NCT04042012

Brief Summary

This study evaluates if the physiotherapy treatment based on eccentric exercise, ultrasound-guided PNE or a combination of both therapies on chronic soleous injuries may cause changes in pain, functionality, dorsal flexion of the foot, balance and muscle fatigue in dancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

July 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

July 27, 2019

Last Update Submit

October 7, 2020

Conditions

Soleus Injury

Outcome Measures

Primary Outcomes (7)

  • change of pain level

    Visual Analogue Scale (VAS: 0=no pain; 100= pain as bad as can be

    Change from Baseline VAS at 3 months months

  • Change of Lunge Test

    This test measures the ankle range of motion. Less than 9/10 cm, range of motion will be considered restricted

    Change from Baseline lunge test at 3 months months

  • Change of the Releve test

    During the unilateral balance test with open eyes, the participant will be asked to hold as much time as possible in the relay position (raised heel of the floor) on one leg

    Change from Baseline releve test at 3 months months

  • Change of the Endurance test

    The unilateral raised heel test. The dancer should repeatedly lift the heel from the floor to the maximum range of plantar flexion movement as many times as possible.

    Change from Baseline endurance test at 3 months months

  • Change of the Balance test

    The test will be conducted with closed eyes, flat feet and barefoot participants and dancers will perform a retiré position. Participants will maintain the position as long as possible.

    Change from Baseline balance test at 3 months months

  • Changes of the DFOS questionnaire

    This questionnaire measures the pain and function (0= bad; 90=well)

    Change from Baseline DFOS questionnaire at 3 months months

  • Change of the Minimal Detectable Change (MCD)

    The minimal detectable change is defined as a valid change in score that is not due to chance. Minimally clinically important difference (MCID), in comparison, goes beyond valid change to assess meaningful difference in dance function

    Change from after treatment at 3 months months

Study Arms (3)

Eccentric group

EXPERIMENTAL

The dancers of this group wil perform a soleus eccentric exercise

Other: Eccentric exercise

PNE group

EXPERIMENTAL

The dancers of this group will receive a PNE treatment, consisting of the application of galvanic current, by ultrasound. The approach will be performed with a transverse axis with a needle orientation that will depend on the location of the target tissue. The parameters will be 3 mA, 3 seconds, 3 impacts (3: 3: 3). The periodicity will be 1day/7day/21day

Other: PNE

Combined group

EXPERIMENTAL

The dancers of this group will receive a combined treatment and will be carried out in the same way as the other two groups.

Other: Combined

Interventions

Eccentric exerciseOTHER

soleus eccentric exercise

Eccentric group
PNEOTHER

the application of galvanic current

PNE group
CombinedOTHER

soleus eccentric exercise and PNE

Combined group

Eligibility Criteria

Age16 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Over 16 years.
  • at least 5 years of formal dance training.
  • at least 20 hours of training per week.
  • Pain in the back of the leg
  • diagnosis of chronic soleus injury

You may not qualify if:

  • Unsurpassed fear of needles
  • History of adverse reactions to needles
  • Immune system disorder
  • Difficulty expressing your feelings properly
  • Epilepsy and / or allergies to metals.
  • Other lower limbs pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Seville

Seville, 41009, Spain

Location

Related Publications (1)

  • De-la-Cruz-Torres B, Barrera-Garcia-Martin I, Valera-Garrido F, Minaya-Munoz F, Romero-Morales C. Ultrasound-Guided Percutaneous Needle Electrolysis in Dancers with Chronic Soleus Injury: A Randomized Clinical Trial. Evid Based Complement Alternat Med. 2020 Aug 27;2020:4156258. doi: 10.1155/2020/4156258. eCollection 2020.

    PMID: 32908559DERIVED

Study Design

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

Study Record Dates

First Submitted

July 27, 2019

First Posted

August 1, 2019

Study Start

August 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 31, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

ES(1)