Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain (WADNECXT)

October 6, 2016 updated by: Inge Ris Hansen, University of Southern Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5230
        • University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pain Management + Training
Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training
Other: Education and training
Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times
Active Comparator: Pain Management
Education in pain management strategies
Behavioral: Pain management
Educational sessions in pain management 4 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
craniocervical flexion test
Time Frame: 12 months
test for the deep cervical flexor muscles
12 months
cervical range of motion
Time Frame: 12 months
12 months
neck positioning test
Time Frame: 12 months
neck joint position error test and gaze stability test
12 months
Self-rated measure Global Perceived Effect
Time Frame: 12 months
questionnaire
12 months
Neck Disability Index
Time Frame: 12 months
questionnaire
12 months
Pain Bothersomeness
Time Frame: 12 months
questionnaire
12 months
Pain Specific Functioning Scale
Time Frame: 4 months and 12 months
questionnaire
4 months and 12 months
TAMPA scale of Kinesiophobia
Time Frame: 12 months
questionnaire
12 months
Impact of Event scale
Time Frame: 12 months
questionnaire
12 months
Euroqol-5D
Time Frame: 12 months
questionnaire
12 months
Mechanical allodynia
Time Frame: 12 months
Pressure pain treshold for selected points
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Region of Southern Denmark
Association of Danish Physiotherapists

Investigators

  • Study Chair: Birgit Juul-Kristensen, ph.d., University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WADNECXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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