The Value of Short-term Pain Relief for the Prediction of Long-term Outcome After Cervical or Lumbar Nerve Root Infiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Health-related quality of life (HRQoL)
研究概览
简要总结
The purpose if this study is to assess the response to nerve root infiltration therapy in patients with cervical or lumbar disc herniations.
详细描述
This prospective, observational study examines the response to routine infiltration therapy in patients suffering from disc herniations of the spine. Using health-related quality of life questionnaires (SF-12 and Neck Pain and Disability Scale and Oswestry Disability Index) and the visual analogue scale the patients will be categorized into ultra-early-, early-, mid-term-, late-responders and non-responders. A two year follow-up of up to 250 patients is planned. With the anonymized participation of this study no patient will experience a change in his treatment plan. Valuable therapeutic management considerations might be drawn from the published results of this study for future patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic (pain) one-level cervical (C3-C8) or lumbar (L1-S1) radiculopathy with radiological evidence of discal nerve root compression
- •Minimum VAS of 20/100
- •Age between 18 - 70 years
排除标准
- •Multilevel disc herniations with multiple symptomatic nerve root compressions
- •Higher motor deficits (Paresis M 0-3 of a peripheral muscle)
- •Age < 18 or > 70 years
- •Pregnancy
- •Allergic reaction against steroids or local anaesthetic
- •Bleeding disorder (Tc < 100.000/ul, Quick <50%, INR > 1.5, abnormal PTT)
- •Known bleeding diathesis
- •Continued anticoagulants (Warfarin = Marcoumar must be bridged with low- or high-molecular heparin; commonly, intake of Aspirin or Clopidogrel is no contraindication for infiltration therapy but is routinely paused when possible)
- •Pseudoradicular pain (e.g. in facet arthrosis, iliosacral arthrosis...) - as evaluated to the best of the knowledge of the admitting physician and radiologist performing the infiltration
- •Osseous spinal or foraminal stenosis
- •Myelopathy
- •Severe scoliosis
- •Active neoplasm
- •History of spinal infection / spondylodiscitis
- •History of spinal surgery or previous infiltration therapy on the currently painful segment
- •Rheumatic disease
研究组 & 干预措施
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
干预措施: Kenacort® (Drug)
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
干预措施: Cervical nerve root infiltration (Procedure)
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
干预措施: Mephamesone (Drug)
Cervical disc herniation
Patients with cervical disc herniation and compression of nerve roots C3-C8.
干预措施: 0.5% bupivacaine (Bupivacain®) (Drug)
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
干预措施: Lumbar nerve root infiltration (Procedure)
Lumbar disc herniation
Patients with lumbar disc herniation and compression of nerve roots L1-S1.
干预措施: 0.5% bupivacaine (Bupivacain®) (Drug)
结局指标
主要结局
Health-related quality of life (HRQoL)
时间窗: 1 month
(SF)-12 questionaire Change from Baseline SF-12 at 1 month
次要结局
- Ability to return to work (0-100%) and time-to-return to work.(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Frequency of opioid use (yes/no)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Oswestry Disability Index (ODI)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Need for hospitalization for disabling pain and time-to-hospitalization.(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Need for repeated infiltrations and time-to-infiltration between the study groups.(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Absolute VAS pain reduction of a repeated "boost"-infiltration(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Reasons for 2nd infiltration / surgery(1 month, 3 months, 6 months, 12 months, 24 months)
- Percent change of pain (VAS)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Neck Pain and Disability Scale (NPAD)(Before, 14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Need for additional surgical therapy and time-to-surgery.(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
- Health-related quality of life (HRQoL)(Before, 14 days, 1, month, 3 months, 6 months, 12 months, 24 months)
- Patient's satisfaction with therapy(14 days, 1 month, 3 months, 6 months, 12 months, 24 months)
研究者
Holger Joswig
Dr. med.
Cantonal Hospital of St. Gallen