Is Chronic Whiplash-associated Pain of Neurogenic Origin?

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

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).

Study Overview

• Status: Completed
• Conditions: Whiplash Injuries
• Intervention / Treatment: Procedure: Neurolysis; Other: Traditional neck-specific exercise program

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • The Department of Neurosurgery, Skåne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Neck Disability Index (NDI)	Questionnaire	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Symptom index	Related symptoms (pain) psychosomatic aspects and any disability due to the neck complaint. Questionnaire.	24 months
Self-Efficacy Scale (SES)	Questionnaire	24 months
Headache Disability Index (HDI)	Questionnaire	24 months
Whiplash Associated Disorders - Disability Index (WAD-DI)	Questionnaire	24 months
Zung Self-Rating Depression Scale (Zung)	Questionnaire	24 months
Modified Somatic Perception Questionnaire (MSPQ)	Questionnaire	24 months
EuroQol questionnaire (EQ-5D)	Questionnaire	24 months
EuroQol thermometer (EQ-VAS)	Questionnaire	24 months
Cervical range of motion (CROM)		12 months
Pain drawing, perceived face and body sensations	The characteristics of the patients sensations/pain are described on two different charts.	12 months
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

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University
• Investigators: Principal Investigator: Leif Anderberg, MD, PhD, The Department of Neurosurgery, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Nerve Block; Physical Therapy Specialty; Exercise therapy; Neurosurgical Procedures
• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries; Whiplash Injuries
• Other Study ID Numbers: Project no 6168/2207