Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis

Completed · Phase 1

Conditions studied: Osteoarthritis, Knee

In brief

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).

Key facts

Study ID

NCT00375544

Run by

Light Sciences LLC

People needed

10

Starts

2006-09-01

Expected to finish

2007-11-01

Last updated by the study team

2009-08-14

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Richard Neiman, M.D. — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.