Clinical trial NCT00254111: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
hand
laser
device
hand pain
stiffness
Lead sponsor: TriTech Manufacturing
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hand pain rating on the VAS at 10 days after treatment onset.
Secondary outcomes:
measure: Hand pain rating on the VAS at 6 weeks after treatment onset,
measure: Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,
measure: Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,
measure: Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,
measure: Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,
measure: Perceived group assignment by subjects at 10 days after treatment onset and at 6 weeks after treatment onset.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Proctology Associates
state: Arizona
city: Long Beach
country: United States
facility: Advanced Wellness Center
state: California
city: Bloomington
country: United States
facility: Advanced Chiropractic
state: Minnesota
Study officials:
affiliation: Regulatory Insight, Inc.
name: Kevin M Walls, M.B.A., RAS
role: STUDY_DIRECTOR
References: