Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.
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.
Lower Back Pain
Other: Medical Care + Chiropractic Care
Other: Conventional Medical Care Only
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
- Numerical Pain Rating Scale (NRS) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]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.
- Roland Morris Disability Questionnaire (RMDQ) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]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.
- Back Pain Functional Scale (BPFS) [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]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. In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.
- Bothersomeness of Symptoms [ Time Frame: at baseline and at all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]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.
- Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]PROMIS was a recently developed scoring system consisting of a battery of assessment tools that measure patient-reported health status.
- Healthcare Utilization & Medication Use [ Time Frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12) ] [ Designated as safety issue: No ]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.
- Tobacco Dependence [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]The level of tobacco dependence will be evaluated as in Fagerstrom & Schneider. We will ask how long the volunteer has smoked, how soon after waking the first cigarette is smoked, and if there are strong cravings when going two hours without a cigarette.
- Patient Satisfaction [ Time Frame: Week 2, week 4, and week 6 ] [ Designated as safety issue: No ]A one item patient satisfaction questionnaire
- Patient Expectation [ Time Frame: Baseline only ] [ Designated as safety issue: No ]Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.
- Tobacco Use [ Time Frame: Baseline, week 6, and week 12 ] [ Designated as safety issue: No ]Volunteers will be asked about their tobacco use with the questionnaire by Gordon et al. The 7-day abstinence will be determined from the point-prevalence of tobacco use. Prolonged abstinence will be defined as no tobacco use in the prior 6 months. Other variables will include annual quit attempts, number of cigarettes smoked per day, extent of current tobacco use, and current readiness to quit.
- Global Improvement Scale [ Time Frame: Week 6 and week 12 ] [ Designated as safety issue: No ]This is a modification of the VAS developed to assess degree of improvement over a specified period of time
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Medical Care + Chiropractic Care
Medical care plus chiropractic manipulative therapy
Other: Medical Care + Chiropractic Care
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
Other: 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692275
|Contact: Bridget Kane, MS, CCRCemail@example.com|
|Contact: Lara Hilton, MPH||310-393-0411 ext firstname.lastname@example.org|
|United States, California|
|Naval Medical Center San Diego||Active, not recruiting|
|San Diego, California, United States, 92134-5000|
|United States, Florida|
|Naval Hospital Pensacola||Active, not recruiting|
|Pensacola, Florida, United States, 32508-5141|
|United States, Maryland|
|Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889-5600|
|Contact: Keith P. Myers, MAJ, MD 301-295-7850 email@example.com|
|Contact: Abigail Roots, BA 240-204-2646 firstname.lastname@example.org|
|Principal Investigator: Keith P. Myers, MAJ, MD|
|Sub-Investigator: William Morgan, DC|
|Sub-Investigator: Terence Kearney, DC|
|Sub-Investigator: Abigail Roots, BA|
|Principal Investigator:||Ian D. Coulter, Ph.D.||RAND Corporation|