Study of the Use of Laser Light to Treat Osteoarthritis of the Hand.

November 14, 2005 updated by: TriTech Manufacturing

Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.

The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis of the hand is a disease that breaks down the cartilage and causes formation of new bone around the joints of the hand, resulting in pain, discomfort, and often lowered ability to move the affected joints. Existing methods of treatment for osteoarthritis of the hand include oral and topical medications, physical therapy, occupational therapy, assistive device use, braces and surgery. This study is intended to evaluate the effectiveness of at-home use of a low level laser device in reducing the symptoms of osteoarthritis of the hand.

Comparison(s): Active low level laser units in addition to rescue pain medication, compared to non-active ('fake') low level laser units in addition to rescue pain medication.

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Recruiting
        • Proctology Associates
        • Contact:
        • Principal Investigator:
          • Rick A Shacket, M.D.
    • California
    • Minnesota
      • Bloomington, Minnesota, United States, 55437
        • Recruiting
        • Advanced Chiropractic
        • Contact:
        • Principal Investigator:
          • Dennis Lenselink, DC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and radiographic diagnosis of osteoarthritis of the hand.
  • Hand symptoms such as pain, aching and stiffness present across the prior six months.
  • Willingness to use only Tylenol to relieve hand symptoms during the study.
  • Primary spoken language is English.

Exclusion Criteria:

  • Current use of narcotics, opiates, morphine, steroids.
  • Previous surgery to the hand.
  • Infection or wound in the hand.
  • Involvement in litigation, worker's compensation claim or receiving disability benefits because of osteoarthritis of the hand.
  • Participation in a research study during the prior 90 days.
  • Pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hand pain rating on the VAS at 10 days after treatment onset.

Secondary Outcome Measures

Outcome Measure
Hand pain rating on the VAS at 6 weeks after treatment onset,
Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TriTech Manufacturing

Investigators

  • Study Director: Kevin M Walls, M.B.A., RAS, Regulatory Insight, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

November 11, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2005

Last Update Submitted That Met QC Criteria

November 14, 2005

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TT-OAV3-70505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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