The Prognostic Value of Biomarkers and the Effect of Tolperisone in Acute Low Back Pain -BETA. A Phase 3 Investigator Initiated Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization is done by non-transparent (opaque) sequentially numbered envelopes, prepared independently from the trial site. The number on the envelope corresponds to the number on the boxes of the trial medication (tolperisone or matching placebo). The envelopes can be opened only at the end of the trial, or in case of emergency. No interim analysis is planned.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy pain-free volunteers (n=30) outside of the randomized study, will participate to establish normal values of blood biomarkers.
排除标准
- •pain, inflammation,
研究组 & 干预措施
Tolperisone
Tolperisone 3 times 150 mg daily, i.e. a daily dose of 450 mg. Treatment lasts for 14 days
干预措施: Tolperisone Hydrochloride (Drug)
Placebo
Matching placebo 3 times daily. Treatment lasts for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the level of biomarkers by the end of the treatment period compared to the pretreatment values.
时间窗: 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
时间窗: 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)
次要结局
- 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))
研究者
Daniel Bereczki
Professor of neurology
Semmelweis University