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Sponsored by: |
Light Sciences LLC |
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Information provided by: | Light Sciences LLC |
ClinicalTrials.gov Identifier: | NCT00375544 |
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).
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis, Knee |
Device: Low level light therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | May 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.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who cannot be expected to be able to comply with the following restrictions during the course of their participation in the study, including during the washout period:
United States, Washington | |
Richard Neiman, M.D. | Recruiting |
Kirkland, Washington, United States, 98034 | |
Contact: Sandy Laurence 425-899-1667 | |
Principal Investigator: Richard Neiman, M.D. |
Study Director: | James C Chen, M.D. | Light Sciences LLC |
Study ID Numbers: | C00011 |
Study First Received: | September 11, 2006 |
Last Updated: | April 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00375544 History of Changes |
Health Authority: | United States: Institutional Review Board |
Laser Therapy, Low-Level Osteoarthritis Phototherapy Osteoarthritis, knee Light-emitting diode |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |