Clinical trial NCT01547611: Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial
Official title: Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Keywords: Rehabilitation
Cervical Spine
Radiculopathy
Disc
Surgery
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Linkoeping
name: Karolinska University Hospital
name: Ryhov County Hospital
name: Lund University Hospital
First posted: 2012-03-08
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 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:
measure: Pain intensity on visual analogue scale (VAS 0-100mm)
timeFrame: 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
measure: Dizziness/ unsteadiness measured on a visual analogue scale (VAS) 0-100mm
timeFrame: The outcome measure is going to report a change over time from baseline to 3, 6, 12 and 24 months follow-up
measure: Modified Odom scale and a question if how important the change is.
timeFrame: 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.
measure: Expectations of treatment fulfilled
timeFrame: The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up.
measure: Background data
timeFrame: 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.
measure: Vocational situation
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Pain-drawing
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Zung questionnaire
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: MSPQ questionnaire
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Distress and risk assessment method (DRAM)
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Patient Enablement Instrument (PEI)
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Coping Strategies Questionnaire
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Work Ability Index
timeFrame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Physical activity/ exercise habits
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Symptom satisfaction
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Pain frequency and pain medication
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Self-efficacy scale
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Question about re-surgery
timeFrame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: EuroQuol five dimensions self report (EQ-5D) and EuroQuol thermometer
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Multidimensional Pain Inventory, Swedish version (MPI-S), MPI-S significant others and open questions
timeFrame: Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Neurological status
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Physical clinical outcome measures
timeFrame: Before intervention and at 3, 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
measure: Patients income
timeFrame: At baseline and at 1 and 2 years follow up. The outcome is going to report a change over time
measure: Copy of the sick-leave receipt from the surgeon
timeFrame: After surgery (baseline, before physiotherapy started)
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Medical and Health Sciences
state: Östergötland
city: Linköping
country: Sweden
facility: Linköping University
state: Östergötland
Study officials:
affiliation: Linkoeping University
name: Anneli Peolsson, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.