The value of blood measurements, ultrasound an muscle electric studies to fortell the outcome of low back pain and sciatic pain and to evaluate the effect of the muscle relaxant tolperison

The prognostic value of Biomarkers and the Effect of Tolperisone in Acute low back pain and sciatic pain – BETA A Phase 3 investigator initiated study - BETA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001885-14-HU

Enrollment

150

Registered

2019-05-29

Start date

2019-08-06

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute low back pain with or withour radicular signs

Interventions

Trade Name: Miderizone 150 mg tablet Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18-80 years with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor etc) in the background, had CT or MRI scan, and who has given written consent to participte in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Pregnancy, hypesensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor etc) in the background of pain.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiological and morphological features (chemical, electrophysiological and ultrasound biomarkers) that reflect the intensity of pain and/or fortell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.;Secondary Objective: Not applicable;Primary end point(s): Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.;Timepoint(s) of evaluation of this end point: Pretreatment value (Day 0) Daily report of patients on pain features (Days 0 - 14) End of treatment values (Day 14 +/- 3)	—

Measure

Time frame

Main Objective: The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiological and morphological features (chemical, electrophysiological and ultrasound biomarkers) that reflect the intensity of pain and/or fortell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain.;Secondary Objective: Not applicable;Primary end point(s): Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.;Timepoint(s) of evaluation of this end point: Pretreatment value (Day 0) Daily report of patients on pain features (Days 0 - 14) End of treatment values (Day 14 +/- 3)

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Secondary

Measure	Time frame
Secondary end point(s): • Change in the level of biomarkers with ceased or greatly reduced pain/paravertebral défense • Change in pain intensity by the end of the treatment period • Change in the level of biomarkers after 2 weeks of tolperisone treatment • Change in the level of paravertebral muscle contraction by the end of the treatment period • Predictive value of the initial levels of biomarkers ;Timepoint(s) of evaluation of this end point: Pretreatment value (Day 0) Endf of treatment values (Day 14 +/- 3)	—

Measure

Time frame

Secondary end point(s): • Change in the level of biomarkers with ceased or greatly reduced pain/paravertebral défense • Change in pain intensity by the end of the treatment period • Change in the level of biomarkers after 2 weeks of tolperisone treatment • Change in the level of paravertebral muscle contraction by the end of the treatment period • Predictive value of the initial levels of biomarkers ;Timepoint(s) of evaluation of this end point: Pretreatment value (Day 0) Endf of treatment values (Day 14 +/- 3)

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Countries

Hungary

Contacts

Public ContactDepartment of Neurology

Semmelweis University

bereczki.daniel@med.semmelweis-univ.hu3612100337

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026