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ACTIVE NOT RECRUITING
NCT05544656
PHASE3

The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "BETA"

Sponsor: Semmelweis University

View on ClinicalTrials.gov

Summary

The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.

Official title: The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain -BETA. A Phase 3 Investigator Initiated Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2019-12-13

Completion Date

2024-06-30

Last Updated

2024-04-17

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Tolperisone Hydrochloride

Tolperisone Hydrochloride tablets of 150 mg, administered three times a day

DRUG

Placebo

matching placebo administered three times a day

Locations (1)

Department of Neurology, Semmelweis University

Budapest, Hungary