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

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultra Probe Laser System
Sponsored by
TriTech Manufacturing
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, hand, laser, device, hand pain, stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Proctology AssociatesRecruiting
  • Advanced Wellness CenterRecruiting
  • Advanced ChiropracticRecruiting

Outcomes

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.

Full Information

First Posted
November 11, 2005
Last Updated
November 14, 2005
Sponsor
TriTech Manufacturing
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1. Study Identification

Unique Protocol Identification Number
NCT00254111
Brief Title
Study of the Use of Laser Light to Treat Osteoarthritis of the Hand.
Official Title
Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
TriTech Manufacturing

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, hand, laser, device, hand pain, stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Ultra Probe Laser System
Primary Outcome Measure Information:
Title
Hand pain rating on the VAS at 10 days after treatment onset.
Secondary Outcome Measure Information:
Title
Hand pain rating on the VAS at 6 weeks after treatment onset,
Title
Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
Title
Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
Title
Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
Title
Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
Title
Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Walls, M.B.A., RAS
Organizational Affiliation
Regulatory Insight, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Proctology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick A Shacket, M.D.
Phone
602-263-8484
Email
drshacket@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rick A Shacket, M.D.
Facility Name
Advanced Wellness Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark deDubovay, D.C.
Phone
562-795-6680
Email
officemanager@advancedwellness.org
First Name & Middle Initial & Last Name & Degree
Wendy
Phone
562-795-6680
Email
officemanager@advancedwellness.org
First Name & Middle Initial & Last Name & Degree
Mark deDubovay, D.C.
Facility Name
Advanced Chiropractic
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55437
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Lenselink, DC
Phone
952-835-6653
Email
drdennis@adv-chiro.com
First Name & Middle Initial & Last Name & Degree
Dennis Lenselink, DC

12. IPD Sharing Statement

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

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