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
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on August 28, 2014