RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Low Level Laser Therapy
Intervention / Treatment

-

Contacts and Locations

Nellis Air Force Base

Mike O'Callaghan Military Medical Center, Nellis Air Force Base, Nevada, United States, 89191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

David Moss,

Study Record Dates

2024-12