Overview

This trial is active, not recruiting.

Condition lower back pain
Treatments medical care + chiropractic care, conventional medical care only
Phase phase 1/phase 2
Sponsor RAND
Collaborator Palmer College of Chiropractic
Start date September 2012
End date December 2016
Trial size 750 participants
Trial identifier NCT01692275, 2010-0782

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Active Comparator)
Medical care plus chiropractic manipulative therapy
medical care + chiropractic care spinal manipulative therapy
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Numerical Pain Rating Scale (NRS)
time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
Roland Morris Disability Questionnaire (RMDQ)
time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)

Secondary Outcomes

Measure
Back Pain Functional Scale (BPFS)
time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel
Principal investigator Ian D. Coulter, Ph.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by RAND.