Low Level Laser Therapy (LLLT) for the Treatment of Hand Osteoarthritis.

David Moss

Status: Terminated

Conditions: Low Level Laser Therapy; Family Medicine; Osteoarthritis; Pain Management; Integrative Medicine

Treatments: Device: Phoenix Thera-Lase System; Device: SHAM Phoenix Thera-Lase System

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04692597

FWH20210010H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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83 participants in 2 patient groups

Group 1 (LLLT)

Experimental group

Description:

Group 1: Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes affected per hand. The protocol for each group will involve one minute of LLLT over each of the following treatment zones: dorsal fingers and thumb, dorsal metacarpals, dorsal wrist, palmar fingers and thumb, palmar metacarpals, palmar wrist for a total of 6 minutes affected on each hand. The LLLT device will be held approximately 12 inches from the skin surface.

Treatment:

Device: Phoenix Thera-Lase System

Group 2 (LLLT Sham)

Sham Comparator group

Description:

Group 2: Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes affected per hand. The protocol for each group will involve one minute of sham LLLT over each of the following treatment zones: dorsal fingers and thumb, dorsal metacarpals, dorsal wrist, palmar fingers and thumb, palmar metacarpals, palmar wrist for a total of 6 minutes affected on each hand. The LLLT device will be held approximately 12 inches from the skin surface.

Treatment:

Device: SHAM Phoenix Thera-Lase System