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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Tolperisone Hydrochloride tablets of 150 mg, administered three times a day
matching placebo administered three times a day
Department of Neurology, Semmelweis University
Budapest, Hungary
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-1β, IL-6, IL-2, IL-8, IL-12, IL-33, CCL3, CXCL1, CCR5, és TNF-α), 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)
Time frame: 14 days
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)
Time frame: daily for 14 days
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
Time frame: 14 days
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)
Time frame: 14 days
Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group
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Subgroup analysis of changes in blood, electrophysiological and ultrasound biomarkers by 14 days in the tolperisone group
Time frame: 14 days
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
Time frame: 14 days
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
Time frame: 14 days
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)
Time frame: 14 days
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)
Time frame: 14 days
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
Time frame: 21 days (14 days treatment plus 7 days post-treatment)