- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01547611
Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial
Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Östergötland
-
Linköping, Östergötland, Sweden, SE-58183
- Linköping University
-
Linköping, Östergötland, Sweden, SE-58183
- Department of Medical and Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 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
|
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
Time Frame: The outcome measure is going to report a change over time from baseline to 3, 6, 12 and 24 months follow-up
|
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.
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.
|
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
Time Frame: The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up.
|
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
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.
|
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
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.
|
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.
|
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.
|
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
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.
|
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
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.
|
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)
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.
|
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)
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.
|
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
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.
|
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
Time Frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
"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
Time Frame: Before intervention and at 6, 12 and 24 months follow-up. The outcome measure is going to report a change over time.
|
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
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.
|
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
Time Frame: Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time.
|
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
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.
|
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)
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.
|
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
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.
|
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
Time Frame: At baseline and at 1 and 2 years follow up. The outcome is going to report a change over time
|
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
Time Frame: After surgery (baseline, before physiotherapy started)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Anneli Peolsson, PhD, Linköping University, Sweden
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rehab. after cervical surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Radiculopathy
-
Marmara UniversityNot yet recruiting
-
Universidad de ZaragozaRecruitingLumbar RadiculopathySpain
-
Linkoeping UniversityRecruitingCervical RadiculopathySweden
-
Icahn School of Medicine at Mount SinaiTerminated
-
Oslo University HospitalActive, not recruiting
-
Universitair Ziekenhuis BrusselVrije Universiteit BrusselCompletedLumbar RadiculopathyBelgium
-
Riphah International UniversityCompletedLumbar RadiculopathyPakistan
-
Cairo UniversityUnknownCervical Radiculopathy
-
Isra UniversityUnknown
-
Shanghai Jiao Tong University Affiliated Sixth...UnknownCervical Radiculopathy
Clinical Trials on Customary treatment
-
Blythedale Children's HospitalCompletedCerebral Palsy | Balance ProblemsUnited States
-
Centre de Recherche de l'Institut Universitaire...Duke University; University of Ottawa; Simon Fraser UniversityUnknownOlder Adults | Mobility Disability | Community DwellingCanada
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Completed
-
U.S. Wound RegistryRecruitingWounds and Injuries | Diabetic Foot | Leg Ulcer | Skin Ulcer | Diabetes Complications | Diabetic Neuropathies | Lymphedema | Peripheral Arterial Disease | Vasculitis | Venous Insufficiency | Varicose Ulcer | Pressure Ulcer | Pyoderma | Surgical Wound Dehiscence | Amputation StumpUnited States
-
University of Southern CaliforniaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedStroke | Cerebrovascular Disorders | Brain Ischemia | Cerebral Infarction | Brain InfarctionUnited States
-
Peking University First HospitalUnknownUpper Tract Urothelial Carcinoma | Bladder Recurrence | NephroureterectomyChina
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; Stanford University; Ohio State University and other collaboratorsRecruitingHemiparesis | Perinatal StrokeUnited States
-
University of SaskatchewanSaskatchewan Health Research FoundationRecruitingDiabetes MellitusCanada
-
NYU Langone HealthThe Commonwealth Fund; The California EndowmentCompleted
-
Swiss Federal Institute of TechnologyCentre Hospitalier Universitaire Vaudois; Swiss Commission for Technology and...Unknown