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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital, Linkoeping
Karolinska University Hospital
Ryhov County Hospital
Lund University Hospital
Information provided by (Responsible Party):
Anneli Peolsson, Linkoeping University
ClinicalTrials.gov Identifier:
NCT01547611
First received: February 27, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Radiculopathy
Other: Customary treatment
Other: Structured behavioural medicine program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • Neck Disability Index (NDI) [ Time Frame: Baseline and change after 3, 6, 12 and 24 months follow-up. The outcome measures is going to report a change over time. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Pain intensity on visual analogue scale (VAS 0-100mm) [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Pain intensity of neck pain, arm pain and headache, respectively

  • Dizziness/ unsteadiness measured on a visual analogue scale (VAS) 0-100mm [ Time Frame: The outcome measure is going to report a change over time from baseline to 3, 6, 12 and 24 months follow-up ] [ Designated as safety issue: No ]
    Dizziness/ unsteadiness measured on a VAS-scale (0=no problems, 100= pretty severe problems).

  • Modified Odom scale and a question if how important the change is. [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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).

  • Expectations of treatment fulfilled [ Time Frame: The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up. ] [ Designated as safety issue: No ]
    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).

  • Background data [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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

  • Vocational situation [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Questionns about sick-leave, ergonomics, expectations of being able to work in 6 months, work ability index

  • Pain-drawing [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Character of pain, number of pain localisation and distributions of symptoms

  • Zung questionnaire [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • MSPQ questionnaire [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Distress and risk assessment method (DRAM) [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Zung and MSPQ questionnaires will be combined in the DRAM instrument

  • Patient Enablement Instrument (PEI) [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Coping Strategies Questionnaire [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Work Ability Index [ Time Frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Physical activity/ exercise habits [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Symptom satisfaction [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    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).

  • Pain frequency and pain medication [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Self-efficacy scale [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    "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).

  • Question about re-surgery [ Time Frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Descriptive data

  • EuroQuol five dimensions self report (EQ-5D) and EuroQuol thermometer [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Health realted quality of life

  • Multidimensional Pain Inventory, Swedish version (MPI-S), MPI-S significant others and open questions [ Time Frame: Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Relationship and support from spouses

  • Neurological status [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    Questions of numbness and tinglings in the arm and hand and pain distribution. Clinical examination: sensibility, reflexes, motor function.

  • Patient Specific Functional Scale (PSFS) [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
  • Physical clinical outcome measures [ Time Frame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time. ] [ Designated as safety issue: No ]
    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

  • Patients income [ Time Frame: At baseline and at 1 and 2 years follow up. The outcome is going to report a change over time ] [ Designated as safety issue: No ]
    Will be used for health echonomic calculations

  • Copy of the sick-leave receipt from the surgeon [ Time Frame: After surgery (baseline, before physiotherapy started) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Experimental: 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.
Other: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547611

Locations
Sweden
Department of Medical and Health Sciences
Linköping, Östergötland, Sweden, SE-58183
Linköping University
Linköping, Östergötland, Sweden, SE-58183
Sponsors and Collaborators
Linkoeping University
University Hospital, Linkoeping
Karolinska University Hospital
Ryhov County Hospital
Lund University Hospital
Investigators
Study Chair: Anneli Peolsson, PhD Linköping University, Sweden
  More Information

No publications provided by Linkoeping University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anneli Peolsson, Assoc. Prof., PhD, MSc PT, Linkoeping University
ClinicalTrials.gov Identifier: NCT01547611     History of Changes
Other Study ID Numbers: Rehab. after cervical surgery
Study First Received: February 27, 2012
Last Updated: May 26, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Linkoeping University:
Rehabilitation
Cervical Spine
Radiculopathy
Disc
Surgery

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014