Effects of Release and Ischemic Pressure of Trigger Points on Neck Pain. A Crossover, Controlled and Randomized Trial.

NCT ID: NCT04546490

Last Updated: 2020-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2020-09-25

Brief Summary

The aim of the study is to compare two manual therapy techniques. By testing if the Pressure Release of Myofascial Trigger Points technique (PRM) is more effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual therapy technique that presents evidences such as Ischemic Pressure technique (IP), and a control group, through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, spanish version.

Detailed Description

The present pilot study is proposed as a crossover, controlled and randomized clinical trial, with blinded evaluation of response variables.

The aim of the study is to test whether the Pressure Release of Myofascial Trigger Points technique(PRM) is effective in treating Myofascial Trigger Points present in the upper trapezius muscle of patients with mechanical cervical pain. This will be compared mainly with another manual technique that presents more evidence such as Ischemic Pressure (IP), through the evaluation of the Visual Analogical Scale (VAS), the Threshold of Pain at Pressure (TPP) and the Northwick Park Questionnaire (NPC) of neck disability, Spanish version.

The patients, with a minimum sample for the pilot study of 30 subjects, of working age (18-50 years) with mechanical neck pain for at least the last month, will be recruited from the clinic "Fisioterapia Los Molinos" in the town of Getafe, the same place where the treatment will be carried out.

They will be randomly divided into three groups: one will be given Pressure Release of Myofascial Trigger Points technique (PRM), another Ischemic Pressure technique (IP), and a last one will be assigned as a control group. In compliance with the corresponding ethical criteria, the three groups will be subjected to random crossover so that no patient is left untreated. Visual Analogical Scale (VAS), Threshold of Pain at Pressure (TPP) and Northwick Park Questionnaire (NPC) of neck disability (spanish version), will be evaluated before and immediately after treatment.

Statistical analysis will be performed by IBM SPSS v22.0 program or a later version, verifying that the sample meets the criteria of normality and homogeneity and comparing the results of the variables through an ANOVA Analysis of variance.

Conditions

Myofascial Trigger Point Pain; Myofascial Pain; Myofascial Pain Syndrome; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pressure release

It will be applied with the patient in a supine position. The therapist will clamp his first and second fingers over the Myofascial Trigger Point located on the upper trapezium, it will be marked previously. The pressure will increase as the therapist perceives a reduction in the resistance offered by the soft tissue under his finger within a period of 90 seconds.

Group Type: EXPERIMENTAL

Pressure Release technique

Intervention Type: OTHER

Manual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger

Ischemic pressure technique

Intervention Type: OTHER

Manual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier.

Ischemic pressure

Patient in supine position, the therapist performs pressure with first and second finger in PGM marked previously, this is performed until the patient tolerance, when the patient refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier. Repeat the process for 90 seconds.

Group Type: EXPERIMENTAL

Pressure Release technique

Intervention Type: OTHER

Manual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger

Ischemic pressure technique

Intervention Type: OTHER

Manual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier.

Control Group

Patient in supine position on the stretcher, the therapist performs a clamp with the first and second finger on the upper trapezius muscle without making any pressure on it during 90 seconds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pressure Release technique

Manual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger

Intervention Type: OTHER

Ischemic pressure technique

Manual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with neck pain in the last month

Exclusion Criteria

• Patients with recent surgeries of the upper quadrant or spine.
• Patients who are currently undergoing pharmacological or physiotherapeutic treatment.
• Patients who have suffered a recent traffic accident or other type of trauma
• Patients who are in the gestation period.
• Patients who have malignant neoplasms.
• Patients who do not sign the informed consent, do not understand the Spanish language or any other circumstance that would prevent their participation in this research will also be discarded
• Patients with no palpable active or latent myofascial trigger points in the upper trapezius muscle

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Iván Batuecas Sánchez

Máster Universitario en Cuidados de Salud

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fisioterapia Los Molinos

Getafe, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Iván Batuecas, manager

Role: primary

ivanbatu@ucm.es

+34699654655

Other Identifiers

C.I. 20/090-E

Identifier Type: -

Identifier Source: org_study_id