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Trial registered on ANZCTR

Registration number

ACTRN12617000794303

Ethics application status

Approved

Date submitted

5/05/2017

Date registered

30/05/2017

Date last updated

20/07/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Neuromodulation percutaneous therapy in young dancers

Scientific title

Inmediate effects of percutaneous electrical stimulation vs therapeutic exercise in flexibility and function Flexor Hallucis Longus Tendon in young dancers

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Flexor Hallucis Longus Tendon inury.

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Percutaneous Electrial Stimulation (PES group). Dancers in this group received the PES by a physiotherapist with 8 years of experience. Specifically, 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). 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

Intervention code [1]

Rehabilitation

Intervention code [2]

Prevention

Comparator / control treatment

Static Stretching Group. Dancers in this group performed static stretching exercise of the FHL muscle. The dancer placed the foot on a step with the maximum possible extension of the MTP joints. Subsequently, she performed maximum dorsiflexion with knee and hip flexion. The position was maintained for 20 seconds and repeated 4 more times. During the 20-second stretching, the therapist supervised the dancers to make sure they did not make any compensation that would alter the stretching position.
Eccentric Group. Dancers in this group performed eccentric exercise of the FHL muscle. The dancer placed the foot the same way as the Stretching Group. The dancer performed 4 sets of flexion-extension 20 repetitions of hip, knee, ankle and first toe.

Control group

Active

Outcomes

Primary outcome [1]

Change in balance, assessed by a single leg balance test.

Timepoint [1]

4 months after interventions

Primary outcome [2]

Change in muscular endurence, assessed by endurance test (heel raise repetitions).

Timepoint [2]

4 months after interventions

Primary outcome [3]

Change in range of motion of first MTF joint, assessed using goniometer.

Timepoint [3]

4 months after interventions

Secondary outcome [1]

None

Timepoint [1]

None

Eligibility

Key inclusion criteria

Inclusion criteria: Female dancers, training at least twenty-five hours per week, pointe training at least five hours per week.

Minimum age

18 Years

Maximum age

30 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

(1) they had sustained an injury to their stance limb in the past year preventing dancing for at least 1 day.; (2) a Personal Psychological Apprehension Scale (PPAS) score >37.5; (3) commonly accepted contraindications to invasive phsyiotherapist technique including chronic joint disease, surgery, prosthesis or osteosynthesis in the area of intervention, cardiac disease, neoplasia, coagulopathy, and use of certain drugs (fluoroquinoles, anticoagulants, corticosteroids or non-steroidal anti-inflammatories); (4) any contraindications to needling per se including unsurmountable fear of needles, history of adverse reaction to needling, immunocompromise, difficulty expressing feelings appropriately and/or allergy to metals; and (5) epilepsy.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

5/06/2017

Actual

10/07/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

24/07/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Spain

State/province [1]

Seville

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Seville

Address [1]

Avicena street, s/n, 41009, Seville, Spain

Country [1]

Spain

Primary sponsor type

University

Name

University of Seville

Address

Avicena street, s/n, 41009, Seville, Spain

Country

Spain

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University Hospital Virgen Macarena-Virgen del Rocio

Ethics committee address [1]

Ethics committee country [1]

Spain

Date submitted for ethics approval [1]

28/03/2017

Approval date [1]

10/07/2017

Ethics approval number [1]

Summary

Brief summary

Introduction. 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 examine the immediate effects of a Stretching exercise, Eccentric exercise and Percutaneous Elecrtrical Stimulation (PES) technique in flexibility and function FHL muscle in young dancers
Method. 45 dancers were recruited for the study, divided randomly into three groups, each comprising 15 dancers: Stretching group, Eccentric group and PES Group. All subjects performed three ballet test, before and after interventions: functional MTP joint extension (range of motion); balanced in unilateral stance heel raised (demi-pointe) and eyes open, until fatigue (balance test); and an unilateral heel raise fatigue test (endurence test). Measurements were taken on each participant´s stance limb.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr BLANCA DE LA CRUZ

Address

Avicena street, s/n, 41009, Seville, Spain
University of Seville

Country

Spain

Phone

+34 666676870

Fax

bcruz@us.es

Contact person for public queries

Name

BLANCA DE LA CRUZ

Address

Avicena street, s/n, 41009, Seville, Spain
University of Seville

Country

Spain

Phone

+34 666676870

Fax

bcruz@us.es

Contact person for scientific queries

Name

BLANCA DE LA CRUZ

Address

Avicena street, s/n, 41009, Seville, Spain
University of Seville

Country

Spain

Phone

+34 666676870

Fax

bcruz@us.es

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Immediate effects of ultrasound-guided percutaneous neuromodulation versus physical exercise on performance of the flexor hallucis longus muscle in professional dancers: a randomised clinical trial	2019	https://doi.org/10.1177/0964528419826103

N.B. These documents automatically identified may not have been verified by the study sponsor.

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