Knee OsteoarthritisNCT04367597
Evaluation of NMES Therapy for Pain Relief Associated With Knee Osteoarthritis
A study testing Home-based Neuromuscular Electrical Stimulation (NMES) therapy in people with Knee Osteoarthritis, run by CyMedica Orthopedics, Inc at 5 sites in United States.
Trial summary
A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Home-based Neuromuscular Electrical Stimulation (NMES) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Apr 2020to 16 Mar 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
- Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
- Willing and able to continue parent trial study treatment.
- Pregnancy test, if it has been >14 days since completion of the parent trial.
- Subject must continue to be willing to refrain from 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 continue to be willing to take acetaminophen (up to 3000 mg/day) or an equivalent as pain medication for the duration of the study.
Show all 10Show fewer
- Subject must continue to be willing to stop taking any pain medications 24 hours prior any scheduled study visit.
- Subject must continue to be willing to stop receiving knee physical therapy of the target knee for the duration of the study.
- Subject must continue be willing to stop wearing any knee unloader brace of the target knee for the duration of the study.
- Subjects must be willing and able to comply with all study procedures for the duration of the clinical study
Who cannot join
- Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
- Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
- Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
- Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
- Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
- Subjects who have had treatment of the target knee with intra-articular injections of steroids since parent trial enrollment. Subjects who have had intra-articular injections of hyaluronic acid since parent trial enrollment.
Show all 16Show fewer
- Subjects who have a scheduled surgery on the target knee within the study period. (Subjects that are contemplating the surgery can be included.)
- Subjects who have used electrotherapy or acupuncture for OA of the target knee since parent trial enrollment year.
- Subjects who have had implanted electrical devices since parent trial enrollment (cardiac pacemakers, deep brain stimulators, implantable cardiac defibrillators).
- Subjects with a current new malignancy or who have received treatment for malignancy since parent trial enrollment, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
- Subjects with a new skin breakdown or infection in the area where the study device will be placed (quadriceps of the target knee).
- Subjects with any newly reported chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) or that have not been well-controlled during the parent trial.
- Subjects who have any new litigation for worker's compensation.
- Subjects with any new condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- Subjects who are pregnant.
- Subject who enrolled in any new clinical study from the last day of treatment in the parent trial that required the use of an investigational device, drug or biologic.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Synergy Group US LLC
Houston, Texas, 77061
Synergy Group US LLC
Katy, Texas, 77450
Synergy Group US LLC
Missouri City, Texas, 77459
Noble Clinical Research
Tucson, Arizona, 85704
Tucson Orthopedic Institute
Tucson, Arizona, 85712
About this study
Official title: A Roll-over Study of CM-2019 Trial (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)
A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.
Read the detailed description
This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) as an adjunctive therapy for pain relief and accelerating functional recovery in patients with knee osteoarthritis. This follow-up trial will include subjects who have been randomized into the CM-2019 trial. Subjects will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is hypothesized that the continued use of CyMedica e-vive NMES may provide additional pain relief and improved knee function for an additional 14 weeks compared to sham.
- Conditions
- Knee Osteoarthritis
- Being tested
- Home-based Neuromuscular Electrical Stimulation (NMES) therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Neuromuscular Electrical Stimulation (NMES) therapyDevice
A home-based NMES treatment applied by the subjects daily
| Study group | Role | What they receive |
|---|---|---|
| Active NMES | Experimental | Not described Receives: Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy |
| Modified NMES sham | Sham comparator | Not described Receives: Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale
Measured: 14 weeks post intervention
Knee pain and function
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey
Measured: 14 weeks post intervention
Knee pain and function
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using KOOS Jr. survey
Measured: 14 weeks post intervention
Secondary outcomes (4)
Knee function
Knee functional improvements including quadriceps strength tes
Measured: 14 weeks post intervention
Knee function
Knee functional improvements including Timed Up and Go test
Measured: 14 weeks post intervention
Knee function
Knee functional improvements including 3 Min walk test
Measured: 14 weeks post intervention
Knee function
Knee functional improvements including Repeated chair rise test
Measured: 14 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 posted29 Apr 2020
- Study start20 Apr 2020
- Primary completion20 Aug 2020
- Study completion16 Mar 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
- Parallel groups
- Model description
- Randomized, sham-controlled, double-blind, multi-center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT04367597
- Sponsor's protocol ID
- CM-2019R
- Status last verified
- Mar 2021
- First submitted
- 23 Apr 2020
- Last updated
- 18 Mar 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Roll-over Study of CM-2019 Trial (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
- NCT04367597
- Acronym / sponsor ID
- CM-2019R
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- CyMedica Orthopedics, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 29 Apr 2020 (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.
A roll-over study of the current CM-2019 trial to assess the same preplanned outcomes of CM-2019 at 14 weeks.
Detailed description
This roll-over study is designed as a 14-week treatment continuation from CM-2019 (parent study), a randomized, sham controlled, double-blind, multi-center study trial to evaluate the efficacy of CyMedica Orthopedics e-vive™ system, a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES) as an adjunctive therapy for pain relief and accelerating functional recovery in patients with knee osteoarthritis. This follow-up trial will include subjects who have been randomized into the CM-2019 trial. Subjects will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is hypothesized that the continued use of CyMedica e-vive NMES may provide additional pain relief and improved knee function for an additional 14 weeks compared to sham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, sham-controlled, double-blind, multi-center
| Arm | Type | Receives |
|---|---|---|
| Active NMES | Experimental | Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy |
| Modified NMES sham | Sham comparator | Device: Home-based Neuromuscular Electrical Stimulation (NMES) therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must provide a signed informed consent for CM-2019R. The subject will be provided with a copy of the signed Informed Consent upon signature.
- Currently enrolled in the parent trial CM-2019 or have successfully completed the parent trial within 21 days of enrollment in the roll-over trial.
- Willing and able to continue parent trial study treatment.
- Pregnancy test, if it has been >14 days since completion of the parent trial.
- Subject must continue to be willing to refrain from 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.
Key exclusion criteria (16 listed)
- Subjects with a new diagnosis of inflammatory arthritis (knee rheumatoid arthritis, active gout, knee joint infection, Lyme disease, SLE, etc.) since parent trial enrollment.
- Subjects with a new diagnosis of severe neuropathy condition and under medication for treatment of the condition since parent trial enrollment.
- Subjects with a new diagnosis of fibromyalgia since parent trial enrollment.
- Subjects who have had an injury or an acute traumatic injury to the target knee since parent trial enrollment.
- Subject must NOT have had arthroscopy of the target knee since parent trial enrollment.
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 |
|---|---|---|
| Home-based Neuromuscular Electrical Stimulation (NMES) therapyA home-based NMES treatment applied by the subjects daily | Device | Active NMES, Modified NMES sham |
Primary outcome
Knee pain
Time frame: 14 weeks post intervention
Assessment of knee pain relief associated with knee osteoarthritis using VAS instrument scale
Knee pain and function
Time frame: 14 weeks post intervention
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using WOMAC survey
Knee pain and function
Time frame: 14 weeks post intervention
Assessment of knee pain relief and function improvements associated with knee osteoarthritis using KOOS Jr. survey
4 secondary outcomes
Knee function
Time frame: 14 weeks post intervention
Knee function
Time frame: 14 weeks post intervention
Knee function
Time frame: 14 weeks post intervention
Knee function
Time frame: 14 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 18 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Neuromuscular Electrical Stimulation (NMES) therapy in people with Knee Osteoarthritis, run by CyMedica Orthopedics, Inc at 5 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 10 inclusion and 16 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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 (time frame: 14 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 18 Mar 2021.