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

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ClinicalTrials.gov Identifier: NCT01431261
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : October 7, 2016
Region of Southern Denmark
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Inge Ris Hansen, University of Southern Denmark

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.

Condition or disease Intervention/treatment Phase
Neck Pain Chronic Pain Syndrome Other: Education and training Behavioral: Pain management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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

Primary Outcome Measures :
  1. Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. craniocervical flexion test [ Time Frame: 12 months ]
    test for the deep cervical flexor muscles

  2. cervical range of motion [ Time Frame: 12 months ]
  3. neck positioning test [ Time Frame: 12 months ]
    neck joint position error test and gaze stability test

  4. Self-rated measure Global Perceived Effect [ Time Frame: 12 months ]

  5. Neck Disability Index [ Time Frame: 12 months ]

  6. Pain Bothersomeness [ Time Frame: 12 months ]

  7. Pain Specific Functioning Scale [ Time Frame: 4 months and 12 months ]

  8. TAMPA scale of Kinesiophobia [ Time Frame: 12 months ]

  9. Impact of Event scale [ Time Frame: 12 months ]

  10. Euroqol-5D [ Time Frame: 12 months ]

  11. Mechanical allodynia [ Time Frame: 12 months ]
    Pressure pain treshold for selected points

Information from the National Library of Medicine

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

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

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): NCT01431261

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University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics
Odense, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
Region of Southern Denmark
Association of Danish Physiotherapists
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Study Chair: Birgit Juul-Kristensen, ph.d. University of Southern Denmark
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inge Ris Hansen, PhD. student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01431261    
Other Study ID Numbers: WADNECXT
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016
Keywords provided by Inge Ris Hansen, University of Southern Denmark:
Chronic neck pain
Whiplash Associated Disorders
Chronic Pain
Neck exercises
Patient Education
Pain Management
Whiplash Injuries
Additional relevant MeSH terms:
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Chronic Pain
Neck Pain
Whiplash Injuries
Neurologic Manifestations
Neck Injuries
Wounds and Injuries