Lower Back PainNCT01692275

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

A study testing Medical Care + Chiropractic Care and Conventional Medical Care Only in people with Lower Back Pain, run by RAND at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Lower Back Pain
What is being tested?: Medical Care + Chiropractic Care and Conventional Medical Care Only
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 750 participants
Where: 3 sitesUnited States
Study dates: Sep 2012to 28 Nov 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

Show all 14Show fewer

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Naval Hospital Pensacola
Pensacola, Florida, 32508-5141
Naval Medical Center San Diego
San Diego, California, 92134-5000

Other trials in United States

About this study

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

Read the 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

Conditions: Lower Back Pain
Being tested: Medical Care + Chiropractic Care, Conventional Medical Care Only
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medical Care + Chiropractic CareOther
Also called spinal manipulative therapy, education self management medication heat and ice
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 OnlyOther
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.

Study groups in NCT01692275
Study group	Role	What they receive
Medical Care + Chiropractic Care	Active comparator	Medical care plus chiropractic manipulative therapy Receives: Other: Medical Care + Chiropractic Care
Conventional Medical Care Only	Active comparator	Conventional medical care only Receives: Other: Conventional Medical Care Only

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, week 6, week 12
Roland Morris Disability Questionnaire (RMDQ)
We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).
Measured: Baseline, week 6, week 12

Secondary outcomes (7)

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).
Measured: Baseline, week 6, week 12
Numerical Pain Rating Scale (NRS) for Past 24 Hours
Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.
Measured: Baseline, week 6, week 12
Healthcare Utilization & Medication Use
Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.
Measured: week 6, week 12
Global Improvement Scale
This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.
Measured: Week 6
Patient Satisfaction
A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].
Measured: Week 6
Patient Expectation
Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.
The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful).
Measured: Baseline only
Back Pain Functional Scale (BPFS)
The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.
Measured: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201228 Nov 2016

First posted25 Sep 2012 (estimated)
Study startSep 2012
Primary completion28 Nov 2016
Study completion28 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Lower Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 750 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01692275
Sponsor's protocol ID: 2010-0782
Status last verified: Dec 2018
First submitted: 6 Sep 2012
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8.
PubMed 26857706
Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105.
PubMed 30646047
Shannon ZK, Long CR, Vining RD, Walter JA, Coulter ID, Goertz CM. Mediators of the effect of chiropractic care on 12- and 52-week outcomes for U.S. active-duty military personnel with low back pain: secondary analysis of a clinical trial. Chiropr Man Therap. 2026 Apr 16;34(1):12. doi: 10.1186/s12998-026-00628-0.
PubMed 41992252
Shannon ZK, Long CR, Vining RD, McCarey J, Walter JA, Coulter ID, Goertz CM. Longer-term chiropractic care outcomes for US active-duty military personnel with low back pain: secondary analysis of a pragmatic clinical trial. BMC Complement Med Ther. 2026 Apr 7;26(1):185. doi: 10.1186/s12906-026-05347-w.
PubMed 41947115
Shannon ZK, Long CR, Chrischilles E, Goertz C, Wallace R, Casteel C, Carnahan RM. Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity. BMJ Open. 2024 Nov 19;14(11):e083509. doi: 10.1136/bmjopen-2023-083509.
PubMed 39566948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Recruiting
Electronic Approach to the Human Massage Therapist
Lower Back Pain
Not yet recruitingPhase 1/2
Mechanistic Evaluation of Polypharmacy Effects for Pain
Chronic Lower Back Pain (CLBP)
RecruitingObservational study
The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain
Low Back Pain, Back Pain Lower Back Chronic
Recruiting
A Comparative Study of Erector Spinae Fascia (ESF) Injection and Dry Needling Combined With Functional Rehabilitation (FR) in Patients With Chronic Low Back Pain Who Have Undergone Spinal Surgery (SPIN-NEED)
Back Pain Lower Back Chronic

All Lower Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel
ClinicalTrials.gov ID: NCT01692275
Acronym / sponsor ID: 2010-0782
Conditions: Lower Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 750 participants (actual)
Lead sponsor: RANDUniversity, hospital or other
Collaborators: Palmer College of Chiropractic, Samueli Institute for Information Biology
Study start: Sep 2012
Primary completion: 28 Nov 2016 (actual)
Study completion: 28 Nov 2016 (actual)
First posted: 25 Sep 2012 (estimated)
Results: Posted 19 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Medical Care + Chiropractic Care	Active comparator	Other: Medical Care + Chiropractic CareMedical care plus chiropractic manipulative therapy
Conventional Medical Care Only	Active comparator	Other: Conventional Medical Care OnlyConventional medical care only

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medical Care + Chiropractic CareAlso: spinal manipulative therapy, education self management medication heat and icePatients 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.	Other	Medical Care + Chiropractic Care
Conventional Medical Care OnlyConventional 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.	Other	Conventional Medical Care Only

Primary outcome

Numerical Rating Scale (NRS) for Prior Week
Time frame: 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)
Time frame: 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).

7 secondary outcomes

Bothersomeness of Symptoms
Time frame: Baseline, week 6, week 12
Numerical Pain Rating Scale (NRS) for Past 24 Hours
Time frame: Baseline, week 6, week 12
Healthcare Utilization & Medication Use
Time frame: week 6, week 12
Global Improvement Scale
Time frame: Week 6
Patient Satisfaction
Time frame: Week 6
Patient Expectation
Time frame: Baseline only
Back Pain Functional Scale (BPFS)
Time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)

Results and safety

Results posted to the registry on 19 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medical Care + Chiropractic Care	375	309
Conventional Medical Care Only	375	316

Primary outcome: Numerical Rating Scale (NRS) for Prior Week

Time frame: Baseline, week 6, week 12. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Site: WRNMMC - UMC n = 125	Site: WRNMMC - UMC + Chiropractic Care n = 125	Site: NHP - UMC n = 125	Site: NHP - UMC + Chiropractic Care n = 125	Site: NMCSD - UMC n = 125	Site: NMCSD - UMC + Chiropractic Care n = 125
Baseline	4.27 (3.88 to 4.66)	4.36 (3.98 to 4.75)	4.73 (4.33 to 5.14)	4.45 (4.04 to 4.85)	4.68 (4.28 to 5.08)	4.87 (4.48 to 5.27)
Week 6	3.90 (3.47 to 4.33)	3.18 (2.75 to 3.61)	3.39 (2.92 to 3.85)	2.17 (1.71 to 2.63)	4.63 (4.19 to 5.07)	3.3 (2.86 to 3.74)
Week 12	3.63 (3.18 to 4.07)	3.21 (2.76 to 3.66)	2.82 (2.33 to 3.3)	1.69 (1.2 to 2.17)	4.0 (3.54 to 4.45)	2.91 (2.45 to 3.36)

Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care vs Site: NHP - UMC vs Site: NHP - UMC + Chiropractic Care vs Site: NMCSD - UMC vs Site: NMCSD - UMC + Chiropractic Care: Mean Difference (Final Values): -1.1 (95% CI -1.4 to -0.7)
Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care vs Site: NHP - UMC vs Site: NHP - UMC + Chiropractic Care vs Site: NMCSD - UMC vs Site: NMCSD - UMC + Chiropractic Care: Mean Difference (Final Values): -0.9 (95% CI -1.2 to -0.5)
Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care: Mean Difference (Final Values): -0.7 (95% CI -1.3 to -0.1)

Primary outcome: Roland Morris Disability Questionnaire (RMDQ)

Time frame: Baseline, week 6, week 12. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Site: WRNMMC - UMC n = 125	Site: WRNMMC - UMC + Chiropractic Care n = 125	Site: NHP - UMC n = 125	Site: NHP - UMC + Chiropractic Care n = 125	Site: NMCSD - UMC n = 125	Site: NMCSD - UMC + Chiropractic Care n = 125
Baseline	9.94 (8.88 to 11.01)	9.36 (8.29 to 10.42)	10.65 (9.52 to 11.78)	10.21 (9.08 to 11.34)	8.81 (7.7 to 9.92)	9.2 (8.08 to 10.32)
Week 6	8.0 (6.8 to 9.19)	6.22 (5.02 to 7.43)	5.22 (3.9 to 6.53)	3.13 (1.83 to 4.43)	8.8 (7.56 to 10.05)	6.1 (4.85 to 7.34)
Week 12	7.25 (6.02 to 8.49)	5.77 (4.52 to 7.02)	4.4 (3.04 to 5.75)	2.47 (1.12 to 3.81)	7.56 (6.29 to 8.84)	4.83 (3.55 to 6.11)

Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care vs Site: NHP - UMC vs Site: NHP - UMC + Chiropractic Care vs Site: NMCSD - UMC vs Site: NMCSD - UMC + Chiropractic Care: Mean Difference (Final Values): -2.2 (95% CI -3.1 to -1.2)
Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care vs Site: NHP - UMC vs Site: NHP - UMC + Chiropractic Care vs Site: NMCSD - UMC vs Site: NMCSD - UMC + Chiropractic Care: Mean Difference (Final Values): -2.0 (95% CI -3.0 to -1.0)
Site: WRNMMC - UMC vs Site: WRNMMC - UMC + Chiropractic Care: Mean Difference (Final Values): -1.8 (95% CI -3.4 to -0.2)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Medical Care	0 of 375 (0%)	13 of 375 (3.5%)	0 of 375
UMC + Chiropractic Care	0 of 375 (0%)	33 of 375 (8.8%)	0 of 375

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26857706Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8.
Background: PubMed 30646047Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105.
Derived from this study: PubMed 41992252Shannon ZK, Long CR, Vining RD, Walter JA, Coulter ID, Goertz CM. Mediators of the effect of chiropractic care on 12- and 52-week outcomes for U.S. active-duty military personnel with low back pain: secondary analysis of a clinical trial. Chiropr Man Therap. 2026 Apr 16;34(1):12. doi: 10.1186/s12998-026-00628-0.
Derived from this study: PubMed 41947115Shannon ZK, Long CR, Vining RD, McCarey J, Walter JA, Coulter ID, Goertz CM. Longer-term chiropractic care outcomes for US active-duty military personnel with low back pain: secondary analysis of a pragmatic clinical trial. BMC Complement Med Ther. 2026 Apr 7;26(1):185. doi: 10.1186/s12906-026-05347-w.
Derived from this study: PubMed 39566948Shannon ZK, Long CR, Chrischilles E, Goertz C, Wallace R, Casteel C, Carnahan RM. Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity. BMJ Open. 2024 Nov 19;14(11):e083509. doi: 10.1136/bmjopen-2023-083509.
Individual participant dataSharing planned: No

Related trials for Lower Back Pain

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ian D. Coulter, Ph.D. principal investigator

RAND

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Medical Care + Chiropractic Care and Conventional Medical Care Only in people with Lower Back Pain, run by RAND at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) for Prior Week (time frame: Baseline, week 6, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01692275, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.