Phantom Limb Pain Clinical Trial
Official title:
Massage Therapy for Phantom Limb Pain: Feasibility and Pilot Study
Verified date | January 2018 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | March 31, 2015 |
Est. primary completion date | March 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Indiana University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PLP Intensity and Interference | PLP intensity and interference were measured with the Brief Pain Inventory (BPI) which has been used in other studies examining PLP, consists of eleven, 11-point questions (0 indicates "no pain" while 10 indicates "worst pain imaginable"), and intensity and interference subscales. The BPI intensity subscale has four questions about the worst, least, and average pain in the past week and current ("right now") pain. The seven BPI interference subscale related questions address pain interference on activity related aspects such as walking ability, normal work, and sleep. | 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. | |
Secondary | Health Related Quality of Life | Health related quality of life is measured using the SF-36v2. The SF-36v2 is a widely-used and validated 36-item patient questionnaire to assess health-related quality of life. It includes eight health domains and yields two summary scales (physical health and mental health). | 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. | |
Secondary | Perceived Benefit | Subjects opinions as to the benefits or effectiveness of the intervention were collected via an 11-point scale asking, "Overall, how beneficial was this treatment for your phantom limb pain? End points for the 11-point scale were: 0="Not beneficial at all" ; 10=Extremely beneficial". Participants were also asked to provide comment on whether they thought "additional treatment as provided in this study would improve [their] PLP". | Participants were asked about their perceived treatment benefit twice, at the end of the second and third 4-week study period. |
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