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CompletedNCT01431261WADNECXTUpdated Oct 7, 2016

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

An interventional study of Education and training and Pain management in Neck Pain and Chronic Pain Syndrome, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-07.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Neck Pain
  • Chronic Pain Syndrome

Keywords

  • Chronic neck pain
  • Whiplash
  • Whiplash Associated Disorders
  • Chronic Pain
  • Neck exercises
  • Training
  • Pacing
  • Patient Education
  • Pain Management
  • Whiplash Injuries
  • Musculoskeletal
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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 200 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • 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

  • Active comparator
    Pain Management

    Education in pain management strategies

    Behavioral: Pain management

Interventions

  • OtherEducation and training

    Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times

  • BehavioralPain management

    Educational sessions in pain management 4 times

06

What researchers measure

Primary outcomes

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

    Time frame: 12 months

Secondary outcomes

  1. craniocervical flexion test

    test for the deep cervical flexor muscles

    Time frame: 12 months

  2. cervical range of motion

    Time frame: 12 months

  3. neck positioning test

    neck joint position error test and gaze stability test

    Time frame: 12 months

  4. Self-rated measure Global Perceived Effect

    questionnaire

    Time frame: 12 months

  5. Neck Disability Index

    questionnaire

    Time frame: 12 months

  6. Pain Bothersomeness

    questionnaire

    Time frame: 12 months

  7. Pain Specific Functioning Scale

    questionnaire

    Time frame: 4 months and 12 months

  8. TAMPA scale of Kinesiophobia

    questionnaire

    Time frame: 12 months

  9. Impact of Event scale

    questionnaire

    Time frame: 12 months

  10. Euroqol-5D

    questionnaire

    Time frame: 12 months

  11. Mechanical allodynia

    Pressure pain treshold for selected points

    Time frame: 12 months

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Study locations

1 site
  • University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics
    Odense, 5230, Denmark
08

References and documents

Publications

  • Ris I, Juul-Kristensen B, Boyle E, Kongsted A, Manniche C, Sogaard K. Chronic neck pain patients with traumatic or non-traumatic onset: Differences in characteristics. A cross-sectional study. Scand J Pain. 2017 Jan;14:1-8. doi: 10.1016/j.sjpain.2016.08.008. Epub 2016 Oct 12. PubMed 28850421 ↗
  • Ris I, Sogaard K, Gram B, Agerbo K, Boyle E, Juul-Kristensen B. Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up. Man Ther. 2016 Dec;26:132-140. doi: 10.1016/j.math.2016.08.004. Epub 2016 Aug 20. PubMed 27598552 ↗
  • Hansen IR, Sogaard K, Christensen R, Thomsen B, Manniche C, Juul-Kristensen B. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Dec 2;12:274. doi: 10.1186/1471-2474-12-274. PubMed 22136113 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01431261
Lead sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Association of Danish Physiotherapists
Responsible party
Inge Ris Hansen (PhD. student, University of Southern Denmark) — Principal investigator
First posted
Sep 9, 2011
Start date
Jan 2012
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Oct 7, 2016

Study contacts

Birgit Juul-Kristensen, ph.d.
study chair · University of Southern Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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