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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.

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

Intervention / Treatment
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* Other: Myofascial trigger points pressure release
* Other: Therapeutic exercise and postural hygiene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREATMENT GROUP<br>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. | Other: Myofascial trigger points pressure release<br>* 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.<br>* Other names: manual compression;Other: Therapeutic exercise and postural hygiene<br>* 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.<br>* Other names: motor control exercise;|
| Active Comparator: CONTROL<br>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. | Other: Therapeutic exercise and postural hygiene<br>* 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.<br>* Other names: motor control exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline. Prior to the first treatment session | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol | 
| 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. | Baseline. Prior to the first treatment session | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol | 
| 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). | Baseline. Prior to the first treatment session | 
| 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). | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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). | Follow-up two weeks after the end of the four-session treatment protocol | 
| 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. | Baseline. Prior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol | 
| 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. | Baseline. Prior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline. Prior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol | 
| 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. | Baseline. Prior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions. | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol. | 
| 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. | BaselinePrior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions. | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol. | 
| 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. | Baseline. Prior to the first treatment session. | 
| 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. | Up to 4 weeks. After the end protocol of four treatment sessions. | 
| 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. | Follow-up two weeks after the end of the four-session treatment protocol. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper trapezius, sternocleidomastoid, manual therapy, trigger points, Myofascial pain syndrome, therapeutic exercise