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Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points

Primary Purpose

Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pressure release 90
Pressure release 60
Pressure release 30
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial Trigger Points, Liberation for Pression, Therapy Soft Tissue

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Grupo Fisioterapia y Dolor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Application 90 minutes pressure release

Application 60 minutes pressure release

Application 30 minutes pressure release

Arm Description

Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle

Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle

Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle

Outcomes

Primary Outcome Measures

Pain pressure threshold (PPT)
PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.

Secondary Outcome Measures

Strength muscle
The investigators will measure strength muscle with a handheld dynamometer. the subject will have to perform a movement of cervical extension resistance against.

Full Information

First Posted
October 27, 2016
Last Updated
October 3, 2017
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT03006822
Brief Title
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points
Official Title
Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
March 20, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome
Keywords
Myofascial Trigger Points, Liberation for Pression, Therapy Soft Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Application 90 minutes pressure release
Arm Type
Experimental
Arm Description
Subjects will receive a pressure release technique for 90 seconds in the levator scapula muscle
Arm Title
Application 60 minutes pressure release
Arm Type
Experimental
Arm Description
Subjects will receive a pressure release technique for 60 seconds in the levator scapula muscle
Arm Title
Application 30 minutes pressure release
Arm Type
Experimental
Arm Description
Subjects will receive a pressure release technique for 30 seconds in the levator scapula muscle
Intervention Type
Other
Intervention Name(s)
Pressure release 90
Other Intervention Name(s)
soft tissue massage, Compression ischemic massage technique
Intervention Description
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Intervention Type
Other
Intervention Name(s)
Pressure release 60
Other Intervention Name(s)
Compression ischemic massage technique, soft tissue massage
Intervention Description
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Intervention Type
Other
Intervention Name(s)
Pressure release 30
Other Intervention Name(s)
Compression ischemic massage technique, soft tissue massage
Intervention Description
This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
Primary Outcome Measure Information:
Title
Pain pressure threshold (PPT)
Description
PPT is defined as the minimal amount of pressure that produce pain. The investigators will measure the muscle levator scapular tenderness.
Time Frame
Change from Baseline PPT at one week
Secondary Outcome Measure Information:
Title
Strength muscle
Description
The investigators will measure strength muscle with a handheld dynamometer. the subject will have to perform a movement of cervical extension resistance against.
Time Frame
Change from Baseline strength muscle at one week
Other Pre-specified Outcome Measures:
Title
Range of cervical mobility
Description
The range of cervical mobility will has measure with cervical goniometer
Time Frame
Change from Baseline range of cervical mobility at one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, Doctor
Organizational Affiliation
Alcalá University (Physical Therapy and pain group)
Official's Role
Study Director
Facility Information:
Facility Name
Grupo Fisioterapia y Dolor
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31060367
Citation
Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
Results Reference
derived

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Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points

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