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Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.

Primary Purpose

Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial, Myofacial Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Myofascial trigger points pressure release
Therapeutic exercise and postural hygiene
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring upper trapezius, sternocleidomastoid, manual therapy, trigger points, Myofascial pain syndrome, therapeutic exercise

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects between 18 and 55 years of age in order to avoid degenerative phenomena. Have suffered from neck pain at least once in the last month. Active or latent myofascial trigger points in the Upper Trapezius and Sternocleidomastoid muscles. Exclusion Criteria: Patients with recent trauma (last 6 months) to the upper quadrant or spine. Patients with pathologies involving malignant neoplasms. Surgery on the trunk or upper limb in the last six months. Patients undergoing pharmacological or physiotherapy treatment at the time of the test. Pregnancy. No myofascial trigger points in the upper trapezius or sternocleidomastoid muscles. Refusal to sign the consent form for the study or not being able to do so.

Sites / Locations

  • Fisioterapia Los MolinosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TREATMENT GROUP

CONTROL

Arm Description

The Pressure Release Technique will be applied. One session per week will be carried out for four weeks. It will be performed on as many trigger points as we find in each muscle associated with the study, leaving a record of them. Also adding postural hygiene and home exercise guidelines. A progression of exercises involving contraction of the deep neck flexor muscles Subjects will be taught to perform slow and controlled craniocervical flexion. It should be performed a minimum of once daily during the treatment regimen. A follow-up of the patients will be carried out with respect to home therapeutic exercise and postural hygiene guidelines.

Postural hygiene guidelines will be given, as well as home therapeutic exercise (identical to the treatment group). About therapeutic exercise, a progression of exercises involving contraction of the deep neck flexor muscles shall be included in the first session. Subjects will be taught to perform slow and controlled craniocervical flexion. Subjects will then be trained to be able to progressively maintain craniocervical flexion through feedback from an air device (Stabilizer™, Chattanooga Group Inc., Chattanooga, TN) placed behind the neck. This sensor monitors the slight flattening of the cervical curve that occurs with contraction of the craniocervical deep flexor musculature. It should be performed a minimum of once daily during the treatment regimen. To this end, patients will be monitored and their understanding and correct follow-up of the treatment will be assessed in each face-to-face session per week, for four weeks, the same as in experimental group.

Outcomes

Primary Outcome Measures

Visual analogue scale. Base
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Visual analogue scale. Post treatment
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Visual analogue scale. Follow up
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Pressure pain threshold. Base
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Pressure pain threshold. Post treatment
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Pressure pain threshold. Follow up
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Cervical Disability Index. Base
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Cervical Disability Index. Post treatment
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Cervical Disability Index. Follow up
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Pain catastrophising scale. Base
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Pain catastrophising scale. Post treatment
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Pain catastrophising scale. Follow up
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Tampa Kinesiophobia Scale (ETK-11). Base
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.
Tampa Kinesiophobia Scale (ETK-11). Post treatment
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.
Tampa Kinesiophobia Scale (ETK-11). Follow up
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.

Secondary Outcome Measures

Swallow-wall distance. Base
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Swallow-wall distance. Post treatment
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Swallow-wall distance. Follow up
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Cervical flexion-extension. Base
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Cervical flexion-extension. Post treatment
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Cervical flexion-extension. Follow up
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Cervical rotation. Base
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Cervical rotation. Post treatment
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Cervical rotation. Follow up
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Side bending. Base
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.
Side bending. Post treatment
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.
Side bending. Follow up
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.

Full Information

First Posted
September 14, 2023
Last Updated
September 20, 2023
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT06051799
Brief Title
Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.
Official Title
Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

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
The study aims to compare the effectiveness of myofascial trigger point treatment using pressure release versus a control group in patients with mechanical neck pain, randomly assigned. In both groups a protocol of therapeutic exercise and postural correction will be carried out
Detailed Description
With the present investigation it is wondered whether the choice of manual therapy techniques, specifically the pressure release of myofascial trigger points in the upper trapezius and sternocleidomastoid muscles, provide significant benefits in combination with therapeutic exercise and postural hygiene (treatment group), as opposed to the unique application of therapeutic exercise and postural hygiene (control group), thus constituting a treatment of choice in patients with mechanical neck pain. A treatment protocol of one session per week will be carried out, and a follow-up two weeks after the end of the treatment protocol. If, as postulated, pressure release is more effective than the treatment received by the control group, the choice of this type of technique for myofascial pain syndrome would benefit a high percentage of people who often come asking for treatment in pain treatment centers. Pressure release provides a painless manual stimulus, thus effectively resolving the symptomatology of myofascial trigger points without the need for invasive treatments or medication, which may have more contraindications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial, Myofacial Pain
Keywords
upper trapezius, sternocleidomastoid, manual therapy, trigger points, Myofascial pain syndrome, therapeutic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, controlled, clinical trial with blinded assessment of response variables. The guidelines of the CONSORT guide will be followed. A follow-up of the participants will be carried out, where measurements will be taken prior to the intervention (baseline), after the protocol of four treatment sessions and fifteen days after the last session.
Masking
ParticipantOutcomes Assessor
Masking Description
The selection of participants and the randomisation sequence will be carried out by the principal investigator using the patient's unique identity number in the centre's programme as a code. After randomisation, participants will be sent by another therapist in the centre to each intervention room without knowing which treatment they will receive. The therapists in charge of delivering the interventions will not know which patient has been assigned to them. Although both therapists and patients will not know which group they are assigned to, obviously the therapist, given the nature of the intervention and the need to know and master the technique, knows which treatment to apply to each subject.
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TREATMENT GROUP
Arm Type
Experimental
Arm Description
The Pressure Release Technique will be applied. One session per week will be carried out for four weeks. It will be performed on as many trigger points as we find in each muscle associated with the study, leaving a record of them. Also adding postural hygiene and home exercise guidelines. A progression of exercises involving contraction of the deep neck flexor muscles Subjects will be taught to perform slow and controlled craniocervical flexion. It should be performed a minimum of once daily during the treatment regimen. A follow-up of the patients will be carried out with respect to home therapeutic exercise and postural hygiene guidelines.
Arm Title
CONTROL
Arm Type
Active Comparator
Arm Description
Postural hygiene guidelines will be given, as well as home therapeutic exercise (identical to the treatment group). About therapeutic exercise, a progression of exercises involving contraction of the deep neck flexor muscles shall be included in the first session. Subjects will be taught to perform slow and controlled craniocervical flexion. Subjects will then be trained to be able to progressively maintain craniocervical flexion through feedback from an air device (Stabilizer™, Chattanooga Group Inc., Chattanooga, TN) placed behind the neck. This sensor monitors the slight flattening of the cervical curve that occurs with contraction of the craniocervical deep flexor musculature. It should be performed a minimum of once daily during the treatment regimen. To this end, patients will be monitored and their understanding and correct follow-up of the treatment will be assessed in each face-to-face session per week, for four weeks, the same as in experimental group.
Intervention Type
Other
Intervention Name(s)
Myofascial trigger points pressure release
Other Intervention Name(s)
Ischemic compression, pressure release, manual compression
Intervention Description
Patient lying down in the supine position, Therapist do a first and second finger pincer grasp is performed on the myofascial trigger points located on the upper trapezius muscle and sternocleidomastoid muscle, this pressure will be increased as the therapist perceives a reduction in soft tissue resistance under the finger over a period of 90 seconds. Previous studies indicate no difference between 60 and 90 seconds of pressure. It will be performed on as many trigger points as we find in each muscle associated with the study.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise and postural hygiene
Other Intervention Name(s)
postural correction, motor control exercise
Intervention Description
Therapeutic exercise and postural hygiene: A progression of exercises with contraction of the deep neck flexor muscles will be included in the first session. Subjects will be taught to perform a slow and controlled craniocervical flexion. Subjects will then be trained to be able to progressively maintain craniocervical flexion through feedback from an air device (Stabilizer™, Chattanooga Group Inc., Chattanooga, TN) placed behind the neck. This sensor monitors the slight flattening of the cervical curve that occurs with contraction of the craniocervical deep flexor musculature. It should be performed at least once a day during the treatment regimen. Also Postural correction exercises carried out regularly throughout the day, especially when seated. Indications are given to avoid pelvic retroversion and maintain a natural lumbar lordosis while performing retraction and adduction of the scapulae and gently lengthening the spine.
Primary Outcome Measure Information:
Title
Visual analogue scale. Base
Description
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Time Frame
Baseline. Prior to the first treatment session
Title
Visual analogue scale. Post treatment
Description
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Visual analogue scale. Follow up
Description
Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Title
Pressure pain threshold. Base
Description
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Time Frame
Baseline. Prior to the first treatment session
Title
Pressure pain threshold. Post treatment
Description
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Pressure pain threshold. Follow up
Description
Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Title
Cervical Disability Index. Base
Description
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Time Frame
Baseline. Prior to the first treatment session
Title
Cervical Disability Index. Post treatment
Description
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Cervical Disability Index. Follow up
Description
Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability).
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Title
Pain catastrophising scale. Base
Description
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Time Frame
Baseline. Prior to the first treatment session.
Title
Pain catastrophising scale. Post treatment
Description
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Pain catastrophising scale. Follow up
Description
It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Title
Tampa Kinesiophobia Scale (ETK-11). Base
Description
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.
Time Frame
Baseline. Prior to the first treatment session.
Title
Tampa Kinesiophobia Scale (ETK-11). Post treatment
Description
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Tampa Kinesiophobia Scale (ETK-11). Follow up
Description
Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Secondary Outcome Measure Information:
Title
Swallow-wall distance. Base
Description
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Time Frame
Baseline. Prior to the first treatment session.
Title
Swallow-wall distance. Post treatment
Description
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions
Title
Swallow-wall distance. Follow up
Description
Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol
Title
Cervical flexion-extension. Base
Description
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Time Frame
Baseline. Prior to the first treatment session.
Title
Cervical flexion-extension. Post treatment
Description
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions.
Title
Cervical flexion-extension. Follow up
Description
Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol.
Title
Cervical rotation. Base
Description
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Time Frame
BaselinePrior to the first treatment session.
Title
Cervical rotation. Post treatment
Description
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions.
Title
Cervical rotation. Follow up
Description
Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol.
Title
Side bending. Base
Description
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.
Time Frame
Baseline. Prior to the first treatment session.
Title
Side bending. Post treatment
Description
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.
Time Frame
Up to 4 weeks. After the end protocol of four treatment sessions.
Title
Side bending. Follow up
Description
Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded.
Time Frame
Follow-up two weeks after the end of the four-session treatment protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects between 18 and 55 years of age in order to avoid degenerative phenomena. Have suffered from neck pain at least once in the last month. Active or latent myofascial trigger points in the Upper Trapezius and Sternocleidomastoid muscles. Exclusion Criteria: Patients with recent trauma (last 6 months) to the upper quadrant or spine. Patients with pathologies involving malignant neoplasms. Surgery on the trunk or upper limb in the last six months. Patients undergoing pharmacological or physiotherapy treatment at the time of the test. Pregnancy. No myofascial trigger points in the upper trapezius or sternocleidomastoid muscles. Refusal to sign the consent form for the study or not being able to do so.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iván Batuecas Sánchez, PhD
Phone
+34699654655
Email
ivanbatu@ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela C Álvarez Melcón, Doctor
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Isidro Fernández López, Doctor
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
María A Atín Arratibel, Doctor
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iván Batuecas Sánchez, PhD
Organizational Affiliation
Universidad Complutense / Fisioterapia Los Molinos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisioterapia Los Molinos
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28906
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iván Batuecas, Director
Phone
+34644722649
Email
fisiopilateslosmolinos@gmail.com
First Name & Middle Initial & Last Name & Degree
Iván Batuecas, PhD
First Name & Middle Initial & Last Name & Degree
Ángela Álvarez, Doctor
First Name & Middle Initial & Last Name & Degree
Isidro Fernández, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The present study is carried out as a doctoral thesis of the principal investigator. Therefore, a scientific dissemination is foreseen in the Complutense University of Madrid as well as in the appropriate journals.
IPD Sharing Time Frame
From July 2024 until the submission of the thesis
IPD Sharing Access Criteria
Upon request to the principal investigator and his research team
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Learn more about this trial

Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.

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