NCT00375544

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 14, 2009

Status Verified

August 1, 2009

First QC Date

September 11, 2006

Last Update Submit

August 12, 2009

Conditions

Osteoarthritis, Knee

Keywords

Laser Therapy, Low-LevelOsteoarthritisPhototherapyOsteoarthritis, kneeLight-emitting diode

Outcome Measures

Primary Outcomes (2)

  • Decreased pain scores on the visual analog scale (VAS)

  • Improved Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) scores

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Low level light therapyDEVICE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard Neiman, M.D.

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • James C Chen, M.D.

    Light Sciences LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2007

Last Updated

August 14, 2009

Record last verified: 2009-08

Locations

US(1)