Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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
    

Intervention name(s): Medical Care + Chiropractic Care; Conventional Medical Care Only
Intervention type(s): Other; Other
Intervention description(s): 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 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 intervention name(s): spinal manipulative therapy; education self management medication heat and ice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research