Trial Review

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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] 291866 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Flexor Hallucis Longus Tendon inury. 303150 0
Condition category
Condition code
Musculoskeletal 302599 302599 0 0
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] 297983 0
Rehabilitation
Intervention code [2] 297984 0
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] 302010 0
Change in balance, assessed by a single leg balance test.
Timepoint [1] 302010 0
4 months after interventions
Primary outcome [2] 302096 0
Change in muscular endurence, assessed by endurance test (heel raise repetitions).
Timepoint [2] 302096 0
4 months after interventions
Primary outcome [3] 302295 0
Change in range of motion of first MTF joint, assessed using goniometer.
Timepoint [3] 302295 0
4 months after interventions
Secondary outcome [1] 334513 0
None
Timepoint [1] 334513 0
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
61
Accrual to date
41
Final
Recruitment outside Australia
Country [1] 8877 0
Spain
State/province [1] 8877 0
Seville

Funding & Sponsors
Funding source category [1] 296367 0
University
Name [1] 296367 0
University of Seville
Country [1] 296367 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Avicena street, s/n, 41009, Seville, Spain
Country
Spain
Secondary sponsor category [1] 295402 0
None
Name [1] 295402 0
None
Address [1] 295402 0
None
Country [1] 295402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297605 0
University Hospital Virgen Macarena-Virgen del Rocio
Ethics committee address [1] 297605 0
Ethics committee country [1] 297605 0
Spain
Date submitted for ethics approval [1] 297605 0
28/03/2017
Approval date [1] 297605 0
10/07/2017
Ethics approval number [1] 297605 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74562 0
Dr BLANCA DE LA CRUZ
Address 74562 0
Avicena street, s/n, 41009, Seville, Spain
University of Seville
Country 74562 0
Spain
Phone 74562 0
+34 666676870
Fax 74562 0
Email 74562 0
[email protected]
Contact person for public queries
Name 74563 0
BLANCA DE LA CRUZ
Address 74563 0
Avicena street, s/n, 41009, Seville, Spain
University of Seville
Country 74563 0
Spain
Phone 74563 0
+34 666676870
Fax 74563 0
Email 74563 0
[email protected]
Contact person for scientific queries
Name 74564 0
BLANCA DE LA CRUZ
Address 74564 0
Avicena street, s/n, 41009, Seville, Spain
University of Seville
Country 74564 0
Spain
Phone 74564 0
+34 666676870
Fax 74564 0
Email 74564 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIImmediate effects of ultrasound-guided percutaneous neuromodulation versus physical exercise on performance of the flexor hallucis longus muscle in professional dancers: a randomised clinical trial2019https://doi.org/10.1177/0964528419826103
N.B. These documents automatically identified may not have been verified by the study sponsor.