- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006822
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae
Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques.
Objective: To determine the time effect of the pressure release technique application in the latent MTrPs of the levator scapulae muscle.
Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.
The manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcala de Henares, Madrid, Spain, 28871
- Grupo Fisioterapia y Dolor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with aged between 18 and 60 years.
- Subjects with presence of latent PGM levator scapulae muscle.
Exclusion Criteria:
- Pregnant.
- Subjects with spontaneous pain.
- Subjects with neck or shoulder pain.
- Subjects with musculoskeletal injuries.
- Subjects with neurological problems.
- Fibromyalgia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Application 90 minutes pressure release
Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle
|
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Other Names:
|
|
Experimental: Application 60 minutes pressure release
Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle
|
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Other Names:
|
|
Experimental: Application 30 minutes pressure release
Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle
|
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold (PPT)
Time Frame: Change from Baseline PPT at one week
|
PPT is defined as the minimal amount of pressure that produce pain.
The investigators will measure the muscle levator scapular tenderness.
|
Change from Baseline PPT at one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength muscle
Time Frame: Change from Baseline strength muscle at one week
|
The investigators will measure strength muscle with a handheld dynamometer.
the subject will have to perform a movement of cervical extension resistance against.
|
Change from Baseline strength muscle at one week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of cervical mobility
Time Frame: Change from Baseline range of cervical mobility at one week
|
The range of cervical mobility will has measure with cervical goniometer
|
Change from Baseline range of cervical mobility at one week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Daniel Pecos-Martin, Doctor, Alcalá University (Physical Therapy and pain group)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Universidad de Alcalá
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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