Relationship Between Balance and Vitamin D in Fibromyalgia Syndrome; A Prospective Cross-Sectional Study with HUR BTG4 Balance Master System®

doi:10.21203/rs.3.rs-2676985/v1

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Research Article

Relationship Between Balance and Vitamin D in Fibromyalgia Syndrome; A Prospective Cross-Sectional Study with HUR BTG4 Balance Master System®

https://doi.org/10.21203/rs.3.rs-2676985/v1

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Journal Publication

published 28 Sep, 2023

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Background

This study aims to show the relationship between balance and Vitamin D levels in Fibromyalgia. It also aims to raise awareness about the link between vitamin D levels, disease severity, and balance.

Results

Data were obtained from 86 patients with FMS and 47 healthy participants. There was a significant difference between the mean values of FIQ, VAS, and BBS in FMS (p < 0.05). A negative correlation was found between BBS and 25(OH) vitamin D levels in FMS (r: -0167, p < 0.05). There was a significant difference in the static balance data in the regression analyses between the groups (R: 0.40. R2:0.16 p:0.000). The regression analysis found that FIQ scores increased with the decrease in Vitamin D values (R: 0.41 R2: 0.17 p: 0.000).

Conclusions

Static balance is markedly impaired in low vitamin D levels. The deterioration in balance caused an increase in FIQ scores. Vitamin D has an important place in the treatment management of FMS and the correction of its negative effects on life. In addition to assessing balance, the information the device provides to improve individual activities will also improve the quality of rehabilitation.

Fibromyalgia

Postural Balance

Vitamin D

Visual Analog Scale

Romberg

Proprioceptive

Stability

Pain

Fibromyalgia Syndrome (FMS) is accompanied by chronic pain, fatigue, sleep disturbance, stiffness, and tenderness in muscles. According to the literature, its prevalence is between 0.2% and 4.7 [1, 2]. Balance is the ability to maintain the gravitational line that supports body weight [3]. Balance and postural control are affected in patients with FMS. The frequency of falls increases due to postural balance disorders [4]. In the literature, balance disorders have been found in 45% of patients with FMS [5]. Studies have shown that balance disorders are associated with pain, disease severity, and muscle strength [1–6]. Clear functional models for balance assessment have not been established. Berg Balance Test is one of the most frequently used tests [5]. Devices such as different video-based systems, accelerometers, postural swing defects, and estimation of fall risk are valuable in that they provide a quantitative measurement of balance disorders [6–8]. The increase in balance disorders in FMS may be associated with increased pain and worsening of the quality of life [9].

Vitamin D is an effective steroid hormone in many conditions, including maintaining bone health. In addition to other functions; It is also effective in strength, walking stability and muscle coordination [10, 11]. The effect of vitamin D on balance disorder has been reported in the literature [12–14]. Proximal muscle weakness and skeletal dysfunction in vitamin D deficiency is the most common theory about the relationship between Vitamin D and balance disorder. It has been reported that Vitamin D deficiency may cause balance problems due to the weakening of lower extremity muscle function, increased risk of falling, decreased bone mineralization, and decreased muscle strength [15–20].

As a result, Vitamin D, directly and indirectly, affects the musculoskeletal system. It has a direct effect on bone metabolism and indirectly affects the development of many chronic diseases. For all these reasons, it seriously affects physical performance. Effects of postural response in which Vitamin D receptors are detected; it is controlled by the brain, spinal cord, brain stem, basal ganglia, and cerebellum [21].

Proprioceptive abnormalities and balance disorders have been reported previously in FMS. There are very few studies in the literature in which dynamic and static balance are evaluated together in FMS. In addition, the number of studies evaluating the balance functions in FMS and, Vitamin D values is quite low. It is important to determine the postural control of patients with FMS.

In our study, we aimed to quantitatively evaluate the postural balance of women with FMS using the HUR Btg4 Balance Master System® (HUR International, Finland). In our measurements made with the device. We examined the relationship between balance and Vitamin D levels and its effect on the FMS.

Material-Methods

Ethics:

The study was conducted according to the principles of the Declaration of Helsinki. Approved by the Fırat University ethics committee (IRB approval number:11.04.2019/06/24).

Study population:

Eighty-six patients who were diagnosed with Fibromyalgia (FMS) according to the American College of Rheumatology (ACR) 2020 criteria and 47 healthy controls [22] were included in this prospective study. The participants were selected from those who applied to the Physical Medicine and Rehabilitation Clinic of our hospital between March 2020 and June 2021. Participants were matched for age, sex, and sociodemographic characteristics. The control group was selected from the relatives of the patients who applied to our clinic, did not meet the FMS criteria, and agreed to participate in the study. Participants did not use pain-related medications during the study. Antipsychotics, inner ear diseases that can cause vision and balance disorders, neurological disorders, malignancy, and lower extremity deformities (single foot deformity, those shorter than 1,5 cm in the lower extremity) may cause secondary Vitamin D deficiency; chronic cardiovascular, metabolic, and endocrine diseases were excluded from the study.

Study design:

The evaluation was done in our clinic and a quiet room. All participants completed self-report questionnaires, and static and dynamic balance assessments were performed after signed informed consent was obtained. Evaluations were carried out in the same order for all participants. The body mass index (BMI) was calculated as kg/m2. Serum Vitamin D levels were determined by the HPLC method in tubes containing K2 EDTA measured and were classified according to the Endocrine Society clinical practice guidelines (The absence is less than 20 ng/ml, deficiency ranges from 20 to 29 ng/ml, and the recommended value is 30 ng/ml and above) [23]. The full assessment took about an hour to assess postural stability.

Measuring Equipment:

Static and dynamic balance assessment was performed using the HUR BTG Balance Master-System® (HUR International, FINLAND) balance and Berg Balance Scale (BBS) test. The HUR BTG Balance Master System® (HUR International, Finland) consists of a portable BTG4- FE platform. Measurements are made on stable platforms and unstable platforms. HUR Btg4 Balance Master System® is a complete solution consisting of the HUR Smart Balance Software for testing and training balance (Fig. 1,2,3) [24]. The stable and unstable platform was checked before every test. Signals were sampled at 100 Hz and filtered. This research selected the area of the 95% confidence ellipse (Area) for COP values. This device is effective in planning individual rehabilitation programs as well as evaluating balance. All participants completed the balance tests.

1) Static evaluation:

Participants remained motionless for at least 5 seconds (preliminary phase) before starting the assessment. After the pre-phase participants stood in an upright position with their arms at their sides. Measurements were made with eyes open (EO) and eyes closed (EC) to eliminate visual input, and on a solid foam-based surface to prevent deterioration of proprioceptive feedback. The parameters of oscillation, Romberg were evaluated. This test evaluates the visual system, vestibular system, and proprioceptive sensory system. The analysis was performed with the patient standing on the platform, barefoot, with 2 cm distance between the heels, with the arms on both sides of the body. The analysis period was 60 seconds. The patient remained motionless at 60-second intervals between each test. This test evaluates the integrity of proprioception [25]. If the patient has a loss of proprioception, balance is achieved by activating the vision and vestibular systems. In proprioceptive disorders, when the eyes are closed, this compensation mechanism does not work and a balance disorder occurs.

2) Dynamic evaluation:

Participants were subjected to right, left, and horizontal pushing with a maximum acceleration of 9,6 m/s2. The leaning angle is based on the person’s height and how far the center of gravity (COG) has moved from its normal position. Responses were evaluated by leaning forward (FW), backward (BW), right (RT), and left (LT), in all directions (total).

Clinical evaluation

Visual Analog Scale (VAS): It is a scale that evaluates the severity of pain. Patients rated their pain on a 10 cm line between 0 and 10.

Fibromyalgia Impact Questionnaire (FIQ): Burchardt et al. created it to assess disease severity and functionality in FMS patients. The FIQ consists of 10 items measuring physical disability and the specific symptoms in the past week. Turkish validity and reliability were performed by Sarmer et al. [26]. Scoring ranges from 0-100. A higher score indicates more impact. The questions are answered by the patient and are simple.

The Berg Balance Scale (BBS): On the scale, consisting of 14 items, the patient is given a score between 0 and 4 for each item. A score between 0 and 20 indicates poor balance, 21 to 40 indicates an acceptable balance, and 41 to 56 indicates a good balance [27–29].

Data Evaluation

The data were analyzed using the statistical package for social sciences (SPSS) version 22 (SPSS Inc. Chicago, IL, USA). Normality analysis was done with the Kolmogorov-Smirnov tests. Normally distributed data were compared with Two-tailed, student's t-test. Spearman's rho correlation test was used for the relationships between the variables. P values < 0.05 were considered significant. Variables that had a significant relationship between them and showed a higher degree of relationship in bivariate analysis were evaluated with the regression model. To calculate the effect size the coefficient of multiple correlations, R, was used. To measure the percentage of the variance predicted by the multiple regression model, the corrected or adjusted R2 was used.

The study included 86 participants with FMS and 47 healthy controls. BMI and age were similar between groups (p>0.05). The mean values of Vitamin D were significantly lower in the FMS group than in the control group (Table 1). There was a significant difference in the tests between the mean values of FIQ, VAS, and BBS in patients with FMS compared to the control group (p<0.05) (Table 1). A statistically significant negative correlation was found between BBS and Vitamin D levels in FMS (r=- 0.167, p<0.05). Correlations of 25 (OH) Vitamin D with BBS, VAS, FIQ showed in Table 2. Table 3 shows multiple regression models. Correlation analysis showed a negative significant relationship between FIQ and Vitamin D. It was determined that the change in Vitamin D values had a significant positive effect on VAS values. The correlation between FMS and the control group with BBS and Vitamin D has shown in Table 4. Regression analysis of balance measurements between groups is shown in Table 5. The evaluations with the device in FMS, EO-COG length (p:0.086), EO-COG velocity (p:0.071) and lengths on a stable platform (SP), and EC-COG velocity on an unstable platform (UP) were found to be significantly higher (p:0.079). There was a significant correlation between Vitamin D and LOS (p <0.05) (p:0.034, r:0.186). There was a significant correlation between EO-COG velocity (r: 0.922, p: 0<0.001), EC-COG velocity (r=-0.46 p: 0.079) on SP, EC-COG velocity on UP, (r: 0.185, p: 0.035). Vitamin D levels were not related to the Romberg test evaluations (r=-0.9, p: 0.353). FIQ values were correlated with EOCOG velocity (SP) (r: 0.46, p: 0<0.001), EC-COG velocity (SP) (r: 0.509, p: 0<0.001), and EOCOG velocity (UP) (r=-0.523, p: 0<0.001). A positive correlation was detected between FIQ and the Romberg test, which is an indicator of proprioceptive sense, in measurements with EO and EC (r: 0.208, p: 0.028). The deterioration in the Romberg test was more pronounced on the foam floor (r = 0.238, p:0.012). There was a correlation between VAS with EO-COG velocity and EC-COG velocity (r: 0.267 p: 0.005, r: 0.38, p:0<0.001), and the Romberg test (UP) (r:0.199 p:0.004). The relationship between BBS and EC-COG velocity was significant (p:0.001). EO-COG velocity and EC-COG velocity were correlated with BBS (r=-0.228 p:0,016, r=-0.356 p:0<0.001). There was no significant relationship between BBS and the Romberg test (r: 0.012 p: 0.899). There were no correlation and no significant relationship between dynamic balance, Vitamin D values, and FIQ. Tablo 6 shows Romberg Correlations on Unstable and Stable platforms in FMS.

The extent and nature of the balance disorder, which is one of the most common symptoms in patients diagnosed with FMS, is still unclear. Our study was conducted to evaluate the relationship between disease activity and balance and the effects of Vitamin D levels on balance in patients with FMS. In the evaluation of balance, measurements made with the HUR Btg Balance Master System® (HUR International, Finland) device and BBS are taken as the basis. Our results show that FIQ, VAS, and BBS were found significantly different between the FMS and the control group. In the patients with FMS who had low Vitamin D levels, the impaired static balance was evident in-device measurements. This deterioration was associated with FIQ and VAS scores.

Balance disorders in individuals with FMS may be related to widespread pain. Spinal motor neurons, and functional and connectivity changes in FMS cause disturbances in motor functions that provide balance [2]. The pathophysiology of chronic pain, which is the main symptom of FMS is explained as nociceptive neurons creating an excessively painful response to normal (painless) effects. The studies demonstrated the existence of pain sensitization in patients with FMS [30, 31]. In our study, the VAS scores in which we evaluated pain were significantly higher in our patients with FMS. Eye-closed tests are more meaningful than eyes-open balance assessments in patients with FMS, suggesting abnormalities in using somatosensory inputs in balance control. Additionally, we detected impairments in the Romberg test. This test determines proprioceptive sense and is performed with eyes closed to eliminate visual input. The visual system plays an important role in proprioception, postural control and stability of the body [32]. In line with the literature, it supports the fact that increased pain may limit the attention given to other tasks. In a study comparing FMS and healthy controls, it was found that balance and motor performance were more impaired in the group with chronic pain [2, 33]. At the same time, in this study of the patients with high FIQ scores, there were significant deteriorations in the balance on the unstable platform in the Romberg test.

In our study, BBS significantly higher in our patients with FMS, in line with the studies supporting balance disorder and BBS elevation in patients with FMS. In a study investigating balance in patients with FMS, BBS was statistically higher than in healthy controls. [34–37]. In this study, BBS was higher in FMS compared to the controls and when the relationship between BBS and Vitamin D was examined, we found that our patients with balance disorder according to BBS had low Vitamin D levels. In our measurements with the device, we determined that Vitamin D levels affect the change in EO-velocity and EC- velocity. In a study investigating the interaction between Vitamin D and balance in 342 patients, the balance was assessed using a pressure plate. Significant impairment in postural sway was found in people with low Vitamin D levels [38]. We think that the lack of significant change in other balance measurements in postural sway is because the Vitamin D values in the control group were below 30 ng/ml.

In this study, the disease severity which we assessed with FIQ, and the relationships between FIQ values and the balance were evaluated. We detected the deterioration in balance was especially correlated with an increase in FIQ values. Additionally, Vitamin D levels were lower in patients with high FIQ Scores. Vitamin D is a steroid hormone that affects strength, gait stability, muscle coordination, and balance. This deficiency causes lower extremity dysfunction, increased risk of falls, decreased bone mineralization, decreased muscle strength, and impaired bone metabolism. Indirect effects on chronic disease development and physical performance have also been noted in the previous literature [39–41]. The significant negative relationship between FIQ scores and Vitamin D levels showed that Vitamin D levels increase the severity of FMS and cause balance disorder in patients.

In our study, the Vitamin D values were lower in FMS patients. Our regression analysis showed a significant negative relationship between FIQ scores and Vitamin D. Vitamin D values and BBS and FIQ scores were negatively correlated in our FMS patients. In a study evaluating the Vitamin D levels of patients with FMS and healthy female patients; it has been reported that FMS patients have lower serum Vitamin D. There was a significant, negative correlation between Vitamin D levels, VAS, and FIQ. In the study conducted by Rezende Pena et al, lower Vitamin D levels were found in patients who presented higher FIQ scores [42]. Jones et al., in their study, found that deterioration in the different balance directions, increased the tendency to fall six-fold in FMS, it was also supported that deterioration in balance increased the probability of falling in FMS [43]. The fact that the deterioration in balance increases the probability of falling in FMS who had low Vitamin D levels, increases the difficulty in doing daily activities and self-efficacy like the disease. This should be considered in the management of patients with FMS.

We aimed to evaluate the direct relationship between balance and Vitamin D in the patient group diagnosed with FMS. The association of low Vitamin D values with balance disorder in FMS, and the increase in FIQ scores, in which we evaluated the exposure to the disease, were supported in our study. Studies in which Vitamin D levels are above 30ng/ml and the balance can be evaluated in patients with FMS are important.

In our study, we also evaluated the balance between stable and unstable platforms. This strengthened the static balance evaluation criteria. Balance measurement with the HUR Btg Balance Master System® in the FMS has not been found in the literature. Our evaluations with HUR BTG Balance eliminated errors caused by the evaluator and ensured that the measurements were objective. Making measurements with eyes closed, which eliminates the compensation mechanism, and obtaining quantitative visual, static, proprioceptive, and dynamic balance data were valuable aspects of our study. This has reduced the possibility of error in our measurements. These are the strengths of our work.

In conclusion, there may be many conditions associated with balance disorder in patients with FMS. We would like to emphasize that the level of Vitamin D in FMS may negatively affect balance and existing pain depending on the severity of the disease. The role of Vitamin D is important in the treatment management of FMS and the correction of its negative effects on self-efficacy. Follow-up studies that will provide quantitative data in the larger population to help determine the effect of Vitamin D levels on balance in FMS are valuable. In addition, the use of devices that test patients' strength and balance before starting the exercise program and provide valuable information to improve individual activities can increase rehabilitation effectiveness.

Funding: No funding was received for this study.

Conflict of interest: The authors declare no confict of interest associated with this study.

Ethical approval: The ethics committee approval was granted on 11/04/2019 (IRB approval number:11.04.2019/06/24from Fırat University Ethics committee).

Consent to participate: The study complied with the Declaration of Helsinki, and informed consent was obtained from all participants.

Written Consent for publication: Written consent for publication was obtained from all participants.

Availability of data and material: The data that support the findings of this study are available on request from the corresponding author.

Code availability (software application or custom code): 'Not applicable'

Acknowledgements: None

Authors' Contributions: NPT, RAB and AE analyzed the cases and designed the study. NPT, RAB, AE and GAK analyzed part of the cases. AE, GAK provided several cases. NPT wrote the draft manuscript, and all authors contributed to the final version

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Tables .1-6 is available in the Supplementary Files section.

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Relationship Between Balance and Vitamin D in Fibromyalgia Syndrome; A Prospective Cross-Sectional Study with HUR BTG4 Balance Master System®

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