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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 20, 2009

Last Updated Date

April 2, 2009

Start Date ^†

January 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00827294 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Home-Based Self-Delivered Mirror Therapy for Phantom Limb Pain

Official Title ^†

A Pilot Study of Self-Delivered Home-Based Mirror Therapy for Phantom Limb Pain

Brief Summary

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.

Detailed Description

Study Phase

Phase 0

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^†

Phantom Limb Pain

Intervention ^†

Behavioral: Mirror Therapy

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

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

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00827294

Responsible Party

Beth Darnall, PhD Principal Investigator, Oregon Health & Science University

Secondary IDs ^††

5K12HD04348807

Study Sponsor ^†

Oregon Health and Science University

Collaborators ^††

Investigators ^†

Principal Investigator:

Beth D Darnall, PhD

Oregon Health and Science University

Information Provided By

Oregon Health and Science University

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.