An interventional study of Myofascial trigger points pressure release and Therapeutic exercise and postural hygiene in Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial and Myofacial Pain, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's planned enrollment of 104 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: 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.
Other: Therapeutic exercise and postural hygiene
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.
Also known as: Ischemic compression, pressure release, manual compression
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.
Also known as: postural correction, motor control exercise
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up two weeks after the end of the four-session treatment protocol
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow-up two weeks after the end of the four-session treatment protocol.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universidad Complutense de Madrid