Migraine Clinical Trial
— MTRPsOfficial title:
Effects of Myofascial Trigger Points Therapy in Migraine.
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: 1. CM group - patients with chronic migraine 2. EMa group - patients with paroxysmal migraine with aura 3. 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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Poland | Regional Research and Development Center | Biala Podlaska | Lubelskie |
Lead Sponsor | Collaborator |
---|---|
Józef Pilsudski University of Physical Education | University School of Physical Education in Wroclaw |
Poland,
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* Note: There are 60 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 [°]. | Before the first treatment. | |
Primary | 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 [°]. | After the first treatment. | |
Primary | 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 [°]. | Before the fourth treatment. | |
Primary | 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 [°]. | After the fourth treatment. | |
Primary | 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 [°]. | Before the seventh treatment. | |
Primary | 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 [°]. | After the seventh treatment. | |
Primary | 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 [°]. | Described data was collected for 1 month after the last intervention. | |
Primary | 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. | Before the first therapy. | |
Primary | 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. | After the first therapy. | |
Primary | 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. | 1 month after intervention completion, the subject completed the WHOQoL-BREF questionnaire again. | |
Primary | 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. | Day 1 | |
Primary | 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. | Day 4 | |
Primary | 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. | Day 7 | |
Primary | 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). | Before the treatment cycle. | |
Primary | 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). | 1 month after the end of treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | Before the first treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | After the first treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | Before the fourth treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | After the fourth treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | Before the seventh treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | After the seventh treatment. | |
Secondary | Myomentric parameter - Frequency | Frequency. Myotonometric frequency of natural oscillations (F-MYO) expressed in [Hz]. | 1 month after the last intervention. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | Before the first treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | After the first treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | Before the fourth treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | After the fourth treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | Before the seventh treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | After the seventh treatment. | |
Secondary | Myomentric parameter - Stiffness | Stiffness. Myotonometric stiffnes (S-MYO) expressed in [N/m]. | 1 month after the last intervention. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | Before the first treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | After the first treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | Before the fourth treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | After the fourth treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | Before the seventh treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | After the seventh treatment. | |
Secondary | Myomentric parameter - Decrement | Decrement. Myotonometric decrement of natural oscillations (D-MYO) expressed in logarithm of damping oscillations [log]. | 1 month after the last intervention. | |
Secondary | 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. | Before the treatment on the first day. | |
Secondary | 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. | After the treatment on the first day. | |
Secondary | 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. | 24 hours after the sixth treatment. | |
Secondary | 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. | Before the treatment on the first day. | |
Secondary | 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. | After the treatment on the first day. | |
Secondary | 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. | 24 hours after the sixth treatment. | |
Secondary | 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. | Before the treatment on the first day. | |
Secondary | 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. | After the treatment on the first day. | |
Secondary | 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. | 24 hours after the sixth treatment. | |
Secondary | 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. | Before the treatment on the first day. | |
Secondary | 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. | After the treatment on the first day. | |
Secondary | 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. | 24 hours after the sixth treatment. |
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