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

NCT04546490 | Unknown DMC

• 1 other identifier: C.I. 20/090-E
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Upper Trapezius Muscle; Manual therapy; Pressure Release Technique; Ischemic Pressure Technique

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Height

  Before the first intervention

• Weight

  Before the first intervention

• Age

  Before the first intervention

• Sex

  Before the first intervention

• Working Status

  Before the first intervention

Study Arms (3)

Pressure release

EXPERIMENTAL

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; Other: Ischemic pressure technique

Ischemic pressure

EXPERIMENTAL

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; Other: Ischemic pressure technique

Control Group

NO INTERVENTION

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

Interventions

Pressure Release technique 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; Pressure release

Ischemic pressure technique 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; Pressure release

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with neck pain in the last month

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Fisioterapia Los Molinos

Getafe, Madrid, 28906, Spain

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not know to which group they have been assigned in each of the interventions Participants will be assigned an individual code by which the outcome assessor will not be able to know what treatment(s) each individual received
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Máster Universitario en Cuidados de Salud

Model Details: Patients, aged 18-50 years with mechanical neck pain for at least the last month, will be randomly divided into three groups: one will be given Pressure Release technique, another Ischemic Pressure technique, and a last one will be assigned as a control group. They will be crosslinked after the first treatment. The variables will be evaluated before and immediately after treatment.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 14, 2020
• Study Start: February 15, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 25, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

ES (1)