Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery (NCT04109638) | Clinical Trial Compass
RecruitingNot Applicable
Pulsed Electromagnetic Field (PEMF) Therapy for Post-operative Pain Following Orthopedic Surgery
United States76 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Subjects may be male or female greater or equal to 18 years of age (ā„ 18) at the time of consent.
ā. Subjects who will be having shoulder or knee surgery are permitted.
ā. Subject must not have used NSAIDs for one (1) week prior to surgery.
ā. Subject must be willing and able to participate in post-operative physical therapy exercises.
ā. Subject must understand and be willing to sign the IRB-approved Informed Consent Document.
Exclusion criteria
ā. Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
ā. 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.
ā. Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record.
ā. Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
ā. Subject is diabetic.
ā. Subject has HIV or hepatitis.
ā. Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
What they're measuring
1
Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days