NCT03006822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2017

Enrollment Period

5 days

First QC Date

October 27, 2016

Last Update Submit

October 3, 2017

Conditions

Myofascial Pain Syndrome

Keywords

Myofascial Trigger PointsLiberation for PressionTherapy Soft Tissue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline PPT at one week

Secondary Outcomes (1)

  • Strength muscle

    Change from Baseline strength muscle at one week

Other Outcomes (1)

  • Range of cervical mobility

    Change from Baseline range of cervical mobility at one week

Study Arms (3)

Application 90 minutes pressure release

EXPERIMENTAL

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

Other: Pressure release 90

Application 60 minutes pressure release

EXPERIMENTAL

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

Other: Pressure release 60

Application 30 minutes pressure release

EXPERIMENTAL

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

Other: Pressure release 30

Interventions

Pressure release 90OTHER

This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.

Also known as: soft tissue massage, Compression ischemic massage technique
Application 90 minutes pressure release
Pressure release 60OTHER

This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.

Also known as: Compression ischemic massage technique, soft tissue massage
Application 60 minutes pressure release
Pressure release 30OTHER

This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.

Also known as: Compression ischemic massage technique, soft tissue massage
Application 30 minutes pressure release

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with aged between 18 and 60 years.
  • Subjects with presence of latent PGM levator scapulae muscle.

You may not qualify if:

  • Pregnant.
  • Subjects with spontaneous pain.
  • Subjects with neck or shoulder pain.
  • Subjects with musculoskeletal injuries.
  • Subjects with neurological problems.
  • Fibromyalgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31060367DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Daniel Pecos-Martin, Doctor

    Alcalá University (Physical Therapy and pain group)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Pecos-Martin, Daniel (Principal Investigator)

Study Record Dates

First Submitted

October 27, 2016

First Posted

December 30, 2016

Study Start

March 15, 2017

Primary Completion

March 20, 2017

Study Completion

July 10, 2017

Last Updated

October 4, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)