Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis

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: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy

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: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Knee pain	Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale	14 weeks post intervention
Knee pain and function	Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey	14 weeks post intervention
Knee pain and function	Assessment of knee pain relief and function improvements associated with knee osteoarthritis using KOOS Jr. survey	14 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee function	Knee functional improvements including quadriceps strength tes	14 weeks post intervention
Knee function	Knee functional improvements including Timed Up and Go test	14 weeks post intervention
Knee function	Knee functional improvements including 3 Min walk test	14 weeks post intervention
Knee function	Knee functional improvements including Repeated chair rise test	14 weeks post intervention

Collaborators and Investigators

• Sponsor: CyMedica Orthopedics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): August 20, 2020
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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