Clinical trial NCT01692275: Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
Official title: Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Palmer College of Chiropractic
name: Samueli Institute for Information Biology
First posted: 2012-09-25
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of chiropractic manipulative therapy for pain management and improved function in active duty service members with low back pain that do not require surgery. The study will also measure the impact of a tobacco cessation program delivered to participants allocated to the chiropractic arm.

Detailed description: Low back pain (LBP) is the most common cause of disability worldwide, but it is even more prevalent in active duty military personnel; more than 50% of all diagnoses resulting in disability discharges from the military across all branches are due to musculoskeletal conditions. LBP has been characterized as "The Silent Military Threat" because of its negative impact on mission readiness and the degree to which it compromises a fit fighting force. For these reasons, military personnel with LBP need a practical and effective treatment that relieves their pain and allows them to return to duty quickly, but also one that preserves function and military readiness, addresses the underlying causes of the episode and protects against re-injury. Currently a clear "gold standard" medical treatment for low back pain does not exist and studies show that evidence-based guidelines are rarely used in general practice. Thus, there is a need to consider innovative treatment options for chronic diseases such as LBP. Therefore the primary purpose of this study is to assess the effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved function in active duty service members with orthopedic injuries or disorders of the low back that do not require surgery. This multi-site Phase II Clinical Comparative Effectiveness Trial is designed to rigorously compare the outcomes of CMT and conventional medical care (CMC) to CMC alone. Chiropractic treatment will include CMT plus ancillary physiotherapeutic interventions. CMC will be delivered following current standards of medical practice at each site. At each of the four participating sites, active military personnel, ages 18-50, who present with acute, sub-acute or chronic low back pain that does not require surgery will be randomized to one of the two treatment groups. Outcome measures include the Numerical Rating Scale for pain, the Roland-Morris Low Back Pain and Disability questionnaire, the Back Pain Functional Scale for assessing function, and the Global Improvement questionnaire for patient perception regarding improvement in function. Patient Expectation and Patient Satisfaction questionnaires will be used to examine volunteer expectations toward care and perceptions of that care. Pharmaceutical use and duty status data will also be collected. The PROMIS-29 will be utilized to compare the general health component and quality of life of the sample at baseline. In addition, doctors of chiropractic are well positioned to provide information to support tobacco cessation. Thus this clinical trial will include a nested study designed to measure the impact of a tobacco cessation program delivered by a doctor of chiropractic. The results from this randomized clinical trial, with a nested tobacco cessation intervention, will provide critical information regarding the health and mission-support benefits of chiropractic health care delivery for active duty service members in the military

Eligibility criteria: Inclusion Criteria:

* Age 18-50 (Inclusive)
* Diagnosis of acute, subacute or chronic low back pain
* Ability to provide voluntary written informed consent
* Active duty at one of the three participating military sites

Exclusion Criteria:

* LBP from other than somatic tissues as determined by history, examination and course (i.e., pain referred from visceral conditions)
* Co-morbid pathology or poor health conditions that may directly impact spinal pain
* Volunteers who have case histories and physical examination findings indicating other than average good health
* Bone and joint pathology contraindicating CMT (Chiropractic Manipulative Therapy)
* Volunteers with recent spinal fracture (within the last 8 weeks), recent spinal surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal or paraspinal infection(s), inflammatory arthropathies and significant/severe osteoporosis will be referred for appropriate care
* Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal segments, cauda equine syndrome)
* Pregnant or planning to become pregnant within 3 months
* Altered mental capacity as determined by the clinician
* Unable to speak English
* Use of manipulative care for any reason within the past month
* Unwilling to provide phone and electronic contact information
* Unable to confirm that they will not be transferred during the active phase of the study, i.e., deployment, receive orders for a distant duty assignment or training site or otherwise be absent from the current military site over the next 8 weeks (active study participation period).
* Does not agree to be enrolled regardless of group assignment
* PTSD Classification

Primary outcomes:
measure: Numerical Rating Scale (NRS) for Prior Week
timeFrame: Baseline, week 6, week 12
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: Baseline, week 6, week 12
Secondary outcomes:
measure: Bothersomeness of Symptoms
timeFrame: Baseline, week 6, week 12
measure: Numerical Pain Rating Scale (NRS) for Past 24 Hours
timeFrame: Baseline, week 6, week 12
measure: Healthcare Utilization & Medication Use
timeFrame: week 6, week 12
measure: Global Improvement Scale
timeFrame: Week 6
measure: Patient Satisfaction
timeFrame: Week 6
measure: Patient Expectation
timeFrame: Baseline only
measure: Back Pain Functional Scale (BPFS)
timeFrame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Pensacola
country: United States
facility: Naval Hospital Pensacola
state: Florida
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: RAND
name: Ian D. Coulter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.