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

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ClinicalTrials.gov Identifier: NCT01831271
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Åsa Dedering, Karolinska University Hospital

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.

Condition or disease Intervention/treatment Phase
Cervical Pain Pain, Radiating Other: Prescribed physical activity Other: Neck specific training Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Prescribed physical activity
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.
Other: Prescribed physical activity
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 training
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.
Other: Neck specific training
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 Measures :
  1. 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


Secondary Outcome Measures :
  1. 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. ]
    Neck Specific Disability is measured with Neck Disability Index (NDI)


Other Outcome Measures:
  1. Health related quality of life [ 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. ]
    Health related quality of life is assessed by the EuroQuol 5 dimensions (EQ-5D).

  2. Self-efficacy [ 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. ]
    Self-efficacy will be measured on the Self-efficacy and Exercise Self-efficacy scales

  3. Symptom satisfaction [ 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. ]
    Symptom satisfaction is rated on 7-grade scale

  4. Fear Avoidance Beliefs [ 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. ]
    Fear Avoidance Beliefs will be measured with Fear Avoidance Beliefs questionnaire (FABQ)and Tampa scale (TSK)

  5. Depression [ 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. ]
    Hostility, anxiety and depression will be measured with Hostility, anxiety and depression scale (HAD)

  6. Coping strategies [ 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. ]
    Coping strategies will be measured with Coping strategy questionnaire

  7. Pain catastrophizing [ 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. ]
    Pain catastrophizing will be measured with Pain catastrophizing scale

  8. Physical activity [ 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. ]
    Physical activity will be measured with International Physical activity questionnaire

  9. Patients specific goals [ 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. ]
    Patients specific goals will measured with Patients specific functional scale and Patient goal assessment scale

  10. Work ability [ 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. ]
    Work ability will be measured with Work Ability Index

  11. Physical clinical outcome measures [ 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. ]
    Clinical examination

  12. 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. ]
  13. 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. ]
  14. Muscle fatigue [ Time Frame: Baseline and change after 15 weeks, 1 year follow up. The outcome measures is going to report a change over time. ]
    Electromyography on the neck muscles

  15. Neck muscle endurance [ Time Frame: Base line, 15 weeks, 6 months, 1 year, 2 years, The outcome measures is going to report a change over time. ]
    Neck muscle endurance time measured in sec for dorsal and ventral neck muscles during a static endurance test



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831271


Locations
Sweden
Department of Physical Therapy, Karolinska University Hospital,
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Linkoeping University
Investigators
Study Chair: Åsa Dedering, PhD Karolinska Institutet

Publications:
Responsible Party: Åsa Dedering, PhD, Head of Department, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01831271     History of Changes
Other Study ID Numbers: KI: 2009/1756-31/4
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

Keywords provided by Åsa Dedering, Karolinska University Hospital:
Exercise, Physical
Physical Activity
Outcome Measures

Additional relevant MeSH terms:
Radiculopathy
Neck Pain
Pain
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms