Impact of Biophoton Therapy on Chronic Severe Arthritis Pain
RecruitingNot applicableNCT06915012
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can alleviate chronic severe pain. Study Design This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in managing chronic severe pain. Approximately 102 patients with chronic severe arthritis pain will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a series of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurse, data-entry specialists, and biostatisticians, as well as the participants (and caregivers), will be blinded about who received which product during the first two weeks of study participation. Study Enrollment Each potentially qualified patient will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified patient will sign the e-ICF and send it to the Study Coordinator. The Study Coordinator will assign the qualified patient a randomized subject number, then the patient will become a study participant. Study Procedure We expect that the participant will stay in this clinical treatment for 12 weeks, or 12 weeks if the participants are randomly placed in a placebo group. The 12 weeks of participation are double-blinded to record the placebo effects, as each set of the study device is labelled with a unique code for use by only one participant. The change of the placebo device to the treatment device will be perform…
Study details
- Official title
- A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Impact of Biophoton Therapy on Chronic Severe Arthritis Pain
- Conditions
- Interventions
- Device: Tesla BioHealing(R) Biophoton Generators
- Sponsor
- First Institute of All Medicines
- Start date
- 2025-03-28
- Primary completion
- 2026-12-31
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06915012