NCT05646160 | RECRUITING | Migraine

Detailed Description:

Detailed Description: I. The specific objectives were to investigate whether the therapy of the shoulder girdle and neck had an effect on: 1. the range of mobility of the cervical spine 2. myometric variables (stiffness, flexibility and tension) of the muscle (trapezius upper part) 3. concentration of selected biochemical factors (S100 beta protein, substance P (SP), calcitonin gene-related peptide (CGRP), brain-derived neurotrophic factor (BDNF) in patients with migraine 4. feel headache 5. feel pain in the muscles of the shoulder girdle 6. feel the quality of life related to health. II. Hypotheses 1. Inactivation of MTrPs by IC-MTRPs therapy improves biomechanical properties of the cervical spine (increases the range of mobility of the cervical spine - lateral inclination, rotation and forward inclination) in people with migraine. 2. Inactivation of MTrPs by IC-MTRPs therapy improves the resting biomechanical properties (reduction of tension, stiffness and increased flexibility) of the muscles of the shoulder girdle. 3. Inactivation of MTrPs by IC-MTRPs therapy reduces the concentration of biochemicals in the blood responsible for the aggravation of migraine pain. 4. TOBS therapy through IC-MTrPs therapy improves biomechanical and biochemical variables, reducing the sensations of headache and muscle pain, improving health-related quality of life in people with migraine. III. The course of research. Before and during the intervention cycle, migraine patients were subjected to biomechanical and biochemical tests. In the morning, fasting blood was drawn on the first and last day of therapy, before and after the intervention, in order to determine the biochemical parameters. Before the start of therapy and one month after the last intervention, the patients completed the WHOQoL-BREF (WHO Quality of Life BREEF) and the VAS (visual analogue scale) for headache and muscle pain during therapy. Before and after the first, fourth and seventh interventions, and one month after the last treatment, myometric measurements of muscle tension, stiffness and flexibility were performed using the Myoton Pro 3 apparatus (Tallinn, Estonia), and biomechanical measurements of cervical spine mobility using the Myo Motion apparatus (Noraxon, Scottsdale, USA). Muscle pain and headache during the procedure were also assessed using the VAS scale. The research was carried out during eight research sessions in the morning, which were carried out according to a strictly defined scheme (for all subjects in the same order and location) IV. Research methods. IV (I) Anthropometric measurements. The subjects' height, weight and body composition were measured using the Tanita BC 418 ma electronic system (Tanita Corporation, Tokyo, Japan T174). Measurement of body mass composition was determined by the electrical bioimpedance (BIA) method. The obtained data were necessary to carry out myometric and accelerometric measurements (mobility of the cervical spine), where it was required to provide the current weight and height of the examined person. IV (II) Biochemical determinations. Blood collection and serum collection. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am before and after the treatment on the first day and 24 hours after the sixth treatment, into test tubes without serum anticoagulants. The sterile blood (8 ml) was left for 30 min at room temperature, then the blood was centrifuged at 1500 rpm / min x g for 10 min. Serum was transferred to new 300 µl tubes and stored at -70 ° C until biochemical determinations were made. Determination of the concentration of SP and S100B, CGRP, BNDF with the immunochemical method of ELISA The concentration of substance P, protein S100beta, calcitonin gene-related peptide (CGRP), BNDF (brain-derived neurotrophic factor) was determined using the immunochemical ELISA method in accordance with the instructions of the kit manufacturers (R\&D systems, Londyn UK). IV (III) Biomechanical measurements of the cervical spine Determination of biomechanical parameters of the cervical spine. For mobility measurements, a set for recording and analyzing human movement in 3D with the use of Noraxon Myo Motion accelerometric sensors (Noraxon, Scottsdale, USA) was used. The measuring device allowed to assess the range of movement of the cervical spine with the motor control of the patient in the movement of the lateral to the right bend and left side, right and left rotations and forward bends. Automatic recording of motion parameters completely eliminated errors related to the subjective assessment of a diagnostician with the use of manual measuring tools. The ROM values will be expressed in degrees \[°\]. Sensors (sensor 1 was mounted at the height of the first spinous process of the thoracic spine (Th1), sensor 2 was mounted on the occiput (Co)) mounted on the patient's head, on an elastic band, have the function of automatic, wireless calibration, thanks to which the above-described data was collected before and after day 1, 4 and 7 of therapy for the muscles of the shoulder girdle and neck and for 1 month after the last intervention. Each of the examined women sat on a stiff armchair, fastened with belts preventing the movement of the torso in order to eliminate measurement errors resulting from the human factor. The examined person made a given neck movement at the clear command of the researcher. First left side bend, then right side bend, then left head rotation, then right side bend, last head tilt forward. The range of motion measured in the research was expressed in degrees. The examiner carried out the measurements without knowing about the study group (blinding) and did not participate in the analysis of the obtained data. IV (IV) Myometric measurements of the muscle properties of the shoulder girdle (tension, stiffness and flexibility) of the muscles. The muscle properties were tested using a Myoton Pro 3 miometer (Myoton, Tallinn, Estonia). The measurement is non-invasive and fast, it takes from 3 to 30 seconds depending on the selected option. In the presented work, the 10 measurement repetition mode was selected, from which the device software calculated the average for each of the three parameters (tension, stiffness and elasticity) and saved it in the device memory. The measurement consisted in placing the measuring tip of the myometer always perpendicular to the skin surface at a strictly defined point before and after the therapy. The researcher moved the device towards the examined tissue until the green light on the body of the device turned on. Such an operation activates the electromagnetic mechanism, which generated mechanical impulses with a constant force deforming the muscle at the measuring point through the moved measuring tip. The meter automatically performed a series of pulses (10), and the researcher held the device steadily in the selected position. The pressure of the tip (punch) is short (10 ms) and of low force (0.40 N), which does not cause a neurological reflex muscle contraction response. The impulse caused mechanical vibrations of the examined muscle, according to which the following parameters were calculated after automatic processing by the accelerometric recording processor: * F (frequency) - it determines the muscle tension and is calculated as the maximum frequency from the power of the accelerometric signal spectrum and is expressed as in hertz \[Hz\]. * S (stiffness) - is calculated from the formula S-MYO = amax. mprobe / \^ l, where amax is the maximum acceleration of the striking measuring tip \[kg\], a \^ l is the maximum distance the stylus has moved \[m\]. This parameter is expressed in \[N / m\] and determines the force generated by the measuring tip of the myometer needed to deform the tested tissue to a specific depth. * D (decrement) - free decrease of vibration calculated from the logarithm: Patient seated steadily and relaxed in a chair with full body support, hands in lap, looking straight ahead. For all patients, six measurement points were carefully indicated on both sides of upper trapezius muscle, i.e. three points on the left upper trapezius (P1, P2, P3) and three on the right upper trapezius (P4, P5, P6). The three testing points were located on an horizontal line between the cervico-thoracic junction of the spine (C7 / Th1) and the shoulder process of scapula in a distance between these points similar for each patient. Going from medial to lateral side the testing points were as follows: (i) the most medial point as P1 on the left and P4 on the right trapezius, which was distant 3 cm laterally from the cervico-thoracic junction of the spine (C7 / Th1); (ii) the next P2 or P5 point (intermediate one) was distant 2 cm laterally from the P1 or P4; (iii) and the most laterally located the P3 or P6 point was distant 2 cm from the P2 or P5 (on the left or right trapezius, respectively) Myometric measurements were performed on each patient before and after the first, fourth and seventh treatments and 1 month after the last intervention in accordance with the manufacturer's instructions. The examiner carried out the measurements without knowing about the study group (blinding) and did not participate in the analysis of the obtained data. IV (V) Assessment of health-related quality of life and pain sensation. 1. Assessment of health-related quality of life using the WHOQoL-BREF scale In order to compare the health-related quality of life before and after therapy, and 1 month after its completion, the subject completed the WHOQoL-BREF questionnaire. All required licenses for the use of the survey in the described research have been obtained. 2. Assessment of pain perception using the VAS scale Pain was assessed with the VAS analog pain scale in graphic form. The subjects were assessed on a scale of 1 to 10, immediately after the therapy of the muscles of the neck and shoulder girdle on days 1, 4 and 7. Patients were asked to answer: "How much did you feel pain in your muscles during the treatment?" The VAS scale also determined the intensity of the perceived headache during the last migraine attack before taking part in the treatment cycle and 1 month after the end of treatment by answering the question: "What was the intensity of the last headache / migraine episode?" V. Statistical analysis. The test results were presented as the arithmetic mean (X) ± standard deviation (SD). The statistical analysis was performed using the STATISTICA v. 10 program (StatSoft, Inc. 2001, Kraków Poland). The Shapiro-Wilk test was used to check the normality of the distribution of serum concentrations of biochemical factors, biomechanical parameters, parameters of muscle properties, myometric tests, tests related to pain and health-related quality of life. Significant deviations from the normal distribution were found, so further analyzes were performed using non-parametric tests. In the case of the analysis of comparisons of several measurements (more than two), the Friedman ANOVA was used and when there were differences between the variables, the Post Hoc For Friedman test. For the comparative analysis of the two measurements (as in the case of the pain analysis), a non-parametric test was used for two dependent samples: Wilcoxon pairwise order. The results were considered statistically significant at the significance level of p \<0.05.