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

LOWBACK-SE-01

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.

2019-12-13

2023-12-31

2024-06-30

Active (not recruiting)

Early phase I

150

Inclusion Criteria: * Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers. Exclusion Criteria: * pain, inflammation,

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single center, randomized double blind study. Randomization is done separately for those with and those without radicular signs.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Randomization is done by non-transparent (opaque) sequentially numbered envelopes, prepared independently from the trial site. The number on the envelope corresponds to the number on the boxes of the trial medication (tolperisone or matching placebo). The envelopes can be opened only at the end of the trial, or in case of emergency. No interim analysis is planned.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-04-17