NCT05030896

Brief Summary

This study evaluates if the physiotherapy treatment based on combination of therapeutic exercise program and ultrasound-guided PNE on chronic soleous injuries may cause changes in pain, dorsal flexion of the ankle and muscle fatigue in female dance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

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

August 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

August 20, 2021

Last Update Submit

November 29, 2021

Conditions

Injury;Sports

Outcome Measures

Primary Outcomes (2)

  • Pain at palpation

    measured by numeric rate scale (0 no pain; 10 worst pain)

    From baseline measurement up to one month

  • Pain at stretch

    measured by numeric rate scale (0 no pain; 10 worst pain)

    From baseline measurement up to one month

Secondary Outcomes (2)

  • ankle dorsiflexion

    From baseline measurement up to one month

  • muscle fatigue

    From baseline measurement up to one month

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will receive EPM and they will perform exercise program during 1 month.

Other: Invasive treatment and exercise therapy

Control group

EXPERIMENTAL

Participants will receive needling puncture and they will perform exercise program during 1 month.

Other: Invasive treatment and exercise therapy

Interventions

Invasive treatment and exercise therapyOTHER

The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture

Control groupExperimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • older than 18 years
  • having a soleus muscle injury
  • chronic injury (\> 3 meses)
  • pain at stretch \> 3 points measured by NRS

You may not qualify if:

  • belenophobia
  • other accuse injury
  • lumbar back pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Seville

Seville, Spain

Location

MeSH Terms

Conditions

Athletic Injuries

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

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

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 1, 2021

Study Start

September 2, 2021

Primary Completion

November 1, 2021

Study Completion

November 30, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Locations

ES(1)