Biophoton therapy for chronic severe arthritis pain relief
A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Impact of Biophoton Therapy on Chronic Severe Arthritis Pain
This study is testing if biophoton therapy can help people with chronic severe arthritis pain feel better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Institute of All Medicines Academic / other |
| Locations | 1 site (Butler, Pennsylvania) |
| Trial ID | NCT06915012 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of biophoton therapy using Tesla BioHealing® Biophoton Generators in alleviating chronic severe pain associated with arthritis. It is a randomized, double-blinded, placebo-controlled intervention involving approximately 102 participants. The primary outcome measure is the Visual Analog Scale (VAS) for pain, while secondary measures include quality of life assessments and various psychological and sleep quality indicators. Participants will be monitored over a 12-week period to assess changes in pain and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with chronic severe arthritis pain lasting at least three months and a pain rating of 5 or higher on the VAS.
Not a fit: Patients with untreated psychiatric disturbances, severe co-morbid conditions, or those relying on ventilators or having implantable electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide significant pain relief and improve the quality of life for patients suffering from chronic severe arthritis.
How similar studies have performed: While biophoton therapy is a novel approach, similar studies in alternative pain management have shown promising results, though this specific method remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to give informed consent for participation in the trial. * Is able and willing to comply with all trial requirements. * Male or female aged 18-80 years old with chronic severe arthritis pain. * ≥3 months duration of chronic severe arthritis pain. * a current VAS pain rating ≥5/10. * Able to complete the treatment for the study period. * Must be fluent in English. Exclusion Criteria: * Untreated psychiatric disturbances that would affect trial participation as judged by the Caregiver or by the clinical study medical professional * Who relies on ventilators * Who had deep brain stimulators, or pacemakers, or implantable electronic devices * Co-morbid conditions that would interfere with study activities or response to treatment, which may include severe chronic pulmonary disease, history of uncontrolled seizures, acute or chronic infectious illness, severe diabetes, kidney failure, or any end-of-life prognosis. * Is participating in another investigational drug or device trial * Has an active infectious disease, such as COVID-19 * Pregnant women.
Where this trial is running
Butler, Pennsylvania
- Tesla BioHealing Medical Center in Butler-PA — Butler, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Mariola Smotrys, MD, MBA, MSc
- Email: Mariola.Smotrys@firstallmed.org
- Phone: 302-500-3010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.