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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Level Laser Therapy, Osteoarthritis, Family Medicine, Pain Management, Integrative Medicine

Intervention / Treatment
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* Device: Phoenix Thera-Lase System
* Device: SHAM Phoenix Thera-Lase System


Participation Criteria
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Eligibility Criteria
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**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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (LLLT)<br>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. | Device: Phoenix Thera-Lase System<br>* Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.<br>|
| Sham Comparator: Group 2 (LLLT Sham)<br>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. | Device: SHAM Phoenix Thera-Lase System<br>* Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defense and Veterans Pain Rating Scale | 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 | visit 1 (Day 1) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 2 (Week 1) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 3 (Week 3) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 4 (Week 4) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 5 (Week 5) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 6 (Week 6) pre-treatment and immediately post-treatment *change same visit | 
| Defense and Veterans Pain Rating Scale | 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 | visit 7 (Week 12) | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 1 (day1) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 2 (week 2) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 3 (week 3) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 4 (week 4) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 5 (week 5) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 6 (week 6) pre-treatment and immediately post-treatment *change same visit | 
| Disabilities of the Arm, Shoulder, and Hand | 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. | visit 7 (week 12) |