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

• ClinicalTrials.gov Identifier: NCT02696083
• Recruitment Status: Completed
• First Posted: March 2, 2016
• Results First Posted: January 12, 2018
• Last Update Posted: January 12, 2018
• Sponsor: Regenesis Biomedical, Inc.
• Information provided by (Responsible Party): Regenesis Biomedical, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: Provant Therapy System	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: February 2, 2016
• Actual Primary Completion Date: September 23, 2016
• Actual Study Completion Date: September 23, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active Treatment	Device: Provant Therapy System

Outcome Measures

Primary Outcome Measures :

1. Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 [ Time Frame: Baseline, 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).

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Colorado

Colorado Orthopaedics

Lone Tree, Colorado, United States, 80124

United States, Washington

Spokane Joint Replacement

Spokane, Washington, United States, 99218

Sponsors and Collaborators

Regenesis Biomedical, Inc.

More Information

• Responsible Party: Regenesis Biomedical, Inc.
• ClinicalTrials.gov Identifier: NCT02696083
• Other Study ID Numbers: RBI.2015.004
• First Posted: March 2, 2016
• Results First Posted: January 12, 2018
• Last Update Posted: January 12, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases