Is Chronic Whiplash-associated Pain of Neurogenic Origin?

NCT ID: NCT02692937

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2017-09-30

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).

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).

Conditions

Whiplash Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Neurolysis

Intervention Type: PROCEDURE

Traditional neck-specific exercise program

Intervention Type: OTHER

Exercise, Active Comparator

Traditional neck-specific exercise program including five individual treatments sessions within 3 months plus home program over 9 months.

Group Type: ACTIVE_COMPARATOR

Traditional neck-specific exercise program

Intervention Type: OTHER

Interventions

Neurolysis

Intervention Type: PROCEDURE

Traditional neck-specific exercise program

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leif Anderberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Department of Neurosurgery, Skåne University Hospital

Locations

The Department of Neurosurgery, Skåne University Hospital

Lund, Skåne County, Sweden

Countries

Sweden

Other Identifiers

Project no 6168/2207

Identifier Type: -

Identifier Source: org_study_id