Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis

March 16, 2021 updated by: CyMedica Orthopedics, Inc

A Roll-over Study of CM-2019 Trial (A Randomized, Sham Controlled, Double-blind, Multi-center Study of Neuromuscular Electrical Stimulation (NMES) as an Adjunctive Therapy for Knee Pain Relief and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients)

A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) as an adjunctive therapy for pain relief and accelerating functional recovery in patients with knee osteoarthritis. This follow-up trial will include subjects who have been randomized into the CM-2019 trial. Subjects will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is hypothesized that the continued use of CyMedica e-vive NMES may provide additional pain relief and improved knee function for an additional 14 weeks compared to sham.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Noble Clinical Research
      • Tucson, Arizona, United States, 85712
        • Tucson Orthopedic Institute
    • Texas
      • Houston, Texas, United States, 77061
        • Synergy Group US LLC
      • Katy, Texas, United States, 77450
        • Synergy Group US LLC
      • Missouri City, Texas, United States, 77459
        • Synergy Group US LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
  2. Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
  3. Willing and able to continue parent trial study treatment.
  4. Pregnancy test, if it has been >14 days since completion of the parent trial.
  5. Subject must continue to be willing to refrain from receiving knee intra-articular injections of steroids, knee intra-articular injections of hyaluronic acid, opioids, and analgesics (except for acetaminophen up to 3000 mg/day or an equivalent) for the duration of the study.
  6. Subject must continue to be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
  7. Subject must continue to be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
  8. Subject must continue to be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
  9. Subject must continue be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
  10. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study

Exclusion Criteria:

  1. Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
  2. Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
  3. Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
  4. Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
  5. Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
  6. Subjects who have had treatment of the target knee with intra-articular injections of steroids since parent trial enrollment. Subjects who have had intra-articular injections of hyaluronic acid since parent trial enrollment.
  7. Subjects who have a scheduled surgery on the target knee within the study period. (Subjects that are contemplating the surgery can be included.)
  8. Subjects who have used electrotherapy or acupuncture for OA of the target knee since parent trial enrollment year.
  9. Subjects who have had implanted electrical devices since parent trial enrollment (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
  10. Subjects with a current new malignancy or who have received treatment for malignancy since parent trial enrollment, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
  11. Subjects with a new skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
  12. Subjects with any newly reported chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) or that have not been well-controlled during the parent trial.
  13. Subjects who have any new litigation for worker's compensation.
  14. Subjects with any new condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
  15. Subjects who are pregnant.
  16. Subject who enrolled in any new clinical study from the last day of treatment in the parent trial that required the use of an investigational device, drug or biologic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active NMES
Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy
A home-based NMES treatment applied by the subjects daily
Sham Comparator: Modified NMES sham
Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy
A home-based NMES treatment applied by the subjects daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee pain
Time Frame: 14 weeks post intervention
Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale
14 weeks post intervention
Knee pain and function
Time Frame: 14 weeks post intervention
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey
14 weeks post intervention
Knee pain and function
Time Frame: 14 weeks post intervention
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using KOOS Jr. survey
14 weeks post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee function
Time Frame: 14 weeks post intervention
Knee functional improvements including quadriceps strength tes
14 weeks post intervention
Knee function
Time Frame: 14 weeks post intervention
Knee functional improvements including Timed Up and Go test
14 weeks post intervention
Knee function
Time Frame: 14 weeks post intervention
Knee functional improvements including 3 Min walk test
14 weeks post intervention
Knee function
Time Frame: 14 weeks post intervention
Knee functional improvements including Repeated chair rise test
14 weeks post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CyMedica Orthopedics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM-2019R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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