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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Southern Denmark
Sponsor:
Collaborators:
Region Southern Denmark
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Inge Ris Hansen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01431261
First received: August 30, 2011
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Neck Pain
Chronic Pain Syndrome
Other: Education and training
Behavioral: Pain management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • craniocervical flexion test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    test for the deep cervical flexor muscles

  • cervical range of motion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • neck positioning test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    neck joint position error test and gaze stability test

  • Self-rated measure Global Perceived Effect [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Neck Disability Index [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Pain Bothersomeness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Pain Specific Functioning Scale [ Time Frame: 4 months and 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • TAMPA scale of Kinesiophobia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Impact of Event scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Euroqol-5D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • Mechanical allodynia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Pressure pain treshold for selected points


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431261

Contacts
Contact: Inge R Hansen, MR +45 65503736 iris@health.sdu.dk
Contact: Birgit Juul-Kristensen, ph.d. +45 65503412 bjuul-kristensen@health.sdu.dk

Locations
Denmark
University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics Recruiting
Odense, Denmark, 5230
Contact: Inge Ris Hansen    +4565503736    iris@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
Region Southern Denmark
Association of Danish Physiotherapists
Investigators
Study Chair: Birgit Juul-Kristensen, ph.d. University of Southern Denmark
  More Information

Additional Information:
No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inge Ris Hansen, PhD. student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01431261     History of Changes
Other Study ID Numbers: WADNECXT
Study First Received: August 30, 2011
Last Updated: June 15, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Chronic neck pain
Whiplash
Whiplash Associated Disorders
Chronic Pain
Neck exercises
Training
Pacing
Patient Education
Pain Management
Whiplash Injuries
Musculoskeletal

Additional relevant MeSH terms:
Neck Pain
Whiplash Injuries
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neck Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014