NCT03941054

Brief Summary

The aim of this study is to analyze the effects of the treatment of the Myosfascial Trigger-Points detected in the gastrocnemius muscles on the neuromuscular response.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 3, 2019

Last Update Submit

May 6, 2019

Conditions

Myofascial Trigger Point Pain

Outcome Measures

Primary Outcomes (3)

  • change of neuromuscular stiffness of the gastrocnemious muscles

    biomechanical property of a muscle that characterizes the resistance to an external force that deforms its initial shape, using a "Myoton".

    10 minutes before the intervention, and 1 minute after the intervention

  • change of elasticity of the gastrocnemious muscles

    Biomechanical property of a muscle that characterizes the ability to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton".

    10 minutes before the intervention, and 1 minute after the intervention

  • change of relaxation of the gastrocnemious muscles

    Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton".

    10 minutes before the intervention, and 1 minute after the intervention

Secondary Outcomes (5)

  • change of active dorsiflexion ROM

    4 minutes before the intervention, and 6 minute after the intervention

  • change of pasive dorsiflexion ROM

    2 minutes before the intervention, and 8 minute after the intervention

  • change of gastrocnemious strength

    5 minutes before the intervention, and 5 minute after the intervention

  • change of pain intensity

    8 minutes before the intervention, and 2 minute after the intervention

  • change of pressure-pain threshold

    7 minutes before the intervention, and 3 minute after the intervention

Study Arms (2)

Control arm

NO INTERVENTION

No intervention

Pressure Release

EXPERIMENTAL

Digitopressure treatment of the Myosfascial Trigger Points

Other: Pressure Release

Interventions

Pressure ReleaseOTHER

Subjets receive digitopressure during 90 seconds for the treatment of the Myosfascial Trigger Points

Pressure Release

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjets with both active or latent Myosfascial Trigger Points

You may not qualify if:

  • Pregnant women
  • Musculoskeletal problems in the last month
  • Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
  • Psychological or nervous alterations
  • Uncomprehension of the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Albert Pérez-Bellmunt, PhD

    Anatomy lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 7, 2019

Study Start

May 2, 2019

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)