RECRUITING

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

Conditions

Knee Injuries Shoulder Injuries Pain, Postoperative PEMF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-02-01

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04109638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent. 2. Subjects who will be having shoulder or knee surgery are permitted. 3. Subject must not have used NSAIDs for one (1) week prior to surgery. 4. Subject must be willing and able to participate in post-operative physical therapy exercises. 5. Subject must understand and be willing to sign the IRB-approved Informed Consent Document.	1. Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS). 2. 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. 3. Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record. 4. Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis. 5. Subject is diabetic. 6. Subject has HIV or hepatitis. 7. Subject has a diagnosis of fibromyalgia or other chronic pain syndrome. 8. Subject has shoulder or knee pain of unknown etiology. 9. 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). 10. 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. 11. Subject is septic, or has a local or systemic infection. 12. 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. 13. 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. 14. 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. 15. 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. 16. Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies. 17. Subject has a mental or physical condition that would prevent them from complying with the study protocol.

Inclusion Criteria

Exclusion Criteria

1. Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent.
2. Subjects who will be having shoulder or knee surgery are permitted.
3. Subject must not have used NSAIDs for one (1) week prior to surgery.
4. Subject must be willing and able to participate in post-operative physical therapy exercises.
5. Subject must understand and be willing to sign the IRB-approved Informed Consent Document.

1. Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
2. 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.
3. Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record.
4. Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
5. Subject is diabetic.
6. Subject has HIV or hepatitis.
7. Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
8. Subject has shoulder or knee pain of unknown etiology.
9. 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).
10. 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.
11. Subject is septic, or has a local or systemic infection.
12. 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.
13. 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.
14. 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.
15. 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.
16. Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
17. Subject has a mental or physical condition that would prevent them from complying with the study protocol.

Contacts and Locations

Study Contact

Michelle Xiao, BS

CONTACT

6507230003

mxiao@stanford.edu

Principal Investigator

Geoffrey D Abrams, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Redwood City, California, 94063

United States

Collaborators and Investigators

Sponsor: Stanford University

Geoffrey D Abrams, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01

Study Completion Date2025-02

Study Record Updates

Study Start Date2021-02-01

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

PEMF

Additional Relevant MeSH Terms

Knee Injuries
Shoulder Injuries
Pain, Postoperative