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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03596216
Other study ID # NM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 24, 2018
Est. completion date August 17, 2018

Study information

Verified date November 2019
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 17, 2018
Est. primary completion date July 24, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Spain Blanca de La Cruz Torres Seville

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (1)

de-la-Cruz-Torres B, Barrera-García-Martín 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. 2019 Aug 25. doi: 10.1111/ner.13040. [Epub ahead of print] — View Citation

Outcome

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