Osteoarthritis, Knee
Conditions
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.
Interventions
DEVICEProvant Therapy System
Sponsors
Regenesis Biomedical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Provant Therapy System | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Active Treatment |
|---|---|
| Age, Continuous | 63.68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 10 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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).
Time frame: Baseline, Days 45 and 90
Population: The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BMP and Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 6 protein markers |
| BMP and Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 8 protein markers |
| Cytokines | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 6 protein markers |
| Cytokines | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 7 protein markers |
| Growth Factors and Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 8 protein markers |
| Growth Factors and Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 10 protein markers |
| Bone Remodeling Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 5 protein markers |
| Bone Remodeling Related Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 4 protein markers |
| Adhesion and Matrix Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 3 protein markers |
| Adhesion and Matrix Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 4 protein markers |
| MPP Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 45 -# of markers that decreased from Baseline | 2 protein markers |
| MPP Proteins | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Day 90 - # of markers that decreased from Baseline | 4 protein markers |