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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low level light therapy
Sponsored by
Light Sciences LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Laser Therapy, Low-Level, Osteoarthritis, Phototherapy, Osteoarthritis, knee, Light-emitting diode

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • Richard Neiman, M.D.

Outcomes

Primary Outcome Measures

Decreased pain scores on the visual analog scale (VAS)
Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores

Secondary Outcome Measures

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

Full Information

First Posted
September 11, 2006
Last Updated
August 12, 2009
Sponsor
Light Sciences LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00375544
Brief Title
Study to Evaluate the Safety and Efficacy of a Low Level Light Device in Patients With Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Light Sciences LLC

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Laser Therapy, Low-Level, Osteoarthritis, Phototherapy, Osteoarthritis, knee, Light-emitting diode

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Low level light therapy
Primary Outcome Measure Information:
Title
Decreased pain scores on the visual analog scale (VAS)
Title
Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores
Secondary Outcome Measure Information:
Title
Reduced use of over the counter (OTC) analgesics post therapy
Title
Improved functionality as determined by measurable increases in knee range of motion (ROM)
Title
Increased exercise ability
Title
No, or decreased knee effusion
Title
Subject satisfaction
Title
Durability of the Clinical Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Chen, M.D.
Organizational Affiliation
Light Sciences LLC
Official's Role
Study Director
Facility Information:
Facility Name
Richard Neiman, M.D.
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

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

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