NCT04692597

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: David Moss · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Level Laser Therapy
• Osteoarthritis
• Family Medicine
• Pain Management
• Integrative Medicine

Interventions

Type	Name	Description
DEVICE	Phoenix Thera-Lase System	Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.
DEVICE	SHAM Phoenix Thera-Lase System	Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.

Timeline

• Start date: 2021-03-02
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2021-01-05
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study