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Trial registered on ANZCTR


Registration number
ACTRN12617000887370
Ethics application status
Approved
Date submitted
14/05/2017
Date registered
16/06/2017
Date last updated
8/02/2021
Date data sharing statement initially provided
8/02/2021
Date results provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Crossover effects of ultrasound-guided percutaneous neuromodulation on contralateral hamstring flexibility.
Scientific title
Immediate Bilateral Effects of Percutaneous Neuromodulation Therapy on Hamstring Flexibility in Subjects with Short Hamstring Syndrome
Secondary ID [1] 291868 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Short Hamstring Syndrome 303154 0
Hamstring Flexibility 303155 0
Condition category
Condition code
Musculoskeletal 302600 302600 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 different groups receiving one of each treatment:
1. Percutaneous Electrical Stimulation (PES group). Subjects in the PES Group received the PES thecnique in the perineurium of the sciatic nerve. 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 his feet outside the table. The sciatic nerve was located at 50% of the distance between the greater trochanter and interlinear articular knee 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 perineurium of sciatic nerve. Prior to inserting a needle, the underlying skin was cleaned with isopropyl alcohol. The intensity of the current was necessary to cause an exacerbated muscle contraction, according to the Valera and Minaya protocol´s: once-off 1.5 mins session, current was applied every 4 times cycle for 20 s.
The intervention will be performed in the department of Physicaltherapy in the University of Seville by a sports physiotherapist with an experience of more than 5 years.
2. Passive Stretching Technique. Subjects in the Stretching group received passive stretching of the hamstring muscles in their dominant leg. While lying supine, a researcher who was blinded to SLR test measures would passively position the subject into the SLR position (hip in flexion, knee in extension, and ankle in neutral) without pain/discomfort to the point where resistance to movement was first noted. This position was then maintained for 20 seconds and repeated further 4 times. During the 20 second stretches, the therapist monitored the subjects to ensure they did not make any compensation that could modify the stretching position. Each subject had a total of 1.5 minutes of stretching on their lower extremity.
3. Neurodynamic Sliding Technique. Subjects in the Neurodynamic group received sciatic neurodynamic sliders, performed in supine. The objective of the technique is to produce a sliding movement of neural (sciatic) structures relative to their adjacent tissues . Sliders involve the application of movement/stress to the nervous system proximally while releasing movement/stress distally and then reversing the sequence. Recent research has shown that sliders actually result in greater excursion than simply stretching the nerve. Subjects were supine with their neck and thoracic spine supported in a forward flexed position. Concurrent hip and knee flexion were alternated dynamically with concurrent hip and knee extension. The therapist alternated the combination of movement depending on the tissue resistance level. This combination of movements was performed for 1.5 minutes on their dominant lower extremity.
Intervention code [1] 297985 0
Prevention
Intervention code [2] 297986 0
Rehabilitation
Intervention code [3] 298175 0
Treatment: Other
Comparator / control treatment
Mechanical Stimulation (Needle group). Subjects in the Needle Group received mechanical stimulation in the perineurium of the sciatic nerve through a needle. The sciatic nerve was located at 50% of the distance between the greater trochanter and interlinear articular knee 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 perineurium of sciatic nerve. Prior to inserting a neddle, the underlying skin was cleaned with isopropyl alcohol. This intervention was performed during 1.5 min.
Every interventions will be performed in the department of Physicaltherapy in the University of Seville by a sports physiotherapist with an experience of more than 5 years.
Control group
Active

Outcomes
Primary outcome [1] 302012 0
The range of hip motion, assessed by passive straight leg raise test (SLR)
Timepoint [1] 302012 0
Baseline and after intervention
Secondary outcome [1] 334514 0
muscular activity assessed by tensiomyography
Timepoint [1] 334514 0
Baseline and after intervention

Eligibility
Key inclusion criteria
Young people, SLR test<=70 degree
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were hamstring injury within the past year, a Personal Psychological Apprehension Scale (PPAS) score >37.5, verbal report of performing regular lower extremity muscle stretching exercises, history of neck trauma (whiplash), neck symptoms, history of fracture in any part of the body, history of growth disorders, history of neurological or orthopedic disorders, diagnosis of herniated disk, low back pain in the last 6 months, and body mass index (BMI) lower than 20 Kg/cm2 or higher than 30 Kg/cm2, 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), 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 epilepsy

Study design
Purpose of the study
Treatment
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)
Simple randomisation using dice-rolling
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2017
Actual
26/06/2017
Date of last participant enrolment
Anticipated
28/07/2017
Actual
28/07/2017
Date of last data collection
Anticipated
28/07/2017
Actual
28/07/2017
Sample size
Target
120
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 8878 0
Spain
State/province [1] 8878 0
Seville

Funding & Sponsors
Funding source category [1] 296368 0
University
Name [1] 296368 0
University of Seville
Country [1] 296368 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Avicena street, s/n, 41009, Seville, Spain
Country
Spain
Secondary sponsor category [1] 295311 0
None
Name [1] 295311 0
None
Address [1] 295311 0
None
Country [1] 295311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297606 0
University Hospital Virgen Macarena-Virgen del Rocio.
Ethics committee address [1] 297606 0
Ethics committee country [1] 297606 0
Spain
Date submitted for ethics approval [1] 297606 0
02/02/2017
Approval date [1] 297606 0
12/05/2017
Ethics approval number [1] 297606 0

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

Contacts
Principal investigator
Name 74566 0
Dr Blanca De la Cruz Torres
Address 74566 0
Avicena street, s/n, 41009, Seville, Spain
Department of Physical Therapy
University of Seville
Country 74566 0
Spain
Phone 74566 0
+34 666676870
Fax 74566 0
Email 74566 0
[email protected]
Contact person for public queries
Name 74567 0
Blanca De la Cruz Torres
Address 74567 0
Avicena street, s/n, 41009, Seville, Spain
Department of Physical Therapy
University of Seville
Country 74567 0
Spain
Phone 74567 0
+34 666676870
Fax 74567 0
Email 74567 0
[email protected]
Contact person for scientific queries
Name 74568 0
Blanca De la Cruz Torres
Address 74568 0
Avicena street, s/n, 41009, Seville, Spain
Department of Physical Therapy
University of Seville
Country 74568 0
Spain
Phone 74568 0
+34 666676870
Fax 74568 0
Email 74568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.