Cervical PainNCT01831271
Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy
A study testing Prescribed physical activity and Neck specific training in people with Cervical Pain and Pain, Radiating, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The overall objective is to evaluate if treatment with a neck-specific exercise program and cognitive behavioural approach improves the outcome compared with prescribed, self-mediated and progressive physical activity in patients with cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cervical Pain, Pain, Radiating
- What is being tested?
- Prescribed physical activity and Neck specific training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Mar 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Magnetic Resonance Imaging (MRI) verified cervical disc disease showing cervical nerve root compression
- Positive Spurling sign and/or cervical extension test
- Clinical examination signs matching the MRI
Who cannot join
- earlier fracture or luxation of the cervical column,
- malignity,
- spinal tumour,
- spinal infection,
- previous surgery in the cervical column,
- co-morbidity such as disease or symptoms contraindicated to perform the treatment program or the measurements,
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- known drug abuse,
- lack of familiarity with the Swedish language,
- diagnosed psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Physical Therapy, Karolinska University Hospital,
Stockholm, 17176
About this study
Official title: Interventions for Patients With Cervical Radiculopathy- Neck-specific Training With a Cognitive Behavioural Approach Compared With Prescribed Physical Activity in a Prospective Randomised Controlled Trial
The overall objective is to evaluate if treatment with a neck-specific exercise program and cognitive behavioural approach improves the outcome compared with prescribed, self-mediated and progressive physical activity in patients with cervical radiculopathy. There is a lack of evidence of the best treatment for the patient category. Many patients are sick-listed for long periods of time with different kind of treatment approaches or without any treatment at all. The present study could fill the identified knowledge gap by strengthening of the currently weak scientific evidence for treatment of the patient category. The long-term effects of the study could be to reduce the time for sick leave and improve the rate of patients returning to work and/ or former activity by optimising treatments. Further on, to decrease the number of patients who finally have surgery for their neck problems and thus reducing the mental, physical and social costs.
Read the detailed description
Patients with cervical radiculopathy have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. The current scientific evidence lacks randomised controlled trials to compare surgery with conservative treatment as well as to evaluate different conservative interventions. Most patients are not candidates for surgery and are sick-listed for long time with different treatment approaches or without any treatment at all. The purpose is to evaluate if treatment with neck-specific training and a cognitive behavioral approach improves the outcome compared with prescribed physical activity. Methods: A randomized controlled trial including 144 patients will compare the intervention neck specific training and cognitive behavioural approach with an intervention of prescribed physical activity. The interventions will be led by experienced and specialised physiotherapists and last 14 weeks. Main outcome variable is pain intensity (VAS scale) accompanied with assessments of impairments and subjective health measurements undertaken before intervention and at 3, 6, 12 and 24 months. Implementation: The results will be presented scientifically as well as popularly in publications and professional meetings. Active implementation strategies to change physiotherapists treatment behaviour will be used. The best method will be chosen after surveying the physiotherapists treating patients in the current study regarding experiences, education and organisational context.
- Conditions
- Cervical Pain, Pain, Radiating
- Being tested
- Prescribed physical activity, Neck specific training
- Keywords
- Exercise, Physical, Physical Activity, Outcome Measures
- Medical subject headings
- Neck Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescribed physical activityOther
Prescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up. Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks. Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise.
Neck specific trainingOther
The active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation. At the start of the intervention motivational interviewing will be included. Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics. All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used.
| Study group | Role | What they receive |
|---|---|---|
| Prescribed physical activity | Other | Prescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up. Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks. Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise. Receives: Other: Prescribed physical activity |
| Neck specific training | Other | The active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation. At the start of the intervention motivational interviewing will be included. Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics. All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used. Receives: Other: Neck specific training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Neck and Arm Pain is measured with Visual Analogue Scale
Measured: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
Secondary outcomes (1)
Disability
Neck Specific Disability is measured with Neck Disability Index (NDI)
Measured: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startAug 2010
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Åsa Dedering, Karolinska University Hospital
- Investigators
- Åsa Dedering, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831271
- Sponsor's protocol ID
- KI: 2009/1756-31/4
- Status last verified
- Sep 2017
- First submitted
- 5 Apr 2013
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dedering A, Halvorsen M, Cleland J, Svensson M, Peolsson A. Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial. BMC Musculoskelet Disord. 2014 Aug 12;15:274. doi: 10.1186/1471-2474-15-274.
PubMed 25115308Dedering A, Peolsson A, Cleland JA, Halvorsen M, Svensson MA, Kierkegaard M. The Effects of Neck-Specific Training Versus Prescribed Physical Activity on Pain and Disability in Patients With Cervical Radiculopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2447-2456. doi: 10.1016/j.apmr.2018.06.008. Epub 2018 Jul 4.
PubMed 30473018
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Patients With Cervical Radiculopathy- Neck-specific Training With a Cognitive Behavioural Approach Compared With Prescribed Physical Activity in a Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01831271
- Acronym / sponsor ID
- KI: 2009/1756-31/4
- Conditions
- Cervical Pain, Pain, Radiating
- Keywords
- Exercise, Physical, Physical Activity, Outcome Measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Aug 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Apr 2013 (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.
The overall objective is to evaluate if treatment with a neck-specific exercise program and cognitive behavioural approach improves the outcome compared with prescribed, self-mediated and progressive physical activity in patients with cervical radiculopathy. There is a lack of evidence of the best treatment for the patient category. Many patients are sick-listed for long periods of time with different kind of treatment approaches or without any treatment at all. The present study could fill the identified knowledge gap by strengthening of the currently weak scientific evidence for treatment of the patient category. The long-term effects of the study could be to reduce the time for sick leave and improve the rate of patients returning to work and/ or former activity by optimising treatments. Further on, to decrease the number of patients who finally have surgery for their neck problems and thus reducing the mental, physical and social costs.
Detailed description
Patients with cervical radiculopathy have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. The current scientific evidence lacks randomised controlled trials to compare surgery with conservative treatment as well as to evaluate different conservative interventions. Most patients are not candidates for surgery and are sick-listed for long time with different treatment approaches or without any treatment at all. The purpose is to evaluate if treatment with neck-specific training and a cognitive behavioral approach improves the outcome compared with prescribed physical activity. Methods: A randomized controlled trial including 144 patients will compare the intervention neck specific training and cognitive behavioural approach with an intervention of prescribed physical activity. The interventions will be led by experienced and specialised physiotherapists and last 14 weeks. Main outcome variable is pain intensity (VAS scale) accompanied with assessments of impairments and subjective health measurements undertaken before intervention and at 3, 6, 12 and 24 months. Implementation: The results will be presented scientifically as well as popularly in publications and professional meetings. Active implementation strategies to change physiotherapists treatment behaviour will be used. The best method will be chosen after surveying the physiotherapists treating patients in the current study regarding experiences, education and organisational context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescribed physical activity | Other | Other: Prescribed physical activityPrescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up. Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks. Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise. |
| Neck specific training | Other | Other: Neck specific trainingThe active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation. At the start of the intervention motivational interviewing will be included. Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics. All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Magnetic Resonance Imaging (MRI) verified cervical disc disease showing cervical nerve root compression
- Positive Spurling sign and/or cervical extension test
- Clinical examination signs matching the MRI
Key exclusion criteria (9 listed)
- earlier fracture or luxation of the cervical column,
- malignity,
- spinal tumour,
- spinal infection,
- previous surgery in the cervical column,
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 |
|---|---|---|
| Prescribed physical activityPrescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up. Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks. Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise. | Other | Prescribed physical activity |
| Neck specific trainingThe active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation. At the start of the intervention motivational interviewing will be included. Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics. All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used. | Other | Neck specific training |
Primary outcome
Pain
Time frame: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
Neck and Arm Pain is measured with Visual Analogue Scale
1 secondary outcome
Disability
Time frame: Baseline and change after 15 weeks, 6 months, 1 year, 2 years follow up. The outcome measures is going to report a change over time.
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 7 Sep 2017.
- Background: PubMed 25115308Dedering A, Halvorsen M, Cleland J, Svensson M, Peolsson A. Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial. BMC Musculoskelet Disord. 2014 Aug 12;15:274. doi: 10.1186/1471-2474-15-274.
- Derived from this study: PubMed 30473018Dedering A, Peolsson A, Cleland JA, Halvorsen M, Svensson MA, Kierkegaard M. The Effects of Neck-Specific Training Versus Prescribed Physical Activity on Pain and Disability in Patients With Cervical Radiculopathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2447-2456. doi: 10.1016/j.apmr.2018.06.008. Epub 2018 Jul 4.
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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.
Åsa Dedering, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescribed physical activity and Neck specific training in people with Cervical Pain and Pain, Radiating, run by Karolinska University Hospital at 1 site 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 3 inclusion and 9 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pain (time frame: Baseline and change after 15 weeks, 6 months, 1 year, 2 years 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 NCT01831271, which also lists 2 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 7 Sep 2017.