NCT05244187

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

November 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 17, 2024

Completed
Last Updated

February 28, 2025

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

February 8, 2022

Results QC Date

April 12, 2024

Last Update Submit

February 14, 2025

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • Primary Safety EndPoint

    Number of participants with adverse events

    after 2 weeks of use

  • Primary Efficacy EndPoint

    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.

    at baseline compared to during 2 weeks of use

Study Arms (2)

OrthoCor Active System

EXPERIMENTAL

OrthoCor Active System used for pain relief

Device: OrthoCor Active System

Standard of care

NO INTERVENTION

standard of care: over-the-counter pain medication

Interventions

OrthoCor Active SystemDEVICE

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.

OrthoCor Active System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals presenting with pain in superficial soft tissue, such as ankle, back, knee, wrist, elbow, shoulder, foot, or neck pain, or minor muscular and joint aches and pains associated with over exertion, strains, sprains, or arthritis
  • Prescribed use of the OrthoCor Active System or Standard of Care (SOC) intervention
  • Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)

You may not qualify if:

  • Have a cardiac pacemaker, cardioverter defibrillator, neurostimulator, infusion pump or any active medical implant
  • Have an implanted metallic lead or any type of wire coil implant, or any implanted system that may contain lead
  • Who are or may be pregnant
  • Have an open wound at the area of application
  • Are not capable or fully aware to the sensation of heat
  • Have poor circulation or heart disease
  • Have diabetes
  • Under the age of 18 or individuals with open bone growth plates
  • Unable to provide consent or obtain consent from a LAR
  • Unwilling or unable to use the OrthoCor Active System or Standard of Care (SOC) intervention
  • Unwilling or unable to complete the daily pain assessment
  • Enrolled in a study to evaluate an investigational drug
  • Prisoner or under incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

GFC of Southeastern Michigan PC

Detroit, Michigan, 48202, United States

Location

Rothman Orthopedic Institute

Washington Township, New Jersey, 08080, United States

Location

Orlin & Cohen Orthopedic Group

Smithtown, New York, 11787, United States

Location

Spinal Pain and Rehabilitation Medicine

Yonkers, New York, 10701, United States

Location

Related Publications (1)

  • Hackel JG, Paci JM, Gupta S, Maravelas DA, North TJ, Paunescu A. Evaluating Noninvasive Pulsed Electromagnetic Field Therapy for Joint and Soft Tissue Pain Management: A Prospective, Multi-center, Randomized Clinical Trial. Pain Ther. 2025 Apr;14(2):723-735. doi: 10.1007/s40122-025-00711-z. Epub 2025 Feb 10.

    PMID: 39928254RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Adelina Paunescu, VP Clinical Affairs
Organization
MEDIcept Inc
apaunescu@medicept.com
781-526-8152

Study Officials

  • Joshua G Hackel, MD

    Andrews Research and Education Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

November 7, 2022

Primary Completion

October 30, 2023

Study Completion

November 23, 2023

Last Updated

February 28, 2025

Results First Posted

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(5)