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

  • STATUS
    Recruiting
  • End date
    Jan 30, 2023
  • participants needed
    64
  • sponsor
    mallory krueger
Updated on 30 April 2022
stiffness
hand osteoarthritis

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.

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.

Details
Condition Low Level Laser Therapy, Osteoarthritis, Family Medicine, Pain Management, Integrative Medicine
Treatment Phoenix Thera-Lase System, SHAM Phoenix Thera-Lase System
Clinical Study IdentifierNCT04692597
Sponsormallory krueger
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
History of treatment with LLLT in the past 12 weeks Surgery within the past 6 weeks
inflammatory bowel associated arthritis
Hand fracture within the past 6 weeks
Pregnancy
Clear my responses

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