Neuromodulation in Professional Dancers

NCT ID: NCT03596216

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-24

Study Completion Date

2018-08-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rehabilitation Sports Physical Therapy Sport Performance Dance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

PENS

Intervention Type OTHER

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.

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

Group Type EXPERIMENTAL

TENS

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Seville

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Blanca de la Cruz Torres

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Blanca De la Cruz Torres, Dr

Role: STUDY_CHAIR

University of Seville

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Blanca de La Cruz Torres

Seville, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

de-la-Cruz-Torres B, Barrera-Garcia-Martin I, Romero-Morales C. Comparative Effects of One-Shot Electrical Stimulation on Performance of the Flexor Hallucis Longus Muscle in Professional Dancers: Percutaneous Versus Transcutaneous? Neuromodulation. 2020 Aug;23(6):865-870. doi: 10.1111/ner.13040. Epub 2019 Aug 25.

Reference Type BACKGROUND
PMID: 31448488 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.