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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

January 20, 2009
September 11, 2009
January 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00827294 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Home-based Self-delivered Mirror Therapy for Phantom Limb Pain
A Pilot Study of Self-delivered Home-based Mirror Therapy for Phantom Limb Pain

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.

Not Provided
Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Phantom Limb Pain
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.
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Beth D Darnall, PhD 503.494.4351 darnallb@ohsu.edu
Contact: Kathy Parker, MSN 503.494.5224
United States
 
NCT00827294
4925 Mirror Therapy, 5K12HD04348807
Yes
Beth Darnall, PhD Principal Investigator, Oregon Health & Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Beth D Darnall, PhD Oregon Health and Science University
Oregon Health and Science University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP