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Completed

NCT Number: NCT01831271

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

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.

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Key information

Conditions

Cervical Pain Behavior Motor Activity Neck Pain Neurologic Manifestations Pain Pain, Radiating Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Karolinska University Hospital,

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Linkoeping University

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2016
Study completion
2017
First posted
Apr 15, 2013
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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