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

Primary Purpose

Neck Pain, Chronic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Education and training
Pain management
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Chronic neck pain, Whiplash, Whiplash Associated Disorders, Chronic Pain, Neck exercises, Training, Pacing, Patient Education, Pain Management, Whiplash Injuries, Musculoskeletal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pain Management + Training

Pain Management

Arm Description

Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training

Education in pain management strategies

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2011
Last Updated
October 6, 2016
Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Association of Danish Physiotherapists
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1. Study Identification

Unique Protocol Identification Number
NCT01431261
Brief Title
Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain
Acronym
WADNECXT
Official Title
Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Region of Southern Denmark, Association of Danish Physiotherapists

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Management + Training
Arm Type
Active Comparator
Arm Description
Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training
Arm Title
Pain Management
Arm Type
Active Comparator
Arm Description
Education in pain management strategies
Intervention Type
Other
Intervention Name(s)
Education and training
Intervention Description
Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times
Intervention Type
Behavioral
Intervention Name(s)
Pain management
Intervention Description
Educational sessions in pain management 4 times
Primary Outcome Measure Information:
Title
Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
craniocervical flexion test
Description
test for the deep cervical flexor muscles
Time Frame
12 months
Title
cervical range of motion
Time Frame
12 months
Title
neck positioning test
Description
neck joint position error test and gaze stability test
Time Frame
12 months
Title
Self-rated measure Global Perceived Effect
Description
questionnaire
Time Frame
12 months
Title
Neck Disability Index
Description
questionnaire
Time Frame
12 months
Title
Pain Bothersomeness
Description
questionnaire
Time Frame
12 months
Title
Pain Specific Functioning Scale
Description
questionnaire
Time Frame
4 months and 12 months
Title
TAMPA scale of Kinesiophobia
Description
questionnaire
Time Frame
12 months
Title
Impact of Event scale
Description
questionnaire
Time Frame
12 months
Title
Euroqol-5D
Description
questionnaire
Time Frame
12 months
Title
Mechanical allodynia
Description
Pressure pain treshold for selected points
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, ph.d.
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics
City
Odense
ZIP/Postal Code
5230
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28850421
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.
Results Reference
derived
PubMed Identifier
27598552
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.
Results Reference
derived
PubMed Identifier
22136113
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.
Results Reference
derived
Links:
URL
http://www.sdu.dk
Description
University of Southern Denmark

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

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