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Is Chronic Whiplash-associated Pain of Neurogenic Origin?

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ClinicalTrials.gov Identifier: NCT02692937
Recruitment Status : Unknown
Verified February 2016 by Region Skane.
Recruitment status was:  Recruiting
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

Brief Summary:
The purpose of this study is to compare the effects of neurolysis with the effects of a exercise program on pain and other symptoms in individuals with chronic whiplash (WAD II-III).

Condition or disease Intervention/treatment Phase
Whiplash Injuries Procedure: Neurolysis Other: Traditional neck-specific exercise program Not Applicable

Detailed Description:

People with whiplash associated disorders (WAD) grade II-III have chronic severe pain and symptoms and reduced quality of life. The origin of the symptoms is still unknown, and there are to date no available guidelines for treatment of this condition. The lack of effective treatment leads to high costs for the patients, and to society, due to considerable medical care and work loss.

After providing a written consent, the patients will be randomized to either surgical treatment with neurolysis of peripheral nerve/s in the back of the head and/or neck plus physiotherapy or to physiotherapy (care-as-usual) only. Both groups will be treated with the same traditional neck-specific exercise program for 12 months. All participants will be evaluated with patient-reported outcomes and clinical examination at baseline, and at 6, 12 and 24 months after inclusion.

The main outcome will be change in NDI from baseline to the 2-year follow-up. A preliminary sample-size calculation shows that 27 patients are needed for each treatment arm to detect a clinically important change of 10 points in NDI, with a between-group standard deviation of 13 point (statistical power of 80 % and a 5% significance level). To account for a 20% drop-out rate, 32 patients will be included per arm. Because this is the first RCT on neurolysis vs care-as-usual treatment, a second sample-size calculation including empirical data will performed by an independent statistician, without breaking the code, when 30 patients in each group have been included. Secondary outcomes include VAS (average pain including pain in the head, neck and face), symptom index, self-efficacy, HDI, WAD-DI, psychosomatic aspects, quality of life and clinical examination. Data will be performed with parametric, or non-parametric statistics, as appropriate, in IBM SPSS Statistics version 22 for Mac (IBM Corp., Armonk, NY, USA). Analysis will be performed according to both intention-to-treat and per protocol. To account for missing data, the previous group means value will be considered to remain form the last occasion and used as carry forward. For continuous data, differences in mean change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. For categorical data, differences in median change (baseline vs follow-up) will be compared between groups and adjusted in relation to baseline values. Effect sizes will be calculated for all measures.

This Randomized Controlled Study is approved and funded by the National Board of Health and Welfare in Sweden (project no 6168/2007).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Chronic Whiplash-associated Pain of Neurogenic Origin? A Study Protocol of a Randomized Controlled Trial Comparing Neurolysis of Peripheral Nerves With Traditional Neck-specific Exercise
Study Start Date : January 2011
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgery and exercise
Neurolysis of peripheral nerves in the back of the head and/or neck. Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months.
Procedure: Neurolysis
Other: Traditional neck-specific exercise program
Active Comparator: Exercise, Active Comparator
Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months.
Other: Traditional neck-specific exercise program



Primary Outcome Measures :
  1. The Neck Disability Index (NDI) [ Time Frame: 24 months ]
    Questionnaire


Secondary Outcome Measures :
  1. The Symptom index [ Time Frame: 24 months ]
    Related symptoms (pain) psychosomatic aspects and any disability due to the neck complaint. Questionnaire.

  2. Self-Efficacy Scale (SES) [ Time Frame: 24 months ]
    Questionnaire

  3. Headache Disability Index (HDI) [ Time Frame: 24 months ]
    Questionnaire

  4. Whiplash Associated Disorders - Disability Index (WAD-DI) [ Time Frame: 24 months ]
    Questionnaire

  5. Zung Self-Rating Depression Scale (Zung) [ Time Frame: 24 months ]
    Questionnaire

  6. Modified Somatic Perception Questionnaire (MSPQ) [ Time Frame: 24 months ]
    Questionnaire

  7. EuroQol questionnaire (EQ-5D) [ Time Frame: 24 months ]
    Questionnaire

  8. EuroQol thermometer (EQ-VAS) [ Time Frame: 24 months ]
    Questionnaire

  9. Cervical range of motion (CROM) [ Time Frame: 12 months ]
  10. Pain drawing, perceived face and body sensations [ Time Frame: 12 months ]
    The characteristics of the patients sensations/pain are described on two different charts.

  11. Exploratory outcome. Perceived pain on a Numeric Rating Scale (NRS) for 14 specific trigger points in the muscles of the occipital region, neck and shoulder. [ Time Frame: 12 months ]
    The physiotherapist palpates each trigger point, according to a detailed protocol developed for the present study.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • trauma that has caused a whiplash injury
  • at least one year of incapacitating chronic neck pain/headache related to the injury (WAD II-III)
  • typical trigger points in the back of the head or in the neck and significant pain relief with local anesthesia towards the painful areas

Exclusion Criteria:

  • mental illness
  • abuse of drugs/alcohol
  • not understanding or reading the Swedish language
  • previous surgery in the back of the head

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692937


Contacts
Contact: Leif Anderberg, MD, PhD +46 7 960 09 55 leif.anderberg@med.lu.se
Contact: Anja Eskilsson anja.eskilsson@med.lu.se

Locations
Sweden
The Department of Neurosurgery, Skåne University Hospital Recruiting
Lund, Skåne, Sweden, 22185
Contact: Leif Anderberg, MD, PhD    +46 7 960 09 55    leif.anderberg@med.lu.se   
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Leif Anderberg, MD, PhD The Department of Neurosurgery, Skåne University Hospital

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT02692937     History of Changes
Other Study ID Numbers: Project no 6168/2207
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016

Keywords provided by Region Skane:
Neurosurgical Procedures
Nerve Block
Exercise therapy
Physical Therapy Specialty

Additional relevant MeSH terms:
Whiplash Injuries
Neck Injuries
Wounds and Injuries