Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
Lead Sponsor:
Light Sciences LLC
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
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).
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Male or female
- At least age 40 years
- Community ambulator without orthoses
- Knee circumference in range of 35.5 - 43 cm. (14-17 inches)
- Moderate OA according to clinician judgment, and/or Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees.
- Exercise induced pain, or for subjects who do not exercise, pain resulting from the activities of daily living, of at least 3 months duration
- Knee pain of greater than 1 on VAS within the last 24 hours before evaluation.
- Fitzpatrick type I, II, or III skin. (very light to darker Caucasian/light Asian.) (Selection avoids excessive light absorption in epidermis)
- Understands and agrees to comply with all study procedures including the daily treatments and follow-up visits
- Able to understand and is voluntarily willing to sign an informed consent form for this study
Exclusion
- Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
- Other causes of knee-related pain (e.g. hip OA, arterial insufficiency, etc) have been ruled out by physical examinations
- Fitzpatrick type IV, V, or VI skin. (Mediterranean/Asian/Hispanic to dark-skinned black)
- Any active Cancer
- History of melanoma to the limb that is being evaluated in this study
- Uncontrolled diabetes mellitus
- Untreated hypertension
- Skin conditions that would interfere with device use/placement
- Psychotic disorder(s), dementia, mental retardation, or other organic mental disorders (subjects who are not mentally and physically able to personally consent for participation in this study are not eligible)
- Any other (including acute) condition, which in the opinion of the investigator, is likely to cause non-compliance or significantly impact treatment outcomes.
- Subject has received intra- or peri- articular steroid, or other, injection therapy within 6 months prior to enrollment in this study.
- Enrolled in any other clinical trial within the last 6 weeks or enrollment in another clinical trial during participation in this trial.
- 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:
- Prescription NSAID use prohibited
- Use of photosensitizing drugs prohibited
- Physiotherapy prohibited for treatment to the limb(s) that is being evaluated in this study.
- Glucosamine use prohibited
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00375544
Start Date
September 1 2006
End Date
November 1 2007
Last Update
August 14 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Richard Neiman, M.D.
Kirkland, Washington, United States, 98034