Massage Therapy for Phantom Limb Pain: Feasibility and Pilot Study

NCT03372668 | Completed

• 1 other identifier: 1405990143
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

Massage therapy is a treatment self-reported by those with phantom limb pain (PLP) as moderately to extremely effective, but no research to date has been specifically designed to examine such efficacy or effectiveness in this regard. The investigators propose that massage therapy can affect PLP by applying treatment to the corresponding intact limb for amputees. Theoretical underpinnings of massage and mirror therapy have guided this study's development to address PLP through the development of a novel massage intervention. The proof-of-concept experimental study examines the feasibility and outcomes of a combined massage and mirror therapy treatment for individuals with lower limb phantom limb pain. Phantom pain severity, intensity, and interference were measured with visual analogue scales (collected twice weekly for the study's duration) and the Brief Pain Index (collected 4 total times across 12 weeks) using a single-subject, withdrawal design with three, 4-week study phases. Intervention consisted of twice weekly, 20-minute treatments for four weeks. Tailored treatments addressed individual phantom pain experience as if occurring on the corresponding, non-removed limb. Participants viewed treatment as though it were being applied to the amputated limb. Specific Aim: Determine the extent to which massage therapy applied in combination with mirror therapy to the intact leg of an amputee addresses PLP severity, intensity, and interference. Hypothesis: massage and mirror treatment session(s) focused on an intact limb will have acute and cumulative benefits (more pronounced and lasting) for PLP severity, intensity, and interference. All study activity to occur on Indiana University's IUPUI campus.

Conditions

Phantom Limb Pain

Keywords

lower limb amputation; PLP

Outcome Measures

Primary Outcomes (1)

• PLP Severity

  PLP severity is measured via visual analogue scales (VAS) of current, average, and worst PLP over the past 2-3 days. Each VAS is a 10cm line with the 10cm end-point indicating "worst pain imaginable" and the 0cm end-point indicating "no pain"

  VAS scores were collected twice weekly (25 times total) throughout the three month study period. Participants were asked to consider the last 2-3 days for the "average" and "worst" VAS and in the moment for the "current" VAS

Secondary Outcomes (3)

• PLP Intensity and Interference

  Participants complete the BPI four times, once at the beginning and/or end of each 4-week study period. The BPI's recall period is one week.

• Health Related Quality of Life

  Participants complete the SF36v2 four times, once at the beginning and/or end of each 4-week study period. The SF36vs's recall period is the past four weeks.

• Perceived Benefit

  Participants were asked about their perceived treatment benefit twice, at the end of the second and third 4-week study period.

Study Arms (1)

All Participants

OTHER

Each study participant will progress through the three, 4-week study periods in the ABA withdrawal design in the same, designated order. The first and third 4-week study periods (or the A periods) have no intervention and only consist of twice weekly data collection. The second 4-week study period (or the B period) will include the twice weekly delivered massage therapy combined with components of mirror therapy intervention.

Other: massage therapy combined with components of mirror therapy

Interventions

massage therapy combined with components of mirror therapy OTHER

Individualized 20-minute, Swedish massage to address participant's unique phantom limb pain experience as if occurring on the corresponding, non-amputated limb. A specially designed apparatus is positioned such that a fixed, real-time image in place of the amputated limb is viewed by the participant during the massage session. The apparatus has a mirror, masking material to hide therapist and participant's lower body, electronic video display, electronic video camera, and equipment to electronically communicate the video signal to the video display. The mirror and video camera positioned to "see" a reflection of the existing limb being massage feds the image to a live video display situated in front of the participant to the correct orientation naturally represent the missing limb.

All Participants

Eligibility Criteria

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

You may qualify if:

• ability to understand verbal or written English
• single limb/appendage, lower limb amputation
• persistent PLP for at least 1 year
• routinely has at least 3 occurrences of PLP per week
• PLP is greater than mild in pain severity according to the pain intensity component of the Brief Pain Inventory (3 or greater out of 10)

You may not qualify if:

• presence of mild or greater traumatic brain injury
• known uncontrolled systemic diseases
• skin issues incompatible with massage application in the area for massage application (open or persistent wounds, fragile skin, etc)
• mental psychosis

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Conditions

Phantom Limb

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

Study Officials

• Niki Munk, PhD

  Indiana University School of Health & Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Repeated measures, single-subject withdrawal design with three, 4-week study phases; also referred to as an ABA withdrawal design. Study intervention consisted of twice weekly, 20-minute treatments for four weeks (8 total treatments) and is delivered during the second 4-week study phase. All subjects who enroll in the study will receive the intervention during the second 4-week study phase. There is no randomization.

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: August 15, 2014
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available for sharing 3 months after publication. Supporting Information items are available at and after publication submissions.
• Access Criteria: The study PI will process and administer IPD and supporting material access via email: nmunk@iu.edu