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A Pilot Prospective, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy in Decreasing Post-Operative Pain Following Orthopedic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• a. a. Low-dose aspirin (81 mg) is permitted.

• Subject must be willing and able to participate in post-operative physical therapy exercises.

• Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

Locations
United States
California
Stanford University
RECRUITING
Redwood City
Contact Information
Primary
Michelle Xiao, BS
mxiao@stanford.edu
6507230003
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2027-02
Participants
Target number of participants: 76
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Endonovo

This content was sourced from clinicaltrials.gov