Knee OsteoarthritisNMESNCT04128618
Evaluation of a Home-based NMES Therapy for Knee Osteoarthritis Pain
A study testing CyMedica e-vive NMES in people with Knee Osteoarthritis, run by CyMedica Orthopedics, Inc at 2 sites in United States.
Trial summary
Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a home-based neuromuscular electrical stimulation (NMES) therapy Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CyMedica e-vive NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2019to 24 Nov 2020
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Subject must be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
- Subject must be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
- Subject must be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
- Subjects must be proficient in English.
- 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 (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.
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- 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).
- Subjects who have contraindications to X-rays.
- 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 (quadriceps of the target knee).
- 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 from the last day of treatment that required the use of an investigational device, drug or biologic
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Noble Clinical Research
Tucson, Arizona, 85704
Site 1
Tucson, Arizona, 85712
About this study
Official title: 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
Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a home-based neuromuscular electrical stimulation (NMES) therapy
- Conditions
- Knee Osteoarthritis
- Being tested
- CyMedica e-vive NMES
- Keywords
- knee OA, arthritis, knee pain
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyMedica e-vive NMESDevice
Neuromuscular Electrical Stimulation (NMES) therapy
| Study group | Role | What they receive |
|---|---|---|
| Active NMES | Experimental | Not described Receives: Device: CyMedica e-vive NMES |
| Modified NMES sham | Sham comparator | Not described Receives: Device: CyMedica e-vive NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain using VAS scale (Visual Analog Scale)
Pain associated with knee osteoarthritis- Unit none (score)
Measured: 12 weeks post intervention
Secondary outcomes (6)
Timed Up & Go (TUG)
Mobility and functionality assessment of the knee- Timed Up \& Go (TUG), unit seconds
Measured: 12 weeks post intervention
Quadriceps muscle strength
Strength assessment, Quadriceps strength using a handheld dynamometer, unit lbs/in
Measured: 12 weeks post intervention
Repeated Chair Rise
Mobility and functionality assessment of the knee- Repeated chair rise, unit none (number of times)
Measured: 12 weeks post intervention
3 min walk test
Mobility and functionality assessment of the knee- 3 min walk test, unit meters
Measured: 12 weeks post intervention
KOOS JR. Survey
Mobility and functionality assessment of the knee- KOOR JR- Unit, none (score)
Measured: 12 weeks post intervention
WOMAC Survey
Mobility and functionality assessment of the knee- WOMAC- Unit, none (score)
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 posted16 Oct 2019
- Study start8 Oct 2019
- Primary completion30 Jul 2020
- Study completion24 Nov 2020
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 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
- NCT04128618
- Sponsor's protocol ID
- CM-2019
- Acronym
- NMES
- Status last verified
- Nov 2020
- First submitted
- 7 Oct 2019
- Last updated
- 25 Nov 2020
- 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 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04128618
- Acronym / sponsor ID
- NMES / CM-2019
- Conditions
- Knee Osteoarthritis
- Keywords
- knee OA, arthritis, knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- CyMedica Orthopedics, IncIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 16 Oct 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.
Evaluation of knee pain and functional mobility of knee osteoarthritis patients with a home-based neuromuscular electrical stimulation (NMES) therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active NMES | Experimental | Device: CyMedica e-vive NMES |
| Modified NMES sham | Sham comparator | Device: CyMedica e-vive NMES |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| CyMedica e-vive NMESNeuromuscular Electrical Stimulation (NMES) therapy | Device | Active NMES, Modified NMES sham |
Primary outcome
Knee pain using VAS scale (Visual Analog Scale)
Time frame: 12 weeks post intervention
Pain associated with knee osteoarthritis- Unit none (score)
6 secondary outcomes
Timed Up & Go (TUG)
Time frame: 12 weeks post intervention
Quadriceps muscle strength
Time frame: 12 weeks post intervention
Repeated Chair Rise
Time frame: 12 weeks post intervention
3 min walk test
Time frame: 12 weeks post intervention
KOOS JR. Survey
Time frame: 12 weeks post intervention
WOMAC Survey
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 25 Nov 2020.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyMedica e-vive NMES in people with Knee Osteoarthritis, run by CyMedica Orthopedics, Inc at 2 sites 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 20 inclusion and 24 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Knee pain using VAS scale (Visual Analog Scale) (time frame: 12 weeks post intervention). 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 25 Nov 2020.