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

Neck Pain Clinical Trial

— WADNECXT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431261
• Other study ID #: WADNECXT
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: October 6, 2016
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Neck Pain
• Whiplash Injuries

Intervention

Other:
• Education and training
Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times

Behavioral:
• Pain management
Educational sessions in pain management 4 times

Locations

Country	Name	City	State
Denmark	University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Association of Danish Physiotherapists, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)		12 months	No
Secondary	craniocervical flexion test	test for the deep cervical flexor muscles	12 months	No
Secondary	cervical range of motion		12 months	No
Secondary	neck positioning test	neck joint position error test and gaze stability test	12 months	No
Secondary	Self-rated measure Global Perceived Effect	questionnaire	12 months	No
Secondary	Neck Disability Index	questionnaire	12 months	No
Secondary	Pain Bothersomeness	questionnaire	12 months	No
Secondary	Pain Specific Functioning Scale	questionnaire	4 months and 12 months	No
Secondary	TAMPA scale of Kinesiophobia	questionnaire	12 months	No
Secondary	Impact of Event scale	questionnaire	12 months	No
Secondary	Euroqol-5D	questionnaire	12 months	No
Secondary	Mechanical allodynia	Pressure pain treshold for selected points	12 months	No

External Links

•   University of Southern Denmark