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

Trial Summary

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 data supports the effectiveness of the treatment Phoenix Thera-Lase System for hand osteoarthritis?

Research shows that low level laser therapy (LLLT), similar to the Phoenix Thera-Lase System, has been used successfully to relieve symptoms like pain and swelling in hand osteoarthritis. Additionally, LLLT has shown promising results in reducing pain in other types of osteoarthritis, such as knee osteoarthritis. ^{1 2 3 4 5}

How does the Phoenix Thera-Lase System treatment for hand osteoarthritis differ from other treatments?

The Phoenix Thera-Lase System uses low level laser therapy (LLLT), which is unique because it involves non-invasive light treatment that triggers photochemical reactions in cells, rather than using heat or medication. This approach is different from traditional treatments that often rely on drugs or physical therapy, and it offers a novel way to potentially relieve pain and improve joint mobility in hand osteoarthritis. ^{1 2 3 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Positive effects of low level laser therapy (LLLT) on Bouchard's and Heberden's osteoarthritis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of High Intensity Laser Therapy for Reduction of Pain in Knee Osteoarthritis. [2018]

4. United States 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Low-energy helium neon laser treatment of thumb osteoarthritis. [2007]

6. England pubmed.ncbi.nlm.nih.gov

WITHDRAWN: Low level laser therapy (Classes III) for treating osteoarthritis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Low level laser therapy (Classes I, II and III) for treating osteoarthritis. [2020]