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
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 20, 2009 | ||||||||
| Last Updated Date | September 11, 2009 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00827294 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Home-based Self-delivered Mirror Therapy for Phantom Limb Pain | ||||||||
| Official Title ICMJE | 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 | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 0 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Phantom Limb Pain | ||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | Not Provided | ||||||||
| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 16 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00827294 | ||||||||
| Other Study ID Numbers ICMJE | 4925 Mirror Therapy, 5K12HD04348807 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Beth Darnall, PhD Principal Investigator, Oregon Health & Science University | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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