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

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

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