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PEMF Therapy for Postoperative Pain After Orthopedic Surgery

N/A
Recruiting
Led By Geoffrey D Abrams, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be willing and able to participate in post-operative physical therapy exercises.
Subjects who will be having shoulder or knee surgery are permitted.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights

Study Summary

This trial is looking at whether PEMF therapy can help reduce pain after shoulder or knee surgery, as well as improve physical function.

Who is the study for?
This trial is for adults over 18 who are having shoulder or knee surgery and can do post-op physical therapy. They must not have taken NSAIDs a week before surgery, be willing to sign consent, and not drink excessively. Excluded are those with HIV, hepatitis, severe mental illness, certain connective tissue diseases, diabetes, unknown pain causes, recent corticosteroid use (except asthma/eye meds), medical marijuana users, compensation/litigation seekers for musculoskeletal issues.Check my eligibility
What is being tested?
The study tests if PEMF therapy using Endonovo SofPulse reduces pain after orthopedic surgery on the shoulder or knee. It measures how much it lowers pain levels at day 10 post-surgery using a visual scale and checks medication usage and physical function outcomes.See study design
What are the potential side effects?
The information provided does not specify side effects of PEMF therapy; however generally PEMF is considered non-invasive with minimal risks which may include mild discomfort or none at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and able to do physical therapy after surgery.
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I am scheduled for shoulder or knee surgery.
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I am 18 years old or older.
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I am taking low-dose aspirin (81 mg).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days
Secondary outcome measures
Mean change from baseline in narcotic pain medicine use at 10 days

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active PEMF GroupActive Control1 Intervention
Participants will have a 1 in 2 chance to get the active treatment device post-operatively. The device will be attached to the post-operative dressing. The device is an Endonovo SofPulse that emits a pulsed electromagnetic field (PEMF). Single blind randomization.
Group II: Placebo PEMF GroupPlacebo Group1 Intervention
Participants will have a 1 in 2 chance to get the placebo treatment device post-operatively. The device will be attached to the post-operative dressing. The Endonovo SofPulse placebo device does not emit a pulsed electromagnetic field (PEMF). Single blind randomization.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,317 Total Patients Enrolled
2 Trials studying Shoulder Injuries
130 Patients Enrolled for Shoulder Injuries
EndonovoUNKNOWN
Geoffrey D Abrams, MDPrincipal InvestigatorStanford University

Media Library

Active PEMF Group Clinical Trial Eligibility Overview. Trial Name: NCT04109638 — N/A
Shoulder Injuries Research Study Groups: Placebo PEMF Group, Active PEMF Group
Shoulder Injuries Clinical Trial 2023: Active PEMF Group Highlights & Side Effects. Trial Name: NCT04109638 — N/A
Active PEMF Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109638 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research currently recruiting volunteers?

"Affirmative. The clinicaltrials.gov website confirms that this medical examination is actively seeking out participants, beginning from February 1st 2021 to July 11th 2022. A total of 76 patients are needed at only one centre for the study."

Answered by AI

To what extent is the clinical trial being conducted with human participants?

"Affirmative. According to clinicaltrials.gov, this medical investigation is presently recruiting volunteers and was initially listed on February 1st 2021 before being revised most recently on July 11th 2022. 76 participants must be identified at a single site for the trial to move forward."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
~16 spots leftby Feb 2025