Trials 2016 Oct 2517(1) 519
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.