PEMF Therapy for Postoperative Pain After Orthopedic Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Corticosteroids, Antineoplastics, Immunosuppressives, others
Disqualifiers: Diabetes, HIV, Hepatitis, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether PEMF therapy can help reduce pain in patients who have had shoulder or knee surgery. PEMF therapy uses electromagnetic waves to interact with the body's cells, which may reduce pain and speed up healing. The study will measure pain levels, medication use, and physical function after surgery. PEMF therapy has been evaluated as a therapeutic strategy for pain management in several clinical scenarios, showing positive efficacy and safety profiles.
Will I have to stop taking my current medications?
The trial requires that you stop taking NSAIDs (non-steroidal anti-inflammatory drugs) for one week before surgery, but low-dose aspirin is allowed. If you are taking corticosteroids, antineoplastic, immunostimulation, or immunosuppressive agents, you must stop them 30 days before surgery, except for asthma and eye medications.
What data supports the effectiveness of the treatment Endonovo SofPulse for postoperative pain after orthopedic surgery?
Research shows that pulsed electromagnetic field (PEMF) therapy, like Endonovo SofPulse, can help reduce pain and improve recovery after surgeries, such as Cesarean sections and joint replacements, by reducing inflammation and promoting healing.
12345Is PEMF therapy safe for humans?
PEMF therapy has been used in various studies for different conditions, including postoperative pain and osteoarthritis, and is generally considered safe for humans based on existing research.
12678How does PEMF therapy differ from other treatments for postoperative pain after orthopedic surgery?
PEMF therapy is unique because it uses electromagnetic fields to reduce pain and inflammation, which is different from traditional pain management methods like medications. It is non-invasive and has shown potential benefits in various surgeries, including joint replacements, by promoting bone healing and reducing chronic pain without the side effects associated with drugs.
12357Eligibility Criteria
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.Inclusion Criteria
I am willing and able to do physical therapy after surgery.
Subject must understand and be willing to sign the IRB-approved Informed Consent Document.
I am scheduled for shoulder or knee surgery.
+3 more
Exclusion Criteria
Subject is currently seeking or receiving worker's compensation for this injury or for an injury that has occurred more than 12 months prior to enrollment in this study or subjects who are currently in litigation or who have a history of litigation related to musculoskeletal diagnoses.
I do not use medical marijuana or CBD oils.
I have an autoimmune disease like rheumatoid arthritis or lupus.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either active or placebo PEMF therapy post-operatively for 10 days
10 days
Daily monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityRedwood City, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
EndonovoCollaborator
References
Pulsed electromagnetic fields for post-appendicectomy pain management: a randomized, placebo-controlled trial. [2022]The value of pulsed electromagnetic field (PEMF) in postoperative pain management, due to the inconsistent findings so far, remains unclear. We extended the evaluation of PEMF on postoperative pain and intravenous (IV) analgesic use to a group of post-appendicectomy Asian patients.
Evaluation of pulsed electromagnetic field therapy for the treatment of chronic postoperative pain following lumbar surgery: a pilot, double-blind, randomized, sham-controlled clinical trial. [2022]The incidence of chronic postoperative pain following lumbar spinal surgery has increased with the overall increase in the prevalence of lumbar surgery. This study was conducted to evaluate the analgesic effectiveness of pulsed electromagnetic field (PEMF) therapy in subjects with persistent pain following lumbar surgery.
Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. [2021]Surgeons seek new methods of pain control to reduce side effects and speed postoperative recovery. Pulsed electromagnetic fields are effective for bone and wound repair and pain and edema reduction. This study examined whether the effect of pulsed electromagnetic fields on postoperative pain was associated with differences in levels of cytokines and angiogenic factors in the wound bed.
Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial. [2018]To evaluate the efficacy of pulsed electromagnetic field (PEMF) in relation to reducing postoperative pain, analgesic use, and wound healing in patients undergoing Cesarean section (C-section).
Role of pulsed electromagnetic fields after joint replacements. [2020]Although the rate of patients reporting satisfaction is generally high after joint replacement surgery, up to 23% after total hip replacement and 34% after total knee arthroplasty of treated subjects report discomfort or pain 1 year after surgery. Moreover, chronic or subacute inflammation is reported in some cases even a long time after surgery. Another open and debated issue in prosthetic surgery is implant survivorship, especially when related to good prosthesis bone ingrowth. Pulsed Electro Magnetic Fields (PEMFs) treatment, although initially recommended after total joint replacement to promote bone ingrowth and to reduce inflammation and pain, is not currently part of usual clinical practice. The purpose of this review was to analyze existing literature on PEMFs effects in joint replacement surgery and to report results of clinical studies and current indications. We selected all currently available prospective studies or RCT on the use of PEMFs in total joint replacement with the purpose of investigating effects of PEMFs on recovery, pain relief and patients' satisfaction following hip, knee or shoulder arthroplasty. All the studies analyzed reported no adverse effects, and good patient compliance to the treatment. The available literature shows that early control of joint inflammation process in the first days after surgery through the use of PEMFs should be considered an effective completion of the surgical procedure to improve the patient's functional recovery.
A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. [2010]Further evaluation of pulsed electromagnetic fields (PEMF), which have been observed to produce numerous biological effects, and have been used to treat delayed union fractures for over a decade.
Use of a pulsed electromagnetic field for treatment of post-operative pain in dogs: a pilot study. [2022]To determine if pulsed electromagnetic field (PEMF) therapy reduces post-operative pain in dogs following ovariohysterectomy, and to evaluate PEMF interaction with post-operative morphine analgesia.
Evidence-based use of pulsed electromagnetic field therapy in clinical plastic surgery. [2022]The initial development of pulsed electromagnetic field (PEMF) therapy and its evolution over the last century for use in clinical surgery has been slow, primarily because of lack of scientifically-derived, evidence-based knowledge of the mechanism of action.