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

Study Overview
=================
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.

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

Conditions
-----------------
Neck Pain, Chronic Pain Syndrome

Intervention / Treatment
-----------------
* Other: Education and training
* Behavioral: Pain management


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic neck pain, Whiplash, Whiplash Associated Disorders, Chronic Pain, Neck exercises, Training, Pacing, Patient Education, Pain Management, Whiplash Injuries, Musculoskeletal