Clinical trial NCT01431261: Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain
Official title: Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: Association of Danish Physiotherapists
First posted: 2011-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
timeFrame: 12 months
Secondary outcomes:
measure: craniocervical flexion test
timeFrame: 12 months
measure: cervical range of motion
timeFrame: 12 months
measure: neck positioning test
timeFrame: 12 months
measure: Self-rated measure Global Perceived Effect
timeFrame: 12 months
measure: Neck Disability Index
timeFrame: 12 months
measure: Pain Bothersomeness
timeFrame: 12 months
measure: Pain Specific Functioning Scale
timeFrame: 4 months and 12 months
measure: TAMPA scale of Kinesiophobia
timeFrame: 12 months
measure: Impact of Event scale
timeFrame: 12 months
measure: Euroqol-5D
timeFrame: 12 months
measure: Mechanical allodynia
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics
Study officials:
affiliation: University of Southern Denmark
name: Birgit Juul-Kristensen, ph.d.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.