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

Osteoarthritis Clinical Trial

Official title:

Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00254111
• Other study ID #: TT-OAV3-70505
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2005
• Last updated: November 14, 2005
• Start date: July 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2005
• Source: TriTech Manufacturing
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Device:
• Ultra Probe Laser System

Locations

Country	Name	City	State
United States	Advanced Chiropractic	Bloomington	Minnesota
United States	Advanced Wellness Center	Long Beach	California
United States	Proctology Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
TriTech Manufacturing

Country where clinical trial is conducted

United States, 

Outcome

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