Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation

NCT05074329 | Unknown FDA Device

• 1 other identifier: TWIST 31-00105
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Hip Pain; Chronic Hip Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  3 Months

• Adverse Events

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

  3 Months

Secondary Outcomes (2)

• Change in Hip Pain: measured by Hip Pain Questionnaire

  3, 6, 9, 12, 24, 36-months

• Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale

  6, 9, 12, 24, 36-Months

Study Arms (2)

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.

Device: Moventis PNS

Delayed

PLACEBO COMPARATOR

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

Device: Moventis PNS

Interventions

Moventis PNS DEVICE

Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.

Active; Delayed

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Uro Medical Corporation: lead

Central Study Contacts

Shanice Saunders

CONTACT

888-691-0585; Contact@uromedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share