Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
Many patients with cervical disc disease have long-lasting and complex symptoms with chronic pain, low levels of physical and psychological function and sick-leave. Surgery on a few segmental levels might be expected to solve the disc-specific pain but not the non-specific neck pain and the patients'illness. As much as 2/3 of the patients have been reported to have remaining physical/ psychological disability long-term after surgery. A structured physiotherapy programme after surgery may improve patients'function and return to work. The main purpose of the study is to evaluate what a well structured rehabilitation program adds to the customary treatment after surgery for radiculopathy due to cervical disc disease in respect to function, disability, workability and cost effectiveness. The study is a prospective randomised controlled multi-centre study, with an independent and blinded investigator comparing two alternatives of rehabilitation. 200 patients in working age, with cervical disc disease with clinical findings and symptoms of cervical nerve root compression will be included after informed consent. After inclusion in the study patients will be randomised to one out of the two alternatives of physiotherapy, (A) customary treatment (information/ advice on the specialist clinic) or (A+B) active physiotherapy; standardised and structured program of neck specific exercises combined with a behavioural approach plus customary treatment. Patients will be evaluated both clinically and with questionnaires before surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months after surgery. Main outcome variable are neck specific disability. Cost-effectiveness will be calculated. The inclusion will preliminary be closed 2012. The study could contribute to a better clinical decision making, a better health care which will reduce physical, mental and social costs for the patients, and improve the rates of patients returning to and staying at work.
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
- Single (Investigator)
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
- •Patients will be included from four Neurosurgical clinics in the south of Sweden and the rehabilitation will be performed in primary care units in several counties.
- •Patients in working age, with MRI-verified cervical disc disease with clinical findings and symptoms of cervical nerve root compression and who have had surgery with anterior decompression and fusion or posterior surgery (foraminotomy/ laminectomy) will be included after informed consent.
排除标准
- •Patients with myelopathy or with a disease or trauma contraindicated to perform the treatment program or the measurements will be excluded and so also patients with lack of familiarity of the Swedish language or with known drug abuse.
研究组 & 干预措施
Customary treatment
Group A (physiotherapy as usual), customary treatment. The staff at the Neurosurgical clinic will give the patient ordinary pre- and postoperative information. The physiotherapist at the Neurosurgical clinic informs the patients what to avoid the first weeks after surgery and the importance of a good posture and ergonomic thinking in daily life. The patient is also instructed how to do exercises for the shoulder range of motion. Patients have ordinary post-surgery visit to the surgeon and to the physiotherapist about 6 weeks after the surgery, where physiotherapist instructs the patient in exercises for active neck range of motion.
干预措施: Customary treatment (Other)
structured behavioural medicine program
Group B (extended physiotherapy treatment), customary treatment (please see above) plus a standardised and structured behavioural medicine program. The behavioural medicine program includes functional behavioural analysis of the problem, medical exercise therapy, strategies to increase self-efficacy in activities and problem-solving strategies for coping with disability.
干预措施: Structured behavioural medicine program (Other)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: Baseline and change after 3, 6, 12 and 24 months follow-up. The outcome measures is going to report a change over time.
NDI will be measured at baseline before surgical intervention. Change from baseline in NDI will be measured at 3, 6, 12 and 24 months follow-up. NDI will be used to investigate Neck specific disability. The 10 sections in the questionnaire are rated on a six-point scale (0-5 point). The scores for all sections are added together and transformed to percentages (where 0% is no pain or difficulties and 100% is highest score for pain and difficulty on all items.
次要结局
- Pain intensity on visual analogue scale (VAS 0-100mm)(The outcome measure is going to report a change over time from baseline and at 6 weeks, 3, 6, 12 and 24 months follow-up)
- Dizziness/ unsteadiness measured on a visual analogue scale (VAS) 0-100mm(The outcome measure is going to report a change over time from baseline to 3, 6, 12 and 24 months follow-up)
- Modified Odom scale and a question if how important the change is.(The outcome measure is going to report a change over time from before surgery to 6 weeks, 3, 6, 12 and 24 months follow-up.)
- MSPQ questionnaire(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Distress and risk assessment method (DRAM)(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Expectations of treatment fulfilled(The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up.)
- Background data(Mainly before treatment started. Some basic background data are also asked at the follow-ups at 6 weeks, 3, 6, 12 and 24 months to control for variations over time.)
- Vocational situation(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Pain-drawing(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Zung questionnaire(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Patient Enablement Instrument (PEI)(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Coping Strategies Questionnaire(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Work Ability Index(Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Physical activity/ exercise habits(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Symptom satisfaction(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Pain frequency and pain medication(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Self-efficacy scale(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Question about re-surgery(Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- EuroQuol five dimensions self report (EQ-5D) and EuroQuol thermometer(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Multidimensional Pain Inventory, Swedish version (MPI-S), MPI-S significant others and open questions(Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Physical clinical outcome measures(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Patients income(At baseline and at 1 and 2 years follow up. The outcome is going to report a change over time)
- Copy of the sick-leave receipt from the surgeon(After surgery (baseline, before physiotherapy started))
- Neurological status(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
- Patient Specific Functional Scale (PSFS)(Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.)
研究者
Anneli Peolsson
Assoc. Prof., PhD, MSc PT
Linkoeping University