Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain

NCT04128618 | Completed DMC FDA Device

• 1 other identifier: CM-2019
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a home-based neuromuscular electrical stimulation (NMES) therapy

Conditions

Knee Osteoarthritis

Keywords

knee OA; arthritis; knee pain

Outcome Measures

Primary Outcomes (1)

• Knee pain using VAS scale (Visual Analog Scale)

  Pain associated with knee osteoarthritis- Unit none (score)

  12 weeks post intervention

Secondary Outcomes (6)

• Timed Up & Go (TUG)

  12 weeks post intervention

• Quadriceps muscle strength

  12 weeks post intervention

• Repeated Chair Rise

  12 weeks post intervention

• 3 min walk test

  12 weeks post intervention

• KOOS JR. Survey

  12 weeks post intervention

Study Arms (2)

Active NMES

EXPERIMENTAL

Device: CyMedica e-vive NMES

Modified NMES sham

SHAM COMPARATOR

Device: CyMedica e-vive NMES

Interventions

CyMedica e-vive NMES DEVICE

Neuromuscular Electrical Stimulation (NMES) therapy

Active NMES; Modified NMES sham

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must provide written, informed consent before any study procedures occur. The subject should be provided with a copy of the signed Informed Consent upon signature.
• Subjects 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
• Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm confirmed by radiograph.
• Subjects who are between the ages of 21 - 85 years.
• Subjects must have a visual analog pain (VAS) score of at least 4 cm on a 10 cm scale for a nominated activity in the target knee at the time of screening.
• For bilateral knee osteoarthritis subjects, the visual analog pain VAS score for a nominated activity of the contralateral knee must be less than 4 cm on the VAS scale.
• Subject has access to a smartphone or tablet (Android or iOS).
• Subject must be ambulatory.
• Subject must be willing to discontinue 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.
• Subject must be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.

You may not qualify if:

• Subjects who have a body mass index ≥ 40 at the time of consent (at the discretion of the PI).
• Subjects with a diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.).
• Subjects with a diagnosis of severe neuropathy condition for the past 6 months and under medication for treatment of the condition.
• Subjects with a diagnosis of fibromyalgia for the past year.
• Subjects who have had an injury or an acute traumatic injury to the target knee within 6 months of screening.
• Subject must NOT have had arthroscopy of the target knee 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- Subjects who are scheduled to go under total knee replacement surgery within the next 3 months at screening will not be enrolled. Subjects 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 who have used Neuromuscular Electrical Stimulation (NMES) in the past year.
• Subjects with significant and clinically evident mal-alignment of the target knee (\> 5 degrees varus or valgus in the target knee).
• Subjects with surgical metallic hardware in the target knee.
• Subjects who have had implanted electrical devices (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).

Sponsors & Collaborators

• CyMedica Orthopedics, Inc: lead

Study Sites (2)

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Site 1

Tucson, Arizona, 85712, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, coordinators, and Investigators are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 16, 2019
• Study Start: October 8, 2019
• Primary Completion: July 30, 2020
• Study Completion: November 24, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)