title: Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial.
abstract: BACKGROUND
  Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain.
  
  
  METHODS
  An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback.
  
  
  CONCLUSIONS
  Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible protocol for use in a definitive multicentre randomized controlled trial.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02126436.
authors: Faculty 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: Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK. turnerw@lsbu.ac.uk.
authors: Warren A
authors: WA
authors: Turner
authors: Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK. nicky.robinson@lsbu.ac.uk.
authors: Nicola
authors: N
authors: Robinson
mesh_terms: D015670:Acupuncture Therapy; D000671:Amputation, Surgical / Q000009:adverse effects / Q000523:psychology*; D000674:Amputees / Q000523:psychology*; D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D007407:Interviews as Topic; D008131:London; D035002:Lower Extremity / Q000294:innervation / Q000601:surgery*; D010147:Pain Measurement; D010591:Phantom Limb / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D012107:Research Design; D018401:Sample Size; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome