THE EFFECT OF AN INNOVATIVE CREAM ON PAIN, MOBILITY, FUNCTIONAL ABILITY AND QUALITY OF LIFE IN PATIENTS WITH NON-SPECIFIC LOW BACK PAIN

INTRODUCTION

Low back pain is most often defined as pain between the rib cage and the lower fold of the buttocks, which can (but does not have to) spread to the legs (1). If this pain is caused by a specific pathophysiological mechanism, we speak of specific low back pain. However, in cases where we are talking about pain without a clear nociceptive-specific cause, that is the case of non-specific low back pain (2).

A preparation called Beaute Vitale® (BV) is a cream that has been empirically used for the past 40 years to relieve symptoms of the locomotor system, especially non-specific low back pain. The aforementioned preparation started to be used in northern Macedonia in the 1980s, and over time, its use has spread to the whole of Southeastern Europe and beyond, mainly through word-of-mouth recommendations. In 2020, the cream was submitted for analysis to the Croatian Institute of Public Health (CIPH), where its composition was defined, and it consists of water, petrolatum, propylene glycol, caprylic/capric triglyceride, PEG 30 glyceryl stearate, glycerine, cetyl alcohol, brown algae Fucus vesiculosus extract, Curcuma longa extract, camphor, benzyl alcohol, and dehydroacetic acid preservative. After the analysis carried out at the Croatian Institute of Public Health (CIPH), the BV cream was registered as a cosmetic product. By looking at the composition of the cream, it is evident that the active substances are brown algae Fucus vesiculosus extract, and Curcuma longa extract, curcumin.

Fucus vesiculosus is a brown seaweed that has been used in herbal medicine for many years as a dietary supplement for joint swelling (3), but it is increasingly being used for relieving the symptoms of osteoarthritis (4) by the probable mechanism of reducing the fibrosis of the synovial membrane (5), and it also indirectly leads to the reduction of joint stiffness, muscle relaxation, and ease of mobility. Fucus vesiculosus is also used locally, however previous papers on local activity have mainly examined the role of this product as an antioxidant used in the cosmetic industry (6). On the other hand, Curcuma longa, which belongs to the ginger family, has been used for many years as an anti-inflammatory substance that systemically affects the symptoms of osteoarthritis (7), but it also has a local effect in the form of volatile oils (9) that are used for muscle relaxation (8), and, in addition to that it indirectly improves mobility.

Non-specific low back pain is a major public health problem (1), and one of the known methods of treatment includes perorally applied muscle relaxants (10) or, for example, massage (11), with the end result of reducing pain and improving mobility.

The aim of this study was to evaluate the effect of the BV preparation on pain, mobility of the lumbar spine, functional capacity and quality of life in patients with acute and subacute non-specific low back pain.

MATERIALS AND METHODS

The study was conducted at the Special Hospital for Medical Rehabilitation “Daruvarske toplice” during the course of one year. The study was conducted in accordance with the 1967 Declaration of Helsinki and its subsequent amendments, as well as with the principles of good clinical practice. All subjects signed an informed consent before any procedure related to the study, and were previously informed in detail about the study, its goals and risks. The approval for this study was given by the Ethics Committee of the Special Hospital for Medical Rehabilitation “Daruvarske toplice” at the session held on March 9th, 2021. The inclusion criteria were non-specific/mechanical low back pain (12), lasting up to 12 weeks in the acute/subacute phase) (1), without the so-called red flags (13), and without an indication for diagnostic radiology, which is not routinely recommended (1, 14). The following patient were excluded: patients with febrile conditions of any genesis, patients who previously had surgery on the lumbar spine or hips, patients with neurological diseases and conditions that could affect the conduct and results of the study, and those who for any reason could not follow the study protocol either due to somatic or psychosocial reasons. According to the already empirically determined protocol, standardised by the manufacturer, the BV cream was applied to the skin of the lumbar and sacral region in a thin layer (to avoid the massage effect), daily, for 7 days, at intervals of 4 months (zero, fourth, eighth and twelfth month). Every day at the same time, for 7 days, the preparation was applied to the subject’s skin in the amount of 90 – 120 g, depending on the constitution of the patient. To avoid the effect of heat, the cream was at room temperature (about 21 ºC), and an air-permeable cotton gauze with 4 – 5 layers was used in the treatment, to keep the preparation on the skin, and to cancel out the effect of heat. When it comes to the active ingredients, Fucus vesiculosus (brown algae) was present in the amount of approximately 3% (3 g), while curcumin was present in the amount of approximately 1% (1 g). During each treatment, the subjects were not allowed to remove the gauze, wash the treated area, or perform activities that would lead to significant sweating, and thus to the loss of the active substance of the preparation from the surface of the skin. During the entire treatment, there was no change in pharmacological therapy, and only paracetamol could be used as the “rescue medication” in the amount of 1 to a maximum of 2 500 mg tablets. It was administered for a maximum of 2 days during an individual treatment, and it was not administered the day before the end of the treatment and on the very last day of the treatment when the evaluation was carried out. During the first treatment, 36 subjects were included. Due to the reduction of low back pain symptoms, but also due to some objective reasons such as the inability to avoid sweating in certain occupations (working conditions), a total of 20 subjects completed all 4 treatments, and the main outcomes were measured precisely in these patients. In the statistical analysis of the research power with the requested number of variables, a sufficient number of subjects was included for this study of the differences in average values between dependent groups using the Wilcoxon signed-rank test with two-tailed hypothesis testing using a beta error of 20% (80% power) and 5% for an alpha error. In the study, the following parameters were measured before and immediately after each treatment, after which a questionnaire (Euro-Quol) EQ-5D-5L, a validated questionnaire for the quality of life assessment with all its domains (15) was used: the Rolland-Morris Disability Questionnaire (RMDQ) was used to assess the quality of life, as a standardised instrument of functional ability in patients with low back pain (16), and measures for spine mobility, Thomayer’s fingertips-to-floor distance test at maximum trunk inclination angle and arms extended towards the floor (17), modified Schober’s test as a standard measure of sagittal mobility for the lumbar spine (18) and the lateral flexion test of the spine, all of which are measured in cm (with one decimal place for mm). During the lateral flexion test, the subject stands upright with his legs together, flexes his torso to one side and then to the other, pulling the outstretched palm against the body (leg), and the distance between the tip of the middle finger and the floor is measured (19).

Anteflexions (Thomayer’s test), sagittal mobility in the area of the lumbar spine (Schober’s test) and lateral flexion of the spine to the left and right are also measured. In addition to that, the subjects filled out the validated Rolland-Morris Disability Questionnaire (RMDQ) as a standard measure of functional ability of patients with low back pain and the EQ-5D-5L as a validated measure of quality of life. All measurements and questionnaires were completed immediately before the first application of the preparation and two days after the last application, for each of the 4 treatments.

All measurements were performed by two specialists in physical medicine and rehabilitation (DK, AK). They took turns at each measurement, and the data for each individual visit was entered in separate parts of the questionnaire, without any insight into previous measurements. Measurements were always made in the same room and at the same time of day.

The Shapiro-Wilk’s test was used for statistical testing of normal distribution, and all tests considered an alpha error < 0.05 for a significant difference. After determining the distribution of the data, the T-test or Wilcoxon test for dependent samples was used in statistics. Exploratory data analysis and statistical analysis was performed using the R v.4.1.2 software (R core team 2021) (20).

RESULTS

The average age of the subjects was 55.6 years. with the share of female respondents around 60% (20/36; 12/20). The summary results of measurements and questionnaires at the beginning and at the end of the observed period are shown in Table 1. After the first treatment that was applied to 36 subjects, all variables except EQ-5D-5L in the domains of anxiety/depression showed significant changes in terms of reduction of symptoms of non-specific low back pain, with increased range of motion. After the second and third treatment applied to a sample of 24 subjects, there was no significant change in movements in those of sagittal mobility, and in individual variables in the EQ-5D-5L questionnaire, but the treatment still significantly reduced pain and improved mobility. Finally, after the fourth treatment was applied to a total of 20 subjects, significant differences were found in the clinical tests of bilateral lateral flexion (p<0.0001) (Figures 1 and 2) and EQ-5D-5L – pain domain (p<0.001) (Figure 3) and mobility (p<0.01) (Figure 4), as well as the VAS (visual analogue scale) scale of overall health (p=0.05) (Figure 5), and all of these changes revealed improved scores. After one year, no significant change was found in Thomayer’s (p=0.2926) and Schober’s tests (p=0.7963), total RMDQ value (p=0.11), and EQ-5D-5L – activity domains (p=0, 1676), self-care (p=0.0708) and anxiety/depression (p=0.7693).

DISCUSSION

In this study conducted on patients with acute and subacute non-specific low back pain, a positive effect of the preparation/cream BV was shown, the topical application of which reduced the symptoms and signs of non-specific low back pain after the very first treatment, while after four treatments applied during the course of one year the positive effect in terms of pain reduction, improvement in spinal mobility in the frontal plane, and in the EQ-5D-3L questionnaire, in the domains of pain, mobility and overall health and well-being was achieved and maintained.

During the long-term use of this preparation, it was noticed that the paravertebral muscles become extremely relaxed after the treatment and acquire a “softer” consistency, are less painful on palpation, with improved mobility in the lumbar spine. Muscle relaxation, which consequently leads to increased mobility, is one of the important elements in the treatment of non-specific low back pain, which was proven in numerous studies (10, 21, 22). When we cover the topic of non-specific low back pain, although by definition it refers to an unknown origin, it is considered that in the majority of patients, the so-called mechanical causes are underlying, (12, 23) and that the relaxation of the paravertebral muscles is extremely important in their treatment. The active substances of the BV cream obtained by analysis are the brown algae, Fucus vesiculosus extract, and Curcuma longa extract, curcumin, which have been used for many years in the treatment of symptoms of the locomotor system. Although Fucus vesiculosus is used systemically to alleviate the symptoms of osteoarthritis (4), which is associated with some cases of non-specific low back pain, the said extract has so far been tested as an oral preparation and not as a topical preparation for degenerative joint diseases. Brown algae extract was also investigated as an anti-inflammatory substance (24), and it could also be associated with non-specific low back pain in a broader context. On the other hand, curcumin, an extract of Curcuma longa, has been examined in several papers as an anti-inflammatory systemic preparation (7, 25, 26), but also as a local preparation (8), which could explain its beneficial effect on the symptoms of non-specific low back pain. In our study, during the first seven-day treatment, there was a change in almost all variables in terms of improved results, while after the third treatment (26 subjects), there was no significant change in 5 of the observed variables. Nevertheless, the positive results that were achieved in some of the key variables that are important for the quality of life of these patients after one year, i.e. after 4 treatments, confirm the effectiveness of the mentioned cream. One should bear in mind that in the third and fourth treatment, only people with more “stubborn” low back pain were treated, whose low back pain was probably unresponsive to other conservative treatments as well. In addition to that, it is worth noting that there was no significant difference in the EQ-5D-5L anxiety/depression variable after any of the treatments, and due to this fact, it could be concluded that during the treatment there was no change in the mental status of the subject or the effect of that component to other study results. The average age of the subjects was 55.6 years, with a higher share of female subjects. In terms of demographics, this is also the most common age (45 – 60) when patients visit the physician for an examination for acute or subacute non-specific low back pain (27). Working conditions were not included in the analysis, although they may certainly have an impact on low back pain symptoms (27), unlike socioeconomic ones, which are still questionable (1). No systemic or local side effects were noted during the study.

This study has certain limitations. The first of these limitations is the relatively small number of subjects who underwent all 4 treatments (20 people), even though that number is sufficient for a valid statistical analysis of the variables of interest. Another limitation is the issue of standardisation of the preparation, given that the ingredients of the cream are manually titrated. Besides that, although we monitored the patients during the course of one year, we have no data on the status of non-specific low back pain after the last treatment. Finally, an important limitation of the study is the absence of a control group. There are certain methodological difficulties for the inclusion of a control group, although in the future one could introduce a comparison with another physical therapy modality.

CONCLUSION

In our sample of patients with acute and subacute non-specific low back pain, the Beaute Vitale® (BV) cream, applied through four seven-day treatments during the course one year, showed effectiveness in terms of improving the mobility of the lumbar spine, and reducing the intensity of pain, improving mobility and the feeling of general health and well-being, without local or systemic side effects. The aforementioned preparation can be used as supportive conservative therapy, along with other methods of conservative treatment of non-specific low back pain. Additional research is needed in terms of comparison with the control group, as well as long-term monitoring of the examined variables in subjects treated with this preparation.

Author’s contribution: Responsible for the concept: all authors; responsible for the methodology: D.K., A.K.; responsible for the formal analysis, D.K., I.S., E.R., Z.V.; responsible for conducting research: D.K., A.K.; responsible for the preparation of the original text: D.K., A.K., Z.V.; responsible for writing the first version of the text (draft): D.K.; responsible for the editing and revision: all authors.

Conflict of interest statement: The company Osteoart d.o.o., which is licensed for the sale of the Beaute Vitale® (BV) cream, provided funding for the research. However, that company had no influence on the design, implementation, results and interpretation of any part of this paper. Therefore, the authors have no conflict of interest regarding this paper.

REFERENCES / LITERATURA

<jrn>1. Chiarotto A, Koes BW. Nonspecific low back pain. N Engl J Med. 2022;386(18):1732–40.PubMedhttps://doi.org/10.1056/NEJMcp2032396</jrn>

<jrn>6. Hermund DB, Torsteinsen H, Vega J, Figueroa FL, Jacobsen C. Screening for new cosmeceuticals from brown Algae Fucus vesiculosus with antioxidant and photo-protecting properties. Mar Drugs. 2022;20(11):687.PubMedhttps://doi.org/10.3390/md20110687</jrn>

<jrn>10. van Tulder MW, Touray T, Furlan AD, Solway S, Bouter LM. Muscle relaxants for non-specific low back pain. Cochrane Database Syst Rev. 2003;2003(2):CD004252.PubMedhttps://doi.org/10.1002/14651858.CD004252</jrn>

<jrn>14. Jarvik JG, Gold LS, Comstock BA, Heagerty PJ, Rundell SD, Turner JA, et al. Association of early imaging for back pain with clinical outcomes in older adults. JAMA. 2015;313(11):1143–53.PubMedhttps://doi.org/10.1001/jama.2015.1871</jrn>

<jrn>17. Boguszewski D, Krupiński M, Białoszewski D. Assessment of the effect of Swedish massage and acupressure in rehabilitation of patients with low back pain. Preliminary report. Ortop Traumatol Rehabil. 2017;19(6):513–21.PubMedhttps://doi.org/10.5604/01.3001.0010.8042</jrn>

<other>23. Grazio S, Lovrenčić–Huzjan A, Ivica M, Vukojević R, Krajač-Čupić A. Dijagnostički postupnik u bolesnika s križoboljom. Fizikalna i rehabilitacijska medicina [Internet]. 202 [pristupljeno 06.02.2023.];36(3–4):190–2.</other>

<jrn>25. Perkins K, Sahy W, Beckett RD. Efficacy of Curcuma for Treatment of Osteoarthritis. J Evid Based Complementary Altern Med. 2017;22(1):156–65.PubMedhttps://doi.org/10.1177/2156587216636747</jrn>

<jrn>26. Wang Z, Winzenberg T, Singh A, Aitken D, Blizzard L, Boesen M, et al. Effect of Curcuma longa extract on serum inflammatory markers and MRI-based synovitis in knee osteoarthritis: secondary analyses from the CurKOA randomised trial. Phytomedicine. 2023;109:154616.PubMedhttps://doi.org/10.1016/j.phymed.2022.154616</jrn>

<jrn>27. Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012;379(9814):482–91.PubMedhttps://doi.org/10.1016/S0140-6736(11)60610-7</jrn>

Table 1 Results of measures and questionnaires before and after the entire treatment period with Beaute Vitale® cream in patients with nonspecific low back pain (N=20).

† Mode or median of results / Mod ili medijan rezultata

§ Mode or median of the difference in results (before-after) / Mod ili medijan razlike rezultata (prije-poslije)

P-value of the dependent t-test or Wilcoxon’s test marked as *(p<=0.05), **(p<0.01), ****(p<0.0001), and without a symbol if the result is not significant (p>0.05). / P-vrijednost zavisnog t-testa ili Wilcoxonovog testa označenog kao *(p<=0,05), **(p<0,01), ****(p<0,0001) i bez simbola ako rezultat nije značajan (p>0,05).

Figure 1 Measurement results of left-sided lateroflexion during the study

Figure 2 Measurement results of right-sided lateroflexion during the study

Figure 3 EQ-5D-5L results – pain domain, during the study

Figure 4 EQ-5D-5L results – mobility domain during the study

Figure 5 EQ-5D-5L results – health domain, during the study