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Effects of MTRPs Therapy in Migraine. (MTRPs)

Primary Purpose

Migraine, Pain, Shoulder, Trapezius Muscle Strain Left

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Ischemic Compression of Myofascial Trigger Points (IC-MTRPs)
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring myometrics, range of motion, migraine, blood tests, muscle pain, ischemic compression Myofascial Trigger Points (IC-MTRPs), muscle mechanical properties

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: age: 18 to 65 years of age, female gender, migraine diagnosed by a specialist neurologist for at least 12 months, no metabolic, cardiological, neurological and orthopedic diseases within the shoulder girdle, and cervical spine, voluntary written consent for examination; criteria according to ICHD-3 allowing to classify the symptoms as migraines. Exclusion Criteria: minors or over 65 years of age, male gender, patients undergoing pharmacological treatment that cannot be discontinued; people with other headaches; past injuries of the musculoskeletal system in the cervical spine and shoulder girdle; skin diseases and other conditions such as deep vein thrombosis, osteoporosis; criteria for excluding migraine according to ICHD-3.

Sites / Locations

  • Regional Research and Development CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

chronic migraine (CM)

episodic migraine with aura (EMa)

episodic migraine without aura (EMb)

Arm Description

CM is diagnosed after a patient has experienced a tension or migraine headache for at least 15 days in a month for at least 3 months, when not less than 8 days is characterized by the symptoms typical of migraine diagnosis.

EMa, known as classical migraine, is characterized by an attack of pain lasting several or tens of minutes, during which the appearance of unilateral visual and sensory symptoms from the central nervous system, usually associated with pain and migraine symptoms.

EMb is diagnosed after at least 5 attacks per month, characterized by a one-sided, pulsating headache of moderate or severe intensity, which increases with physical activity, sometimes with vomiting, and sensitivity to light and sound. This episode of migraine must last from 4 to 72 hours.

Outcomes

Primary Outcome Measures

ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
ROM cervical spine
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. The ROM values will be expressed in degrees [°].
Health-related quality of life
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Health-related quality of life
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Health-related quality of life
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Muscle pain perception
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Muscle pain perception
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Muscle pain perception
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Headache pain perception
The VAS scale also determined the intensity of the perceived headache during the last migraine attack. Headache pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale (VAS).
Headache pain perception
The VAS scale also determined the intensity of the perceived headache during the last migraine attack. Headache pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale (VAS).

Secondary Outcome Measures

Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Frequency
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Stiffness
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Myomentric parameter - Decrement
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Blood parameter - SP
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter - SP
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter - SP
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter S100beta
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter S100beta
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter S100beta
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter CGRP
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter CGRP
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter CGRP
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter BNDF
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter BNDF
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Blood parameter BNDF
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.

Full Information

First Posted
November 23, 2022
Last Updated
March 1, 2023
Sponsor
Józef Piłsudski University of Physical Education
Collaborators
Wroclaw University of Health and Sport Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05646160
Brief Title
Effects of MTRPs Therapy in Migraine.
Acronym
MTRPs
Official Title
Effects of Myofascial Trigger Points Therapy in Migraine.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Józef Piłsudski University of Physical Education
Collaborators
Wroclaw University of Health and Sport Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Case series, repeated-measures design, pilot study. Adult, female, migraine patients underwent seven Ischemic Compression Myofascial Trigger Points (IC-MTrPs) therapy sessions. The aim of the study is to investigate whether therapy of the shoulder girdle and neck muscles by deactivating MTrPs causes modification of biomechanical and biochemical variables in the blood and reduces headache in people with migraine, improving their quality of life by improving their health. People qualified for the study were divided into 3 groups according to the type of migraine: CM group - patients with chronic migraine EMa group - patients with paroxysmal migraine with aura EMb group - patients with paroxysmal migraine without an aura. All patients underwent 7 interventions in the area of the muscles of the shoulder girdle and neck (by deactivating trigger points) performed every 2 or 3 days. They did not take any headache medications during the treatment period. However, during a migraine attack, they could undergo treatments and research measurements. Biomechanical measurements of the cervical spine, shoulder girdle muscles and blood chemistry were performed before, during and after the patients' therapy. All treatments were performed on the following muscles: m. trapesius pars descendent (trapezius upper), m. sternocleidomastoideus (sternocleidomastoid), m. temporalis (temporal), m. legator scapulae (levator scapula), m. supraspinatus (supraspinatus), m. suboccipitales (suboccipital).
Detailed Description
Detailed Description: I. The specific objectives were to investigate whether the therapy of the shoulder girdle and neck had an effect on: the range of mobility of the cervical spine myometric variables (stiffness, flexibility and tension) of the muscle (trapezius upper part) 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 feel headache feel pain in the muscles of the shoulder girdle feel the quality of life related to health. II. Hypotheses 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. 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. Inactivation of MTrPs by IC-MTRPs therapy reduces the concentration of biochemicals in the blood responsible for the aggravation of migraine pain. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Pain, Shoulder, Trapezius Muscle Strain Left, Trapezius Muscle Strain Right, Muscle Pain, Trigger Point Pain, Myofascial, Cervical Pain
Keywords
myometrics, range of motion, migraine, blood tests, muscle pain, ischemic compression Myofascial Trigger Points (IC-MTRPs), muscle mechanical properties

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic migraine (CM)
Arm Type
Experimental
Arm Description
CM is diagnosed after a patient has experienced a tension or migraine headache for at least 15 days in a month for at least 3 months, when not less than 8 days is characterized by the symptoms typical of migraine diagnosis.
Arm Title
episodic migraine with aura (EMa)
Arm Type
Experimental
Arm Description
EMa, known as classical migraine, is characterized by an attack of pain lasting several or tens of minutes, during which the appearance of unilateral visual and sensory symptoms from the central nervous system, usually associated with pain and migraine symptoms.
Arm Title
episodic migraine without aura (EMb)
Arm Type
Experimental
Arm Description
EMb is diagnosed after at least 5 attacks per month, characterized by a one-sided, pulsating headache of moderate or severe intensity, which increases with physical activity, sometimes with vomiting, and sensitivity to light and sound. This episode of migraine must last from 4 to 72 hours.
Intervention Type
Other
Intervention Name(s)
Ischemic Compression of Myofascial Trigger Points (IC-MTRPs)
Other Intervention Name(s)
MTRPs therapy, trigger points therapy/compression
Intervention Description
IC-MTrPs intervention was made first on the right side and then on the left side and this order was the same in each patient. Before starting the therapeutic procedure, the MTrPs localizations were identified by palpation and pinch pressure in patients lying back on the couch. During the procedure, a qualified physiotherapist sat behind the subject's head. The pressure was sustained for about 5 seconds with a 2-3 seconds pause. In each subject, the intervention lasted 15 minutes on the same measurement day in the morning. The subjects underwent cycle of seven IC-MTrPs therapeutic sessions, with 3 days brakes between each session, that lasted in total about a 3-weeks (25 days).
Primary Outcome Measure Information:
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
Before the first treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
After the first treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
Before the fourth treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
After the fourth treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
Before the seventh treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
After the seventh treatment.
Title
ROM cervical spine
Description
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. The ROM values will be expressed in degrees [°].
Time Frame
Described data was collected for 1 month after the last intervention.
Title
Health-related quality of life
Description
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Time Frame
Before the first therapy.
Title
Health-related quality of life
Description
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Time Frame
After the first therapy.
Title
Health-related quality of life
Description
Health-related quality of life will be expressed as points of the WHOQoL-BREF scale [point]. The subject completed the WHOQoL-BREF questionnaire.
Time Frame
1 month after intervention completion, the subject completed the WHOQoL-BREF questionnaire again.
Title
Muscle pain perception
Description
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Time Frame
Day 1
Title
Muscle pain perception
Description
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Time Frame
Day 4
Title
Muscle pain perception
Description
The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale.
Time Frame
Day 7
Title
Headache pain perception
Description
The VAS scale also determined the intensity of the perceived headache during the last migraine attack. Headache pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale (VAS).
Time Frame
Before the treatment cycle.
Title
Headache pain perception
Description
The VAS scale also determined the intensity of the perceived headache during the last migraine attack. Headache pain perception will be expressed in [cm] as the distance between the two end points (between value 1 and 10) of visual analog scale (VAS).
Time Frame
1 month after the end of treatment.
Secondary Outcome Measure Information:
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
Before the first treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
After the first treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
Before the fourth treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
After the fourth treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
Before the seventh treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
After the seventh treatment.
Title
Myomentric parameter - Frequency
Description
Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz].
Time Frame
1 month after the last intervention.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
Before the first treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
After the first treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
Before the fourth treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
After the fourth treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
Before the seventh treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
After the seventh treatment.
Title
Myomentric parameter - Stiffness
Description
Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m].
Time Frame
1 month after the last intervention.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
Before the first treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
After the first treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
Before the fourth treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
After the fourth treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
Before the seventh treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
After the seventh treatment.
Title
Myomentric parameter - Decrement
Description
Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log].
Time Frame
1 month after the last intervention.
Title
Blood parameter - SP
Description
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
Before the treatment on the first day.
Title
Blood parameter - SP
Description
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
After the treatment on the first day.
Title
Blood parameter - SP
Description
The concentration of substance P was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of substance P expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
24 hours after the sixth treatment.
Title
Blood parameter S100beta
Description
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
Before the treatment on the first day.
Title
Blood parameter S100beta
Description
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
After the treatment on the first day.
Title
Blood parameter S100beta
Description
The concentration of protein S100beta was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of protein S100beta expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
24 hours after the sixth treatment.
Title
Blood parameter CGRP
Description
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
Before the treatment on the first day.
Title
Blood parameter CGRP
Description
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
After the treatment on the first day.
Title
Blood parameter CGRP
Description
The concentration of calcitonin gene-related peptide (CGRP) was determined by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of calcitonin gene-related peptide (CGRP) expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
24 hours after the sixth treatment.
Title
Blood parameter BNDF
Description
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
Before the treatment on the first day.
Title
Blood parameter BNDF
Description
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
After the treatment on the first day.
Title
Blood parameter BNDF
Description
The concentration of BNDF (brain-derived neurotrophic factor) was determied by immunochemical ELISA method according to the kit manufacturers' instructions (R&D systems, London UK). The concentration of BNDF expressed in [ng/ml]. Peripheral blood from the ulnar vein was collected on an empty stomach between 6:00 am and 9:00 am into test tubes without serum anticoagulants.
Time Frame
24 hours after the sixth treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age: 18 to 65 years of age, female gender, migraine diagnosed by a specialist neurologist for at least 12 months, no metabolic, cardiological, neurological and orthopedic diseases within the shoulder girdle, and cervical spine, voluntary written consent for examination; criteria according to ICHD-3 allowing to classify the symptoms as migraines. Exclusion Criteria: minors or over 65 years of age, male gender, patients undergoing pharmacological treatment that cannot be discontinued; people with other headaches; past injuries of the musculoskeletal system in the cervical spine and shoulder girdle; skin diseases and other conditions such as deep vein thrombosis, osteoporosis; criteria for excluding migraine according to ICHD-3.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciek Olesiejuk
Phone
+48603125812
Email
maciej.olesiejuk@awf.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Łuć
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneta Łuć
Organizational Affiliation
Regional Research and Development Center in Biała Podlaska
Official's Role
Study Director
Facility Information:
Facility Name
Regional Research and Development Center
City
Biała Podlaska
State/Province
Lubelskie
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aneta Łuć
Phone
833428853

12. IPD Sharing Statement

Plan to Share IPD
No
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