Impact of Biophoton Therapy on Chronic Severe Arthritis Pain

NCT06915012 | Recruiting FDA Device

• 1 other identifier: FIAM-PN385
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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 performed by the study device management team staff, who will not inform the study participant or study research staff who are involved in study data collection. Each participant assigned to the Control Group will be treated with the 4 placebo devices on the bed. Each participant assigned to the Treatment Group will receive 4 Biophoton generator devices and placed on the bed on each side of the body. Each participant will use the Treatment or Control device for at least 8 hours every night for the 12 weeks during sleep. During the day, participants are welcome to bring the study devices and place them near the bodies during the daytime. At the end of the initial 12 weeks, study participants randomized to the Placebo group will be advised whether they will use the Open-Labeled product to treat them for 4 to 12 weeks. Only the visual analog scale of the pain data will be collected after the switch. Each participant will be guided by study team staff to perform the following tests on their assigned testing days: a visual analog scale, brief pain inventory, pain disability index, the standard SF-36 questionnaires (SF-36) for measuring life quality, the Pittsburgh Sleep Quality Index, a Patient Global Impression of Change, a Hospital Anxiety and Depression Scale, and inflammatory markers that provide objective evidence of inflammation. Investigational Product and Mode of Administration Tesla BioHealing Biophotonizer is an over-the-counter (OTC) medical device, and it can be used by anyone who wants to increase blood circulation and reduce bodily pains. For this study, the active or inactive Biophotonizer will be labeled with a code. The participant and/or caregiver cannot know if the devices are active or inactive. When the participant places the devices close to the body, she/he may or may not receive life force energy. The participant will record changes in quality of life and complete the standard study questionnaires at baseline and the end of each 2-week interval. Comparator and Mode of Administration Clinical measurements will be conducted by medical professionals. The same shape, size, and weight of the device without generating biophotons is to be labeled with a random code and used as a comparator. The comparator device will be placed close to the body during sleep during the entire study period. The participant will record the life quality changes and answer the standard study questionnaires. Clinical measurements will be conducted by medical professionals. Study Duration Estimated date of the first patient enrolled: November 15, 2024. The estimated date of the last patient completed: November 15, 2025. Participants in the Treatment Group and Control Group will actively participate in the study for 12 or 24 weeks. Each Participant will answer the standard study questionnaires several times, respectively, at the baseline, at the end of each 2-week interval after starting the study treatment.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• To determine if treatment with Biophoton Generator can significantly reduce arthritis pain

  VAS score to measure reduction in pain levels

  3 months

Secondary Outcomes (2)

• To determine if treatment with Biophoton Generator can significantly improve life quality

  3 months

• If the use of pain killer can be reduced

  3 months

Study Arms (2)

Active Treatment Arm with Biophoton Therapy

EXPERIMENTAL

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

Device: Tesla BioHealing(R) Biophoton Generators

Comparison Arm treated with Placebo-Device

PLACEBO COMPARATOR

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

Device: Tesla BioHealing(R) Biophoton Generators

Interventions

Tesla BioHealing(R) Biophoton Generators DEVICE

Biophoton generators have been reported to reduce severe chronic pain significantly. This is to determine its efficacy.

Active Treatment Arm with Biophoton Therapy; Comparison Arm treated with Placebo-Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Institute of All Medicines: lead

Study Sites (1)

Tesla BioHealing Medical Center in Butler-PA

Butler, Pennsylvania, 16001, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• James Z Liu, MD, PhD

  First Institute of All Medicines

  STUDY CHAIR

Central Study Contacts

Mariola Smotrys, MD, MBA, MSc

CONTACT

302-500-3010; Mariola.Smotrys@firstallmed.org

Ben Jagiello, MD

CONTACT

412-654-4583; ben.jaggiello@firstallmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each active or inactive Biophotonizer will be labeled individually with a code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 two-group study.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 7, 2025
• Study Start: March 28, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 7, 2025

Record last verified: 2025-04

Locations

US (1)