Effects of MTRPs Therapy in Migraine.

NCT05646160 | Unknown

• 2 other identifiers: SKE 01-52 / 201714/21//10/11/2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• m. trapesius pars descendent (trapezius upper),
• m. sternocleidomastoideus (sternocleidomastoid),
• m. temporalis (temporal),
• m. legator scapulae (levator scapula),
• m. supraspinatus (supraspinatus),
• m. suboccipitales (suboccipital).

Conditions

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

Outcome Measures

Primary Outcomes (15)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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

• 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

• 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

• 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.

• 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 Outcomes (33)

• Myomentric parameter - Frequency

  Before the first treatment.

• Myomentric parameter - Frequency

  After the first treatment.

• Myomentric parameter - Frequency

  Before the fourth treatment.

• Myomentric parameter - Frequency

  After the fourth treatment.

• Myomentric parameter - Frequency

  Before the seventh treatment.

Study Arms (3)

chronic migraine (CM)

EXPERIMENTAL

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.

Other: Ischemic Compression of Myofascial Trigger Points (IC-MTRPs)

episodic migraine with aura (EMa)

EXPERIMENTAL

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.

Other: Ischemic Compression of Myofascial Trigger Points (IC-MTRPs)

episodic migraine without aura (EMb)

EXPERIMENTAL

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.

Other: Ischemic Compression of Myofascial Trigger Points (IC-MTRPs)

Interventions

Ischemic Compression of Myofascial Trigger Points (IC-MTRPs) OTHER

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).

Also known as: MTRPs therapy, trigger points therapy/compression

chronic migraine (CM); episodic migraine with aura (EMa); episodic migraine without aura (EMb)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead
• Wroclaw University of Health and Sport Sciences: collaborator

Study Sites (1)

Regional Research and Development Center

Biała Podlaska, Lublin Voivodeship, 21-500, Poland

RECRUITING

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  PMID: 39893364 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Shoulder Pain; Myalgia; Myofascial Pain Syndromes; Neck Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain

Study Officials

• Aneta Łuć

  Regional Research and Development Center in Biała Podlaska

  STUDY DIRECTOR

Central Study Contacts

Maciek Olesiejuk

CONTACT

+48603125812; maciej.olesiejuk@awf.edu.pl

Łuć

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 12, 2022
• Study Start: January 15, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 2, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)