Study of the Use of Laser Light to Treat Osteoarthritis of the Hand.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00254111|
Recruitment Status : Unknown
Verified November 2005 by TriTech Manufacturing.
Recruitment status was: Recruiting
First Posted : November 15, 2005
Last Update Posted : November 15, 2005
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Device: Ultra Probe Laser System||Not Applicable|
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 (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.|
|Study Start Date :||July 2005|
|Study Completion Date :||July 2006|
- Hand pain rating on the VAS at 10 days after treatment onset.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254111
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|Contact: Rick A Shacket, M.D. 602-263-8484 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Wendy 562-795-6680 firstname.lastname@example.org|
|Principal Investigator: Mark deDubovay, D.C.|
|United States, Minnesota|
|Bloomington, Minnesota, United States, 55437|
|Contact: Dennis Lenselink, DC 952-835-6653 email@example.com|
|Principal Investigator: Dennis Lenselink, DC|
|Study Director:||Kevin M Walls, M.B.A., RAS||Regulatory Insight, Inc.|