NCT03963674

Brief Summary

The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

February 5, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

May 28, 2019

Status Verified

February 1, 2019

Enrollment Period

Same day

First QC Date

May 20, 2019

Last Update Submit

May 23, 2019

Conditions

Myofascial Pain SyndromeContraction

Keywords

Neuromuscular responsediacutaneous fibrolysis

Outcome Measures

Primary Outcomes (8)

  • Delay time change

    Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).

    4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later

  • Contraction time change

    Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).

    4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later

  • Sustain time change

    time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).

    4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later

  • Relaxation time change

    time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).

    4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later

  • Maximal displacement change

    Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).

    4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later

  • Stiffness change

    Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).

    2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later

  • Elasticity change

    Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).

    2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later

  • Relaxation change

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

    2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later

Secondary Outcomes (1)

  • Gastrocnemious strength change

    8 minutes before the intervention, 1 minute after the intervention and 30 minutes later

Study Arms (2)

Diacutaneous fibrolysis

EXPERIMENTAL
Other: Diacutaneous fibrolysis

Control

NO INTERVENTION

Interventions

Diacutaneous fibrolysisOTHER

Diacutaneous fibrolysis over the gastrocnemious muscles

Diacutaneous fibrolysis

Eligibility Criteria

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

You may not qualify if:

  • Muscle injury in the last two months
  • To not understand the study orders
  • Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Pérez-Bellmunt

Sant Cugat del Vallès, Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

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
Principal investigator

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 28, 2019

Study Start

February 5, 2019

Primary Completion

February 5, 2019

Study Completion

June 5, 2019

Last Updated

May 28, 2019

Record last verified: 2019-02

Locations

ES(1)