Osteoarthritis, KneeNCT02696083

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

A study testing Provant Therapy System in people with Osteoarthritis, Knee, run by Regenesis Biomedical, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Provant Therapy System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 2 sitesUnited States
Study dates: 2 Feb 2016to 23 Sep 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject age is greater than or equal to 45 years and less than 80 years of age.
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.
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.
Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
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).

Who cannot join

Subject has documented Kellgren-Lawrence radiograph score of 1.
Subject has undergone viscosupplementation treatment for the knee within 2 months of the Screening Visit.
Subject has had a total or partial knee replacement.
Subject has used topical or oral steroids within 2 months of the Screening Visit.
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.
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.

Show all 18Show fewer

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).
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.
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.
Subject has a history of blood cancer (e.g., leukemia, lymphoma, multiple myeloma).
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.
Subject has a Body Mass Index (BMI) > 38 kg/m2.
Subject has a serious psychosocial co-morbidity.
Subject has a history of drug or alcohol abuse within one year prior to screening.
Subject has an implanted pacemaker, defibrillator, neurostimulator, spinal cord stimulator, bone stimulator, cochlear implant, or other implanted device with an implanted metal lead(s).
Subject is currently pregnant or planning on becoming pregnant prior to Day 90.
Subject is unwilling or unable to follow study instructions, or comply with the treatment regimen, study visits, and diary entries.
Subject is in current litigation regarding knee pain or is receiving Worker's Compensation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Colorado Orthopaedics
Lone Tree, Colorado, 80124
Spokane Joint Replacement
Spokane, Washington, 99218

Other trials in United States

About this study

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

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.

Conditions: Osteoarthritis, Knee
Being tested: Provant Therapy System
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Provant Therapy SystemDevice

Study groups in NCT02696083
Study group	Role	What they receive
Active Treatment	Experimental	Not described Receives: Device: Provant Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, Days 45 and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201623 Sep 2016

First posted2 Mar 2016 (estimated)
Study start2 Feb 2016
Primary completion23 Sep 2016
Study completion23 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02696083
Sponsor's protocol ID: RBI.2015.004
Status last verified: Dec 2017
First submitted: 17 Feb 2016
Last updated: 12 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02696083
Acronym / sponsor ID: RBI.2015.004
Conditions: Osteoarthritis, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
Study start: 2 Feb 2016 (actual)
Primary completion: 23 Sep 2016 (actual)
Study completion: 23 Sep 2016 (actual)
First posted: 2 Mar 2016 (estimated)
Results: Posted 12 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active Treatment	Experimental	Device: Provant Therapy System

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subject age is greater than or equal to 45 years and less than 80 years of age.
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.
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.
Subject is willing and able to give written informed consent and to comply with all parts of the study protocol.
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).

Key exclusion criteria (18 listed)

Subject has documented Kellgren-Lawrence radiograph score of 1.
Subject has undergone viscosupplementation treatment for the knee within 2 months of the Screening Visit.
Subject has had a total or partial knee replacement.
Subject has used topical or oral steroids within 2 months of the Screening Visit.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Provant Therapy System	Device	Active Treatment

Primary outcome

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).

Results and safety

Results posted to the registry on 12 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Treatment (Provant Therapy System)	19	13

Primary outcome: Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90

Time frame: Baseline, Days 45 and 90. Count of units. Unit: protein markers

Measure	BMP and Related Proteins n = 19	Cytokines n = 19	Growth Factors and Related Proteins n = 19	Bone Remodeling Related Proteins n = 19	Adhesion and Matrix Proteins n = 19	MPP Proteins n = 19
Day 45 -# of markers that decreased from Baseline	6	6	8	5	3	2
Day 90 - # of markers that decreased from Baseline	8	7	10	4	4	4

Population analysed: The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Treatment	0 of 19 (0%)	10 of 19 (52.6%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Provant Therapy System in people with Osteoarthritis, Knee, run by Regenesis Biomedical, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 (time frame: Baseline, Days 45 and 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02696083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.