Treating Selected Chronic WAD Patients: Cervical Fusion or Multidimensional Rehabilitation. A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- Complaints of WAD
研究概览
简要总结
Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Some of them, however, present with symptoms that might indicate pain from a motion segment, possibly the disc. Our aim was therefore to test this possibility by performing a randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD patients.
Methods: Patients with a specified symptomatology, all with pronounced symptoms for long periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal rehabilitation (24 pat.). All patients were investigated before start of the study and at follow-up approximately two years after treatment by four independent examiners from disciplines usually involved in treating WAD patients. The patients also gave their own assessments of the treatment results. Seven patients in each group did not undergo the allocated treatment for various reasons.
详细描述
Outcomes:
representing different disciplines: neurology, orthopedics, physical medicine and psychology. Each patient´s perceived change in outcome was also assessed. Assessment was made before treatment and at follow-up two years afterwards.
In addition to the assessments of outcome made by the examiners, the patients completed the SF-36, EQ-5D and BIS (Balanced Inventory for Spinal Disorders) questionnaires before treatment and at follow-up. The results of these assessments will be given in a forthcoming paper.
6b. No changes in trial outcomes were made during the study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year.
- •They should be in the age group 18 to 60 years,
- •have been actively working up until the accident,
- •should not have had previous neck pain.
- •All patients should have had a plain X-ray and an MRI showing no specific changes.
- •The patients should present with pronounced neck pain with the origin in the midline.
- •The character of the pain should be dull, aching, and, with sudden movements, stabbing in the same area.
- •Palpation and pressure in that area should provoke deep pain..
排除标准
- •Previous pain in the neck, previous surgery
结局指标
主要结局
Complaints of WAD
时间窗: Independent examiners
SF-36 questionnaire
时间窗: Follow-up at 2 years
次要结局
- Range of neck movement(Follow-up at 2 years)
- Complaints of WAD(SF-36)
研究者
Bo Nyström
MD, PhD
Spinal Surgery Clinic, Strängnäs