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Tracking Information | |||||||||
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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 † |
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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. |
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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. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 16 | ||||||||
Estimated Completion Date | December 2010 | ||||||||
Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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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 † |
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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. |