Biology and Clinical Outcomes of Chiropractic Spinal Manipulative Therapy in the Treatment of Patients With Acute Inflammatory Radiculopathy Secondary to Lumbar Disc Herniation: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of recruitment of eligible patients
研究概览
简要总结
Comparisons of surgical and non-operative treatment of patients with acute sciatica secondary to lumbar intervertebral disc herniation (AS/LDH) have shown no appreciable difference in outcome. The composition of the non-operative treatment of this patient population remains poorly defined. Spinal manipulative therapy (SMT) has demonstrated value in the treatment of AS/LDH. Recent preliminary studies suggest that SMT provides therapeutic benefit through the modulation of in vivo inflammatory mediators. This feasibility study will define the key experimental variables required to conduct a large multicentre study that will clarify the biological and clinical outcomes of SMT in the treatment of patients with AS/LDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chief complaint of sciatica rather than lower back pain
- •pain of up to 6 months' duration
- •a McCulloch criteria score of 5/5 (two clinical symptoms and two clinical signs of sciatica, and diagnostic imaging confirming the presence of a herniated nucleus pulposus contacting a spinal nerve root at the appropriate level)
- •fluency in spoken and written English to ensure subjects understand the content of questionnaires and consent
排除标准
- •progressive neurological deficit
- •spinal fracture
- •spinal tumor
- •spinal infection
- •spinal nerve root motor score of less than 4/5
- •spinal stenosis that is not attributable to a herniated disc
- •any other significant spinal ailment or local or generalized co-morbidity ailment that could affect outcomes independently of SMT ( e.g. seronegative spondyloarthropathy, malignancy).
结局指标
主要结局
Rate of recruitment of eligible patients
时间窗: The number of patients recruited per week for 19 months
次要结局
- mRDQ and VAS(Change from baseline and 24 weeks post-surgery and/or post-CSMT)
- Total mRNA levels (isolated from disc tissue and disc / periradicular lavage samples) of interleukins 1,10 and 11, MIP-1 beta TNF alpha, and chemotactic protein alpha.(Specimens will be harvested an average of 6 weeks post-randomization)
- mRMQ and VAS(Change from baseline and 12 weeks post-surgery and/or post-CSMT)
- Cytokine and cytokine mRNA levels in serum.(Change from baseline cytokine and mRNA levels in serum and 24 weeks post-surgery and/or post-CSMT)
- Cytokine and cytokine mRNA levels in serum(Change from baseline cytokine and mRNA levels in serum and 12 weeks post-surgery and/or post-CSMT)
- Modified Roland Disability Questionnaire (mRDQ) score and Visual Analogue Scale (VAS) pain scale.(Change from baseline and 4-weeks prior to surgery or commencing 4-weeks of CSMT.)
研究者
Dr. Paul Bishop
Clinical Associate Professor, I.C.O.R.D. Research Professor, Division of Spine, Department of Orthopaedics, University of British Columbia
Vancouver General Hospital