Study of the Use of Laser Light to Treat Osteoarthritis of the Hand.
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Ultra Probe Laser System Osteoarthritis of the Hand Clinical Study.|
- 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.
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||July 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254111
|United States, Arizona|
|Phoenix, Arizona, United States, 85014|
|United States, California|
|Advanced Wellness Center|
|Long Beach, California, United States, 90803|
|United States, Minnesota|
|Bloomington, Minnesota, United States, 55437|
|Study Director:||Kevin M Walls, M.B.A., RAS||Regulatory Insight, Inc.|