Knee OsteoarthritisNMESNCT03980964
Evaluation of NMES for Reducing Pain and Improving Functional Outcomes in Knee OA Patients
A study testing Active NMES in people with Knee Osteoarthritis and Knee Pain Chronic, run by CyMedica Orthopedics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- What is being tested?
- Active NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- 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.
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- 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.
- Subjects who have any ongoing litigation for worker's compensation.
- Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- Subjects who are pregnant.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Reducing Pain and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Being tested
- Active NMES
- Keywords
- NMES, arthritis, knee pain, osteoarthritis, electrical stimulation therapy
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active NMESDevice
Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy
| Study group | Role | What they receive |
|---|---|---|
| Active NMES | Experimental | Treatment arm receives an active NMES therapy including a conductive garment with NMES therapy, electrodes, and mobile app. Receives: 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. Receives: Device: Active NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) pain level
Pain for a nominated activity causing the worst knee pain
Measured: 12 weeks post intervention
Visual Analogue Scale (VAS) pain level
Worst pain at rest
Measured: 12 weeks post intervention
Visual Analogue Scale (VAS) pain level
Worst pain walking
Measured: 12 weeks post intervention
Secondary outcomes (11)
Quadriceps strength
Isometric quadriceps strength or torque
Measured: 12 weeks post intervention
TUG
Timed Up and Go test
Measured: 12 weeks post intervention
Repeated chair rise
Repeated chair rise test
Measured: 12 weeks post intervention
Stair climb
Stair climb
Measured: 12 weeks post intervention
6 min walk test
6 min walk test
Measured: 12 weeks post intervention
Activity
Average number of daily steps
Measured: 12 weeks post intervention
Pain related medication
NSAIDS, Narcotics
Measured: 12 weeks post intervention
Knee injections
HA and CS injections
Measured: 12 weeks post intervention
Physical therapy
Utilization of physical therapy
Measured: 12 weeks post intervention
Ambulation assist devices
Utilization of ambulation assist devices
Measured: 12 weeks post intervention
Plan for TKA surgery
Plan for TKA surgery
Measured: 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start7 Jun 2019
- Primary completion22 May 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CyMedica Orthopedics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980964
- Sponsor's protocol ID
- CY-0030-306
- Acronym
- NMES
- Status last verified
- May 2021
- First submitted
- 7 Jun 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Reducing Pain and Improving Functional Outcomes in Knee Osteoarthritis (OA) Patients
- ClinicalTrials.gov ID
- NCT03980964
- Acronym / sponsor ID
- NMES / CY-0030-306
- Conditions
- Knee Osteoarthritis, Knee Pain Chronic, Knee Arthritis
- Keywords
- NMES, arthritis, knee pain, osteoarthritis, electrical stimulation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CyMedica Orthopedics, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active NMES | Experimental | Device: Active NMESTreatment arm receives an active NMES therapy including a conductive garment with NMES therapy, electrodes, and mobile app. |
| Inactive NMES | Sham comparator | Device: Active NMESControl arm receives inactive NMES therapy including a conductive garment (no NMES and no electrodes), and mobile app. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (20 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active NMESDaily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy | Device | Active NMES, Inactive NMES |
Primary outcome
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
11 secondary outcomes
Quadriceps strength
Time frame: 12 weeks post intervention
TUG
Time frame: 12 weeks post intervention
Repeated chair rise
Time frame: 12 weeks post intervention
Stair climb
Time frame: 12 weeks post intervention
6 min walk test
Time frame: 12 weeks post intervention
Activity
Time frame: 12 weeks post intervention
Pain related medication
Time frame: 12 weeks post intervention
Knee injections
Time frame: 12 weeks post intervention
Physical therapy
Time frame: 12 weeks post intervention
Ambulation assist devices
Time frame: 12 weeks post intervention
Plan for TKA surgery
Time frame: 12 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active NMES in people with Knee Osteoarthritis and Knee Pain Chronic, run by CyMedica Orthopedics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) pain level (time frame: 12 weeks post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.