Is Chronic Whiplash-associated Pain of Neurogenic Origin?
Condition: Whiplash Injuries
MeSH terms: Whiplash Injuries
Study type: Interventional

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).
    

Intervention name(s): Neurolysis; Traditional neck-specific exercise program
Intervention type(s): Procedure; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurosurgical Procedures; Nerve Block; Exercise therapy; Physical Therapy Specialty