Acupuncture for the Treatment of Phantom Limb Syndrome

Summary

The purpose of this study is to evaluate the feasibility and effectiveness of acupuncture for the treatment of phantom limb syndrome in lower limb amputees and pilot an acupuncture protocol. The study will be a comparative effectiveness study comparing acupuncture and standard care versus standard care alone and will be a randomised controlled trial using a mixed methods approach. The study hypothesis is a course of acupuncture will reduce the symptoms of phantom limb syndrome in lower limb amputees.

The study will be based the Amputee Rehabilitation Unit, London. Twenty lower limb amputees with phantom limb syndrome will be randomly assigned to either receive usual care or usual care plus acupuncture. Acupuncture intervention will include 8 treatments over 4 weeks and treatment will involve using both body and auricular acupuncture points. Usual care will include physiotherapy, occupational therapy, pharmacological intervention and other interventions as deemed appropriate by clinical staff.

An eleven point numerical rating scale will be the primary outcome measure in this study. Secondary outcome measures will include the Short Form McGill Pain Questionnaire 2, EQ-5D-5L, Hospital Anxiety and Depression Scale, Perceived Stress Scale, Insomnia Severity Index, Participant Global Impression of Change and information will also be obtained on rescue medication. A cheek swab will also be taken to explore potential subgroups of responders in relation to the genetic polymorphism of the glucocorticoid receptor. Outcomes will be recorded weekly for the duration of the study and one and three months post completion of the study. In order to identify protocol acceptability and acceptability of outcome measures five participants will be interviewed post completion of the study. Data will also inform feasibility such as recruitment rate, completion rate and reasons for dropout.

Data from this study will guide the development of a full randomised controlled trial.

Conditions

• Phantom Limb Syndrome

Interventions

OTHER

Acupuncture

Participants will receive a course of traditional Chinese acupuncture. Acupuncture will be pragmatic but strict guidelines will be adhered to including: using a combination of body and auricular acupuncture, treating the opposite limb to amputation and possibly the residual limb, using auricular acupuncture points such as shen men, sympathetic, points corresponding to the lower limb, using body acupuncture points around the stump (depending on tissue health and the patient), mirroring local and distal points by needling them on the opposite limb, points on the lower back taking a segmental approach to dermatomal pain, including points such as LI4 + LR3, LR3, GV20, SP10, electro-acupuncture may be used, retaining the needles for 20-30 minutes, treating twice weekly for four weeks.

OTHER

Usual care

The group will receive usual care (including physiotherapy, occupational therapy, medical intervention and any other intervention as deemed appropriate by clinical staff).

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• London South Bank University

  lead OTHER

Principal Investigators

• Nicola Robinson, PhD · London South Bank University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• United Kingdom

Study Locations