NCT03596216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

Same day

First QC Date

July 11, 2018

Last Update Submit

November 2, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in balance

    Assessed by a single leg balance test

    1 day

  • Change in muscular endurence,

    Assessed by endurance test (heel raise repetitions).

    1 day

  • Change in range of motion of first MTF joint

    Assessed using goniometer.

    1 day

Study Arms (2)

Percutaneous Electrial Stimulation (PES group).

EXPERIMENTAL

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

Transcutaneous Electrial Stimulation (TENS group)

EXPERIMENTAL

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

Interventions

PENSOTHER

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.

Percutaneous Electrial Stimulation (PES group).
TENSOTHER

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.

Transcutaneous Electrial Stimulation (TENS group)

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blanca de La Cruz Torres

Seville, 41010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 31448488BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Blanca De la Cruz Torres, Dr

    University of Seville

    STUDY CHAIR

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
Doctor

Study Record Dates

First Submitted

July 11, 2018

First Posted

July 23, 2018

Study Start

July 24, 2018

Primary Completion

July 24, 2018

Study Completion

August 17, 2018

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations