Family Medicine, Integrative Medicine, Low Level Laser Therapy, Osteoarthritis, Pain Management
Conditions
Brief 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.
Interventions
DEVICEPhoenix Thera-Lase System
Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.
DEVICESHAM 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.
Sponsors
David Moss
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Defense and Veterans Pain Rating Scale | visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit | The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used |
| Disabilities of the Arm, Shoulder, and Hand | visit 1 (day1) pre-treatment and immediately post-treatment *change same visit | The DASH is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point likert scale with 1 being no difficulty and 5 bring unable to perform the activity. |
Countries
United States
Outcome results
None listed