Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT04109638
Status
Recruiting

Conditions

  • Knee Injuries
  • Pain, Postoperative
  • Shoulder Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Endonovo SofPulse — DEVICE
    The 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2021
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active PEMF Group
    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.
  • Sham Comparator: Placebo PEMF Group
    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.

Primary Outcome Measure

Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days [ Time Frame: 10 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94063-

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