Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Decreased pain scores on the visual analog scale (VAS)
- Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores
- Reduced use of over the counter (OTC) analgesics post therapy
- Improved functionality as determined by measurable increases in knee range of motion (ROM)
- Increased exercise ability
- No, or decreased knee effusion
- Subject satisfaction
- Durability of the Clinical Response
|Study Start Date:||September 2006|
|Study Completion Date:||November 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375544
|United States, Washington|
|Richard Neiman, M.D.|
|Kirkland, Washington, United States, 98034|
|Study Director:||James C Chen, M.D.||Light Sciences LLC|