NCT05244187

Study to Evaluate the OrthoCor Active System for Pain Relief

Completed NA Results posted Last updated 28 February 2025

What this trial tests

NA trial testing OrthoCor Active System in Pain in 120 participants. Completed in 23 November 2023.

Timeline

7 November 2022

Primary endpoint
30 October 2023

23 November 2023

Quick facts

Lead sponsor	Caerus Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	7 November 2022
Primary completion	30 October 2023
Estimated completion	23 November 2023
Sites	5 locations across United States

Drugs / interventions tested

• OrthoCor Active System

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Caerus Corporation

Who can join

18 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Safety EndPoint Primary · after 2 weeks of use

Number of participants with adverse events

Group	Value	95% CI
OrthoCor Active System	2
Standard of Care	2

Primary Efficacy EndPoint Primary · at baseline compared to during 2 weeks of use

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.

Group	Value	95% CI
OrthoCor Active System	-1.8	-2.1 – -1.5
Standard of Care	-0.5	-0.8 – -0.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OrthoCor Active System

Serious: 0/59 (0%)

Deaths: 0/59

Standard of Care

Serious: 0/61 (0%)

Deaths: 0/61

Other adverse events (4 terms — click to expand)

Reaction	System	OrthoCor Active System	Standard of Care
shoulder pain	Surgical and medical procedures	—	—
tingling	Surgical and medical procedures	—	—
difficulty bending knee	Surgical and medical procedures	—	—
sleepiness	Social circumstances	—	—

Data from ClinicalTrials.gov NCT05244187 adverse events section.

Sponsor's own description

This is a prospective, multi-center, randomized, pivotal study to evaluate the OrthoCor Active System in individuals prescribed its use in comparison with the standard of care intervention for pain relief.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating Noninvasive Pulsed Electromagnetic Field Therapy for Joint and Soft Tissue Pain Management: A Prospective, Multi-center, Randomized Clinical Trial.
   Hackel JG, Paci JM, Gupta S, Maravelas DA, et al · · 2025 · cited 2× · PMID 39928254 · DOI 10.1007/s40122-025-00711-z