Chronic Knee PainNCT04580732
Clinical Trial of the MiniStim PNS for Knee Pain- "FLEX" Study
A study testing MiniStim PNS in people with Chronic Knee Pain, run by MiniStim LLC at 1 site in United States.
Trial summary
This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Knee Pain
- What is being tested?
- MiniStim PNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving informed consent and willing to follow all study related procedures;
- Women and men >18 years of age;
- Baseline VAS score of > 5;
- History of chronic, function-limiting knee pain of at least three months;
- Not had recent surgical procedures of the knee within the last three months;
- ≥50% temporary relief from temporary nerve diagnostics;
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- No evidence of anatomic abnormalities that could jeopardize the placement of the device;
- Able to operate programmer, recharger, study assessments and provide accurate responses;
- Appropriate candidate for the implant procedure based on the opinion of investigator.
Who cannot join
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study;
- Subject noted no relief from temporary nerve diagnostics;
- Inability to achieve appropriate positioning;
- Inability to understand informed consent and protocol;
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- Conditions requiring recurring MRI evaluation or diathermy procedures;
- Anatomical restrictions such that device placement is not possible;
- Have a life expectancy of less than 1-year;
- Worker's compensation claimants;
- Based on opinion of investigator any legal concerns that would preclude his/her enrollment in the study or potentially confound results;
- Deemed unsuitable for enrollment by investigator based on medical history or physical examination.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seva Medical
Lewisville, Texas, 75057
Bambi Fritz, 214-306-4116, bfritz@oshun.run
About this study
Official title: Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study
This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.
Read the detailed description
This is a prospective, randomized, controlled, multi-center study in which up to 300 evaluable subjects will receive MiniStim PNS. Target subjects will have chronic knee pain.
Subjects will be randomized into either the active or delayed group. Devices will be activated post-op in accordance to the randomization assignment. Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit.
The primary endpoint will be at 3-Months, comparing Active vs. Delayed data from baseline data, and subjects in the Delay group will begin stimulation. At the 3-month visit, VAS will be completed and compared to baseline VAS, during this visit the safety and efficacy of the device will be assessed, and subjects in the Delayed group will be instructed to begin daily stimulation for a minimum of 2 hours a day. Subjects will be seen at 3-month intervals through the 12-Month visit for data collection and adverse event review. Subjects will continue therapy and followed for a total of 36-months with primary outcomes assessed at 3-months. Their participation in the study will end at 36-months.
- Conditions
- Chronic Knee Pain
- Being tested
- MiniStim PNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniStim PNSDevice
MiniStim PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Receives: Device: MiniStim PNS |
| Delayed | Placebo comparator | The delayed group will begin 2-hour stimulation/day at the 3-Month visit. Receives: Device: MiniStim PNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Improvement pain defined as a >50% pain relief as measured by VAS without increase in baseline medications. To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.
Measured: 3-Months
Adverse Events
Device- and procedure-related Adverse Events (AE) rate at 3-months.
Measured: 3-months
Secondary outcomes (5)
Physical Function: Ability to do one-legged knee bends
The ability to do one-legged knee bends (percentage increase in knee bends).
Measured: 3, 6, 9, 12, 24, 36-months
Subset Symptoms: Mental Component Score
Change in Mental Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).
Measured: 3, 6, 9, 12, 24, 36-months
Medication Usage
Medication usage before and after treatment in active and delayed group subjects.
Measured: 3, 6, 9, 12, 24, 36-months
Change in Range of Motion
Change in knee range of motion as measured with Knee Range of Motion questionnaire.
Measured: 3, 6, 9, 12, 24, 36-months
Subset Symptoms: Physical Component Score
Change in Physical Component Score measured by SF-36 questionnaire measured on a scale of 1-5; 1 (all of the time) to 5 (none of the time).
Measured: 3, 6, 9, 12, 24, 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start5 May 2021
- Primary completionDec 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Knee PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiniStim LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580732
- Sponsor's protocol ID
- FLEX 31-00104
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized Trial of the MiniStim PNS for Knee Pain- "FLEX" Study
- ClinicalTrials.gov ID
- NCT04580732
- Acronym / sponsor ID
- FLEX 31-00104
- Conditions
- Chronic Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- MiniStim LLCIndustry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 8 Oct 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.
This is a prospective, multi-center, randomized, study in which 300 evaluable subjects will be randomized 1:1 to receive active or delayed therapy with Moments PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up. The primary endpoint is a >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications, with additional measurements assessed at 3, 6, 9, 12, 24, and 36-months.
Detailed description
This is a prospective, randomized, controlled, multi-center study in which up to 300 evaluable subjects will receive MiniStim PNS. Target subjects will have chronic knee pain.
Subjects will be randomized into either the active or delayed group. Devices will be activated post-op in accordance to the randomization assignment. Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit.
The primary endpoint will be at 3-Months, comparing Active vs. Delayed data from baseline data, and subjects in the Delay group will begin stimulation. At the 3-month visit, VAS will be completed and compared to baseline VAS, during this visit the safety and efficacy of the device will be assessed, and subjects in the Delayed group will be instructed to begin daily stimulation for a minimum of 2 hours a day. Subjects will be seen at 3-month intervals through the 12-Month visit for data collection and adverse event review. Subjects will continue therapy and followed for a total of 36-months with primary outcomes assessed at 3-months. Their participation in the study will end at 36-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: MiniStim PNSSubjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. |
| Delayed | Placebo comparator | Device: MiniStim PNSThe delayed group will begin 2-hour stimulation/day at the 3-Month visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving informed consent and willing to follow all study related procedures;
- Women and men >18 years of age;
- Baseline VAS score of > 5;
- History of chronic, function-limiting knee pain of at least three months;
- Not had recent surgical procedures of the knee within the last three months;
Key exclusion criteria (12 listed)
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study;
- Subject noted no relief from temporary nerve diagnostics;
- Inability to achieve appropriate positioning;
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 |
|---|---|---|
| MiniStim PNSMiniStim PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin. | Device | Active, Delayed |
Primary outcome
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Time frame: 3-Months
Improvement pain defined as a >50% pain relief as measured by VAS without increase in baseline medications. To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.
Adverse Events
Time frame: 3-months
Device- and procedure-related Adverse Events (AE) rate at 3-months.
5 secondary outcomes
Physical Function: Ability to do one-legged knee bends
Time frame: 3, 6, 9, 12, 24, 36-months
Subset Symptoms: Mental Component Score
Time frame: 3, 6, 9, 12, 24, 36-months
Medication Usage
Time frame: 3, 6, 9, 12, 24, 36-months
Change in Range of Motion
Time frame: 3, 6, 9, 12, 24, 36-months
Subset Symptoms: Physical Component Score
Time frame: 3, 6, 9, 12, 24, 36-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiniStim PNS in people with Chronic Knee Pain, run by MiniStim LLC 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanice Saunders (888-691-0585, contact@micronmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale (time frame: 3-Months). The study lists 2 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 6 Oct 2023.