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

NCT04692597 | Terminated FDA Device

• 1 other identifier: FWH20210010H
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Level Laser Therapy; Osteoarthritis; Family Medicine; Pain Management; Integrative Medicine

Outcome Measures

Primary Outcomes (14)

• 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)

Study Arms (2)

Group 1 (LLLT)

EXPERIMENTAL

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

Group 2 (LLLT Sham)

SHAM COMPARATOR

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

Interventions

Phoenix Thera-Lase System DEVICE

Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.

Group 1 (LLLT)

SHAM Phoenix Thera-Lase System DEVICE

Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.

Group 2 (LLLT Sham)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• David Moss: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (18)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 5, 2021
• Study Start: March 2, 2021
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)