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Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint Pain

NCT05357300 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-05-06

No results posted yet for this study

Summary

Prospective randomized controlled study, primary objective: Pain reduction in patients with chronic Sacroiliac joint pain after therapy either with Peripheral Nerve Stimulation or with best medical treatment.

Randomization 4:3 to operative (PNS=Peripheral Nerve Stimulation) arm or conservative (BMT= Best Medical Treatment) arm with crossover possibility for the BMT group after 6 months.

Conditions

  • Sacroiliac Joint Pain

Interventions

DEVICE

Peripheral Nerve Stimulation

Implant of percutaneous leads for peripheral nerve stimulation of the rami dorsales of the SIJ and gluteal or abdominal implant of impulse generator

Sponsors & Collaborators

  • PD Dr. med. Simon Bayerl

    lead OTHER

Principal Investigators

  • Simon H Bayerl, MD · Charite University, Berlin, Germany

  • Dimitri Tkatschenko, MD · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357300 on ClinicalTrials.gov