Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Trunk Neuromuscular Control
研究概览
简要总结
The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.
The investigators hypothesize that:
- both treatment groups will demonstrate significant improvements in pain and function;
- only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •duration of the current episode less than 3 months,
- •average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
- •self-report global function less than 80% (0-100 %, 100% = normal pain free function)
- •Oswestry Index > 19%
- •no physical therapy or chiropractic treatment for the current episode of low back pain.
- •clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding
排除标准
- •permanent structural spinal deformity (e.g., scoliosis),
- •spinal fracture or history of spinal fracture,
- •osteoporosis,
- •inflammatory joint disease,
- •signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
- •previous spinal surgery,
- •frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
- •pain or paresthesia below the knee,
- •leg length discrepancy of greater than 2.5 cm,
- •history of neurologic disease that required hospitalization,
- •active treatment of another medical illness that would preclude participation in any aspect of the study,
- •vestibular dysfunction,
- •extreme psychosocial involvement
- •allergies to medical tape or adhesives
- •Body mass index greater than 30 kg/m2
研究组 & 干预措施
Core Stabilization
8-week core stabilization program in 3 stage that emphasizes use of specific local trunk stabilizing muscles to restore active control and stability to the trunk.
8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions
干预措施: Core Stabilization (Other)
Trunk Motion and Fitness
8-week exercise program in 3 stages emphasizing spine motion, general trunk flexibility and strengthening and cardiovascular fitness.
8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions
干预措施: Trunk Motion and Fitness (Other)
结局指标
主要结局
Trunk Neuromuscular Control
时间窗: Baseline, 8 weeks
Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.
次要结局
- Clinical Outcomes(Baseline, 8-weeks)
研究者
Sheri Silfies
Principal Investigator
Drexel University