Clinical trial NCT05544656: The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain and Sciatic Pain "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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Low Back Pain
Keywords: back pain
sciatic pain
biomarkers
Lead sponsor: Semmelweis University
Sponsor class: OTHER
Collaborators: name: National Research Develpment and Innovation Fund, Hungary
name: MEDITOP Pharmaceutical LTD, Hungary
First posted: 2022-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized double blind study. Randomization is done separately for those with and those without radicular signs.
Primary purpose: TREATMENT

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.

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,

Primary outcomes:
measure: Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
timeFrame: 14 days
measure: Patient reported change in pain features
timeFrame: daily for 14 days
Secondary outcomes:
measure: Change in the level of biomarkers enlisted in Primary Outcome 1 in the subgroup of those with ceased or greatly reduced pain
timeFrame: 14 days
measure: Change in the intensity of pain by the end of the treatment period
timeFrame: 14 days
measure: Change in the level of biomarkers enlisted in Primary Outcome 1 by the end of the treatment period in the tolperisone group
timeFrame: 14 days
measure: Change in the level of paravertebral muscle contraction by the end of the treatment period
timeFrame: 14 days
measure: Predictive value of the initial levels of biomarkers enlisted in Primary Outcome 1
timeFrame: 14 days
measure: Global impression of change by the patient
timeFrame: 14 days
measure: Global clinical impression of change (GCI) by the investigator
timeFrame: 14 days
measure: Number of participants with treatment-related adverse events
timeFrame: 21 days (14 days treatment plus 7 days post-treatment)
Other outcomes:
measure: Patient reported sleep quality
timeFrame: Daily from 1-14 days
measure: Fingertip-to-floor distance
timeFrame: 14 days
Locations:
city: Budapest
country: Hungary
facility: Department of Neurology, Semmelweis University
Study officials:
affiliation: Semmelweis University
name: Daniel Bereczki, MD, POhD,DSc
role: PRINCIPAL_INVESTIGATOR
References: