Home-Based Self-Delivered Mirror Therapy for Phantom Limb Pain - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00827294

Purpose

The goals of the study are to determine whether self-delivered, home-based mirror therapy decreases the frequency and intensity of phantom limb pain and improves mood and physical function in persons with phantom limb pain.

The investigators hypothesize that self-delivered home-based mirror therapy will significantly decrease phantom pain intensity, will improve mood, and will improve function at one-month follow-up.

Condition	Intervention	Phase
Phantom Limb Pain	Behavioral: Mirror Therapy	Phase 0

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study of Self-Delivered Home-Based Mirror Therapy for Phantom Limb Pain

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Change in phantom pain intensity (from baseline to one month; also measured at 2 months and 3 months to see if treatment gains are sustained). Pain intensity is measured with the Brief Pain Inventory-short form (BPI-sf)at all time points [ Time Frame: Months: 1, 2, 3; our primary outcome is pain change at month 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Outcome will be determined by measuring change in depressive symptoms (using the Center for Epidemiology Depression Scale (CES-D) (comparing baseline levels of depressive symptoms to one month) [ Time Frame: Measured at months 1, 2, 3; Our main interest is outcome for depression at month 1 ] [ Designated as safety issue: No ]
Outcome will be determined by measuring changes in pain-related anxiety levels (baseline to one month) as measured by the Pain Anxiety Symptom Scale. [ Time Frame: Measured at months 1-3; primary interest in outcome at month 1 ] [ Designated as safety issue: No ]
Sleep quality. Outcome for sleep quality will be measured using the Pittsburgh Sleep Quality Index. [ Time Frame: Outcome will be measured at months 1-3 with our main interest being outcome at month 1 ] [ Designated as safety issue: No ]
Pain Catastrophizing. We will measure outcome for pain catastrophizing with the Pain Catastrophizing Scale. [ Time Frame: Outcome will be measured at months 1-3 with our main interest being outcome at month 1 ] [ Designated as safety issue: No ]
Pain medication usage. We will measure whether mirror therapy decreases pain medication usage. [ Time Frame: Outcome will be measured at months 1-3 with our main interest being month 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The study is designed as a single group trial comparing pre- and post-treatment measures. Between thirteen and sixteen subjects will be enrolled.

Each subject will receive an information sheet and instruction in performing mirror therapy at home. Subjects will be asked to practice mirror therapy 20-30 minutes daily. Prior to beginning treatment, subjects will complete standard questionnaires designed to measure phantom pain level, function, depressive symptoms, pain-related anxiety, catastrophizing, and sleep quality. Subjects will also be asked about current use of pain medications and demographic data will be collected. Subjects will complete the same questionnaires 1 month, 2 months, 3 months, and 6 months after beginning treatment. Subjects will also be asked to keep a daily diary to record the frequency of their home treatment sessions. Study staff will check in with the study subjects weekly for the first month after beginning treatment, and monthly thereafter.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-75 years
Unilateral amputation of upper or lower limb
At least 1 month after surgical healing
English-speaking (since not all study materials have been translated)

Exclusion Criteria:

History of brain injury or cognitive difficulties
Severe mental illness that impairs cognition or function
Suicidal ideation
Current substance abuse or dependence
Amputation related to diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827294

Contacts

Contact: Beth D Darnall, PhD	503.494.4351	darnallb@ohsu.edu
Contact: Kathy Parker, MSN	503.494.5224

Locations

United States, Oregon
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Beth D Darnall, PhD 503-494-4351 darnallb@ohsu.edu
Contact: Kathy Parker, MSN 503.494.5224 parkerk@ohsu.edu
Principal Investigator: Beth D Darnall, PhD

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Beth D Darnall, PhD

Oregon Health and Science University

More Information

Publications:

Darnall BD. Self-delivered home-based mirror therapy for lower limb phantom pain. Am J Phys Med Rehabil. 2009 Jan;88(1):78-81.

Responsible Party:	Oregon Health & Science University ( Beth Darnall, PhD Principal Investigator )
Study ID Numbers:	4925 Mirror Therapy, 5K12HD04348807
Study First Received:	January 20, 2009
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00827294 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Phantom limb pain
Mirror therapy
amputation
Limb loss
treatment

Study placed in the following topic categories:

Signs and Symptoms
Neurologic Manifestations
Pain
Analgesics

Phantom Limb
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations

Phantom Limb
Neurobehavioral Manifestations
Perceptual Disorders

ClinicalTrials.gov processed this record on May 06, 2009