Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial

Study Overview
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Brief Summary
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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.

Official Title
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Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial

Conditions
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Radiculopathy

Intervention / Treatment
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* Other: Customary treatment
* Other: Structured behavioural medicine program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Customary treatment<br>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. | Other: Customary treatment<br>* 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.<br>|
| Experimental: structured behavioural medicine program<br>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. | Other: Structured behavioural medicine program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index (NDI) | 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. | Baseline and change after 3, 6, 12 and 24 months follow-up. The outcome measures is going to report a change over time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-drawing | Character of pain, number of pain localisation and distributions of symptoms | 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. | 
| 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) | Zung and MSPQ questionnaires will be combined in the DRAM instrument | 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 | How patients would feel about having their current neck symptoms for the rest of their lives was rated on a seven grade scale (1= delighted, 7=terrible). | 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 | People´s beliefs about their capabilities to produce designated levels of performance that exercise influence overe events that affect their lives Self efficacy (Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident). | 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 | Descriptive data | 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 | Health realted quality of life | 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 | Relationship and support from spouses | Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time. | 
| Neurological status | Questions of numbness and tinglings in the arm and hand and pain distribution. Clinical examination: sensibility, reflexes, motor function. | 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. | 
| Physical clinical outcome measures | Range of motion in the neck, head repositioning accuracy (cervical kinesteshia), hand strength, balance (sharpened Romberg, walking in a figure of eight), neck muscle endurance | 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 | Will be used for health echonomic calculations | 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 | Copy of the sickness certificate written by the physician. The certificate will be analysed due to quality with the emphasis on how the cervical radiculopathy impact on function and work ability and due to the quality of sickness certificate in relation to Swedish insurance office rules. | After surgery (baseline, before physiotherapy started) | 
| Pain intensity on visual analogue scale (VAS 0-100mm) | Pain intensity of neck pain, arm pain and headache, respectively | 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 | Dizziness/ unsteadiness measured on a VAS-scale (0=no problems, 100= pretty severe problems). | 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. | A 1 to 6 point scale of treatment outcome. 1=recovered, 2=much better, 3=better, 4=unchanged, 5=worse, 6= much worse. How important is the change on a 0 to 10 point horizontal scale (0=not at all important, 10= very important). | 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. | 
| Expectations of treatment fulfilled | Fulfillment of the expectations for surgery at follow-ups was measured on a four-grade scale (1=yes, completely; 2=yes, partially; 3=no, not at all; or 4= do not know). | The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up. | 
| Background data | Pain history, pain debute, pain duration, pain medication, other diseases and problems than from the neck, age, sex, smoking, family and social life, expectations of the treatment, care seeking, type of work | 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 | Questionns about sick-leave, ergonomics, expectations of being able to work in 6 months, work ability index | Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Cervical Spine, Radiculopathy, Disc, Surgery