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

NCT06051799 | Unknown

• 1 other identifier: 23/186-EC_X_Tesis
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the effectiveness of myofascial trigger point treatment using pressure release versus a control group in patients with mechanical neck pain, randomly assigned. In both groups a protocol of therapeutic exercise and postural correction will be carried out

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

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (12)

• Swallow-wall distance. Base

  Baseline. Prior to the first treatment session.

• Swallow-wall distance. Post treatment

  Up to 4 weeks. After the end protocol of four treatment sessions

• Swallow-wall distance. Follow up

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

• Cervical flexion-extension. Base

  Baseline. Prior to the first treatment session.

• Cervical flexion-extension. Post treatment

  Up to 4 weeks. After the end protocol of four treatment sessions.

Study Arms (2)

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.

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.

Other: Therapeutic exercise and postural hygiene

Interventions

Myofascial trigger points pressure release OTHER

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

TREATMENT GROUP

Therapeutic exercise and postural hygiene OTHER

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

CONTROL; TREATMENT GROUP

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Fisioterapia Los Molinos

Getafe, Madrid, 28906, Spain

RECRUITING

Related Publications (26)

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Myofascial Pain Syndromes; Facial Pain

Interventions

Acupressure; Continuous Positive Airway Pressure; Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Angela C Álvarez Melcón, Doctor

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• Isidro Fernández López, Doctor

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• María A Atín Arratibel, Doctor

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• Iván Batuecas Sánchez, PhD

  Universidad Complutense / Fisioterapia Los Molinos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iván Batuecas Sánchez, PhD

CONTACT

+34699654655; ivanbatu@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The selection of participants and the randomisation sequence will be carried out by the principal investigator using the patient's unique identity number in the centre's programme as a code. After randomisation, participants will be sent by another therapist in the centre to each intervention room without knowing which treatment they will receive. The therapists in charge of delivering the interventions will not know which patient has been assigned to them. Although both therapists and patients will not know which group they are assigned to, obviously the therapist, given the nature of the intervention and the need to know and master the technique, knows which treatment to apply to each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 25, 2023
• Study Start: September 25, 2023
• Primary Completion: July 31, 2024
• Study Completion: September 20, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From July 2024 until the submission of the thesis
• Access Criteria: Upon request to the principal investigator and his research team

Locations

ES (1)