Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study

Background: Post amputation, the complication 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 multi-centred randomised controlled trial assessing the effectiveness of acupuncture for treating lower limb amputees with PLP. Methods: A mixed methods embedded design including a randomised controlled trial and semi-structured interviews was undertaken. A total of 15 participants with PLP were randomly assigned to receive either 8 pragmatic Traditional Chinese Medicine acupuncture treatments and usual care or usual care alone over four weeks. Outcomes measures were completed at baseline, weekly throughout the study and at one month post completion of the study and included; a numerical pain rating scale, Short-Form McGill Pain Questionnaire 2, EQ-5D-5L, Hospital Anxiety and Depression Scale, Perceived Stress Scale 10 item, Insomnia Severity Index, 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. Results: 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 one 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. Conclusions: 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 a definitive trial may be possible, a multi-centred trial with adequate sample size and blinding is now needed. Trial registration: ClinicalTrials.gov: NCT02126436. Registration date: 9.4.2014.