Neuromodulation in Professional Dancers

November 2, 2019 updated by: Blanca de la Cruz Torres, University of Seville

One-Shot Percutaneous Electrical Nerve Stimulation vs. Transcutaneous Electrical Nerve Stimulation for Performance Flexor Hallucis Longus Muscle in Professional Dancers

Tendinopathy of the flexor hallucis longus (FHL), colloquially referred to as "dancer's tendinitis," is a common condition in dancers and attributed to high demand on this muscle in positions of extreme ankle plantarflexion and metatarsophalangeal (MTP) flexion and extension. Tradicional conservative treatment includes rest from pain-inducing activities including pointe work and jumping, physical therapy a focusing on movilization of the joints of the first ray and subtalar joint, and antiinflamatory medications. Unfortunately, dancer frecuently do not follow recommendations to rest due to the competitive nature of the field. Those who do not respond to conservative treatment undergo more serious interventions including steroid injections or surgery, each with additional risks and recovery time. To develop experimental protocols aimed at prevention and nonsurgical interventions are needed. Therefore, the aim of this study was To investigate the effects of one shot of low-frequency percutaneous electrical nerve stimulation (PENS) vs. one shot of transcutaneous electrical nerve stimulation (TENS) in performance of the Flexor Hallucis Longus muscle in young dancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41010
        • Blanca de La Cruz Torres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female dancers
  • Training at least twenty-five hours per week
  • Pointe training at least five hours per week.

Exclusion Criteria:

  • They had sustained an injury to their stance limb in the past year preventing dancing for at least 1 day
  • Personal Psychological Apprehension Scale (PPAS) score >37.5
  • Commonly accepted contraindications to invasive phsyiotherapist technique
  • Any contraindications to needling per se.
  • Commonly accepted contraindications to electrotherapy
  • Epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous Electrial Stimulation (PES group).

This intervention consisted in the application of an asymmetric biphasic rectangular current. The subject lay prone with her feet outside the table. The FHL muscle was located at 50% of the distance between the fibular head and inferior border of the lateral malleolus on the posterior aspect of the fibular by ultrasound machine (cross-section) (Logiq, GE Healthcare, USA) and then, a needle (0.30mm x 0.40mm) was inserted, perpendicular to the surface of the skin, until the muscle belly. Prior to inserting a neddle, the underlying skin was cleaned with isopropyl alcohol. The intensity of the current was necessary to cause an exacerbated muscle contraction, during 1.5 min acording to the Valera and Minaya protocol´s.

This intervention was performed once in each participant, on one leg only (stance limb), It's only once, it was not a treatment
Other: PENS
This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is an invasive intervention by ultrasound and needles.
Experimental: Transcutaneous Electrial Stimulation (TENS group)

This intervention consisted in the application of an asymmetric biphasic rectangular current. The subject lay prone with her feet outside the table. The FHL muscle was located at 50% of the distance between the fibular head and inferior border of the lateral malleolus on the posterior aspect of the fibular by ultrasound machine (cross-section) (Logiq, GE Healthcare, USA),and then, one self-adhesive electrode was placed on the back of the leg and the other on the sole of the foot. The intensity of the current was necessary to cause an exacerbated muscle contraction, during 1.5 min.

This intervention was performed once in each participant, on one leg only (stance limb), It's only once, it was not a treatment
Other: TENS
This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is a non-invasive intervention by self-adhesive electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in balance
Time Frame: 1 day
Assessed by a single leg balance test
1 day
Change in muscular endurence,
Time Frame: 1 day
Assessed by endurance test (heel raise repetitions).
1 day
Change in range of motion of first MTF joint
Time Frame: 1 day
Assessed using goniometer.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Study Chair: Blanca De la Cruz Torres, Dr, University of Seville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Actual)

July 24, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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