Trial Outcomes & Findings for Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel. (NCT NCT01692275)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

750 participants

Primary outcome timeframe

Baseline, week 6, week 12

Results posted on

2018-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	375	375
Overall Study COMPLETED	309	316
Overall Study NOT COMPLETED	66	59

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	57	48
Overall Study Withdrawal by Subject	9	11

Baseline Characteristics

Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	Total n=750 Participants Total of all reporting groups
Age, Continuous	34.4 years STANDARD_DEVIATION 8.4 • n=93 Participants	34.7 years STANDARD_DEVIATION 8.6 • n=4 Participants	25.5 years STANDARD_DEVIATION 7.9 • n=27 Participants	25.7 years STANDARD_DEVIATION 7.5 • n=483 Participants	32.4 years STANDARD_DEVIATION 7.4 • n=36 Participants	32.4 years STANDARD_DEVIATION 7.5 • n=10 Participants	30.9 years STANDARD_DEVIATION 8.7 • n=115 Participants
Sex: Female, Male Female	39 Participants n=93 Participants	40 Participants n=4 Participants	19 Participants n=27 Participants	18 Participants n=483 Participants	30 Participants n=36 Participants	29 Participants n=10 Participants	175 Participants n=115 Participants
Sex: Female, Male Male	86 Participants n=93 Participants	85 Participants n=4 Participants	106 Participants n=27 Participants	107 Participants n=483 Participants	95 Participants n=36 Participants	96 Participants n=10 Participants	575 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	9 Participants n=4 Participants	29 Participants n=27 Participants	12 Participants n=483 Participants	21 Participants n=36 Participants	31 Participants n=10 Participants	118 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=93 Participants	116 Participants n=4 Participants	96 Participants n=27 Participants	113 Participants n=483 Participants	104 Participants n=36 Participants	94 Participants n=10 Participants	632 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Asian	6 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	11 Participants n=36 Participants	6 Participants n=10 Participants	30 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	41 Participants n=93 Participants	42 Participants n=4 Participants	17 Participants n=27 Participants	15 Participants n=483 Participants	14 Participants n=36 Participants	20 Participants n=10 Participants	149 Participants n=115 Participants
Race/Ethnicity, Customized White	62 Participants n=93 Participants	62 Participants n=4 Participants	102 Participants n=27 Participants	106 Participants n=483 Participants	88 Participants n=36 Participants	87 Participants n=10 Participants	507 Participants n=115 Participants
Race/Ethnicity, Customized Other or unspecified	16 Participants n=93 Participants	18 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants	11 Participants n=36 Participants	17 Participants n=10 Participants	71 Participants n=115 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Numerical Rating Scale (NRS) for Prior Week Week 12	3.63 units on a scale Interval 3.18 to 4.07	3.21 units on a scale Interval 2.76 to 3.66	2.82 units on a scale Interval 2.33 to 3.3	1.69 units on a scale Interval 1.2 to 2.17	4.0 units on a scale Interval 3.54 to 4.45	2.91 units on a scale Interval 2.45 to 3.36	—	—
Numerical Rating Scale (NRS) for Prior Week Baseline	4.27 units on a scale Interval 3.88 to 4.66	4.36 units on a scale Interval 3.98 to 4.75	4.73 units on a scale Interval 4.33 to 5.14	4.45 units on a scale Interval 4.04 to 4.85	4.68 units on a scale Interval 4.28 to 5.08	4.87 units on a scale Interval 4.48 to 5.27	—	—
Numerical Rating Scale (NRS) for Prior Week Week 6	3.90 units on a scale Interval 3.47 to 4.33	3.18 units on a scale Interval 2.75 to 3.61	3.39 units on a scale Interval 2.92 to 3.85	2.17 units on a scale Interval 1.71 to 2.63	4.63 units on a scale Interval 4.19 to 5.07	3.3 units on a scale Interval 2.86 to 3.74	—	—

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Roland Morris Disability Questionnaire (RMDQ) Baseline	9.94 units on a scale Interval 8.88 to 11.01	9.36 units on a scale Interval 8.29 to 10.42	10.65 units on a scale Interval 9.52 to 11.78	10.21 units on a scale Interval 9.08 to 11.34	8.81 units on a scale Interval 7.7 to 9.92	9.2 units on a scale Interval 8.08 to 10.32	—	—
Roland Morris Disability Questionnaire (RMDQ) Week 6	8.0 units on a scale Interval 6.8 to 9.19	6.22 units on a scale Interval 5.02 to 7.43	5.22 units on a scale Interval 3.9 to 6.53	3.13 units on a scale Interval 1.83 to 4.43	8.8 units on a scale Interval 7.56 to 10.05	6.1 units on a scale Interval 4.85 to 7.34	—	—
Roland Morris Disability Questionnaire (RMDQ) Week 12	7.25 units on a scale Interval 6.02 to 8.49	5.77 units on a scale Interval 4.52 to 7.02	4.4 units on a scale Interval 3.04 to 5.75	2.47 units on a scale Interval 1.12 to 3.81	7.56 units on a scale Interval 6.29 to 8.84	4.83 units on a scale Interval 3.55 to 6.11	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Bothersomeness of Symptoms Baseline	3.6 units on a scale Interval 3.5 to 3.8	3.5 units on a scale Interval 3.3 to 3.6	3.7 units on a scale Interval 3.6 to 3.9	3.6 units on a scale Interval 3.4 to 3.8	3.5 units on a scale Interval 3.3 to 3.6	3.4 units on a scale Interval 3.3 to 3.6	—	—
Bothersomeness of Symptoms Week 6	3.0 units on a scale Interval 2.8 to 3.2	2.8 units on a scale Interval 2.6 to 3.0	2.7 units on a scale Interval 2.4 to 2.9	2.1 units on a scale Interval 1.9 to 2.3	3.2 units on a scale Interval 3.0 to 3.4	2.8 units on a scale Interval 2.6 to 2.9	—	—
Bothersomeness of Symptoms Week 12	2.9 units on a scale Interval 2.7 to 3.1	2.8 units on a scale Interval 2.6 to 3.0	2.4 units on a scale Interval 2.1 to 2.6	1.8 units on a scale Interval 1.6 to 2.1	2.9 units on a scale Interval 2.6 to 3.1	2.4 units on a scale Interval 2.2 to 2.6	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Numerical Pain Rating Scale (NRS) for Past 24 Hours Baseline	5.4 units on a scale Interval 5.2 to 5.7	5.6 units on a scale Interval 5.4 to 5.8	6.1 units on a scale Interval 5.9 to 6.4	5.9 units on a scale Interval 5.6 to 6.1	5.4 units on a scale Interval 5.2 to 5.6	5.4 units on a scale Interval 5.2 to 5.6	—	—
Numerical Pain Rating Scale (NRS) for Past 24 Hours Week 6	4.5 units on a scale Interval 4.1 to 5.0	3.9 units on a scale Interval 3.4 to 4.3	3.4 units on a scale Interval 2.9 to 3.9	2.1 units on a scale Interval 1.6 to 2.6	5.3 units on a scale Interval 4.8 to 5.7	3.6 units on a scale Interval 3.2 to 4.1	—	—
Numerical Pain Rating Scale (NRS) for Past 24 Hours Week 12	4.4 units on a scale Interval 3.9 to 4.9	3.7 units on a scale Interval 3.2 to 4.2	3.0 units on a scale Interval 2.4 to 3.5	1.4 units on a scale Interval 0.9 to 2.0	4.3 units on a scale Interval 3.8 to 4.8	3.2 units on a scale Interval 2.7 to 3.7	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Healthcare Utilization & Medication Use Week 6 Med Frequency · 0 days	25 Participants	36 Participants	28 Participants	34 Participants	39 Participants	40 Participants	—	—
Healthcare Utilization & Medication Use Week 6 Med Frequency · 1-2 days	20 Participants	24 Participants	12 Participants	17 Participants	22 Participants	20 Participants	—	—
Healthcare Utilization & Medication Use Week 6 Med Frequency · 3-4 days	13 Participants	7 Participants	10 Participants	1 Participants	12 Participants	8 Participants	—	—
Healthcare Utilization & Medication Use Week 6 Med Frequency · 5-6 days	8 Participants	8 Participants	1 Participants	3 Participants	10 Participants	9 Participants	—	—
Healthcare Utilization & Medication Use Week 6 Med Frequency · 7 days	14 Participants	8 Participants	11 Participants	8 Participants	9 Participants	8 Participants	—	—
Healthcare Utilization & Medication Use Week 6 Med Frequency · missing	45 Participants	42 Participants	63 Participants	62 Participants	33 Participants	40 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · 0 days	26 Participants	38 Participants	38 Participants	48 Participants	49 Participants	42 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · 1-2 days	23 Participants	15 Participants	7 Participants	5 Participants	21 Participants	23 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · 3-4 days	9 Participants	12 Participants	7 Participants	4 Participants	10 Participants	7 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · 5-6 days	10 Participants	1 Participants	4 Participants	2 Participants	4 Participants	5 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · 7 days	12 Participants	17 Participants	6 Participants	4 Participants	8 Participants	8 Participants	—	—
Healthcare Utilization & Medication Use Week 12 Med Frequency · missing	45 Participants	42 Participants	63 Participants	62 Participants	33 Participants	40 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Global Improvement Scale A little better	12 Participants	20 Participants	11 Participants	7 Participants	8 Participants	22 Participants	—	—
Global Improvement Scale About the same	37 Participants	18 Participants	15 Participants	5 Participants	47 Participants	26 Participants	—	—
Global Improvement Scale A little worse	15 Participants	2 Participants	8 Participants	1 Participants	23 Participants	5 Participants	—	—
Global Improvement Scale Much worse	3 Participants	2 Participants	1 Participants	1 Participants	6 Participants	0 Participants	—	—
Global Improvement Scale missing	36 Participants	32 Participants	54 Participants	52 Participants	27 Participants	31 Participants	—	—
Global Improvement Scale Completely gone	1 Participants	2 Participants	7 Participants	16 Participants	0 Participants	4 Participants	—	—
Global Improvement Scale Much better	12 Participants	26 Participants	20 Participants	32 Participants	10 Participants	22 Participants	—	—
Global Improvement Scale Moderately better	9 Participants	23 Participants	9 Participants	11 Participants	4 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: 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 \[extremely satisfied\].

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Patient Satisfaction	5.65 units on a scale Interval 5.19 to 6.11	7.64 units on a scale Interval 7.17 to 8.11	6.04 units on a scale Interval 5.51 to 6.56	8.34 units on a scale Interval 7.82 to 8.85	4.34 units on a scale Interval 3.86 to 4.83	7.45 units on a scale Interval 6.97 to 7.93	—	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC n=750 Participants All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care n=750 Participants All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Patient Expectation Expectation UMC + Chiropractic Care	8.2 units on a scale Standard Deviation 1.8	8.4 units on a scale Standard Deviation 1.6	8.1 units on a scale Standard Deviation 1.9	8.3 units on a scale Standard Deviation 1.9	8.6 units on a scale Standard Deviation 1.8	8.5 units on a scale Standard Deviation 1.9	8.3 units on a scale Standard Deviation 1.9	8.4 units on a scale Standard Deviation 1.8
Patient Expectation Expectation UMC	5.3 units on a scale Standard Deviation 2.4	4.9 units on a scale Standard Deviation 2.5	5.3 units on a scale Standard Deviation 2.3	5.4 units on a scale Standard Deviation 2.5	4.5 units on a scale Standard Deviation 2.8	5.2 units on a scale Standard Deviation 3.0	5.0 units on a scale Standard Deviation 2.5	5.2 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Site: WRNMMC - UMC n=125 Participants 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.	Site: WRNMMC - UMC + Chiropractic Care n=125 Participants 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.	Site: NHP - UMC n=125 Participants 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.	Site: NHP - UMC + Chiropractic Care n=125 Participants 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.	Site: NMCSD - UMC n=125 Participants 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.	Site: NMCSD - UMC + Chiropractic Care n=125 Participants 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.	All Sites - UMC All 3 sites combined (WRNMMC, NHP, NMCSD) 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.	All Sites Combined - UMC + Chiropractic Care All 3 sites combined (WRNMMC, NHP, NMCSD) 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.
Back Pain Functional Scale (BPFS) Baseline	39.48 units on a scale Interval 37.5 to 41.47	39.18 units on a scale Interval 37.2 to 41.16	37.68 units on a scale Interval 35.57 to 39.78	38 units on a scale Interval 35.9 to 40.1	39.97 units on a scale Interval 37.9 to 42.03	39.98 units on a scale Interval 37.9 to 42.06	—	—
Back Pain Functional Scale (BPFS) Week 2	42.08 units on a scale Interval 39.92 to 44.23	42.65 units on a scale Interval 40.52 to 44.7	44.21 units on a scale Interval 41.81 to 46.59	46.76 units on a scale Interval 44.46 to 49.06	39.07 units on a scale Interval 36.87 to 41.28	42.45 units on a scale Interval 40.24 to 44.66	—	—
Back Pain Functional Scale (BPFS) Week 4	42.03 units on a scale Interval 39.76 to 44.3	44.77 units on a scale Interval 42.49 to 47.04	46.45 units on a scale Interval 43.93 to 48.97	50.31 units on a scale Interval 47.87 to 52.76	39.36 units on a scale Interval 37.03 to 41.68	45.02 units on a scale Interval 42.69 to 47.35	—	—
Back Pain Functional Scale (BPFS) Week 6	42.72 units on a scale Interval 40.47 to 44.96	45.74 units on a scale Interval 43.5 to 47.98	48.55 units on a scale Interval 46.06 to 51.04	52.64 units on a scale Interval 50.21 to 55.08	40.52 units on a scale Interval 38.2 to 42.83	46.02 units on a scale Interval 43.72 to 48.32	—	—
Back Pain Functional Scale (BPFS) Week 12	43.73 units on a scale Interval 41.43 to 46.03	45.51 units on a scale Interval 43.2 to 47.82	49.7 units on a scale Interval 47.15 to 52.25	54.56 units on a scale Interval 52.04 to 57.07	43.57 units on a scale Interval 41.23 to 45.91	47.8 units on a scale Interval 45.46 to 50.15	—	—

Adverse Events

Usual Medical Care

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

UMC + Chiropractic Care

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Usual Medical Care n=375 participants at risk 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.	UMC + Chiropractic Care n=375 participants at risk 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.
Musculoskeletal and connective tissue disorders Spine-related pain	2.4% 9/375 • Number of events 10 • 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.	6.4% 24/375 • Number of events 30 • 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.
Musculoskeletal and connective tissue disorders Spine-related pain with radiation	0.80% 3/375 • Number of events 4 • 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.	1.3% 5/375 • Number of events 5 • 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.
Musculoskeletal and connective tissue disorders Extremity pain	0.00% 0/375 • 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.	1.1% 4/375 • Number of events 4 • 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.
Musculoskeletal and connective tissue disorders General stiffness/tightness	0.00% 0/375 • 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.	0.27% 1/375 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Muscle spasm/cramp	0.00% 0/375 • 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.	0.53% 2/375 • Number of events 2 • 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.
Musculoskeletal and connective tissue disorders Muscle pain	0.27% 1/375 • Number of events 1 • 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.	0.00% 0/375 • 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.

Additional Information

Dr. Cyndy Long

Palmer Center for Chiropractic Research

Phone: 563-884-5157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place