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Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy

Primary Purpose

Cervical Pain, Pain, Radiating

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Prescribed physical activity
Neck specific training
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain focused on measuring Exercise, Physical, Physical Activity, Outcome Measures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • known drug abuse,
  • lack of familiarity with the Swedish language,
  • diagnosed psychiatric disorder

Sites / Locations

  • Department of Physical Therapy, Karolinska University Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Prescribed physical activity

Neck specific training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain
Neck and Arm Pain is measured with Visual Analogue Scale

Secondary Outcome Measures

Disability
Neck Specific Disability is measured with Neck Disability Index (NDI)

Full Information

First Posted
April 5, 2013
Last Updated
September 6, 2017
Sponsor
Karolinska University Hospital
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01831271
Brief Title
Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain, Pain, Radiating
Keywords
Exercise, Physical, Physical Activity, Outcome Measures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prescribed physical activity
Arm Type
Other
Arm Description
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.
Arm Title
Neck specific training
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Prescribed physical activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Neck specific training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Neck and Arm Pain is measured with Visual Analogue Scale
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.
Secondary Outcome Measure Information:
Title
Disability
Description
Neck Specific Disability is measured with Neck Disability Index (NDI)
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.
Other Pre-specified Outcome Measures:
Title
Health related quality of life
Description
Health related quality of life is assessed by the EuroQuol 5 dimensions (EQ-5D).
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.
Title
Self-efficacy
Description
Self-efficacy will be measured on the Self-efficacy and Exercise Self-efficacy scales
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.
Title
Symptom satisfaction
Description
Symptom satisfaction is rated on 7-grade scale
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.
Title
Fear Avoidance Beliefs
Description
Fear Avoidance Beliefs will be measured with Fear Avoidance Beliefs questionnaire (FABQ)and Tampa scale (TSK)
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.
Title
Depression
Description
Hostility, anxiety and depression will be measured with Hostility, anxiety and depression scale (HAD)
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.
Title
Coping strategies
Description
Coping strategies will be measured with Coping strategy questionnaire
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.
Title
Pain catastrophizing
Description
Pain catastrophizing will be measured with Pain catastrophizing scale
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.
Title
Physical activity
Description
Physical activity will be measured with International Physical activity questionnaire
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.
Title
Patients specific goals
Description
Patients specific goals will measured with Patients specific functional scale and Patient goal assessment scale
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.
Title
Work ability
Description
Work ability will be measured with Work Ability Index
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.
Title
Physical clinical outcome measures
Description
Clinical examination
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.
Title
Cervical range of motion
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.
Title
Hand strength
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.
Title
Muscle fatigue
Description
Electromyography on the neck muscles
Time Frame
Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time.
Title
Neck muscle endurance
Description
Neck muscle endurance time measured in sec for dorsal and ventral neck muscles during a static endurance test
Time Frame
Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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, known drug abuse, lack of familiarity with the Swedish language, diagnosed psychiatric disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Åsa Dedering, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Physical Therapy, Karolinska University Hospital,
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25115308
Citation
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.
Results Reference
background
PubMed Identifier
30473018
Citation
Dedering 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.
Results Reference
derived

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Neck-specific Training or Prescribed Physical Activity for Patients With Cervical Radiculopathy

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