Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RAND
- 入组人数
- 750
- 试验地点
- 6
- 主要终点
- Numerical Rating Scale (NRS) for Prior Week
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Medical Care + Chiropractic Care
Medical care plus chiropractic manipulative therapy
干预措施: Medical Care + Chiropractic Care (Other)
Conventional Medical Care Only
Conventional medical care only
干预措施: Conventional Medical Care Only (Other)
结局指标
主要结局
Numerical Rating Scale (NRS) for Prior Week
时间窗: Baseline, week 6, week 12
Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week 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.
Roland Morris Disability Questionnaire (RMDQ)
时间窗: Baseline, week 6, week 12
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. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).
次要结局
- Bothersomeness of Symptoms(Baseline, week 6, week 12)
- Healthcare Utilization & Medication Use(week 6, week 12)
- Back Pain Functional Scale (BPFS)(Baseline and all endpoint visits (week 2, week 4, week 6, week 12))
- Numerical Pain Rating Scale (NRS) for Past 24 Hours(Baseline, week 6, week 12)
- Global Improvement Scale(Week 6)
- Patient Satisfaction(Week 6)
- Patient Expectation(Baseline only)