RadiculopathyNCT01547611
Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Multi-Centre Trial
A study testing Customary treatment and Structured behavioural medicine program in people with Radiculopathy, run by Linkoeping University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiculopathy
- What is being tested?
- Customary treatment and Structured behavioural medicine program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Department of Medical and Health Sciences
Linköping, Östergötland County, SE-58183
Linköping University
Linköping, Östergötland County, SE-58183
About this study
Official title: Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial
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
- Being tested
- Customary treatment, Structured behavioural medicine program
- Keywords
- Rehabilitation, Cervical Spine, Radiculopathy, Disc, Surgery
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customary treatmentOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Structured behavioural medicine program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pain intensity of neck pain, arm pain and headache, respectively
Measured: 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
Dizziness/ unsteadiness measured on a VAS-scale (0=no problems, 100= pretty severe problems).
Measured: 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.
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).
Measured: 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
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).
Measured: The outcome measure is going to report a change from 6 weeks, 3, 6, 12 and 24 months follow-up.
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
Measured: 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
Questionns about sick-leave, ergonomics, expectations of being able to work in 6 months, work ability index
Measured: 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
Character of pain, number of pain localisation and distributions of symptoms
Measured: 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
Measured: 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
Measured: 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)
Zung and MSPQ questionnaires will be combined in the DRAM instrument
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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).
Measured: 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
Measured: 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
"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).
Measured: 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
Descriptive data
Measured: 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
Health realted quality of life
Measured: 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
Relationship and support from spouses
Measured: Before intervention and at 12 and 24 months follow-up. The outcome measure is going to report a change over time.
Neurological status
Questions of numbness and tinglings in the arm and hand and pain distribution. Clinical examination: sensibility, reflexes, motor function.
Measured: 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)
Measured: 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
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
Measured: 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
Will be used for health echonomic calculations
Measured: 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
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.
Measured: After surgery (baseline, before physiotherapy started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital, Ryhov County Hospital, Lund University Hospital
- Responsible party
- Principal investigator, Anneli Peolsson, Linkoeping University
- Investigators
- Anneli Peolsson, PhD, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547611
- Sponsor's protocol ID
- Rehab. after cervical surgery
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2012
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36882483Peolsson 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.
PubMed 34894316Lam 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.
PubMed 33663038Liew 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.
PubMed 33533164Liew 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.
PubMed 31985097Peolsson 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.
PubMed 30901755Wibault 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.
PubMed 29087809Peolsson 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.
PubMed 24502414
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Physiotherapy After Surgery for Cervical Disc Disease: a Prospective Randomised Multi-Centre Trial
- ClinicalTrials.gov ID
- NCT01547611
- Acronym / sponsor ID
- Rehab. after cervical surgery
- Conditions
- Radiculopathy
- Keywords
- Rehabilitation, Cervical Spine, Radiculopathy, Disc, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- University Hospital, Linkoeping, Karolinska University Hospital, Ryhov County Hospital, Lund University Hospital
- Study start
- Jan 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customary treatment | Active comparator | Other: Customary treatmentGroup 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. |
| structured behavioural medicine program | Experimental | Other: Structured behavioural medicine programGroup 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customary treatmentThe 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 programThe 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 |
Primary outcome
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.
25 secondary outcomes
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Patients income
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 36882483Peolsson 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.
- Derived from this study: PubMed 34894316Peolsson 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.
- Derived from this study: PubMed 33663038Lam 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.
- Derived from this study: PubMed 33533164Liew 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.
- Derived from this study: PubMed 31985097Liew 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.
- Derived from this study: PubMed 30901755Peolsson 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.
- Derived from this study: PubMed 29087809Wibault 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.
- Derived from this study: PubMed 24502414Peolsson 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.
- Individual participant dataSharing planned: No
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Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anneli Peolsson, PhD study chair
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customary treatment and Structured behavioural medicine program in people with Radiculopathy, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547611, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.