Trial Outcomes & Findings for Study to Evaluate the OrthoCor Active System for Pain Relief (NCT NCT05244187)

NCT ID: NCT05244187

Last Updated: 2025-02-28

Results Overview

Number of participants with adverse events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 120 participants
• Primary outcome timeframe: after 2 weeks of use
• Results posted on: 2025-02-28

Participant Flow

Participant milestones

Measure	OrthoCor Active System OrthoCor Active System used for pain relief OrthoCor Active System: The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.	Standard of Care standard of care: over-the-counter pain medication
Overall Study STARTED	59	61
Overall Study COMPLETED	48	43
Overall Study NOT COMPLETED	11	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate the OrthoCor Active System for Pain Relief

Baseline characteristics by cohort

Measure	OrthoCor Active System n=59 Participants OrthoCor Active System used for pain relief OrthoCor Active System: The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.	Standard of Care n=61 Participants standard of care: over-the-counter pain medication	Total n=120 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 16.3 • n=5 Participants	56.5 years STANDARD_DEVIATION 16.2 • n=7 Participants	55.3 years STANDARD_DEVIATION 16.2 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	59 Participants n=5 Participants	61 Participants n=7 Participants	120 Participants n=5 Participants

PRIMARY outcome

Timeframe: after 2 weeks of use

Population: ITT

Number of participants with adverse events

Outcome measures

Measure	OrthoCor Active System n=59 Participants OrthoCor Active System used for pain relief OrthoCor Active System: The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.	Standard of Care n=61 Participants standard of care: over-the-counter pain medication
Primary Safety EndPoint	2 Participants	2 Participants

PRIMARY outcome

Timeframe: at baseline compared to during 2 weeks of use

Population: PP

Change from baseline of Mankoski pain scale between OrthoCor and standard of care. The Mankoski pain scale ranges from 0 representing no pain to 10 representing pain causing unconsciousness.

Outcome measures

Measure	OrthoCor Active System n=48 Participants OrthoCor Active System used for pain relief OrthoCor Active System: The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.	Standard of Care n=43 Participants standard of care: over-the-counter pain medication
Primary Efficacy EndPoint	-1.8 score on a scale Interval -2.1 to -1.5	-0.5 score on a scale Interval -0.8 to -0.1

Adverse Events

OrthoCor Active System

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	OrthoCor Active System n=59 participants at risk OrthoCor Active System used for pain relief OrthoCor Active System: The OrthoCor Active System is a portable (battery operated) non-invasive device that delivers Pulsed Electromagnetic Field (PEMF) therapy for General Use of temporary pain relief, utilizing wraps that position the therapy, such as on the ankle, back, knee, wrist, elbow, shoulder, foot, or neck.	Standard of Care n=61 participants at risk standard of care: over-the-counter pain medication
Surgical and medical procedures shoulder pain	0.00% 0/59 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer	1.6% 1/61 • Number of events 1 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer
Surgical and medical procedures tingling	1.7% 1/59 • Number of events 1 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer	0.00% 0/61 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer
Surgical and medical procedures difficulty bending knee	1.7% 1/59 • Number of events 1 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer	0.00% 0/61 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer
Social circumstances sleepiness	0.00% 0/59 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer	1.6% 1/61 • Number of events 1 • 2 weeks FDA definitions of adverse events was used and all events experienced by the patients were reported adn evaluated by a safety officer

Additional Information

Adelina Paunescu, VP Clinical Affairs

MEDIcept Inc

Phone: 781-526-8152

Email: apaunescu@medicept.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place