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Clinical Trials/NCT01431261
NCT01431261
Completed
Not Applicable

Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain

University of Southern Denmark1 site in 1 country200 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
University of Southern Denmark
Enrollment
200
Locations
1
Primary Endpoint
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.

Detailed Description

Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life. Physical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain. Thus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach. The study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Inge Ris Hansen

PhD. student

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • chronic neck pain for at least 6 months
  • reduced physical neck function (NDI minimum 10)
  • pain primarily in the neck region,
  • finished any medical /radiological examinations
  • able to read and understand Danish and
  • able to participate in the exercise program.

Exclusion Criteria

  • radiculopathies upper extremity
  • neurological deficits
  • in a process of examining for unknown pathology,
  • experimental medical treatment,
  • being in a unstable social situation
  • pregnancy
  • fractures
  • suffering from depression
  • other known coexisting medical conditions which would severely restrict participation in the exercise program

Outcomes

Primary Outcomes

Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)

Time Frame: 12 months

Secondary Outcomes

  • TAMPA scale of Kinesiophobia(12 months)
  • Euroqol-5D(12 months)
  • Pain Specific Functioning Scale(4 months and 12 months)
  • Mechanical allodynia(12 months)
  • Self-rated measure Global Perceived Effect(12 months)
  • Pain Bothersomeness(12 months)
  • craniocervical flexion test(12 months)
  • cervical range of motion(12 months)
  • Impact of Event scale(12 months)
  • neck positioning test(12 months)
  • Neck Disability Index(12 months)

Study Sites (1)

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