LLLT for Hand Osteoarthritis

Overseen By Amanda Crawford

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: David Moss

Disqualifiers: Rheumatoid arthritis, Psoriatic arthritis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with hand osteoarthritis, a condition causing pain, aching, or stiffness in the hands. It compares the effects of low-level laser therapy (LLLT) using the Phoenix Thera-Lase system with a placebo (a treatment that resembles the real one but isn't) to determine if LLLT can reduce pain and improve hand function. Participants will receive treatment once a week for six weeks and will rate their pain and hand use during the trial. Those with access to care at Nellis Air Force Base and who experience hand pain along with certain joint changes might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Phoenix Thera-Lase System is safe for treating hand osteoarthritis?

Research has shown that low-level laser therapy (LLLT) is generally safe for patients. The Phoenix Thera-Lase device used in this trial has received FDA approval, indicating it meets safety standards for other uses. Past studies reported no major adverse reactions with LLLT. Although the treatment did not significantly improve pain relief or function for hand osteoarthritis, it proved safe for participants. This suggests that the treatment is likely safe for people, with no major side effects expected. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-level laser therapy (LLLT) for hand osteoarthritis because it offers a non-invasive alternative to traditional treatments like NSAIDs, corticosteroid injections, and physical therapy. Unlike these options, the Phoenix Thera-Lase System uses a focused laser light to potentially reduce pain and inflammation by stimulating cellular repair processes at the affected areas. Additionally, this treatment is unique because it delivers therapy without the side effects commonly associated with medication, providing a promising option for those seeking relief without pharmaceuticals.

What evidence suggests that the Phoenix Thera-Lase System might be an effective treatment for hand osteoarthritis?

Research has shown that Low Level Laser Therapy (LLLT) can reduce pain and improve movement in people with osteoarthritis. Studies have found that LLLT significantly eases pain and increases joint flexibility, particularly in the knees. Additionally, LLLT provides lasting relief, maintaining pain reduction even after treatment ends. This trial will evaluate the effectiveness of LLLT using the Phoenix Thera-Lase System for hand osteoarthritis. Although this trial focuses on hand osteoarthritis, positive results in other joints suggest it could also be effective for hands. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I experience hand pain, aching, or stiffness.

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

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

Exclusion Criteria

Pregnancy

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

I have had surgery in the last 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LLLT or sham LLLT weekly for six weeks. At each visit, patients rate their pain using the DVPRS and assess functionality using the DASH questionnaire.

6 weeks

6 visits (in-person)

Follow-up

Participants have a follow-up visit six weeks after the treatment protocol for a final assessment of pain and function.

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Phoenix Thera-Lase System
• SHAM Phoenix Thera-Lase System

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 1 (LLLT) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

David Moss

Lead Sponsor

Trials

6

Recruited

830+

mallory krueger

Lead Sponsor

Trials

1

Recruited

130+

Published Research Related to This Trial

In a study involving 88 osteoarthritis patients, low level laser therapy (LLLT) did not show significant improvements in pain relief, morning stiffness, or overall functional status compared to sham treatment.

However, LLLT did result in a notable improvement in carpometacarpal opposition and grip strength, suggesting some specific benefits despite overall lack of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. Brosseau, L., Wells, G., Marchand, S., et al.[2022]

Low Level Laser Therapy (LLLT) has shown statistically significant effectiveness in reducing pain and improving knee range of motion in patients with osteoarthritis, based on a review of eight trials involving 233 patients treated with laser and 172 with placebo.

While five trials indicated positive outcomes for LLLT compared to placebo, the variability in results suggests that further research is needed to standardize treatment methods and explore optimal dosages and anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Low level laser therapy (Classes III) for treating osteoarthritis. Brosseau, L., Robinson, V., Wells, G., et al.[2020]

Low level laser therapy (LLLT) significantly reduced pain and swelling and improved joint mobility in patients with hand osteoarthritis after just five to seven treatment sessions, with effects persisting for up to eight weeks.

The study involved 34 patients who received between 5 to 10 LLLT sessions, demonstrating that LLLT is a safe and effective non-invasive treatment option for managing symptoms of Heberden's and Bouchard's osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of low level laser therapy (LLLT) on Bouchard's and Heberden's osteoarthritis. Baltzer, AW., Ostapczuk, MS., Stosch, D.[2018]

A meta-analysis of seven trials involving 345 patients found that Low Level Laser Therapy (LLLT) showed conflicting results for pain relief in osteoarthritis, with no significant overall effect on pain scores, but some studies reported beneficial outcomes.

Lower doses of LLLT were found to be as effective as higher doses for reducing pain and improving knee range of motion, suggesting that treatment parameters may significantly influence the therapy's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low level laser therapy (Classes I, II and III) for treating osteoarthritis. Brosseau, L., Welch, V., Wells, G., et al.[2020]

The systematic review of low-level laser therapy (LLLT) for osteoarthritis from the Cochrane Library was found to be neither robust nor valid, as it favored negative conclusions by omitting relevant trials and data.

When all trials were included in a sensitivity analysis, the results shifted significantly in favor of LLLT, indicating that the therapy may be more effective than previously reported, highlighting the need for diverse expert representation in review groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Cochrane Reviews in controversial areas be biased? A sensitivity analysis based on the protocol of a Systematic Cochrane Review on low-level laser therapy in osteoarthritis. Bjordal, JM., Bogen, B., Lopes-Martins, RA., et al.[2018]

In a study of 81 patients with thumb osteoarthritis, HeNe laser treatment showed some minor benefits, such as reduced tenderness in certain joints and a slight increase in pinch strength, but these effects were not significant across most measures.

The study concluded that while the HeNe laser treatment is safe with minimal adverse effects, it is not an effective treatment for osteoarthritis of the thumb, as most outcomes did not differ significantly from the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-energy helium neon laser treatment of thumb osteoarthritis. Basford, JR., Sheffield, CG., Mair, SD., et al.[2007]

In a pilot study involving 72 patients with knee osteoarthritis, high intensity laser therapy (HILT) significantly reduced pain levels after seven treatment sessions compared to a sham laser group, indicating its efficacy.

The study suggests that HILT could be a preferred treatment option for knee osteoarthritis due to its substantial pain relief effects, as measured by VAS and dolorimetry assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of High Intensity Laser Therapy for Reduction of Pain in Knee Osteoarthritis. Angelova, A., Ilieva, EM.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04692597

Low Level Laser Therapy (LLLT) for the Treatment of Hand ... This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis.

2. withpower.com withpower.com/trial/phase-osteoarthritis-2-2021-618b8

LLLT for Hand Osteoarthritis Low Level Laser Therapy (LLLT) has shown statistically significant effectiveness in reducing pain and improving knee range of motion in patients with ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT04692597

Low Level Laser Therapy (LLLT) for the Treatment of Hand ... This study is a randomized, control trial of Active Duty and DoD Beneficiaries, age 18 years or older, with complaints of hand osteoarthritis.

4. researchgate.net researchgate.net/publication/319229164_Effect_of_High-Intensity_Laser_Treatments_on_Chronic_Pain_Related_to_Osteoarthritis_in_Former_Professional_Athletes_A_Case_Series

Effect of High-Intensity Laser Treatments on Chronic Pain ... Background: We evaluated the use of a new higher intensity 42 Watt cold laser for treating chronic pain related to osteoarthritis (OA) in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35743513/

and Long-Term Effectiveness of Low-Level Laser Therapy ... Pain was reduced substantially in both groups. LLLT seemed to provide a positive add-on effect in the follow-up period in terms of reduced ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15704096/

Randomized controlled trial on low level laser therapy ... Conclusions: LLLT is no better than placebo at reducing pain, morning stiffness, or improving functional status for OA-hand patients. Copyright 2005 Wiley-Liss, ...