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

BACKGROUND: 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. METHODS: 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. 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 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. 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 that a definitive trial may be possible, a multicentred trial with adequate sample size and blinding is now needed. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02126436 , registered on 4 September 2014.

Perceptions of phantom limb pain in lower limb amputees and its effect on quality of life: a qualitative study.

BACKGROUND: Phantom limb pain (PLP) is a prevalent complication post-amputation. Currently, qualitative literature exploring the experience of PLP in amputees is sparse, and little is known about whether the educational needs of amputees are being met. OBJECTIVES: To explore lower limb amputees' descriptive lived experiences of PLP, to understand how PLP affects quality of life and to determine whether amputees feel they are provided with adequate information about PLP. METHODS: A qualitative descriptive approach, situated under the constructivist paradigm was taken, consisting of cross-sectional semi-structured interviews. A purposive sample of 15 lower limb amputees, 1-3 months post-surgery with past or current experience of PLP were interviewed once about their experience of PLP. Interviews were audio-recorded, transcribed verbatim and analysed using Framework Analysis. Interviews were conducted while participants were inpatients at an amputee rehabilitation unit in London. RESULTS: Six key themes were identified during analysis, of which three were related to PLP and are reported on in this article (real and physical phantoms, living with a phantom and being informed). PLP had numerous painful qualities. The phantom felt real, with kinetic and kinaesthetic properties. PLP had multiple meanings to amputees, was considered a reminder of circumstances and could affect quality of life. Information provided about PLP was inadequate. CONCLUSION: PLP can be a severe and annoying experience acting as a reminder of amputees' circumstances. Information provided about PLP is inadequate, with some amputees still perceiving PLP as mental and imaginary. Education about PLP and awareness and accessibility to non-pharmacological interventions needs to be improved.

Integrative treatment for low back pain: An exploratory systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Low back pain (LBP) is a common musculoskeletal condition often treated using integrative medicine (IM). Most reviews have focused on a single complementary and alternative medicine (CAM) therapy for LBP rather than evaluating wider integrative approaches. This exploratory systematic review aimed to identify randomized controlled trials (RCTs) and provide evidence on the effectiveness, cost effectiveness and adverse effects of integrative treatment for LBP. METHODS: A literature search was conducted in 12 English and Chinese databases. RCTs evaluating an integrative treatment for musculoskeletal related LBP were included. Reporting, methodological quality and relevant clinical characteristics were assessed and appraised. Metaanalyses were performed for outcomes where trials were sufficiently homogenous. RESULTS: Fifty-six RCTs were identified evaluating integrative treatment for LBP. Although reporting and methodological qualities were poor, meta-analysis showed a favourable effect for integrative treatment over conventional and CAM treatment for back pain and function at 3 months or less follow-up. Two trials investigated costs, reporting £ 5332 per quality adjusted life years with 6 Alexander technique lessons plus exercise at 12 months follow-up; and an increased total costs of $244 when giving an additional up to 15 sessions of CAM package of care at 12 weeks. Sixteen trials mentioned safety; no severe adverse effects were reported. CONCLUSION: Integrative treatment that combines CAM with conventional therapies appeared to have beneficial effects on pain and function. However, evidence is limited due to heterogeneity, the relatively small numbers available for subgroup analyses and the low methodological quality of the included trials. Identification of studies of true IM was not possible due to lack of reporting of the intervention details (registration No. CRD42013003916).

Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial.

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/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02126436.

Developing an acupuncture protocol for treating phantom limb pain: a Delphi consensus study.

BACKGROUND: Little is known about how a Traditional Chinese Medicine (TCM) approach could be used to treat phantom limb pain (PLP). There is currently no standard acupuncture protocol in the literature to treat this syndrome. OBJECTIVES: To achieve consensus among a group of acupuncture practitioners on the pathology and recommended treatment of PLP and devise an acupuncture protocol for the treatment of this condition. METHODS: A classical Delphi approach was used using two parallel online Delphi studies. One study focused on participants with past experience of treating PLP (TPLP, n=7) and the other on practitioners with no past experience (NTPLP, n=16). Two hypothetical case studies were provided and participants were asked for responses on how they would treat these patients. Three rounds were included. Participants were also invited to rate and comment on the finalised protocol. Round 1 data were analysed using content analysis. In subsequent rounds an a priori criterion for defining consensus was set at ≤1.75 IQR. A group median of 5-6 was considered to mean 'agree'. RESULTS: 19 participants completed all Delphi rounds (12 NTPLP, 7 TPLP). 108 NTPLP and 76 TPLP statements were generated and circulated in round 2; 53% of the NTPLP statements and 62% of the TPLP statements met consensus in round 2 and 45% of the NTPLP statements and 44% of the TPLP statements met consensus in round 3. Participants all agreed with the final protocol developed. CONCLUSIONS: The protocol developed does not claim to be best practice but provides a preliminary consensus from practitioners practising acupuncture for the treatment of PLP.