Trial Outcomes & Findings for Proof of Concept Study of PEMF (Pulsed Electromagnetic Field) Therapy in Subjects With Osteoarthritis of the Knee (NCT NCT02696083)
NCT ID: NCT02696083
Last Updated: 2018-01-12
Results Overview
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).
COMPLETED
NA
19 participants
Baseline, Days 45 and 90
2018-01-12
Participant Flow
Participant milestones
| Measure |
Active Treatment (Provant Therapy System)
Provant Therapy System
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Proof of Concept Study of PEMF (Pulsed Electromagnetic Field) Therapy in Subjects With Osteoarthritis of the Knee
Baseline characteristics by cohort
| Measure |
Active Treatment
n=19 Participants
Provant Therapy System
|
|---|---|
|
Age, Continuous
|
63.68 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 45 and 90Population: The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).
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).
Outcome measures
| Measure |
BMP and Related Proteins
n=9 protein markers
BMP and related protein synovial markers measured included 9 markers: bone morphologic proteins (BMP-2, BMP-4, BMP-6, BMP-7, BMP-9) and related proteins Activin A, Osteoactivin (Ostact), sonic hedgehog (Shh N) and Dickkopf (DKK-1).
|
Cytokines
n=7 protein markers
The 7 synovial markers measured included the levels of interleukin cytokines and tumor necrosis factor alpha (Il-1α, IL-1β, IL-6, IL-8, IL-11, IL-17 and TNFα),
|
Growth Factors and Related Proteins
n=10 protein markers
The 10 synovial markers included in this group include 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 (FGF-1, FGF-2, AR, PDGF BB, TGF b1, TGF b2, TGF b3, OPG, OPN and IGF-1
|
Bone Remodeling Related Proteins
n=6 protein markers
The 6 synovial fluid markers in this group included monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine (MCP-1, M-CSF, MIP-1a, RANK, TRANCE).
|
Adhesion and Matrix Proteins
n=4 protein markers
This group includes 4 adhesion and matrix metalloproteinase proteins: ICAM-1, P-CadH, VCAM-1, and VE-CadH.
|
MPP Proteins
n=4 protein markers
The 4 matrix metalloproteinase proteins analyzed in this group include the following: MMP-2, MMP-3, MMP-9, and MMP-13.
|
|---|---|---|---|---|---|---|
|
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
|
6 protein markers
|
8 protein markers
|
5 protein markers
|
3 protein markers
|
2 protein markers
|
|
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
|
7 protein markers
|
10 protein markers
|
4 protein markers
|
4 protein markers
|
4 protein markers
|
Adverse Events
Active Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Treatment
n=19 participants at risk
Provant Therapy System
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Increased knee pain
|
47.4%
9/19 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Increase knee swelling
|
5.3%
1/19 • Number of events 1
|
|
Renal and urinary disorders
Exacerbation of patients end stage renal failure
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Anterior C6-C7 Cervical Diskectomy and Fusion with Partial Laminectomy, Medial facetectomy and foram
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left knee buckled
|
5.3%
1/19 • Number of events 1
|
|
Ear and labyrinth disorders
Prominent Menieres Episode
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
- Publication restrictions are in place
Restriction type: OTHER