Clinical trial NCT06051799: Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain.
Official title: Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

Detailed description: With the present investigation it is wondered whether the choice of manual therapy techniques, specifically the pressure release of myofascial trigger points in the upper trapezius and sternocleidomastoid muscles, provide significant benefits in combination with therapeutic exercise and postural hygiene (treatment group), as opposed to the unique application of therapeutic exercise and postural hygiene (control group), thus constituting a treatment of choice in patients with mechanical neck pain.

A treatment protocol of one session per week will be carried out, and a follow-up two weeks after the end of the treatment protocol.

If, as postulated, pressure release is more effective than the treatment received by the control group, the choice of this type of technique for myofascial pain syndrome would benefit a high percentage of people who often come asking for treatment in pain treatment centers. Pressure release provides a painless manual stimulus, thus effectively resolving the symptomatology of myofascial trigger points without the need for invasive treatments or medication, which may have more contraindications.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale. Base
timeFrame: Baseline. Prior to the first treatment session
measure: Visual analogue scale. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Visual analogue scale. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
measure: Pressure pain threshold. Base
timeFrame: Baseline. Prior to the first treatment session
measure: Pressure pain threshold. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Pressure pain threshold. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
measure: Cervical Disability Index. Base
timeFrame: Baseline. Prior to the first treatment session
measure: Cervical Disability Index. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Cervical Disability Index. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
measure: Pain catastrophising scale. Base
timeFrame: Baseline. Prior to the first treatment session.
measure: Pain catastrophising scale. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Pain catastrophising scale. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
measure: Tampa Kinesiophobia Scale (ETK-11). Base
timeFrame: Baseline. Prior to the first treatment session.
measure: Tampa Kinesiophobia Scale (ETK-11). Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Tampa Kinesiophobia Scale (ETK-11). Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
Secondary outcomes:
measure: Swallow-wall distance. Base
timeFrame: Baseline. Prior to the first treatment session.
measure: Swallow-wall distance. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions
measure: Swallow-wall distance. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol
measure: Cervical flexion-extension. Base
timeFrame: Baseline. Prior to the first treatment session.
measure: Cervical flexion-extension. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions.
measure: Cervical flexion-extension. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol.
measure: Cervical rotation. Base
timeFrame: BaselinePrior to the first treatment session.
measure: Cervical rotation. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions.
measure: Cervical rotation. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol.
measure: Side bending. Base
timeFrame: Baseline. Prior to the first treatment session.
measure: Side bending. Post treatment
timeFrame: Up to 4 weeks. After the end protocol of four treatment sessions.
measure: Side bending. Follow up
timeFrame: Follow-up two weeks after the end of the four-session treatment protocol.
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Fisioterapia Los Molinos
state: Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Angela C Álvarez Melcón, Doctor
role: STUDY_DIRECTOR
affiliation: Universidad Complutense de Madrid
name: Isidro Fernández López, Doctor
role: STUDY_DIRECTOR
affiliation: Universidad Complutense de Madrid
name: María A Atín Arratibel, Doctor
role: STUDY_DIRECTOR
affiliation: Universidad Complutense / Fisioterapia Los Molinos
name: Iván Batuecas Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
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