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

NCT ID: NCT00254111

Last Updated: 2005-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis

Keywords

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osteoarthritis hand laser device hand pain stiffness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ultra Probe Laser System

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriTech Manufacturing

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kevin M Walls, M.B.A., RAS

Role: STUDY_DIRECTOR

Regulatory Insight, Inc.

Locations

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Proctology Associates

Phoenix, Arizona, United States

Site Status RECRUITING

Advanced Wellness Center

Long Beach, California, United States

Site Status RECRUITING

Advanced Chiropractic

Bloomington, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Rick A Shacket, M.D.

Role: primary

Mark deDubovay, D.C.

Role: primary

Wendy

Role: backup

Dennis Lenselink, DC

Role: primary

Other Identifiers

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TT-OAV3-70505

Identifier Type: -

Identifier Source: org_study_id