NCT04109638 · Stanford University
Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
What this study is about
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).
View original scientific description
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.
Interventions
DEVICE
Endonovo SofPulse
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.
Primary outcome measures
Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days
Time frame: 10 days
The VAS is a subjective pain scale from 0 to 10, with 0 representing no pain.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Subject is diabetic.
- Subject has HIV or hepatitis.
- Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
- Subject has shoulder or knee pain of unknown etiology.
- Subject has had an active malignancy in the past 5 years OR has an active or on-going neoplastic disease, except for benign skin cancer(s).
- Subject has undergone administration, within 30 days prior to surgery, of any type of corticosteroid (with the exception of asthma medications and ophthalmic medications), antineoplastic, immunostimulation or immunosuppressive agent.
- Subject is septic, or has a local or systemic infection.
- Subject has an admitted active substance abuse problem which includes recreational drugs and/or narcotics or a history of substance abuse where history is defined as "not under the care of a physician" for more than 5 years. a. Prescriptive medical marijuana is not permitted, including CBD oils.
- Subject consumes more than 14 (men) or 7 (women) standard drinks (alcoholic units) per week where a drink equals a 12 oz. beer, or a 5 oz. glass of wine, or a 1.5 oz. shot of liquor.
- 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.
- Subject has major mental illnesses including major depression, bipolar disorder, schizophrenia or dementia that would prevent them from following the protocol and/or independently completing the patient reported outcomes measures.
- Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
- Subject has a mental or physical condition that would prevent them from complying with the study protocol.
Where
- Redwood City, California
Collaborators
Endonovo
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations