The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain -BETA. A Phase 3 Investigator Initiated Study
Overview
- Phase
- Phase 3
- Intervention
- Tolperisone Hydrochloride
- Conditions
- Low Back Pain
- Sponsor
- Semmelweis University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Daniel Bereczki
Professor of neurology
Semmelweis University
Eligibility Criteria
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,
Arms & Interventions
Tolperisone
Tolperisone 3 times 150 mg daily, i.e. a daily dose of 450 mg. Treatment lasts for 14 days
Intervention: Tolperisone Hydrochloride
Placebo
Matching placebo 3 times daily. Treatment lasts for 14 days
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
Time Frame: 14 days
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)
Patient reported change in pain features
Time Frame: daily for 14 days
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)
Secondary Outcomes
- Change in the level of biomarkers enlisted in Primary Outcome 1 in the subgroup of those with ceased or greatly reduced pain(14 days)
- Change in the intensity of pain by the end of the treatment period(14 days)
- Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group(14 days)
- Change in the level of paravertebral muscle contraction by the end of the treatment period(14 days)
- Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1(14 days)
- Global impression of change by the patient(14 days)
- Global clinical impression of change (GCI) by the investigator(14 days)
- Number of participants with treatment-related adverse events(21 days (14 days treatment plus 7 days post-treatment))