Biophoton Therapy for Arthritis Pain

(Severe Pain Trial)

Overseen By Mariola Smotrys, MD, MBA, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: First Institute of All Medicines

Disqualifiers: Psychiatric disturbances, Ventilators, Electronic devices, others

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether biophoton therapy, delivered through a special device, can ease chronic severe arthritis pain. Participants will use either an active device that emits biophotons or a placebo device that does not. The goal is to determine if this therapy can reduce pain and improve quality of life for those with long-term severe arthritis pain. It suits individuals who have experienced severe arthritis pain for more than three months. Participants must be able to follow trial instructions and communicate in English.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new pain relief options.

Do I need to stop my current medications to join 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 study team to get a clear answer.

What prior data suggests that this biophoton therapy device is safe for arthritis pain?

Previous studies have shown that biophoton therapy holds promise in reducing inflammation and pain, particularly in conditions like arthritis affecting muscles and joints. This treatment is generally considered safe. Reports indicate it is a non-invasive option with minimal side effects, meaning most people do not experience significant problems. Although research continues, current data suggest it is well-tolerated and could be a good choice for those seeking new ways to relieve pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical arthritis treatments, which often involve medications like NSAIDs or corticosteroids to reduce inflammation and pain, Biophoton Therapy offers a non-invasive alternative by using light-based technology. This therapy is unique because it targets pain at the cellular level, potentially promoting healing and reducing discomfort without the side effects associated with drugs. Researchers are excited about Biophoton Therapy because it could improve the quality of life for arthritis patients, providing a new avenue for pain management that doesn't rely on pharmaceuticals.

What evidence suggests that biophoton therapy is effective for arthritis pain?

Studies have shown that using light to aid healing, known as photobiomodulation, can reduce inflammation and repair cartilage in arthritis. In a clinical trial with 43 participants, low-level laser therapy, a treatment similar to biophoton therapy, significantly reduced long-term muscle and joint pain. This trial will evaluate the efficacy of Biophoton Therapy in reducing pain and improving the quality of life for patients with arthritis. The active treatment arm will receive Biophoton Therapy, while the comparison arm will use a placebo device. This suggests that biophoton therapy might help manage arthritis pain by using light to support the body's healing processes. While strong evidence supports pain reduction, results can vary, and more research is needed to fully understand its effects on arthritis. ^{1 2 3 6 7}

Who Is on the Research Team?

James Z Liu, MD, PhD

Principal Investigator

First Institute of All Medicines

Are You a Good Fit for This Trial?

This trial is for individuals with chronic severe arthritis pain. Participants must be able to commit to a 12 or 24-week study period, use the therapy device nightly, and complete questionnaires. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Able to complete the treatment for the study period

Must be fluent in English

My current pain level is 5 or higher on a scale of 0 to 10.

Exclusion Criteria

Participation in another investigational drug or device trial

Untreated psychiatric disturbances that would affect trial participation as judged by the Caregiver or by the clinical study medical professional

History of deep brain stimulators, pacemakers, or implantable electronic devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive either the Biophoton Generator or placebo device for 12 weeks, using the device for at least 8 hours every night

12 weeks

6 visits (virtual) at 2-week intervals

Open-label extension (optional)

Participants in the placebo group may opt to use the active Biophoton Generator for an additional 4 to 12 weeks

4-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Biophoton Therapy

Trial Overview The trial tests if Tesla BioHealing Biophoton Generators can reduce arthritis pain. It's randomized and double-blinded, comparing active devices against placebo ones that look identical but don't emit biophotons.

How Is the Trial Designed?

Group I: Active Treatment Arm with Biophoton Therapy Experimental Treatment 1 Intervention

This arm is to determine the efficacy of the Biophoton Generator in reducing pain and improving the quality of life of patients with arthritis.

Group II: Comparison Arm treated with Placebo-Device Placebo Group 1 Intervention

This arm is to compare with the active devices in reducing pain and improving the quality of life of patients with arthritis.

Who Is Running the Clinical Trial?

First Institute of All Medicines

Lead Sponsor

Trials

4

Recruited

220+

Published Research Related to This Trial

In a clinical trial involving 43 participants, low-level laser therapy using green and violet wavelengths significantly reduced chronic musculoskeletal pain, with visual analog pain scores dropping from 71.79 to 34.02 just three minutes after treatment (p < 0.0001).

A remarkable 81.4% of participants experienced a reduction of 30% or more in their pain scores, supporting the efficacy of this therapy and leading to the first FDA clearance for the combined use of these laser wavelengths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Impact of High Photon Energy Wavelengths on the Treatment of Chronic Neck and Shoulder Pain. Sammons, T., Gair, K., Silverman, RG., et al.[2023]

Intra-articular Botulinum toxin A (BoNT/A) injections significantly improved pain and function in two rheumatoid arthritis patients with persistent monoarthritis, showing over 40% improvement after treatment.

The benefits of the treatment lasted for 15-18 months, with complete resolution of ankle swelling by 15 months and metatarsophalangeal joint swelling by one month, suggesting BoNT/A could be a promising alternative for patients who do not respond to corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular botulinum toxin A as an adjunctive therapy for refractory joint pain in patients with rheumatoid arthritis receiving biologics: a report of two cases. Singh, JA., Mahowald, ML.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06915012

Impact of Biophoton Therapy on Chronic Severe Arthritis Pain This will provide important evidence why biophoton generators can be effective in alleviating chronic severe arthritis pain [Time Frame: baseline, 0-2, 0-4, 0-6 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10531845/

The Mechanisms and Efficacy of Photobiomodulation ... While some studies have shown that PBM can reduce inflammation and repair cartilage in arthritis [18,19], others have failed to find significant ...

3. withpower.com withpower.com/trial/biophoton-therapy-for-arthritis-pain-ce4a3

Biophoton Therapy for Arthritis Pain (Severe Pain Trial) In a clinical trial involving 43 participants, low-level laser therapy using green and violet wavelengths significantly reduced chronic musculoskeletal pain, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2957070/

Biophoton Detection and Low-Intensity Light Therapy In this review, we will present the case for pursuing further investigation into the potential clinical partnership between biophoton detection and LILT.

5. pagepressjournals.org pagepressjournals.org/bam/article/view/13107

Low level laser therapy and rheumatoid arthritis LLLT shows promise in improving grip strength and reducing morning stiffness in RA patients, though it does not significantly impact pain relief ...

6. crimsonpublishers.com crimsonpublishers.com/mapp/fulltext/MAPP.000564.php

Integrating Biophoton Therapy with Pharmacological ... Biophoton therapy is widely regarded as a safe, non-invasive modality with minimal adverse effects across diverse populations and clinical ...

7. scirp.org scirp.org/journal/paperinformation?paperid=112348

Biophoton Imaging Evaluation of the Process ... In this study, we found that the biophoton emission in the hind paws of RA rats was significantly higher than that of the control group.