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Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

Primary Purpose

Idiopathic Hip Pain, Chronic Hip Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Moventis PNS
Sponsored by
Uro Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hip Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active

    Delayed

    Arm Description

    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.

    The delayed group will begin 2-hour stimulation/day at the 3-Month visit.

    Outcomes

    Primary Outcome Measures

    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.
    Adverse Events
    Device- and procedure-related Adverse Events (AE) rate at 3-months.

    Secondary Outcome Measures

    Change in Hip Pain: measured by Hip Pain Questionnaire
    Current hip pain will be accessed and the history of hip pain will be recorded.
    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.

    Full Information

    First Posted
    September 29, 2021
    Last Updated
    September 29, 2021
    Sponsor
    Uro Medical Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05074329
    Brief Title
    Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
    Official Title
    Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uro Medical Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Hip Pain, Chronic Hip Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Delayed
    Arm Type
    Placebo Comparator
    Arm Description
    The delayed group will begin 2-hour stimulation/day at the 3-Month visit.
    Intervention Type
    Device
    Intervention Name(s)
    Moventis PNS
    Intervention Description
    Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.
    Primary Outcome Measure Information:
    Title
    Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
    Description
    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.
    Time Frame
    3 Months
    Title
    Adverse Events
    Description
    Device- and procedure-related Adverse Events (AE) rate at 3-months.
    Time Frame
    3 Months
    Secondary Outcome Measure Information:
    Title
    Change in Hip Pain: measured by Hip Pain Questionnaire
    Description
    Current hip pain will be accessed and the history of hip pain will be recorded.
    Time Frame
    3, 6, 9, 12, 24, 36-months
    Title
    Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
    Description
    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.
    Time Frame
    6, 9, 12, 24, 36-Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shanice Saunders
    Phone
    888-691-0585
    Email
    Contact@uromedical.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Upon study completion

    Learn more about this trial

    Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

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