Clinical trial NCT04692597: Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.
Official title: Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Level Laser Therapy
Osteoarthritis
Family Medicine
Pain Management
Integrative Medicine
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2021-01-05
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis. Subjects will be randomized into one of two groups receiving either LLLT or sham LLLT. Subjects will receive LLLT or sham LLLT weekly over a period of six weeks. At each visit, patients will rate their pain using the Defense and Veterans Pain Rating Scale (DVPRS) and assess their functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Subjects will have a follow up visit six weeks after the treatment protocol for a final assessment of pain and function. The Phoenix Thera-Lase laser is a Class II, 510k cleared device (#K151521) and is legally marketed in the US. Investigators are using in accordance with its approved labeling and no changes to the approved labeling are being sought.

Detailed description: This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis. Subjects will be randomized into one of two groups receiving either LLLT or sham LLLT. Subjects will receive LLLT or sham LLLT weekly over a period of six weeks. At each visit, patients will rate their pain using the Defense and Veterans Pain Rating Scale (DVPRS) and assess their functionality using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Subjects will have a follow up visit six weeks after the treatment protocol for a final assessment of pain and function. The Phoenix Thera-Lase laser is a Class II, 510k cleared device (#K151521) and is legally marketed in the US. Investigators are using in accordance with its approved labeling and no changes to the approved labeling are being sought.

The Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue and to temporarily increase local blood circulation. It is specifically designed as a high-power laser with an output power of 35 Watts and an output wavelength of1064 nm. The study will be utilizing an output power of 74 Watts and an output wavelength of 1275 nm.

Eligibility criteria: \*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and Female Active Duty and DoD Beneficiaries aged 18 years or older
* Hand pain, aching, or stiffness

And at least 3 of the 4 following features:

* Hard tissue enlargement of 2 or more of 10 selected joints
* Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints
* Fewer than 3 swollen metacarpophalangeal (MCP) joints
* Deformity of at least 1 of 10 selected joints

(The 10 selected joints are the first carpometacarpal (CMC), second and third proximal interphalangeal (PIP), second and third DIP joints of both hands.)

Exclusion Criteria:

* Known diagnosis of another type of arthritis: rheumatoid, psoriatic, crystalline, inflammatory bowel associated arthritis
* History of treatment with LLLT in the past 12 weeks Surgery within the past 6 weeks
* Hand fracture within the past 6 weeks
* Pregnancy

Primary outcomes:
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 2 (Week 1) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 3 (Week 3) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 4 (Week 4) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 5 (Week 5) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 6 (Week 6) pre-treatment and immediately post-treatment *change same visit
measure: Defense and Veterans Pain Rating Scale
timeFrame: visit 7 (Week 12)
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 1 (day1) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 2 (week 2) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 3 (week 3) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 4 (week 4) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 5 (week 5) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 6 (week 6) pre-treatment and immediately post-treatment *change same visit
measure: Disabilities of the Arm, Shoulder, and Hand
timeFrame: visit 7 (week 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
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