Randomised feasibility study of physiotherapy for patients with functional motor symptoms

J Neurol Neurosurg Psychiatry. 2017 Jun;88(6):484-490. doi: 10.1136/jnnp-2016-314408. Epub 2016 Sep 30.

Abstract

Objective: To determine the feasibility of conducting a randomised controlled trial of a specialist physiotherapy intervention for functional motor symptoms (FMS).

Methods: A randomised feasibility study was conducted recruiting patients with a clinically established diagnosis of FMS from a tertiary neurology clinic in London, UK. Participants were randomised to the intervention or a treatment as usual control. Measures of feasibility and clinical outcome were collected and assessed at 6 months.

Results: 60 individuals were recruited over a 9-month period. Three withdrew, leaving 29 intervention and 28 controls participants in the final analysis. 32% of patients with FMS met the inclusion criteria, of which 90% enrolled. Acceptability of the intervention was high and there were no adverse events. At 6 months, 72% of the intervention group rated their symptoms as improved, compared to 18% in the control group. There was a moderate to large treatment effect across a range of outcomes, including three of eight Short Form 36 (SF36) domains (d=0.46-0.79). The SF36 Physical function was found to be a suitable primary outcome measure for a future trial; adjusted mean difference 19.8 (95% CI 10.2 to 29.5). The additional quality adjusted life years (QALY) with intervention was 0.08 (95% CI 0.03 to 0.13), the mean incremental cost per QALY gained was £12 087.

Conclusions: This feasibility study demonstrated high rates of recruitment, retention and acceptability. Clinical effect size was moderate to large with high probability of being cost-effective. A randomised controlled trial is needed.

Trial registration number: NCT02275000; Results.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Cognitive Behavioral Therapy
  • Combined Modality Therapy
  • Conversion Disorder / diagnosis
  • Conversion Disorder / psychology
  • Conversion Disorder / rehabilitation*
  • Disability Evaluation
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Interdisciplinary Communication
  • Intersectoral Collaboration
  • Male
  • Middle Aged
  • Motor Disorders / diagnosis
  • Motor Disorders / psychology
  • Motor Disorders / rehabilitation*
  • Outcome Assessment, Health Care
  • Patient Acceptance of Health Care / psychology
  • Physical Therapy Modalities*
  • Quality of Life / psychology
  • Quality-Adjusted Life Years

Associated data

  • ClinicalTrials.gov/NCT02275000