Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The primary objective of this study is to prospectively determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) therapy is beneficial in reducing patient-reported post-operative pain, as measured by visual analog scale (VAS). The amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment will also be measured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent.
Subjects who will be having shoulder or knee surgery are permitted.
Subject must not have used NSAIDs for one (1) week prior to surgery.
Subject must be willing and able to participate in post-operative physical therapy exercises.
Disqualifiers
Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
Subject has a known inflammatory or autoimmune connective tissue disease such as, but not limited to, gout affecting the shoulder, scleroderma, SLE, rheumatoid disease, or calcific tendonitis of the shoulder.
Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record.
Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
Trial design
Design model
Parallel
Treatments tested in this trial
Endonovo SofPulse
DeviceThe active device emits PEMF signal whereas the placebo device does not emit a PEMF signal. The active device is on for 15 minutes at a time, every two hours, for 10 days.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Active PEMF GroupActive comparator 1 intervention
Group B: Placebo PEMF GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days
The VAS is a subjective pain scale from 0 to 10, with 0 representing no pain.
Time frame
10 daysSecondary outcomes
1
Mean change from baseline in narcotic pain medicine use at 10 days
Pain medication will be documented every 24 hours.
Time frame
10 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Stanford University
Lead sponsor
Endonovo
Collaborator
Source ClinicalTrials.gov