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Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain

Karuna Labs Inc. · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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chronic-painfibromyalgialow-back-painrheumatoid-arthritis
The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.
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