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Impact of Biophoton Therapy on Chronic Severe Arthritis Pain

RecruitingNAAges 18 Years - 80 YearsAllFirst Institute of All Medicines
NCT06915012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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.
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What it tests

  • Tesla BioHealing(R) Biophoton Generators
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Where

1 site
Tesla BioHealing Medical Center in Butler-PA
Butler, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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