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

Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547611
• Other study ID #: Rehab. after cervical surgery
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: March 5, 2018
• Start date: January 2009
• Est. completion date: December 2014

Study information

• Verified date: March 2018
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Department of Medical and Health Sciences	Linköping	Östergötland
Sweden	Linköping University	Linköping	Östergötland

Sponsors (5)

Lead Sponsor	Collaborator
Linkoeping University	Karolinska University Hospital, Lund University Hospital, Ryhov County Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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)