Massage Therapy for Phantom Limb Pain: Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- PLP Severity
研究概览
简要总结
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.
详细描述
Potential participants self-identify themselves to study personnel by contacting the PI via office phone or IU email. Potential participants were informed of the research study through word-of-mouth and fliers at pain and prosthetic clinics and amputee support groups in the Indianapolis area which will invite interested individuals to contact the PI for more information and a telephone screening for eligibility. If an interested individual screens eligible and is interested after hearing more about the study, an appointment for an Informed Consent Visit will be made.
All subjects who enroll in the study will receive the intervention. There is no randomization.
Study Procedures
Subjects were initially informed of what the study entails upon completion of the phone screening for eligibility and their indication of interest. After the study details were described, the potential subject was invited to schedule a time to come to campus for a formal informed consent and familiarization session. Time between the phone discussion and the scheduled appointment could range from hours to days. The actual environment for collecting informed consent was in the PI's lab were all study activity took place. The Informed Consent Document was reviewed in its entirety and potential subjects given the opportunity to ask any additional questions. After all questions were answered, the potential subject was invited to provide their informed consent by signing the IC document. After consent was obtained, the familiarization session and collection of baseline measures commenced.
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; also referred to as an ABA withdrawal design. Study intervention consisted of twice weekly, 20-minute treatments for four weeks and is delivered during the second 4-week study phase. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
All Participants
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.
干预措施: massage therapy combined with components of mirror therapy (Other)
结局指标
主要结局
PLP Severity
时间窗: 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
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"
次要结局
- 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.)
研究者
Niki Munk
Assistant Professor
Indiana University