Is Chronic Whiplash-associated Pain of Neurogenic Origin?

Whiplash Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692937
• Other study ID #: Project no 6168/2207
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: September 2017

Study information

• Verified date: April 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Whiplash Injuries

Intervention

Procedure:
• Neurolysis

Other:
• Traditional neck-specific exercise program

Locations

Country	Name	City	State
Sweden	The Department of Neurosurgery, Skåne University Hospital	Lund	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Neck Disability Index (NDI)	Questionnaire	24 months
Secondary	The Symptom index	Related symptoms (pain) psychosomatic aspects and any disability due to the neck complaint. Questionnaire.	24 months
Secondary	Self-Efficacy Scale (SES)	Questionnaire	24 months
Secondary	Headache Disability Index (HDI)	Questionnaire	24 months
Secondary	Whiplash Associated Disorders - Disability Index (WAD-DI)	Questionnaire	24 months
Secondary	Zung Self-Rating Depression Scale (Zung)	Questionnaire	24 months
Secondary	Modified Somatic Perception Questionnaire (MSPQ)	Questionnaire	24 months
Secondary	EuroQol questionnaire (EQ-5D)	Questionnaire	24 months
Secondary	EuroQol thermometer (EQ-VAS)	Questionnaire	24 months
Secondary	Cervical range of motion (CROM)		12 months
Secondary	Pain drawing, perceived face and body sensations	The characteristics of the patients sensations/pain are described on two different charts.	12 months
Secondary	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.	The physiotherapist palpates each trigger point, according to a detailed protocol developed for the present study.	12 months