Efficacy and Tolerability of Injectable Collagen-Containing Products in Comparison to Trimecaine in Patients with Acute Lumbar Spine Pain (Study FUTURE-MD-Back Pain)
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Physiol. Res. 68 (Suppl. 1): S65-S74, 2019 https://doi.org/10.33549/physiolres.934326 Efficacy and Tolerability of Injectable Collagen-Containing Products in Comparison to Trimecaine in Patients With Acute Lumbar Spine Pain (Study FUTURE-MD-Back Pain) K. PAVELKA1, H. JAROSOVA1, L. MILANI2,3, Z. PROCHAZKA4, P. KOSTIUK4, L. KOTLAROVA5, A. M. MERONI6, J. SLIVA7 1Institute of Rheumatology, Prague, Czech Republic, 2University Sapienza, Rome, Italy, 3University of Siena, Italy, 4Edukafarm, Prague, Czech Republic, 5Department of Pharmacology, InpharmClinic, Jesenice u Prahy, Czech Republic, 6Department of Orthopedics and Traumatology, Niguarda Hospital, Milano, Italy, 7Third Faculty of Medicine, Charles University, Prague, Czech Republic Received August 22, 2019 Accepted September 4, 2019 Summary Corresponding author Low back pain (LBP) represents an important subgroup of J. Slíva, Department of Pharmacology, Third Faculty of Medicine, vertebrogenic pain with estimated prevalence around 80 %. Charles University, Ruská 87, 100 00 Prague 10, Czech Republic. Locally acting injectable collagen for topical application has E-mail: [email protected] recently extended the limited range of treatment options. The aim of the study was to evaluate the efficacy and safety of Introduction injectable collagen in patients with LBP. Patients suffering from LBP (< three months) were enrolled. They were administered Musculoskeletal pain including vertebrogenic either collagen 4 ml or trimecaine 1 % 4 ml in the form of pain is among the most common health complaints with subcutaneous paravertebral injections into eight pre-specified significant social and economic consequences. The points (0.5 ml per each point) in the following schedule: two incidence of musculoskeletal pain increases with the administrations in the first and second week, one in the third rising average age of the population and decreases the week. The pain intensity, Thomayer distance, Oswestry disability quality of life of a growing number of affected people. index, Lasseque test, quality of life, consumption of rescue Back pain represents an important subgroup of medication and safety were evaluated. Exertional and rest pain, vertebrogenic pain. It is reported that approximately 80 % evaluated by a visual analogue scale, gradually decreased in both of the population in developed countries have back pain groups. Both treatments showed a statistically significant problems for which they seek medical help, at least once improvement in mobility and quality of life. The consumption of in a lifetime (NICE 2016). paracetamol as a rescue medication was significantly lower in Back pain can be classified according to its patients treated with collagen than in the group treated with localization as neck pain (NP) or low back pain (LBP). trimecaine (p=0.048). The analgesic efficacy of locally acting Pain/discomfort affecting the area from the lower rib injectable collagen, as well as an analgesic sparing effect when margin to the lower gluteal fold is called LBP. Lower compared to local anesthetics were demonstrated. limb pain may or may not be present at the same time. LBP can be classified by its duration as acute (back pain Key words episodes lasting no more than three months, sometimes Low back pain • Injectable collagen • Analgesics • Paracetamol • a subgroup of subacute pain lasting 6 to 12 weeks is also Trimecaine • Pain distinguished) or chronic (when pain lasts more than three months). The recurrence of problems after at least PHYSIOLOGICAL RESEARCH • ISSN 0862-8408 (print) • ISSN 1802-9973 (online) 2019 Institute of Physiology of the Czech Academy of Sciences, Prague, Czech Republic Fax +420 241 062 164, e-mail: [email protected], www.biomed.cas.cz/physiolres S66 Pavelka et al. Vol. 68 a six-month symptom free period is known as recurrent nonspecific LBP, paracetamol is recommended as the LBP (this form must be distinguished from chronic LBP first-line treatment and nonsteroidal anti-inflammatory exacerbation). According to the etiology, LBP is drugs (NSAIDs) or muscle relaxants are recommended as classified as specific when the pathological process the second-line treatment. In some cases, acupuncture is causing the pain is known (e.g. inflammatory or used; however, today it is believed to be suitable only for degenerative process, fracture, radicular syndrome, etc.) chronic LBP (Furlan et al. 2005, Itoh et al. 2004) or or nonspecific (when such a causative process is not a local anesthetic is applied. Collagen-containing apparent). products intended for topical application have also Patients with acute back pain which subsides recently extended the limited range of treatment options within six weeks to three months represent the majority (Pavelka et al. 2019). Other possible therapeutic of the affected people. However, approximately 2-7 % of approaches have been postulated. These include (for patients move to the group of chronic pain that can example) newer intradiscal therapies (Charneux et al. seriously affect not only health, but due to limited 2017, Knezevic et al. 2017), modulation of galanin working ability, also the social and economic aspects of receptors (Zhang et al. 2019), modulation of TRPA-1 a patient’s life. This type of chronic pain, due to back (Liu et al. 2019, Yamamotova et al. 2017), monoclonal disorders, contributes to the extent of 90 % of social antibody tanezumab (Webb et al. 2018), etc. (Bhangare costs of sick leave. Concerning back pain distribution et al. 2017). according to age groups, elderly patients are affected One of the major causes of musculoskeletal pain more often. In younger people, back pain typically arises is weakness of the internal and external joint stabilization from excessive burden to normal spinal structures. With systems. The basic component of these systems is advancing age, pathological processes (i.e. processes of collagen, the sufficient content and quality of, which are degenerative nature) play an increasing role in the essential for the intact function of these structures. A lack etiology. The symptoms and morphological findings of of collagen or failure of its composition leads to LBP have a very weak correlation and the pain is not weakening of the support systems and joint always proportional to the pathological changes. hypermobility, especially in non-physiological positions. The patient’s history and neurological This leads to premature wear of these systems and further examination play important diagnostic roles. If severe increases the risk of progressive degeneration of spinal pathology is suspected (specific biomedical factors structures such as cartilage. Slack hypermobile elements or so-called “red flags”, e.g. root syndromes, fractures of the support system stimulate pain receptors and lead to and infections), imaging techniques are indicated to muscle tension around the joints (Milani 2010, Stone et specify the cause (e.g. X-ray, magnetic resonance al. 1997). On the basis of these findings, collagen- imaging [MRI]). Psychosocial factors (so-called “yellow containing products for local administration (as medical flags”) also play an important role and increase the risk of devices generally known as MD-products) have been problem chronification. If no specific causative factors developed. These include the MD-Lumbar, MD-Neural are presented, the condition is called nonspecific LBP and MD-Muscle products (Guna, Milano, Italy) used in (Nice 2016). our study. Patients with acute lumbar spine pain were The problem of back pain treatment is complex enrolled if their condition required the administration of due to the existence of many well-known, but also some local anesthetics or collagen-containing products. unknown pathophysiological factors that make treatment This study evaluated the efficacy and safety of the difficult. The ranges of medical procedures include MD-Lumbar, MD-Nural and MD-Muscle products in a multidisciplinary approach with conservative methods comparison to the subcutaneously administered local to minimally invasive interventions to surgical treatment. anesthetic trimecaine. Conservative procedures in acute nonspecific LBP include mainly rehabilitation and medications (NICE Methods 2016, van Tulder et al. 2006). These non-invasive treatment methods are effective in 80 to 90 % of patients Patients with LBP and therefore, conservative treatment is Adult outpatients of both sexes who met the considered the method of choice for most patients with diagnostic criteria for acute lumbar spine pain, defined as back pain syndromes. In the treatment of acute LBP lasting no more than three months, were enrolled in 2019 Injectable Collagen in LBP S67 a prospective, single-blind clinical trial titled FUTURE- improve the functionality of the joints, improves the profile MD-Back Pain. A total of 97 patients were enrolled and of the collagen fibres and, consequently, all the anatomical were randomized into two groups. Randomization collagen-containing structures. When strengthening the was performed by a generator (available from joint stabilization systems with locally administered www.randomization.com) using random permuted blocks collagen, an analgesic effect is achieved in addition to (blocks of 20 subjects), with a randomization ratio a structural recovery (creating biological support, so-called of 3:1. All patients underwent in total seven visits bioscaffold). The locally administered collagen in these (V): V1 – Day 0, V2 – Day 3±2, V3 – Day 7±2, V4 – products helps to relieve painful muscle tension