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

Not Applicable

Recruiting

• Conditions: Myofacial Pain; Myofascial Pain Syndrome of Neck; Trigger Point Pain, Myofascial
• Interventions: Other: Myofascial trigger points pressure release; Other: Therapeutic exercise and postural hygiene

• Registration Number: NCT06051799
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study Start: 2023-09-25
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25
• Primary Completion: 2024-07-31
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TREATMENT GROUP	Therapeutic exercise and postural hygiene	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.
TREATMENT GROUP	Myofascial trigger points pressure release	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.
CONTROL	Therapeutic exercise and postural hygiene	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.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions	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.
Cervical Disability Index. Base	Baseline. Prior to the first treatment session	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	Baseline. Prior to the first treatment session.	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	Follow-up two weeks after the end of the four-session treatment protocol	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). Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions	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.
Cervical Disability Index. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions	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. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions	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). Follow up	Follow-up two weeks after the end of the four-session treatment protocol	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.
Visual analogue scale. Base	Baseline. Prior to the first treatment session	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. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions	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.
Tampa Kinesiophobia Scale (ETK-11). Base	Baseline. Prior to the first treatment session.	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.
Visual analogue scale. Follow up	Follow-up two weeks after the end of the four-session treatment protocol	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	Baseline. Prior to the first treatment session	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	Follow-up two weeks after the end of the four-session treatment protocol	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. Follow up	Follow-up two weeks after the end of the four-session treatment protocol	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).

Secondary Outcome Measures

Name	Time	Method
Swallow-wall distance. Base	Baseline. Prior to the first treatment session.	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	Up to 4 weeks. After the end protocol of four treatment sessions	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. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions.	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.
Side bending. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions.	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.
Cervical flexion-extension. Base	Baseline. Prior to the first treatment session.	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. Post treatment	Up to 4 weeks. After the end protocol of four treatment sessions.	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	Baseline. Prior to the first treatment session.	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.
Swallow-wall distance. Follow up	Follow-up two weeks after the end of the four-session treatment protocol	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. Follow up	Follow-up two weeks after the end of the four-session treatment protocol.	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. Follow up	Follow-up two weeks after the end of the four-session treatment protocol.	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. Base	BaselinePrior to the first treatment session.	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. Follow up	Follow-up two weeks after the end of the four-session treatment protocol.	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.

Trial Locations

Locations (1)

Fisioterapia Los Molinos; 🇪🇸 Getafe, Madrid, Spain