title: Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study.
abstract: Post amputation, the complication of phantom limb pain (PLP) is prevalent and difficult to manage. This study aimed to determine whether it was feasible and acceptable to undertake a definitive multicentred randomised controlled trial assessing the effectiveness of acupuncture for treating lower limb amputees with PLP.
  
  
  
  A mixed-methods embedded design, including a randomised controlled trial and semistructured interviews, was undertaken. A total of 15 participants with PLP were randomly assigned to receive either eight pragmatic Traditional Chinese Medicine acupuncture treatments and usual care or usual care alone over 4 weeks. Outcome measures were completed at baseline, weekly throughout the study and at 1 month post completion of the study and included: a numerical pain-rating scale, the Short-Form McGill Pain Questionnaire 2, the EQ-5D-5 L, the Hospital Anxiety and Depression Scale, the Perceived Stress Scale 10-item, the Insomnia Severity Index, and the Patient Global Impression of Change. Post completion of the trial, participants in the acupuncture group were interviewed about their experience. Feasibility-specific data were also collected.
  
  
  
  Of 24 amputees meeting the study inclusion criteria, 15 agreed to participate (recruitment rate 62.50 %). Qualitatively, acupuncture was perceived to be beneficial and effective. Quantitatively, acupuncture demonstrated clinically meaningful change in average pain intensity (raw change = 2.69) and worst pain intensity (raw change = 4.00). Feasibility-specific data identified that before undertaking a definitive trial, recruitment, practitioner adherence to the acupuncture protocol, completion of outcome measures at 1 month follow-up and blinding should be addressed. Appropriate outcome measures were identified for use in a definitive trial. Data were generated for future sample size calculations (effect size 0.64). Allowing for a 20 % dropout rate, a sample size of 85 participants per group would be needed in a future definitive trial.
  
  
  
  A future definitive trial may be possible if the areas identified in this study are addressed. As acupuncture may be effective at treating PLP, and as this feasibility study suggests that a definitive trial may be possible, a multicentred trial with adequate sample size and blinding is now needed.
  
  
  
  ClinicalTrials.gov Identifier: NCT02126436 , registered on 4 September 2014.
authors: School of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK. trevelye@lsbu.ac.uk.
authors: Esmé G
authors: EG
authors: Trevelyan
authors: School of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK.
authors: Warren A
authors: WA
authors: Turner
authors: School of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK.
authors: Lynn
authors: L
authors: Summerfield-Mann
authors: School of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK.
authors: Nicola
authors: N
authors: Robinson
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D000368:Aged; D000671:Amputation, Surgical / Q000009:adverse effects* / Q000523:psychology; D000674:Amputees / Q000523:psychology*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D035002:Lower Extremity / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010591:Phantom Limb / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D036301:Qualitative Research; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
keywords: Acupuncture; Amputation; Mixed-methods research; Phantom limb; Randomised controlled trial