Acupuncture for the Treatment of Phantom Limb Syndrome

NCT02126436 | Completed

• 1 other identifier: PLP001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

phantom limb pain; phantom limb sensation; acupuncture; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Rating Scale

  An eleven point scale will be used. The scale will present the numbers 0-10 with a description at 0 of 'no pain' and a description at 10 of 'pain as bad as you can imagine'. Participants will be asked to rate their average phantom pain over the last week

  Change from baseline at four weeks

Secondary Outcomes (18)

• Change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)

  Change from baseline at four weeks

• Change in EQ-5D-5L

  Change from baseline at four weeks

• Change in Hospital Anxiety and Depression Scale (HADS)

  Change from baseline at four weeks

• Change in The Insomnia Severity Index (ISI)

  Change from baseline at four weeks

• Patient Global Impression of Change (PGIC)

  At four weeks

Other Outcomes (2)

• Information will be obtained on adverse effects

  At week one, two, three and four

• Cheek swab

  Collect at baseline (before intervention)

Study Arms (2)

Acupuncture

ACTIVE COMPARATOR

Eight treatments of acupuncture will be given to participants twice weekly over four weeks. A combination of body and auricular acupuncture will be given and treatment will be pragmatic. In addition the group will receive usual care (including physiotherapy, occupational therapy, medical intervention and any other intervention as deemed appropriate by clinical staff).

Other: Acupuncture; Other: Usual care

Usual care

OTHER

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

Other: Usual care

Interventions

Acupuncture OTHER

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.

Acupuncture

Usual care OTHER

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

Acupuncture; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or above, full cognitive ability and able to communicate in English, able to provide informed consent and written informed consent obtained, current inpatients at the ARU (at time of enrolment), traumatic or medical amputation of a lower limb (greater than toes), currently experiencing phantom limb syndrome (with a verbal rating score of \>4/10) in a lower limb.

You may not qualify if:

• Less than 18 years of age, poorly controlled epilepsy, severe haemophilia or other bleeding / clotting disorders, pacemaker (if using electro-acupuncture), undergoing or recently undergone chemotherapy or bone marrow transplant, cognitive impairment and / or unable to give consent or communicate in English, medically unwell or severe other health complications (as advised by the medical consultant in charge of the participant), congenital limb absence, pregnancy, any skin changes or removal of lymph nodes on the body, ear or scalp that would preclude placement of acupuncture needles, needle phobia

Sponsors & Collaborators

• London South Bank University: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

GSTFT Amputee Rehabilitation Unit, Lambeth Community Care Centre, Monkton Street

London, SE11 4TX, United Kingdom

Location

Related Publications (4)

• Hu, X., Trevelyan, E., Yang, G., Lee, M. S., Lorenc, A., Liu, J. and Robinson, N. (2014a) The effectiveness of acupuncture or TENS for phantom limb syndromeII: A narrative review of case studies, European Journal of Integrative Medicine, (in press).

  BACKGROUND

• Hu, X., Trevelyan, E., Yang, G., Lee, M. S., Lorenc, A., Liu, J. and Robinson, N. (2014b) The effectiveness of acupuncture/TENS for phantom limb syndrome. I: A systematic review of controlled clinical trials, European Journal of Integrative Medicine, (in press).

  BACKGROUND

• Trevelyan EG, Turner WA, Summerfield-Mann L, Robinson N. Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study. Trials. 2016 Oct 25;17(1):519. doi: 10.1186/s13063-016-1639-z.

  PMID: 27782861 DERIVED

• Trevelyan EG, Turner WA, Robinson N. Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial. Trials. 2015 Apr 12;16:158. doi: 10.1186/s13063-015-0668-3.

  PMID: 25873101 DERIVED

MeSH Terms

Conditions

Phantom Limb

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Nicola Robinson, PhD

  London South Bank University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 30, 2014
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

GB (1)