Clinical Trials Logo

Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05074329
Study type Interventional
Source Micron Medical Corporation
Contact Shanice Saunders
Phone 888-691-0585
Email Contact@uromedical.com
Status Not yet recruiting
Phase N/A
Start date November 2021
Completion date June 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04438265 - Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment
Completed NCT03006094 - The Greek Version of the Chronic Pain Grade Questionnaire (CPGQ) N/A
Completed NCT02479828 - Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients N/A
Withdrawn NCT02861170 - Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability N/A
Completed NCT03469817 - Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System N/A
Recruiting NCT05822310 - Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain N/A