Idiopathic Hip PainNCT05074329
Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
A study testing Moventis PNS in people with Idiopathic Hip Pain and Chronic Hip Pain, run by Uro Medical Corporation.
Trial summary
This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis 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 to 90 years
- Conditions the study is for
- Idiopathic Hip Pain, Chronic Hip Pain
- What is being tested?
- Moventis PNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Jun 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving informed consent;
- Capable and willing to follow all study related procedures;
- Women and men >18 years of age;
- Diagnosis of hip pain;
- Baseline VAS score of >5;
- >50% temporary relief from temporary nerve diagnostic evaluation;
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- No evidence of anatomic abnormalities that could jeopardize device placement;
- Able to operate programmer, recharger, study assessments and provide accurate responses;
- Appropriate candidate for the implant procedure.
Who cannot join
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Pregnant or plan to become pregnant during study;
- Less than 1-year post-partum and/or are breast-feeding;
- Symptoms existing for less than 6 months;
- Multiple complaints that will not be amenable to study;
- Current diagnosis of a Neurological disease;
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- Daily opioid usage exceeding CDC recommendations;
- Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- Conditions requiring recurring MRI evaluation or diathermy procedures;
- Uncontrolled diabetes (HbA1C > 8.5);
- Known or suspected substance abuse within the last 2-years;
- Uncontrolled major depression or uncontrolled psychiatric disorders;
- Worker's compensation claimants;
- History of adverse reaction to local anesthetic drugs;
- History of coagulopathy or bleeding disorder;
- Anatomical restrictions such that device placement is not possible;
- Chronic or acute conditions that could interfere with the interpretations of the outcome assessment for pain and bodily function;
- Have a life expectancy of less than 1-year;
- Neurogenic or vascular claudication;
- Inability to achieve appropriate positioning and inability to understand informed consent and protocol;
- Deemed unsuitable for enrollment by investigator based on history or physical examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up.
Read the detailed description
This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain.
Subjects will be randomized into either a delayed or immediate continuation 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 is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of >50% pain relief.
- Conditions
- Idiopathic Hip Pain, Chronic Hip Pain
- Being tested
- Moventis PNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moventis PNSDevice
Moventis 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: Moventis PNS |
| Delayed | Placebo comparator | The delayed group will begin 2-hour stimulation/day at the 3-Month visit. Receives: Device: Moventis 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 (2)
Change in Hip Pain: measured by Hip Pain Questionnaire
Current hip pain will be accessed and the history of hip pain will be recorded.
Measured: 3, 6, 9, 12, 24, 36-months
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: 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 posted12 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Hip 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074329
- Sponsor's protocol ID
- TWIST 31-00105
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon study completion
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
- ClinicalTrials.gov ID
- NCT05074329
- Acronym / sponsor ID
- TWIST 31-00105
- Conditions
- Idiopathic Hip Pain, Chronic Hip Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Uro Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Oct 2021 (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, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up.
Detailed description
This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain.
Subjects will be randomized into either a delayed or immediate continuation 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 is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of >50% pain relief.
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: Moventis 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: Moventis PNSThe delayed group will begin 2-hour stimulation/day at the 3-Month visit. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capable of giving informed consent;
- Capable and willing to follow all study related procedures;
- Women and men >18 years of age;
- Diagnosis of hip pain;
- Baseline VAS score of >5;
Key exclusion criteria (21 listed)
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Pregnant or plan to become pregnant during study;
- Less than 1-year post-partum and/or are breast-feeding;
- Symptoms existing for less than 6 months;
- Multiple complaints that will not be amenable to study;
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 |
|---|---|---|
| Moventis PNSMoventis 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.
2 secondary outcomes
Change in Hip Pain: measured by Hip Pain Questionnaire
Time frame: 3, 6, 9, 12, 24, 36-months
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
Time frame: 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 12 Oct 2021.
- Individual participant dataSharing planned: Yes. Upon study completion
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Moventis PNS in people with Idiopathic Hip Pain and Chronic Hip Pain, run by Uro Medical Corporation.
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 21 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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@uromedical.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 12 Oct 2021.