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Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients (NMES)

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ClinicalTrials.gov Identifier: NCT03980964
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
CyMedica Orthopedics, Inc

Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE June 7, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Visual Analogue Scale (VAS) pain level [ Time Frame: 12 weeks post intervention ]
    Pain for a nominated activity causing the worst knee pain
  • Visual Analogue Scale (VAS) pain level [ Time Frame: 12 weeks post intervention ]
    Worst pain at rest
  • Visual Analogue Scale (VAS) pain level [ Time Frame: 12 weeks post intervention ]
    Worst pain walking
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2019)
  • Quadriceps strength [ Time Frame: 12 weeks post intervention ]
    Isometric quadriceps strength or torque
  • TUG [ Time Frame: 12 weeks post intervention ]
    Timed Up and Go test
  • Repeated chair rise [ Time Frame: 12 weeks post intervention ]
    Repeated chair rise test
  • Stair climb [ Time Frame: 12 weeks post intervention ]
    Stair climb
  • 6 min walk test [ Time Frame: 12 weeks post intervention ]
    6 min walk test
  • Activity [ Time Frame: 12 weeks post intervention ]
    Average number of daily steps
  • Pain related medication [ Time Frame: 12 weeks post intervention ]
    NSAIDS, Narcotics
  • Knee injections [ Time Frame: 12 weeks post intervention ]
    HA and CS injections
  • Physical therapy [ Time Frame: 12 weeks post intervention ]
    Utilization of physical therapy
  • Ambulation assist devices [ Time Frame: 12 weeks post intervention ]
    Utilization of ambulation assist devices
  • Plan for TKA surgery [ Time Frame: 12 weeks post intervention ]
    Plan for TKA surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients
Official Title  ICMJE Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Reducing Pain and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
Brief Summary The present prospective trial is designed to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) for reducing pain and accelerating functional recovery in patients with knee osteoarthritis. This post-market trial will involve patients who have been diagnosed with knee osteoarthritis, Kelgren-Lawrence Grades II, III, and IV. It is hypothesized that the use of the CyMedica e-vive NMES can reduce pain, improve knee function, and improve quality of life.
Detailed Description

The study will be conducted at Lenox Hill Hospital, Northwell Health, located in New York, New York, and involve a total of 120 patients. All study patients will be evenly divided into two groups: (a) conductive garment and mobile app with NMES therapy; (b) conductive garment and mobile app without NMES therapy (sham).

Eligible patients will be evaluated according to the time and events schedule. Clinical outcomes will be assessed from 1 to 10 days before day of intervention and followed up after intervention over a 24 weeks ± 1 week study period.

These two groups will be analyzed using several outcome measures including validated patient-reported outcome measures including Visual Analogue Scale (VAS) pain level, the Knee Injury and Osteoarthritis Outcome Score (KOOS) JR., KOOS ADL, and WOMAC survey. Functional measures include isometric quadriceps strength, Time Up and Go (TUG), 6 minute walk test, repeated chair rise test, stair climb test, and number of steps recorded by an Apple Watch Series 3 or a Samsung watch. Reduction of use of anti-inflammatory medications (NSAIDS) and narcotics, use of ambulation assist devices, plan for TKA procedure survey, device compliance use, and patient satisfaction survey will be tracked The primary endpoint for the study is Visual Analogue Scale (VAS) pain The proprietary app for this product will be used to track device usage (intensity, duration of session, frequency of use), VAS, WOMAC, and KOOS JR.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
One-way crossover- Patients from the control cohort are allowed to crossover to the treatment cohort after 12 weeks of study enrollment, if a subject would request receiving knee intra-articular injections of hyaluronic acid (HA) or corticosteroids (CS) or opioids. Patients are also allowed to crossover to the treatment arm if they decide to drop out of the study due to the potential lack of clinical benefits from the sham treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Knee Osteoarthritis
  • Knee Pain Chronic
  • Knee Arthritis
Intervention  ICMJE Device: Active NMES
Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy
Study Arms  ICMJE
  • Experimental: Active NMES
    Treatment arm receives an active NMES therapy including a conductive garment with NMES therapy, electrodes, and mobile app.
    Intervention: Device: Active NMES
  • Sham Comparator: Inactive NMES
    Control arm receives inactive NMES therapy including a conductive garment (no NMES and no electrodes), and mobile app.
    Intervention: Device: Active NMES
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with symptomatic Kellgren-Lawrence (KL) Grade 2, 3, or 4 OA by radiograph (AP tunnel view) within 30 days prior to day 0 visit, where the K-L grades are defined as:

    • Grade 0: no radiographic features of OA are present
    • Grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping
    • Grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph
    • Grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity
    • Grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
  2. Patients who are between the ages of 18 - 85 years
  3. Patient has signed informed consent
  4. Patient has access to a smartphone or tablet (Android or iOS)
  5. Subject must be ambulatory.
  6. Subject must be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
  7. Subjects must be proficient in English.
  8. Subject must be willing and able to sign an informed consent document.
  9. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.

Exclusion Criteria:

  1. Subjects who have a body mass index > 40 at the time of consent. Exclusion of a patient with BMI>40 is up to the discretion of the PI.
  2. Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
  3. Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
  4. Subject must NOT have had arthroscopy within 8 weeks of randomization.
  5. Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
  6. Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of screening.
  7. Subjects who have had a scheduled surgery on the target knee within the study period.

    (Note- Patients who are scheduled to go under surgery within the next 6 months will be excluded. Patients that are contemplating the surgery can be included.)

  8. Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening
  9. Subjects with significant and clinically evident mal-alignment of the target knee (> 10 degrees varus or valgus in the target knee).
  10. Subjects with surgical metallic hardware in the target knee.
  11. Subjects who have contraindications to MRI and X-rays, for example, implanted electrical devices (cardiac pacemakers, deep brain stimulators).
  12. Subjects with a current malignancy or who have received treatment for malignancy with the last 5 years, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
  13. Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (> 5 years).
  14. Subjects with skin breakdown or infection in the area where the study device will be placed.
  15. Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) that have not been well-controlled for at least 3 months prior to screening.
  16. Subjects who have any ongoing litigation for worker's compensation.
  17. Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
  18. Subjects who are pregnant.
  19. Subject must not have participated in a clinical study within the past 12 weeks that required the use of an investigational device, drug or biologic
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kereshmeh Shahriari 480-239-8553 kereshmeh@cymedicaortho.com
Contact: Jeff Zywicki 480-207-1741 jeff.z@cymedicaortho.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980964
Other Study ID Numbers  ICMJE CY-0030-306
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CyMedica Orthopedics, Inc
Study Sponsor  ICMJE CyMedica Orthopedics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CyMedica Orthopedics, Inc
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP