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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.)

Locations
United States
Nevada
Mike O'Callaghan Military Medical Center
RECRUITING
Nellis Air Force Base
Contact Information
Primary
Amanda Crawford
amanda.j.crawford.ctr@mail.mil
7026533600
Time Frame
Start Date: 2021-03-02
Estimated Completion Date: 2025-12
Participants
Target number of participants: 126
Treatments
Experimental: Group 1 (LLLT)
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.
Sham_comparator: Group 2 (LLLT Sham)
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.
Related Therapeutic Areas
Sponsors
Leads: David Moss

This content was sourced from clinicaltrials.gov

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