Myofascial Pain Syndrome of NeckNCT06051799

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

A study testing Myofascial trigger points pressure release and Therapeutic exercise and postural hygiene in people with Myofascial Pain Syndrome of Neck and Trigger Point Pain, Myofascial, run by Universidad Complutense de Madrid at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial, Myofacial Pain
What is being tested?: Myofascial trigger points pressure release and Therapeutic exercise and postural hygiene
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteSpain
Study dates: 25 Sep 2023to 20 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Iván Batuecas Sánchez, PhD contact

+34699654655

ivanbatu@ucm.es

Spain1 site, 1 recruiting

Fisioterapia Los Molinos
Getafe, Madrid, 28906
Iván Batuecas, Director, +34644722649, fisiopilateslosmolinos@gmail.com
Iván Batuecas, PhD
Recruiting

Other trials in Spain

About this study

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

Read the 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.

Conditions: Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial, Myofacial Pain
Being tested: Myofascial trigger points pressure release, Therapeutic exercise and postural hygiene
Keywords: upper trapezius, sternocleidomastoid, manual therapy, trigger points, Myofascial pain syndrome, therapeutic exercise
Medical subject headings: Myofascial Pain Syndromes, Facial Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Myofascial trigger points pressure releaseOther
Also called Ischemic compression, pressure release, manual compression
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.
Therapeutic exercise and postural hygieneOther
Also called postural correction, motor control exercise
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.

Study groups in NCT06051799
Study group	Role	What they receive
TREATMENT GROUP	Experimental	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. Receives: Other: Myofascial trigger points pressure release; Other: Therapeutic exercise and postural hygiene
CONTROL	Active comparator	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. Receives: Other: Therapeutic exercise and postural hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up two weeks after the end of the four-session treatment protocol

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up two weeks after the end of the four-session treatment protocol.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202320 Sep 2024

First posted25 Sep 2023
Study start25 Sep 2023 (estimated)
Primary completion31 Jul 2024 (estimated)
Study completion20 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Myofascial Pain Syndrome of NeckStudies of the same condition, open and under way.
More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Outcomes assessor
Enrolment: 104 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06051799
Sponsor's protocol ID: 23/186-EC_X_Tesis
Status last verified: Sep 2023
First submitted: 14 Sep 2023
Last updated: 25 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.
PubMed 23158466
Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
PubMed 28025371
Chao YW, Lin JJ, Yang JL, Wang WT. Kinesio taping and manual pressure release: Short-term effects in subjects with myofasical trigger point. J Hand Ther. 2016 Jan-Mar;29(1):23-9. doi: 10.1016/j.jht.2015.10.003. Epub 2015 Nov 6.
PubMed 26705672
Grieve R, Barnett S, Coghill N, Cramp F. The prevalence of latent myofascial trigger points and diagnostic criteria of the triceps surae and upper trapezius: a cross sectional study. Physiotherapy. 2013 Dec;99(4):278-84. doi: 10.1016/j.physio.2013.04.002. Epub 2013 Jul 2.
PubMed 23830716
Oliveira-Campelo NM, de Melo CA, Alburquerque-Sendin F, Machado JP. Short- and medium-term effects of manual therapy on cervical active range of motion and pressure pain sensitivity in latent myofascial pain of the upper trapezius muscle: a randomized controlled trial. J Manipulative Physiol Ther. 2013 Jun;36(5):300-9. doi: 10.1016/j.jmpt.2013.04.008. Epub 2013 Jun 12.
PubMed 23769263
Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
PubMed 25768071
De Meulemeester KE, Castelein B, Coppieters I, Barbe T, Cools A, Cagnie B. Comparing Trigger Point Dry Needling and Manual Pressure Technique for the Management of Myofascial Neck/Shoulder Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):11-20. doi: 10.1016/j.jmpt.2016.10.008.
PubMed 28017188
Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
PubMed 31060367
Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
PubMed 29025044
Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2020 Dec;50:102220. doi: 10.1016/j.msksp.2020.102220. Epub 2020 Jul 24.
PubMed 32827852
de Zoete RM, Armfield NR, McAuley JH, Chen K, Sterling M. Comparative effectiveness of physical exercise interventions for chronic non-specific neck pain: a systematic review with network meta-analysis of 40 randomised controlled trials. Br J Sports Med. 2020 Nov 2:bjsports-2020-102664. doi: 10.1136/bjsports-2020-102664. Online ahead of print.
PubMed 33139256
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
PubMed 22036893
Hou CR, Tsai LC, Cheng KF, Chung KC, Hong CZ. Immediate effects of various physical therapeutic modalities on cervical myofascial pain and trigger-point sensitivity. Arch Phys Med Rehabil. 2002 Oct;83(10):1406-14. doi: 10.1053/apmr.2002.34834.
PubMed 12370877
Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.
PubMed 18804003
Rodriguez-Sanz J, Malo-Urries M, Corral-de-Toro J, Lopez-de-Celis C, Lucha-Lopez MO, Tricas-Moreno JM, Lorente AI, Hidalgo-Garcia C. Does the Addition of Manual Therapy Approach to a Cervical Exercise Program Improve Clinical Outcomes for Patients with Chronic Neck Pain in Short- and Mid-Term? A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Sep 10;17(18):6601. doi: 10.3390/ijerph17186601.
PubMed 32927858

Want to know more?

Iván Batuecas Sánchez, PhD

+34699654655

ivanbatu@ucm.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Myofascial Pain Syndrome of Neck trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT06051799
Acronym / sponsor ID: 23/186-EC_X_Tesis
Conditions: Myofascial Pain Syndrome of Neck, Trigger Point Pain, Myofascial, Myofacial Pain
Keywords: upper trapezius, sternocleidomastoid, manual therapy, trigger points, Myofascial pain syndrome, therapeutic exercise
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 104 participants (estimated)
Lead sponsor: Universidad Complutense de MadridUniversity, hospital or other
Study start: 25 Sep 2023 (estimated)
Primary completion: 31 Jul 2024 (estimated)
Study completion: 20 Sep 2024 (estimated)
First posted: 25 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
TREATMENT GROUP	Experimental	Other: Myofascial trigger points pressure release, Other: Therapeutic exercise and postural hygieneThe 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	Active comparator	Other: Therapeutic exercise and postural hygienePostural 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Myofascial trigger points pressure releaseAlso: Ischemic compression, pressure release, manual compressionPatient 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.	Other	TREATMENT GROUP
Therapeutic exercise and postural hygieneAlso: postural correction, motor control exerciseTherapeutic 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.	Other	CONTROL, TREATMENT GROUP

Primary outcome

Visual analogue scale. Base
Time frame: 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.
Visual analogue scale. Post treatment
Time frame: 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.
Visual analogue scale. Follow up
Time frame: 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
Time frame: 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. Post treatment
Time frame: 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.
Pressure pain threshold. Follow up
Time frame: 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. Base
Time frame: 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).
Cervical Disability Index. Post treatment
Time frame: 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).
Cervical Disability Index. Follow up
Time frame: 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).
Pain catastrophising scale. Base
Time frame: 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. Post treatment
Time frame: 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.
Pain catastrophising scale. Follow up
Time frame: 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). Base
Time frame: 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.
Tampa Kinesiophobia Scale (ETK-11). Post treatment
Time frame: 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.
Tampa Kinesiophobia Scale (ETK-11). Follow up
Time frame: 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.

12 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
Results publication: PubMed 23158466Munoz-Munoz S, Munoz-Garcia MT, Alburquerque-Sendin F, Arroyo-Morales M, Fernandez-de-las-Penas C. Myofascial trigger points, pain, disability, and sleep quality in individuals with mechanical neck pain. J Manipulative Physiol Ther. 2012 Oct;35(8):608-13. doi: 10.1016/j.jmpt.2012.09.003.
Results publication: PubMed 28025371Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.
Results publication: PubMed 26705672Chao YW, Lin JJ, Yang JL, Wang WT. Kinesio taping and manual pressure release: Short-term effects in subjects with myofasical trigger point. J Hand Ther. 2016 Jan-Mar;29(1):23-9. doi: 10.1016/j.jht.2015.10.003. Epub 2015 Nov 6.
Results publication: PubMed 23830716Grieve R, Barnett S, Coghill N, Cramp F. The prevalence of latent myofascial trigger points and diagnostic criteria of the triceps surae and upper trapezius: a cross sectional study. Physiotherapy. 2013 Dec;99(4):278-84. doi: 10.1016/j.physio.2013.04.002. Epub 2013 Jul 2.
Results publication: PubMed 23769263Oliveira-Campelo NM, de Melo CA, Alburquerque-Sendin F, Machado JP. Short- and medium-term effects of manual therapy on cervical active range of motion and pressure pain sensitivity in latent myofascial pain of the upper trapezius muscle: a randomized controlled trial. J Manipulative Physiol Ther. 2013 Jun;36(5):300-9. doi: 10.1016/j.jmpt.2013.04.008. Epub 2013 Jun 12.
Results publication: PubMed 25768071Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
Results publication: PubMed 28017188De Meulemeester KE, Castelein B, Coppieters I, Barbe T, Cools A, Cagnie B. Comparing Trigger Point Dry Needling and Manual Pressure Technique for the Management of Myofascial Neck/Shoulder Pain: A Randomized Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):11-20. doi: 10.1016/j.jmpt.2016.10.008.
Results publication: PubMed 31060367Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
Results publication: PubMed 29025044Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
Results publication: PubMed 32827852Tsiringakis G, Dimitriadis Z, Triantafylloy E, McLean S. Motor control training of deep neck flexors with pressure biofeedback improves pain and disability in patients with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2020 Dec;50:102220. doi: 10.1016/j.msksp.2020.102220. Epub 2020 Jul 24.
Results publication: PubMed 33139256de Zoete RM, Armfield NR, McAuley JH, Chen K, Sterling M. Comparative effectiveness of physical exercise interventions for chronic non-specific neck pain: a systematic review with network meta-analysis of 40 randomised controlled trials. Br J Sports Med. 2020 Nov 2:bjsports-2020-102664. doi: 10.1136/bjsports-2020-102664. Online ahead of print.
Results publication: PubMed 22036893Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Iván Batuecas Sánchez, PhD contact

+34699654655

ivanbatu@ucm.es

Angela C Álvarez Melcón, Doctor study director

Universidad Complutense de Madrid

Isidro Fernández López, Doctor study director

Universidad Complutense de Madrid

María A Atín Arratibel, Doctor study director

Universidad Complutense de Madrid

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Iván Batuecas Sánchez, PhD (+34699654655, ivanbatu@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale. Base (time frame: Baseline. Prior to the first treatment session). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06051799, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.