Assessment of Chiropractic Treatment: Strength and Balance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Isometric muscle strength test using force transducer
研究概览
简要总结
This study is a randomized controlled trial designed to compare the effects of 4 weeks of chiropractic care to a waitlist control group on measures of strength, balance, and endurance in military personnel experiencing non-surgical low back pain.
详细描述
This study will assess three functional outcomes (strength, balance and endurance) and patient-reported outcomes in participants with low back pain (LBP) treated with chiropractic care, providing evidence that may enhance our understanding of the relationship between functional outcomes and chiropractic care. The findings from this study may support the use of chiropractic care for military personnel as an effective, conservative treatment for low back pain that may also help preserve or improve functional outcomes and thus, allow active duty personnel to better perform the physical demands required of them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18 - ≤ 40, inclusive
- •Able to provide written informed consent
- •Self-reported acute, subacute or chronic LBP at initial screen and baseline visit
- •Pain intensity of ≥ 2 on NRS within the past 24 hours.
- •Active duty status
排除标准
- •Any chiropractic care within 30 days of informed consent
- •Any LBP confirmed or suspected to arise from a visceral source
- •Spinal pathology or any other condition(s) contraindicating SM
- •LBP for which specific treatments outside those available within study parameters are indicated
- •Any spinal fracture within the past 6 months
- •Any spinal surgery within the past 6 months
- •LBP with positive neurologic signs indicating spinal nerve root compression, or LBP with presumptive or confirmed spinal nerve root compression
- •Imaging evidence of neuroforaminal or spinal canal stenosis or the clinical presentation of neurogenic claudication
- •Chronic pain syndrome diagnosis
- •Diagnosis or suspected systemic inflammatory arthropathy of the spine
- •Referral needed to evaluate or treat an urgent or emergent condition or to determine the status of a condition that pertains to eligibility
- •Unable to safely perform strength, balance, or endurance tests, or the ability to assess health status
- •Pregnant or planning to become pregnant within the next 6 weeks
- •Knowledge of impending transfer or absence during study period
- •Seeking or referred for Medical Evaluation Board / Physical Evaluation Board disability status (to ensure safety while performing study tests and to avoid confounding due to the potential for competing recovery goals)
- •Unable or unwilling to comply with study protocols
- •Patellar height is <15 inches or >25.5 inches
研究组 & 干预措施
Chiropractic Care (CC)
Participants in the CC group will receive evaluation and treatment (chiropractic manipulative therapy) from a doctor of chiropractic over a 4 week period.
干预措施: Chiropractic manipulative therapy (Procedure)
Waitlist control group (WC)
Participants allocated to the waitlist control group will not receive any chiropractic treatment during the active study period. These individuals will be scheduled for one additional study visit following allocation. This final study visit will be scheduled 4 weeks after allocation (± 7 days). WC participants are not restricted from receiving any other healthcare during study participation. However, participants in the WC group will be asked not to receive any chiropractic care or spinal manipulation by any other provider during the 4 week intervention period. After WC participants complete the final study visit, they will be offered chiropractic care. This treatment will not be part of the study and no data will be collected at these visits.
结局指标
主要结局
Isometric muscle strength test using force transducer
时间窗: Baseline and week 4
During the isometric muscle strength test, participants will first be placed in a safety harness and instructed into a proper lifting position. Participants will then be instructed to pull up (with gradually increasing effort levels) against a handle attached to a force transducer with a metallic chain. Participants will be instructed to immediately stop pulling on the handle if they experience any increased discomfort. The maximum pulling force recorded during the 3 tests will be used for data analysis, and these measurements will be taken at the first and last study visit. The outcome will be the change in strength following the 4-week intervention period.
次要结局
- One-Leg Standing Test (Stork test) via computer-activated timer(Baseline and week 4)
- Stopwatch-timed trunk muscle endurance assessment (Biering-Sorensen test)(Baseline and week 4)
研究者
Ian Coulter
Principal Investigator
RAND