Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oregon Health and Science University
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00827294
First received: January 20, 2009
Last updated: September 11, 2009
Last verified: September 2009
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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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain |
Resource links provided by NLM:
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:
-
Behavioral: Mirror Therapy
The study is designed as a single group trial comparing pre- and post-treatment measures. Up to 40 subjects will be enrolled. Each subject will receive instruction in performing mirror therapy at home, either in person or by viewing a DVD. 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:
| Responsible Party: | Beth Darnall, PhD Principal Investigator, Oregon Health & Science University |
| ClinicalTrials.gov Identifier: | NCT00827294 History of Changes |
| Other Study ID Numbers: | 4925 Mirror Therapy, 5K12HD04348807 |
| Study First Received: | January 20, 2009 |
| Last Updated: | September 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Phantom limb pain Mirror therapy amputation Limb loss treatment |
Additional relevant MeSH terms:
|
Phantom Limb Perceptual Disorders Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013