Osteoarthritis, Knee Clinical Trial
Official title:
A Phase I Single Center Open Label Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC (LSLLC) phototherapy device for home (self) treatment of knee osteoarthritis (OA).
This Phase I study is being conducted to examine the efficacy of the Light Sciences LLC
(LSLLC) phototherapy device for home (self) - treatment of knee osteoarthritis (OA).
Clinical efficacy will be assessed by evaluating the level of reported pain, including the
use of analgesics, various measures of functional improvement, and clinical symptomology
during a three week period of daily treatments. Durability of the clinical response for
twelve weeks following therapy will also be examined. In addition, device safety will be
assessed. As this is an early stage-prototype device, subject input regarding the usability
of the device will be sought.
Subjects will be required to achieve three weeks of wash-out from all OA therapies prior to
the start of phototherapy. Acetaminophen will be allowed during this time. During the three
week active treatment and twelve week follow-up periods, subjects will be required to
refrain from acetaminophen as well as OA therapies. However, subjects will be encouraged to
speak with the investigator should any symptoms become difficult to manage. In addition to
clinical assessments, subjects will be required to keep a daily diary.
The clinical objectives of the study will be met if at least five of ten subjects report
decreased pain scores and improvement on an osteoarthritis index. While minimum or no safety
issues are expected, the occurrence of skin changes to the area exposed to the device will
be carefully monitored.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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