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Shifting Away From Pain: a Neurocognitive Approach in Treatment of Whiplash

U

University Ghent

Status

Completed

Conditions

Whiplash Injuries

Treatments

Behavioral: Modern pain neuroscience approach
Behavioral: Usual care physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04077619
G001419N (Other Grant/Funding Number)
B143201630602

Details and patient eligibility

About

The broad aim of this study is to investigate the effect of a modern neuroscience approach, which combines education on pain neuroscience with cognition-targeted exercise therapy and stress management, on brain structure and networks in patients with chronic whiplash-associated disorders (CWAD) in comparison to a control physiotherapy treatment.

Full description

This project runs in parallel to a larger randomized-controlled trial (RCT) in which the 'modern neuroscience approach to WAD' is compared to usual care evidence-based physiotherapy (clinical trial registration number: NCT03239938). For the current study, additional magnetic resonance imaging (MRI) measures will be taken in a subsample of patients, who will be recruited from this larger RCT. In addition, a pain-free age- and sex-matched control group will be recruited for comparison.

The current study consists of 2 MRI measurements that will take place at the University Hospital of Ghent (UZ Gent): baseline (pre-treatment) and follow-up (post-treatment; approximately 16 weeks after baseline). After pre-treatment assessment, the patients will be randomly allocated to the modern neuroscience approach or usual care physiotherapy, as part of the RCT.

Enrollment

95 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

CWAD group:

Inclusion Criteria:

  • Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
  • Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
  • Native Dutch speaker
  • Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
  • Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans (in both measurement times: before the start of the rehabilitation and after the end of the rehabilitation).

Exclusion Criteria:

  • Neuropathic pain
  • Being pregnant or having given birth in the preceding year
  • Chronic fatigue syndrome
  • Fibromyalgia
  • Cardiovascular disorders
  • Epilepsy
  • Endocrinological disorders
  • Rheumatic disorders
  • Psychiatric disorders
  • History of neck surgery
  • Loss of consciousness during/after the whiplash trauma
  • MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
  • Psychiatric condition and ongoing medication that would alter emotional or sensory processing
  • Claustrophobia.

Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers

  • a history of a chronic pain syndrome
  • a pain condition in the last six months for which treatment was sought

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

95 participants in 2 patient groups

Modern pain neuroscience approach
Experimental group
Description:
Behavioral: Modern pain neuroscience approach
Treatment:
Behavioral: Modern pain neuroscience approach
Usual care evidence-based physiotherapy
Active Comparator group
Description:
Behavioral: Usual care evidence-based physiotherapy
Treatment:
Behavioral: Usual care physiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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