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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra Probe Laser System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Hand pain rating on the VAS at 10 days after treatment onset. |
| Measure | Description | Time Frame |
|---|---|---|
| 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, | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Walls, M.B.A., RAS | Regulatory Insight, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Proctology Associates | Recruiting | Phoenix | Arizona | 85014 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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. |
| Advanced Wellness Center | Recruiting | Long Beach | California | 90803 | United States |
|
| Advanced Chiropractic | Recruiting | Bloomington | Minnesota | 55437 | United States |
|