal fracture (within the last 8 weeks), recent spinal surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant/severe osteoporosis will be referred for appropriate care * Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal segments, cauda equine syndrome) * Pregnant or planning to become pregnant within 3 months * Altered mental capacity as determined by the clinician * Unable to speak English * Use of manipulative care for any reason within the past month * Unwilling to provide phone and electronic contact information * Unable to confirm that they will not be transferred during the active phase of the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the next 8 weeks (active study participation period). * Does not agree to be enrolled regardless of group assignment * PTSD Classification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) for Prior Week | Baseline, week 6, week 12 | 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. |
| Roland Morris Disability Questionnaire (RMDQ) | Baseline, week 6, week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline, week 6, week 12 | 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. |
| Healthcare Utilization & Medication Use | week 6, week 12 | 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. |
| Patient Satisfaction | Week 6 | A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 \[not at all satisfied\] to 10 \[extremely satisfied\]. |
| Patient Expectation | Baseline only | 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). |
| Back Pain Functional Scale (BPFS) | Baseline and all endpoint visits (week 2, week 4, week 6, week 12) | 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. |
| Global Improvement Scale | Week 6 | 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. |
| Bothersomeness of Symptoms | Baseline, week 6, week 12 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 125 |
| 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. | 125 |
| 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. | 125 |
| 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. | 125 |
| 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. | 125 |
| 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. | 125 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 57 | 48 |
| Overall Study | Withdrawal by Subject | 9 | 11 |
Baseline characteristics
| Characteristic | Site: WRNMMC - UMC | Site: WRNMMC - UMC + Chiropractic Care | Site: NHP - UMC | Site: NHP - UMC + Chiropractic Care | Site: NMCSD - UMC | Site: NMCSD - UMC + Chiropractic Care | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.4 years STANDARD_DEVIATION 8.4 | 34.7 years STANDARD_DEVIATION 8.6 | 25.5 years STANDARD_DEVIATION 7.9 | 25.7 years STANDARD_DEVIATION 7.5 | 32.4 years STANDARD_DEVIATION 7.4 | 32.4 years STANDARD_DEVIATION 7.5 | 30.9 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 9 Participants | 29 Participants | 12 Participants | 21 Participants | 31 Participants | 118 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 116 Participants | 96 Participants | 113 Participants | 104 Participants | 94 Participants | 632 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 3 Participants | 3 Participants | 1 Participants | 11 Participants | 6 Participants | 30 Participants |
| Race/Ethnicity, Customized Black or African American | 41 Participants | 42 Participants | 17 Participants | 15 Participants | 14 Participants | 20 Participants | 149 Participants |
| Race/Ethnicity, Customized Other or unspecified | 16 Participants | 18 Participants | 2 Participants | 7 Participants | 11 Participants | 17 Participants | 71 Participants |
| Race/Ethnicity, Customized White | 62 Participants | 62 Participants | 102 Participants | 106 Participants | 88 Participants | 87 Participants | 507 Participants |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 19 Participants | 18 Participants | 30 Participants | 29 Participants | 175 Participants |
| Sex: Female, Male Male | 86 Participants | 85 Participants | 106 Participants | 107 Participants | 95 Participants | 96 Participants | 575 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 375 | 0 / 375 |
| other Total, other adverse events | 13 / 375 | 33 / 375 |
| serious Total, serious adverse events | 0 / 375 | 0 / 375 |
Outcome results
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.
Time frame: Baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Site: WRNMMC - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 3.90 units on a scale |
| Site: WRNMMC - UMC | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.27 units on a scale |
| Site: WRNMMC - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 3.63 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 3.18 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.36 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 3.21 units on a scale |
| Site: NHP - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 3.39 units on a scale |
| Site: NHP - UMC | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.73 units on a scale |
| Site: NHP - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 2.82 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 2.17 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.45 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 1.69 units on a scale |
| Site: NMCSD - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 4.63 units on a scale |
| Site: NMCSD - UMC | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.68 units on a scale |
| Site: NMCSD - UMC | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 4.0 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Baseline | 4.87 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 12 | 2.91 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Rating Scale (NRS) for Prior Week | Week 6 | 3.3 units on a scale |
Comparison: All sites combined (week 6) - Between-group differences of mean in LBP95% CI: [-1.4, -0.7]
Comparison: All sites combined (week 12) - Between-group differences of mean in LBP95% CI: [-1.2, -0.5]
Comparison: Walter Reed site (week 6) - Between-group differences of mean in LBP95% CI: [-1.3, -0.1]
Comparison: Walter Reed site (week 12) - Between-group differences of mean in LBP95% CI: [-1, 0.2]
Comparison: Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP95% CI: [-1.8, -0.6]
Comparison: Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP95% CI: [-1.8, -0.5]
Comparison: Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP95% CI: [-1.9, -0.8]
Comparison: Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP95% CI: [-1.7, -0.5]
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).
Time frame: Baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Site: WRNMMC - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 8.0 units on a scale |
| Site: WRNMMC - UMC | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 9.94 units on a scale |
| Site: WRNMMC - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 7.25 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 6.22 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 9.36 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 5.77 units on a scale |
| Site: NHP - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 5.22 units on a scale |
| Site: NHP - UMC | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 10.65 units on a scale |
| Site: NHP - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 4.4 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 3.13 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 10.21 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 2.47 units on a scale |
| Site: NMCSD - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 8.8 units on a scale |
| Site: NMCSD - UMC | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 8.81 units on a scale |
| Site: NMCSD - UMC | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 7.56 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Baseline | 9.2 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 12 | 4.83 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Roland Morris Disability Questionnaire (RMDQ) | Week 6 | 6.1 units on a scale |
Comparison: All sites combined (week 6) - RMDQ Between-Group Differences in Disability95% CI: [-3.1, -1.2]
Comparison: All sites combined (week 12) - RMDQ Between-Group Differences in Disability95% CI: [-3, -1]
Comparison: Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability95% CI: [-3.4, -0.2]
Comparison: Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability95% CI: [-3.2, 0.2]
Comparison: Pensacola site (week 6) - RMDQ Between-Group Differences in Disability95% CI: [-3.8, -0.4]
Comparison: Pensacola site (week 12) - RMDQ Between-Group Differences in Disability95% CI: [-3.7, -0.2]
Comparison: San Diego site (week 6) - RMDQ Between-Group Differences in Disability95% CI: [-4.3, -1.1]
Comparison: San Diego site (week 12) - RMDQ Between-Group Differences in Disability95% CI: [-4.4, -1.1]
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.
Time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Site: WRNMMC - UMC | Back Pain Functional Scale (BPFS) | Week 6 | 42.72 units on a scale |
| Site: WRNMMC - UMC | Back Pain Functional Scale (BPFS) | Week 4 | 42.03 units on a scale |
| Site: WRNMMC - UMC | Back Pain Functional Scale (BPFS) | Baseline | 39.48 units on a scale |
| Site: WRNMMC - UMC | Back Pain Functional Scale (BPFS) | Week 12 | 43.73 units on a scale |
| Site: WRNMMC - UMC | Back Pain Functional Scale (BPFS) | Week 2 | 42.08 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 2 | 42.65 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 4 | 44.77 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 6 | 45.74 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Baseline | 39.18 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 12 | 45.51 units on a scale |
| Site: NHP - UMC | Back Pain Functional Scale (BPFS) | Week 12 | 49.7 units on a scale |
| Site: NHP - UMC | Back Pain Functional Scale (BPFS) | Baseline | 37.68 units on a scale |
| Site: NHP - UMC | Back Pain Functional Scale (BPFS) | Week 2 | 44.21 units on a scale |
| Site: NHP - UMC | Back Pain Functional Scale (BPFS) | Week 4 | 46.45 units on a scale |
| Site: NHP - UMC | Back Pain Functional Scale (BPFS) | Week 6 | 48.55 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Baseline | 38 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 6 | 52.64 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 4 | 50.31 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 12 | 54.56 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 2 | 46.76 units on a scale |
| Site: NMCSD - UMC | Back Pain Functional Scale (BPFS) | Week 2 | 39.07 units on a scale |
| Site: NMCSD - UMC | Back Pain Functional Scale (BPFS) | Week 4 | 39.36 units on a scale |
| Site: NMCSD - UMC | Back Pain Functional Scale (BPFS) | Week 6 | 40.52 units on a scale |
| Site: NMCSD - UMC | Back Pain Functional Scale (BPFS) | Baseline | 39.97 units on a scale |
| Site: NMCSD - UMC | Back Pain Functional Scale (BPFS) | Week 12 | 43.57 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 2 | 42.45 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Baseline | 39.98 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 12 | 47.8 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 4 | 45.02 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Back Pain Functional Scale (BPFS) | Week 6 | 46.02 units on a scale |
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).
Time frame: Baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Site: WRNMMC - UMC | Bothersomeness of Symptoms | Week 6 | 3.0 units on a scale |
| Site: WRNMMC - UMC | Bothersomeness of Symptoms | Baseline | 3.6 units on a scale |
| Site: WRNMMC - UMC | Bothersomeness of Symptoms | Week 12 | 2.9 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 6 | 2.8 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Bothersomeness of Symptoms | Baseline | 3.5 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 12 | 2.8 units on a scale |
| Site: NHP - UMC | Bothersomeness of Symptoms | Week 6 | 2.7 units on a scale |
| Site: NHP - UMC | Bothersomeness of Symptoms | Baseline | 3.7 units on a scale |
| Site: NHP - UMC | Bothersomeness of Symptoms | Week 12 | 2.4 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 6 | 2.1 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Bothersomeness of Symptoms | Baseline | 3.6 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 12 | 1.8 units on a scale |
| Site: NMCSD - UMC | Bothersomeness of Symptoms | Week 6 | 3.2 units on a scale |
| Site: NMCSD - UMC | Bothersomeness of Symptoms | Baseline | 3.5 units on a scale |
| Site: NMCSD - UMC | Bothersomeness of Symptoms | Week 12 | 2.9 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Bothersomeness of Symptoms | Baseline | 3.4 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 12 | 2.4 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Bothersomeness of Symptoms | Week 6 | 2.8 units on a scale |
Comparison: All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.6, -0.2]
Comparison: All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.6, -0.2]
Comparison: Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.5, 0.1]
Comparison: Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.5, 0.1]
Comparison: Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.8, -0.2]
Comparison: Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.8, -0.2]
Comparison: San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.7, -0.2]
Comparison: San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP95% CI: [-0.7, -0.1]
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.
Time frame: Week 6
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Site: WRNMMC - UMC | Global Improvement Scale | Moderately better | 9 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | Much worse | 3 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | A little worse | 15 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | A little better | 12 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | missing | 36 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | Much better | 12 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | About the same | 37 Participants |
| Site: WRNMMC - UMC | Global Improvement Scale | Completely gone | 1 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | Moderately better | 23 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | A little worse | 2 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | Completely gone | 2 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | About the same | 18 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | Much better | 26 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | Much worse | 2 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | A little better | 20 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Global Improvement Scale | missing | 32 Participants |
| Site: NHP - UMC | Global Improvement Scale | A little better | 11 Participants |
| Site: NHP - UMC | Global Improvement Scale | About the same | 15 Participants |
| Site: NHP - UMC | Global Improvement Scale | missing | 54 Participants |
| Site: NHP - UMC | Global Improvement Scale | Much better | 20 Participants |
| Site: NHP - UMC | Global Improvement Scale | Much worse | 1 Participants |
| Site: NHP - UMC | Global Improvement Scale | Moderately better | 9 Participants |
| Site: NHP - UMC | Global Improvement Scale | A little worse | 8 Participants |
| Site: NHP - UMC | Global Improvement Scale | Completely gone | 7 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | About the same | 5 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | missing | 52 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | Completely gone | 16 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | Much better | 32 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | Moderately better | 11 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | A little better | 7 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | A little worse | 1 Participants |
| Site: NHP - UMC + Chiropractic Care | Global Improvement Scale | Much worse | 1 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | Completely gone | 0 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | Much better | 10 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | A little worse | 23 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | Much worse | 6 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | A little better | 8 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | Moderately better | 4 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | missing | 27 Participants |
| Site: NMCSD - UMC | Global Improvement Scale | About the same | 47 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | Much better | 22 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | A little better | 22 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | Moderately better | 15 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | A little worse | 5 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | About the same | 26 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | missing | 31 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | Much worse | 0 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Global Improvement Scale | Completely gone | 4 Participants |
Comparison: All sites combined: 6 weeks95% CI: [0.13, 0.25]
Comparison: Walter Reed site: 6 weeks95% CI: [0.16, 0.42]
Comparison: Naval Hospital Pensacola site: 6 weeks95% CI: [0.1, 0.33]
Comparison: Naval Medical Center San Diego site: 6 weeks95% CI: [0.08, 0.21]
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.
Time frame: week 6, week 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 9 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 25 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 23 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 45 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 13 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 12 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 8 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 14 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 10 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 45 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 20 Participants |
| Site: WRNMMC - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 26 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 42 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 38 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 12 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 24 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 8 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 8 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 36 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 15 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 17 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 7 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 42 Participants |
| Site: WRNMMC - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 1 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 6 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 10 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 7 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 1 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 63 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 4 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 38 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 7 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 11 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 12 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 28 Participants |
| Site: NHP - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 63 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 5 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 34 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 17 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 1 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 3 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 8 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 62 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 48 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 4 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 2 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 4 Participants |
| Site: NHP - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 62 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 9 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 12 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 39 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 33 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 8 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 10 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 22 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 10 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 4 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 49 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 21 Participants |
| Site: NMCSD - UMC | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 33 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 1-2 days | 23 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 7 days | 8 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 3-4 days | 7 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 5-6 days | 9 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | missing | 40 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 5-6 days | 5 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 3-4 days | 8 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 1-2 days | 20 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 7 days | 8 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | 0 days | 40 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 12 Med Frequency | 0 days | 42 Participants |
| Site: NMCSD - UMC + Chiropractic Care | Healthcare Utilization & Medication Use | Week 6 Med Frequency | missing | 40 Participants |
Comparison: Week 6: All 3 sites combined95% CI: [0.54, 0.97]
Comparison: Week 12: All 3 sites combined95% CI: [0.58, 1]
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.
Time frame: Baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Site: WRNMMC - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 4.5 units on a scale |
| Site: WRNMMC - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 5.4 units on a scale |
| Site: WRNMMC - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 4.4 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 3.9 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 5.6 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 3.7 units on a scale |
| Site: NHP - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 3.4 units on a scale |
| Site: NHP - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 6.1 units on a scale |
| Site: NHP - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 3.0 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 2.1 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 5.9 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 1.4 units on a scale |
| Site: NMCSD - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 5.3 units on a scale |
| Site: NMCSD - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 5.4 units on a scale |
| Site: NMCSD - UMC | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 4.3 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Baseline | 5.4 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 12 | 3.2 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Numerical Pain Rating Scale (NRS) for Past 24 Hours | Week 6 | 3.6 units on a scale |
Comparison: All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-1.6, -0.8]
Comparison: All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-1.6, -0.7]
Comparison: Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-1.3, -0.02]
Comparison: Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-1.5, -0.1]
Comparison: Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-2, -0.7]
Comparison: Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-2.3, -0.8]
Comparison: San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-2.3, -1]
Comparison: San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean95% CI: [-1.9, -0.5]
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).
Time frame: Baseline only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Site: WRNMMC - UMC | Patient Expectation | Expectation UMC + Chiropractic Care | 8.2 units on a scale | Standard Deviation 1.8 |
| Site: WRNMMC - UMC | Patient Expectation | Expectation UMC | 5.3 units on a scale | Standard Deviation 2.4 |
| Site: WRNMMC - UMC + Chiropractic Care | Patient Expectation | Expectation UMC + Chiropractic Care | 8.4 units on a scale | Standard Deviation 1.6 |
| Site: WRNMMC - UMC + Chiropractic Care | Patient Expectation | Expectation UMC | 4.9 units on a scale | Standard Deviation 2.5 |
| Site: NHP - UMC | Patient Expectation | Expectation UMC + Chiropractic Care | 8.1 units on a scale | Standard Deviation 1.9 |
| Site: NHP - UMC | Patient Expectation | Expectation UMC | 5.3 units on a scale | Standard Deviation 2.3 |
| Site: NHP - UMC + Chiropractic Care | Patient Expectation | Expectation UMC + Chiropractic Care | 8.3 units on a scale | Standard Deviation 1.9 |
| Site: NHP - UMC + Chiropractic Care | Patient Expectation | Expectation UMC | 5.4 units on a scale | Standard Deviation 2.5 |
| Site: NMCSD - UMC | Patient Expectation | Expectation UMC + Chiropractic Care | 8.6 units on a scale | Standard Deviation 1.8 |
| Site: NMCSD - UMC | Patient Expectation | Expectation UMC | 4.5 units on a scale | Standard Deviation 2.8 |
| Site: NMCSD - UMC + Chiropractic Care | Patient Expectation | Expectation UMC + Chiropractic Care | 8.5 units on a scale | Standard Deviation 1.9 |
| Site: NMCSD - UMC + Chiropractic Care | Patient Expectation | Expectation UMC | 5.2 units on a scale | Standard Deviation 3 |
| All Sites - UMC | Patient Expectation | Expectation UMC | 5.0 units on a scale | Standard Deviation 2.5 |
| All Sites - UMC | Patient Expectation | Expectation UMC + Chiropractic Care | 8.3 units on a scale | Standard Deviation 1.9 |
| All Sites Combined - UMC + Chiropractic Care | Patient Expectation | Expectation UMC + Chiropractic Care | 8.4 units on a scale | Standard Deviation 1.8 |
| All Sites Combined - UMC + Chiropractic Care | Patient Expectation | Expectation UMC | 5.2 units on a scale | Standard Deviation 2.7 |
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 \[extremely satisfied\].
Time frame: Week 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Site: WRNMMC - UMC | Patient Satisfaction | 5.65 units on a scale |
| Site: WRNMMC - UMC + Chiropractic Care | Patient Satisfaction | 7.64 units on a scale |
| Site: NHP - UMC | Patient Satisfaction | 6.04 units on a scale |
| Site: NHP - UMC + Chiropractic Care | Patient Satisfaction | 8.34 units on a scale |
| Site: NMCSD - UMC | Patient Satisfaction | 4.34 units on a scale |
| Site: NMCSD - UMC + Chiropractic Care | Patient Satisfaction | 7.45 units on a scale |
Comparison: All sites combined: 6 weeks95% CI: [2.1, 2.8]
Comparison: Walter Reed site: 6 weeks95% CI: [1.4, 2.6]
Comparison: Naval Hospital Pensacola site: 6 weeks95% CI: [1.6, 3]
Comparison: Naval Medical Center San Diego site: 6 weeks95% CI: [2.5, 3.7]