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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by TriTech Manufacturing.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
TriTech Manufacturing
ClinicalTrials.gov Identifier:
NCT00254111
First received: November 11, 2005
Last updated: November 14, 2005
Last verified: November 2005
  Purpose

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.


Condition Intervention
Osteoarthritis
Device: Ultra Probe Laser System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.

Resource links provided by NLM:


Further study details as provided by TriTech Manufacturing:

Primary Outcome Measures:
  • Hand pain rating on the VAS at 10 days after treatment onset.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: July 2005
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254111

Locations
United States, Arizona
Proctology Associates Recruiting
Phoenix, Arizona, United States, 85014
Contact: Rick A Shacket, M.D.    602-263-8484    drshacket@yahoo.com   
Principal Investigator: Rick A Shacket, M.D.         
United States, California
Advanced Wellness Center Recruiting
Long Beach, California, United States, 90803
Contact: Mark deDubovay, D.C.    562-795-6680    officemanager@advancedwellness.org   
Contact: Wendy    562-795-6680    officemanager@advancedwellness.org   
Principal Investigator: Mark deDubovay, D.C.         
United States, Minnesota
Advanced Chiropractic Recruiting
Bloomington, Minnesota, United States, 55437
Contact: Dennis Lenselink, DC    952-835-6653    drdennis@adv-chiro.com   
Principal Investigator: Dennis Lenselink, DC         
Sponsors and Collaborators
TriTech Manufacturing
Investigators
Study Director: Kevin M Walls, M.B.A., RAS Regulatory Insight, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00254111     History of Changes
Other Study ID Numbers: TT-OAV3-70505
Study First Received: November 11, 2005
Last Updated: November 14, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by TriTech Manufacturing:
osteoarthritis
hand
laser
device
hand pain
stiffness

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014