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

Primary Purpose

Myofascial Trigger Point Pain, Myofascial Pain, Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pressure Release technique
Ischemic pressure technique
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring Upper Trapezius Muscle, Manual therapy, Pressure Release Technique, Ischemic Pressure Technique

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fisioterapia Los MolinosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pressure release

Ischemic pressure

Control Group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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
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
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
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
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.
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.

Secondary Outcome Measures

Height
Height of the subject
Weight
Weight of the subject
Age
Age of the subject
Sex
Sex of the subject
Working Status
Working status of the subject

Full Information

First Posted
August 20, 2020
Last Updated
September 4, 2020
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04546490
Brief Title
Effects of Release and Ischemic Pressure of Trigger Points on Neck Pain. A Crossover, Controlled and Randomized Trial.
Official Title
Effects of Pressure Release and Ischemic Pressure of Myofascial Trigger Points on Mechanical Neck Pain. A Crossover, Controlled and Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Anticipated)
Study Completion Date
September 25, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain, Myofascial Pain, Myofascial Pain Syndrome, Neck Pain
Keywords
Upper Trapezius Muscle, Manual therapy, Pressure Release Technique, Ischemic Pressure Technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pressure release
Arm Type
Experimental
Arm Description
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.
Arm Title
Ischemic pressure
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Pressure Release technique
Intervention Description
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
Intervention Name(s)
Ischemic pressure technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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
Time Frame
Before the intervention
Title
Visual Analog Scale
Description
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
Time Frame
immediately after the intervention
Title
Pain Threshold at Pressure
Description
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
Time Frame
Before the intervention
Title
Pain Threshold at Pressure
Description
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
Time Frame
immediately after the intervention
Title
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
Description
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.
Time Frame
Before the intervention
Title
Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability
Description
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.
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Height
Description
Height of the subject
Time Frame
Before the first intervention
Title
Weight
Description
Weight of the subject
Time Frame
Before the first intervention
Title
Age
Description
Age of the subject
Time Frame
Before the first intervention
Title
Sex
Description
Sex of the subject
Time Frame
Before the first intervention
Title
Working Status
Description
Working status of the subject
Time Frame
Before the first intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fisioterapia Los Molinos
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28906
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iván Batuecas, manager
Phone
+34699654655
Email
ivanbatu@ucm.es
First Name & Middle Initial & Last Name & Degree
Iván Batuecas

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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