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

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

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.

Study Overview

• Status: Unknown
• Conditions: Neck Pain; Myofascial Pain; Myofascial Pain Syndrome; Myofascial Trigger Point Pain
• Intervention / Treatment: Other: Pressure Release technique; Other: Ischemic pressure technique

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Getafe, Madrid, Spain, 28906
      • Recruiting
      • Fisioterapia Los Molinos
      • Contact: Iván Batuecas, manager; Phone Number: +34699654655; Email: ivanbatu@ucm.es
      • Principal Investigator: Iván Batuecas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: 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; 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.
EXPERIMENTAL: 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.	Other: 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; 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.
NO_INTERVENTION: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer	Before the intervention
Visual Analog Scale	Place a mark in a chart according to the state of pain you are in at the moment, taking into account that the left extreme is the absence of pain and the opposite is the worst pain you may suffer	immediately after the intervention
Pain Threshold at Pressure	Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort. At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter	Before the intervention
Pain Threshold at Pressure	Evaluated with a pressure algometer. It will be assessed with the subject in a comfortable position, back supported by the backrest, feet on the floor and arms relaxed. The algometer will be placed perpendicular to the previously marked Miofascial Trigger Point. Once it is in place, the pressure should be increased one kilogram by second until the patient begins to feel discomfort. At this point the application will be stopped. Three measurements were made and the average will be calculated. Measured by Kilograms per square centimeter	immediately after the intervention
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability	The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.	Before the intervention
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability	The questionnaire consists of nine questions related to pain intensity, sleep, weight load, leisure and social activities, work and driving. Each one of them presents five possible answers graduated from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height of the subject	Before the first intervention
Weight	Weight of the subject	Before the first intervention
Age	Age of the subject	Before the first intervention
Sex	Sex of the subject	Before the first intervention
Working Status	Working status of the subject	Before the first intervention

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2020
• Primary Completion (ANTICIPATED): September 15, 2020
• Study Completion (ANTICIPATED): September 25, 2020

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (ACTUAL): September 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Manual therapy; Upper Trapezius Muscle; Pressure Release Technique; Ischemic Pressure Technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Neck Pain; Myofascial Pain Syndromes
• Other Study ID Numbers: C.I. 20/090-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No