What side effects are associated with this type of intervention?

Low-Level Laser Therapy (LLLT) is generally well-tolerated with minimal side effects, which may include temporary redness or irritation at the treatment site. Other non-pharmacologic treatments for pain management, such as ultrasound and shortwave diathermy, have shown inconsistent results in efficacy. Ultrasound therapy may cause mild discomfort or a warming sensation, while shortwave diathermy can lead to skin burns if not properly administered. Overall, these treatments are considered safe with proper use, but their effectiveness can vary.

What prior FDA approvals exist?

The FDA has approved several treatments for pain management that focus on reducing pain and inflammation and promoting tissue repair. These include pharmacologic therapies such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and muscle relaxants. Additionally, non-pharmacologic treatments like ultrasound therapy and shortwave diathermy have been explored, though their efficacy varies. Low-Level Laser Therapy (LLLT) has shown promise in clinical trials for conditions like chronic low back pain and osteoarthritis, but results have been inconsistent, and more research is needed to establish standardized protocols and long-term efficacy.

What other types of research exist?

Promising novel alternatives to Low-Level Laser Therapy (LLLT) for pain management include: <ol> <li>Topical Nitroglycerin: This treatment has shown potential in improving tendon healing and reducing pain in chronic tendinopathies by stimulating collagen synthesis.</li> <li>Ultrasound-Guided Percutaneous Needle Tenotomy: This technique involves using a needle to fenestrate tendinotic tissue and has shown good outcomes in patients with chronic elbow tendinopathy.</li> <li>Platelet-Rich Plasma (PRP) Injections: PRP has been found to improve function and reduce pain in the intermediate period for conditions like lateral epicondylitis.</li> <li>Botulinum Toxin A Injections: Although not standard, this treatment has shown some efficacy in refractory elbow tendinopathy by stimulating an inflammatory response.</li> <li>Percutaneous Electrical Nerve Stimulation (PENS): This method has shown moderate to substantial pain relief in chronic low back pain by targeting dermatomal levels with low-level electrical stimulation.</li> </ol>

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Low Level Laser Therapy

LLLT for Hand Osteoarthritis

N/A

Recruiting

Research Sponsored by David Moss

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hard tissue enlargement of 2 or more of 10 selected joints

Hard tissue enlargement of 2 or more distal interphalangeal (DIP) joints

Must not have

Known diagnosis of another type of arthritis: rheumatoid, psoriatic, crystalline, inflammatory bowel associated arthritis

Surgery within the past 6 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 7 (week 12)

Summary

This trial is testing a special light therapy called Low-Level Laser Therapy (LLLT) to see if it helps reduce pain and improve function in adults with hand osteoarthritis. The laser works by warming up tissues to relieve pain and improve blood flow. Low-Level Laser Therapy (LLLT) has been used in various fields to promote tissue repair, reduce inflammation, and relieve pain.

Who is the study for?

This trial is for Active Duty and DoD Beneficiaries over 18 with hand osteoarthritis, showing specific joint enlargements and deformities but not more than three swollen joints. Excluded are those who've had recent surgery or fractures, pregnant individuals, patients treated with LLLT in the past 12 weeks, or have other arthritis types.

What is being tested?

The study tests the Phoenix Thera-Lase System's effectiveness on hand osteoarthritis pain and function against a sham (placebo) device. Participants will receive weekly treatments for six weeks and have their pain and hand functionality assessed using DVPRS and DASH questionnaires.

What are the potential side effects?

Since this trial involves a low-level laser therapy system versus a sham treatment, side effects may be minimal to none. However, potential mild side effects could include local discomfort or skin irritation at the site of application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have swelling in 2 or more of my major joints.

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I have swelling in two or more of my finger joints closest to the nails.

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I have less than 3 swollen finger joints.

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One of my joints is deformed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a specific type of arthritis (rheumatoid, psoriatic, etc.).

Select...

I have had surgery in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 7 (week 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 7 (week 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 7 (week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Hand

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 1 (LLLT)Experimental Treatment1 Intervention

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.

Group II: Group 2 (LLLT Sham)Placebo Group1 Intervention

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Low-Level Laser Therapy (LLLT) reduces pain and inflammation and promotes tissue repair and regeneration by using specific wavelengths of light to penetrate tissues, which can stimulate cellular activity and enhance blood flow. Topical nitroglycerin may improve tendon healing by stimulating collagen synthesis through the release of nitric oxide. Ultrasound-guided percutaneous needle tenotomy involves using a needle to break up tendinotic tissue and calcifications, potentially stimulating an inflammatory response that promotes healing. Understanding these mechanisms helps pain management patients and their doctors choose the most appropriate treatment based on the underlying causes of their pain and the specific benefits of each therapy.

Preliminary clinical experience of low-level laser therapy for the treatment of canine osteoarthritis-associated pain: A retrospective investigation on 17 dogs.Photobiomodulation therapy by NIR laser in persistent pain: an analytical study in the rat.The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.