Proof of Concept Study of PEMF (Pulsed Electromagnetic Field) Therapy in Subjects With Osteoarthritis of the Knee

A Multicenter, Open-Label, Single-Arm, Proof of Concept Study of Pulsed Electromagnetic Field (PEMF) Therapy to Evaluate Synovial Fluid Markers in Subjects With Osteoarthritis of the Knee

To investigate the effect of PEMF treatment when administered twice daily over a 90-day period by looking at synovial fluid in subjects with osteoarthritis of the knee.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Provant Therapy System

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Colorado Orthopaedics
  • Washington
    • Spokane, Washington, United States, 99218
      • Spokane Joint Replacement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject age is greater than or equal to 45 years and less than 80 years of age.
2. Subject has documented Kellgren-Lawrence radiograph score of 2, 3, or 4. Attempts will be made to include at least 3 subjects in each category.
3. Subject is on a stable analgesic regimen for at least two weeks prior to the Screening Visit and anticipates being able to remain on that regimen throughout the study.
4. Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
5. Female subjects must be post-menopausal, surgically sterile, abstinent, or practicing (or agree to practice) an effective method of birth control if they are sexually active for the duration of the study. (Effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier methods, and/or male partner sterilization).

Exclusion Criteria:

1. Subject has documented Kellgren-Lawrence radiograph score of 1.
2. Subject has undergone viscosupplementation treatment for the knee within 2 months of the Screening Visit.
3. Subject has had a total or partial knee replacement.
4. Subject has used topical or oral steroids within 2 months of the Screening Visit.
5. Subject has undergone any anesthetic injection into the knee within 30 days prior to the Screening Visit or within 6 weeks prior to the Screening Visit for long acting lidocaine injection products.
6. Subject has other diseases of the knee joint including inflammatory arthritis (i.e., rheumatoid arthritis, spondyloarthritis, gout and pseudogout), autoimmune disease (i.e., connective tissue disorders), septic arthritis, previous knee injury or intra-articular fracture.
7. Subject will be unable to treat daily over the course of the 90 day treatment period (e.g., travelling without the ability to take Provant).
8. Subject has received any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Screening Visit or is enrolled in another clinical trial.
9. Subject has a history of a solid tumor that is not in complete remission for greater than 2 years other than successfully treated non-metastatic basal cell or squamous cell carcinomas of the skin in the treatment area.
10. Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
11. Subject has an ongoing painful condition, other than osteoarthritis, that in the opinion of the investigator might have a confounding influence on the safety or effectiveness analyses for this study.
12. Subject has a Body Mass Index (BMI) > 38 kg/m2.
13. Subject has a serious psychosocial co-morbidity.
14. Subject has a history of drug or alcohol abuse within one year prior to screening.
15. Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
16. Subject is currently pregnant or planning on becoming pregnant prior to Day 90.
17. Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen, study visits, and diary entries.
18. Subject is in current litigation regarding knee pain or is receiving Worker's Compensation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Treatment	Device: Provant Therapy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90	Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).	Baseline, Days 45 and 90

Collaborators and Investigators

• Sponsor: Regenesis Biomedical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): September 23, 2016
• Study Completion (Actual): September 23, 2016

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: February 25, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: RBI.2015.004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO