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

Low Back Pain Clinical Trial

— BETA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05544656
• Other study ID #: LOWBACK-SE-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 13, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators include 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, already had CT or MRI scan during routine workup, and who have given written consent to participate in the study. Exclusion criteria are pregnancy, hypersensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor, etc) in the background of pain. The patients will be given 3 times daily 150 mg tolperisone or placebo in addition to standard therapy in a randomized double-blind design. Treatment will last for 14 days and a final follow-up is performed at 21 days. Clinical condition and biomarkers will be tested before treatment and at 14 days. Patients fill in a diary on a daily basis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Tolperisone Hydrochloride
Tolperisone Hydrochloride tablets of 150 mg, administered three times a day
• Placebo
matching placebo administered three times a day

Locations

Country	Name	City	State
Hungary	Department of Neurology, Semmelweis University	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Semmelweis University	MEDITOP Pharmaceutical LTD, Hungary, National Research Develpment and Innovation Fund, Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient reported sleep quality	Changes in sleep quality reported in patient diary on a 4-grade scale (1: undisturbed sleep; 2: woke up once due to pain; 3: woke up more than once due to pain; 4: could not sleep at all due to pain).	Daily from 1-14 days
Other	Fingertip-to-floor distance	The patient is asked to bend forward and attempt to reach for the floor with their fingertips. The distance between the patient's right long finger and the floor is measured using a standard measuring tape in centimeters.	14 days
Primary	Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.	Changes in the values of blood biomarkers (nociceptin/orphanin FQ, Met-Enkephalin-Arg6-Phe7 (MEAP), pro-inflammatory cytokines (IL-1ß, IL-6, IL-2, IL-8, IL-12, IL-33, CCL3, CXCL1, CCR5, és TNF-a), anti-inflammatory cytokines (IL-10 and IL-4), monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory proteins-1b (MIP-1b), platelet-derived growth factor (PDGF AA), vascular endothelial growth factor (VEGF), GM-CSF=granulocyte-macrophage colony-stimulating factor, CGRP (calcitonin gene related peptide), substance P, noradrenalin (norepinephrine), in electrophysiologic markers (quantitative electromyography with surface electrodes in the paravertebral muscles in prone and standing position) and ultrasound markers (bilateral measurements of cross sectional area and antero-posterior diameter of paravertebral muscles in prone and standing position)	14 days
Primary	Patient reported change in pain features	Self evaluation of pain by the patient on a visual scale from zero (no pain at all) to 10 (the most severe pain the patient can imagine)	daily for 14 days
Secondary	Change in the level of biomarkers enlisted in Primary Outcome 1 in the subgroup of those with ceased or greatly reduced pain	Subgroup analysis of the change in biomarkers restricted to those with ceased or greatly reduced pain	14 days
Secondary	Change in the intensity of pain by the end of the treatment period	Self evaluation of pain by the patient on a visual scale from zero (no pain at all) to 10 (the most severe pain the patient can imagine)	14 days
Secondary	Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group	Subgroup analysis of changes in blood, electrophysiological and ultrasound biomarkers by 14 days in the tolperisone group	14 days
Secondary	Change in the level of paravertebral muscle contraction by the end of the treatment period	Analysis restricted to the electrophysiological and ultrasound biomarkers enlisted in Primary Outcome 1	14 days
Secondary	Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1	Evaluation of the association of the initial biomarker values enlisted in Primary Outcome 1 with the 14-day pain features	14 days
Secondary	Global impression of change by the patient	Patient self evaluation of changes by the end of treatment on a 6-grade scale (has become symptom-free; major improvement; minor improvement; no change; minor worsening; major worsening)	14 days
Secondary	Global clinical impression of change (GCI) by the investigator	Subjective evaluation of changes by the end of treatment on a 6-grade scale by the investigator (has become symptom-free; major improvement; minor improvement; no change; minor worsening; major worsening)	14 days
Secondary	Number of participants with treatment-related adverse events	Any adverse events reported during the 14 days of treatment and the 7-day post-treatment period	21 days (14 days treatment plus 7 days post-treatment)