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Sponsored by: |
Oregon Health and Science University |
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Information provided by: | Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT00827294 |
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 |
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Phantom Limb Pain |
Behavioral: Mirror Therapy |
Phase 0 |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beth D Darnall, PhD | 503.494.4351 | darnallb@ohsu.edu |
Contact: Kathy Parker, MSN | 503.494.5224 |
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 |
Principal Investigator: | Beth D Darnall, PhD | Oregon Health and Science University |
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 |
Phantom limb pain Mirror therapy amputation Limb loss treatment |
Signs and Symptoms Neurologic Manifestations Pain Analgesics |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations |
Phantom Limb Neurobehavioral Manifestations Perceptual Disorders |