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.