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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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ClinicalTrials.gov Identifier: NCT04546490
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Iván Batuecas Sánchez, Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Myofascial Trigger Point Pain Myofascial Pain Myofascial Pain Syndrome Neck Pain Other: Pressure Release technique Other: Ischemic pressure technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Double (Participant, Outcomes 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
Primary Purpose: Treatment
Official Title: Effects of Pressure Release and Ischemic Pressure of Myofascial Trigger Points on Mechanical Neck Pain. A Crossover, Controlled and Randomized Clinical Trial
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 25, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: Before the intervention ]
    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

  2. Visual Analog Scale [ Time Frame: immediately after the intervention ]
    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

  3. Pain Threshold at Pressure [ Time Frame: Before the intervention ]

    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


  4. Pain Threshold at Pressure [ Time Frame: immediately after the intervention ]

    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


  5. Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability [ Time Frame: Before the intervention ]
    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.

  6. Northwick Park Questionary (Spanish Modified Version) for Cervical Spine disability [ Time Frame: immediately after the intervention ]
    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 :
  1. Height [ Time Frame: Before the first intervention ]
    Height of the subject

  2. Weight [ Time Frame: Before the first intervention ]
    Weight of the subject

  3. Age [ Time Frame: Before the first intervention ]
    Age of the subject

  4. Sex [ Time Frame: Before the first intervention ]
    Sex of the subject

  5. Working Status [ Time Frame: Before the first intervention ]
    Working status of the subject



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546490


Locations
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Spain
Fisioterapia Los Molinos Recruiting
Getafe, Madrid, Spain, 28906
Contact: Iván Batuecas, manager    +34699654655    ivanbatu@ucm.es   
Principal Investigator: Iván Batuecas         
Sponsors and Collaborators
Universidad Complutense de Madrid
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Responsible Party: Iván Batuecas Sánchez, Máster Universitario en Cuidados de Salud, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT04546490    
Other Study ID Numbers: C.I. 20/090-E
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Iván Batuecas Sánchez, Universidad Complutense de Madrid:
Upper Trapezius Muscle
Manual therapy
Pressure Release Technique
Ischemic Pressure Technique
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Neck Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases