Clinical Trial: Examining Brain Changes Using Functional Magnetic Resonance Imaging (fMRI) in Amputees With Phantom Limb Pain Following Mirror Therapy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Study Using Functional MRI to Examine Changes in the Brain in Unilateral Lower Limb Amputees Treated With Mirror Therapy for Phantom Limb Pain.
Brief Summary: Almost everyone who has a traumatic limb amputated will experience a phantom limb - the vivid impression that the limb not only still is present, but also in many cases, painful. Preliminary data from study WRAMC WU# 05-71034, "Pilot study to assess the efficacy of mirror-box and mental visualization treatments on phantom limb pain" demonstrates that 4 weeks of mirror therapy is effective for treating phantom limb pain (PLP) and suggests that vision is a key component modulating PLP and may be the explanation for the efficacy of mirror therapy, as subjects view the reflected image of their intact limb while attempting to move the amputated, or phantom, limb. We propose conducting a study using functional magnetic resonance imaging (fMRI) to identify brain regions critical for the mirror effect and to study the relationship of visual activation to the sensation of phantom pain. Subjects will have an fMRI scan prior to starting therapy, 2 weeks after starting mirror therapy and again after 4 weeks of mirror therapy. Data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, and the average intensity of pain.
Detailed Summary:
This is a prospective trial that will use fMRI to identify brain regions critical to the generation of PLP, examine the role of mirror therapy and the visual system in the de-activation of pain pathways, and observe how changes in the brain may be correlated with the level of PLP. Subjects must have PLP and have sustained a unilateral lower extremity amputation prior to enrollment. All subjects will be screened initially by a neurologist, physiatrist, or research coordinator according to the inclusion and exclusion criteria. A detailed medical history will be taken and documented, and a neurologist will conduct a documented physical examination. Subjects who do not meet the study inclusion criteria will not be eligible to participate in this research study, but will continue to receive current best practice of care. If a subject's pain becomes severe during the course of the study, pain medication will be available to them.
All subjects willing to participate in the study will be required to sign a DA 5303-R (see appendix for Voluntary Agreement Affidavit) prior to enrollment in the study. Once enrolled, all subjects will undergo baseline entry evaluations quantifying their current pain perception using the following evaluation tools: the Visual Analogue Scale (VAS) and the short version of the McGill Pain Questionnaire (Appendix 1) along with a short questionnaire on phantom limb pain frequency and duration (Appendix 5). Subjects will also be queried about their use of current pain medications along with the dosages on a weekly basis. Although helpful tools in the standard of care, the questionnaires completed by the subjects and the list of medications reported by the subjects in this study are for research data collection purposes only. In order to maintain subject confidentiality, only the subject's identification code-and not the subject's name-will appear on the que
Sponsor: United States Department of Defense
Current Primary Outcome:
- The identification of brain regions activated before and after treatment with mirror therapy. [ Time Frame: 0, 2, and 4 weeks ]
- phantom limb pain as measured using the VAS and McGill [ Time Frame: daily for 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Walter Reed Army Medical Center
Dates:
Date Received: March 14, 2008
Date Started: February 2008
Date Completion: February 2010
Last Updated: April 14, 2008
Last Verified: April 2008
