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

NCT03980964 | Completed DMC FDA Device

• 1 other identifier: CY-0030-306
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis

Keywords

NMES; arthritis; knee pain; osteoarthritis; electrical stimulation therapy

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS) pain level

  Pain for a nominated activity causing the worst knee pain

  12 weeks post intervention

• Visual Analogue Scale (VAS) pain level

  Worst pain at rest

  12 weeks post intervention

• Visual Analogue Scale (VAS) pain level

  Worst pain walking

  12 weeks post intervention

Secondary Outcomes (11)

• Quadriceps strength

  12 weeks post intervention

• TUG

  12 weeks post intervention

• Repeated chair rise

  12 weeks post intervention

• Stair climb

  12 weeks post intervention

• 6 min walk test

  12 weeks post intervention

Study Arms (2)

Active NMES

EXPERIMENTAL

Treatment arm receives an active NMES therapy including a conductive garment with NMES therapy, electrodes, and mobile app.

Device: Active NMES

Inactive NMES

SHAM COMPARATOR

Control arm receives inactive NMES therapy including a conductive garment (no NMES and no electrodes), and mobile app.

Device: Active NMES

Interventions

Active NMES DEVICE

Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy

Active NMES; Inactive NMES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients who are between the ages of 18 - 85 years
• Patient has signed informed consent
• Patient has access to a smartphone or tablet (Android or iOS)
• Subject must be ambulatory.
• Subject must be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
• Subjects must be proficient in English.
• Subject must be willing and able to sign an informed consent document.
• Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.

You may not qualify if:

• Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
• Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
• Subject must NOT have had arthroscopy within 8 weeks of randomization.
• Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
• Subjects who have had intra-articular injections of hyaluronic acid within 12 weeks of screening.
• 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.)
• Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening
• Subjects with significant and clinically evident mal-alignment of the target knee (\> 10 degrees varus or valgus in the target knee).
• Subjects with surgical metallic hardware in the target knee.
• Subjects who have contraindications to MRI and X-rays, for example, implanted electrical devices (cardiac pacemakers, deep brain stimulators).
• 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.
• Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (\> 5 years).
• Subjects with skin breakdown or infection in the area where the study device will be placed.
• 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.

Sponsors & Collaborators

• CyMedica Orthopedics, Inc: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis; Osteoarthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 10, 2019
• Study Start: June 7, 2019
• Primary Completion: May 22, 2020
• Study Completion: April 16, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)