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

NCT01547611 | Completed DMC

• 1 other identifier: Rehab. after cervical surgery
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Radiculopathy

Keywords

Rehabilitation; Cervical Spine; Radiculopathy; Disc; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• 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.

• 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.

Study Arms (2)

Customary treatment

ACTIVE COMPARATOR

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

structured behavioural medicine program

EXPERIMENTAL

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

Interventions

Customary treatment OTHER

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.

Customary treatment

Structured behavioural medicine program OTHER

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.

structured behavioural medicine program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linkoeping University: lead
• University Hospital, Linkoeping: collaborator
• Karolinska University Hospital: collaborator
• Ryhov County Hospital: collaborator
• Lund University Hospital: collaborator

Study Sites (2)

Department of Medical and Health Sciences

Linköping, Östergötland County, SE-58183, Sweden

Location

Linköping University

Linköping, Östergötland County, SE-58183, Sweden

Location

Related Publications (8)

• Peolsson A, Lofgren H, Dedering A, Kristedal M, Oberg B, Zsigmond P, Wibault J. Neurological outcomes after surgery and postoperative rehabilitation for cervical radiculopathy due to disc disease: a 2-year-follow-up of a randomized clinical trial. Sci Rep. 2023 Mar 7;13(1):3830. doi: 10.1038/s41598-023-31005-z.

  PMID: 36882483 DERIVED

• Peolsson A, Wibault J, Lofgren H, Dedering A, Oberg B, Zsigmond P, Wahlin C. Work Ability After Anterior Cervical Decompression and Fusion Followed by a Structured Postoperative Rehabilitation: Secondary Outcomes of a Prospective Randomized Controlled Multi-Centre Trial with a 2-year Follow-up. J Occup Rehabil. 2022 Sep;32(3):473-482. doi: 10.1007/s10926-021-10015-6. Epub 2021 Dec 11.

  PMID: 34894316 DERIVED

• Lam K, Peolsson A, Soldini E, Lofgren H, Wibault J, Dedering A, Oberg B, Zsigmond P, Barbero M, Falla D. Larger pain extent is associated with greater pain intensity and disability but not with general health status or psychosocial features in patients with cervical radiculopathy. Medicine (Baltimore). 2021 Feb 26;100(8):e23718. doi: 10.1097/MD.0000000000023718.

  PMID: 33663038 DERIVED

• Liew BXW, Peolsson A, Falla D, Cleland JA, Scutari M, Kierkegaard M, Dedering A. Mechanisms of recovery after neck-specific or general exercises in patients with cervical radiculopathy. Eur J Pain. 2021 May;25(5):1162-1172. doi: 10.1002/ejp.1741. Epub 2021 Feb 24.

  PMID: 33533164 DERIVED

• Liew BXW, Peolsson A, Scutari M, Lofgren H, Wibault J, Dedering A, Oberg B, Zsigmond P, Falla D. Probing the mechanisms underpinning recovery in post-surgical patients with cervical radiculopathy using Bayesian networks. Eur J Pain. 2020 May;24(5):909-920. doi: 10.1002/ejp.1537. Epub 2020 Feb 21.

  PMID: 31985097 DERIVED

• Peolsson A, Lofgren H, Dedering A, Oberg B, Zsigmond P, Hedevik H, Wibault J. Postoperative structured rehabilitation in patients undergoing surgery for cervical radiculopathy: a 2-year follow-up of a randomized controlled trial. J Neurosurg Spine. 2019 Mar 22;31(1):60-69. doi: 10.3171/2018.12.SPINE181258. Print 2019 Jul 1.

  PMID: 30901755 DERIVED

• Wibault J, Oberg B, Dedering A, Lofgren H, Zsigmond P, Peolsson A. Structured postoperative physiotherapy in patients with cervical radiculopathy: 6-month outcomes of a randomized clinical trial. J Neurosurg Spine. 2018 Jan;28(1):1-9. doi: 10.3171/2017.5.SPINE16736. Epub 2017 Nov 3.

  PMID: 29087809 DERIVED

• Peolsson A, Oberg B, Wibault J, Dedering A, Zsigmond P, Bernfort L, Kammerlind AS, Persson LC, Lofgren H. Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial. BMC Musculoskelet Disord. 2014 Feb 6;15:34. doi: 10.1186/1471-2474-15-34.

  PMID: 24502414 DERIVED

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Anneli Peolsson, PhD

  Linkoeping University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., PhD, MSc PT

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 8, 2012
• Study Start: January 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)