Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000386437
Ethics application status
Approved
Date submitted
4/01/2016
Date registered
23/03/2016
Date last updated
26/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry needling effects on muscle recruitment pattern and motor control in basketball players with functional ankle instability
Scientific title
Dry needling effects on muscle recruitment pattern and motor control in basketball players with functional ankle instability
Secondary ID [1] 288191 0
None
Universal Trial Number (UTN)
U1111-1177-8977
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional ankle instability 297096 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297335 297335 0 0
Physiotherapy
Musculoskeletal 297336 297336 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Deep dry needling on ankle joint stability muscles involves using a needle to reach the target muscle looking for obtaining changes in the muscle recruitment measured in terms of electromyography and outcomes of centre of pressures. The target muscles will be fibularis longus and tibialis anterior muscles. Both of them will be palpated with flat technique and needle will be inserted (a) perpendicular to skin surface in a lateral to medial direction toward the fibula bone for fibularis longus muscle; and (b) whith a slight medial direction toward the tibia for tibialis anterior muscle. The needle will remain for a maximum of 2 minutes while the multiple rapid insertions technique is applied in order to obtain sharp pain, referred pain or local twitch. Treatment will be administered by trained physiotherapists and will be developed in a single 10 minute session, including patient preparation and muscle evaluation before dry needling as well as ischemic compression applied after treatment. Measures will be obtained four times: just before and after the dry needling application, 48 hours and 1 month after intervention.
Intervention code [1] 293822 0
Treatment: Other
Comparator / control treatment
Placebo dry needling involves using a placebo needle which will not penetrate the target muscles. The needle will rest on skin surface above fibularis longus and tibialis anterior muscles for a maximum of 2 minutes pretending to apply multiple rapid insertions techique. Sharp pain, referred pain and local twitch are not expected to occur. Treatment will be administered by trained physiotherapists and will be developed in a single 10 minute session, including patient preparation and muscle evaluation before placebo dry needling as well as ischemic compression applied after treatment. Measures will be obtained four times: just before and after the dry needling application, 48 hours and 1 month after intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 296898 0
Muscle reaction time: the time, in milliseconds, that passes between the stimulus and the start of the response. It will be measured by surface electromyography on fibularis longus and tibialis anterior muscles of the dominant leg.
Timepoint [1] 296898 0
Pre-intervention; inmediately, 48 hours and 1 month post-intervention.
Primary outcome [2] 297245 0
Displacement area of the centre of pressures: total distance traversed by centre of pressure during the unipedal stance test. It will be measured in square millimetres by using a centre of pressures platform.
Timepoint [2] 297245 0
Pre-intervention; inmediately, 48 hours and 1 month post-intervention.
Primary outcome [3] 297246 0
Ankle funtionality: measured by the Functional Ankle Ability Measure (FAAM) Test.
Timepoint [3] 297246 0
Pre-intervention and 1 month after intervention.
Secondary outcome [1] 319644 0
Recruitment pattern: the succesive activation of motor unit action potentials with increasing strenght of voluntary contraction. It will be measured in milliseconds by using surface electromyography.
Timepoint [1] 319644 0
Pre-intervention; inmediately, 48 hours and 1 month post-intervention.
Secondary outcome [2] 320458 0
Displacement velocity of the centre of pressures: the distance traversed by centre of pressures per time unit (millimetres per second) during the unipedal stance test. It is obtained from displacement area and unipedal stance test duration. A centre of pressures platform will be required.
Timepoint [2] 320458 0
Pre-intervention; inmediately, 48 hours and 1 month post-intervention.
Secondary outcome [3] 320459 0
Sway variability: the variability, represented by standard deviation, in displacement area and velocity. A centre of pressures platform will be required.
Timepoint [3] 320459 0
Pre-intervention; inmediately, 48 hours and 1 month post-intervention.

Eligibility
Key inclusion criteria
1. Playing basketball.
2. History of, at least, 1 significant ankle sprain.
a. The first ankle sprain must have occurred at least 12 months before inclusion in the research.
b. It must have provoked signs of inflammation.
c. It must have led to, at least, one day of physical activity loss.
3. History of previous twist ("giving away") episodes, recurrent sprains and / or feeling of ankle joint instability.
a. 2 or more episodes of twist must have taken place in at least 6 months before inclusion in the study.
b. Recurrent ankle sprains involves 2 or more episodes within the same ankle joint.
c. Feeling ankle instability is defined as "the situation because of which during activities of daily living (ADLs) and sport activities the subject perceives that the ankle joint is unstable. This is usually associated with fear of suffering an acute sprain ".
d. It must be confirmed the presence of ankle instability through a self-administered questionnaire (CAIT).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of previous surgeries on musculoskeletal structures in any of the lower extremities.
2. Previous fracture events on any of the lower limbs that required realignment techniques.
3. Suffering from acute musculoskeletal injuries on other joints of the lower limb in the previous three months, responsible for, at least, one day of physical activity loss.
4. Vestibular and neurological disorders .
5. Feeling pain in other areas at the same time of evaluation.

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 a randomisation table from a statistic book. The allocation will be stratified by age and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
For sample size calculation, fibularis longus muscle reaction time was considered as the primary outcome and the software GPower 3.0.18 was employed. An effect size (f) of 0.25 was considered, Assuming 0.5 as the value of correlation among repeated measures, 0.5 as the value of nonsphericity correction (E); and establishing a 0.80 statistic power, alpha level of 0.05 and 2 groups in which 4 measurements will be accomplished, a total of 24 participants were obtained. The follow-up loss was assumed to be about 15%, and a total of 28 participants will be necessary, 14 participants per group.

Data will be organized and analyzed with the Statistical Package for the Social Sciences (SPSS ) version 20.0 for Windows.
Previously to statistical analysis a study of dependent variables normality will be realized in order to determine the type of tests (parametric or non-parametric) to carry out subsequently. For this, the Shapiro- Wilk test will be used. For a value of Sig .
over 0.05, variables will be considered to be distributed normally. For a Sig value of
Sig . less than 0.05 il will be necessary to take into account the sample size to determine whether the assumption of parametric assumptions infringement is tolerable.

The descriptive statistical analysis of data obtained will be expressed with mean and standard deviation (SD) in case variables match normality. Median and interquartile range will be used in case that variables do not match normality. Qualitative variables wil be expressed as absolute frequencies and percentages.

Then, homogeneity / initial contrast of the two observed groups will be checked on sex, age and pretest results of the dependent variables. In the case of sex variable, homogeneity will be checked using the Pearson's Chi -squared test. After that, either Mann-Whitney U test, Student T test or Welch's T test will be realized for age.

Finally an analysis of the contrast between the values obtained in the pre versus post test values as well as contrast between groups will be developed by using Wilcoxon signed-rank test or paired-samples T test.

All statistical data will consider a confidence interval (CI) of 95 %.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/03/2016
Actual
28/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 7474 0
Spain
State/province [1] 7474 0
Madrid

Funding & Sponsors
Funding source category [1] 292585 0
University
Name [1] 292585 0
Universidad de Alcala
Country [1] 292585 0
Spain
Primary sponsor type
University
Name
Universidad de Alcala
Address
Campus Cientifico-Tecnologico: Carretera de Madrid-Barcelona, Km: 33.600. Alcala de Henares.
Country
Spain
Secondary sponsor category [1] 291308 0
None
Name [1] 291308 0
Address [1] 291308 0
Country [1] 291308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294070 0
Comite de etica de la Investigacion y de Experimentacion animal de la Universidad de Alcala
Ethics committee address [1] 294070 0
Ethics committee country [1] 294070 0
Spain
Date submitted for ethics approval [1] 294070 0
07/07/2015
Approval date [1] 294070 0
22/07/2015
Ethics approval number [1] 294070 0
CEIM/HU/2015/28

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 676 676 0 0
/AnzctrAttachments/369813-Informe_CEIM_HU_2015_28.pdf

Contacts
Principal investigator
Name 62310 0
Mrs Jenny Patricia Solano Quiroga
Address 62310 0
Maria Escribano Fisioterapia: 51 Juan Laso St, El Casar, 19170 (Guadalajara)
Country 62310 0
Spain
Phone 62310 0
+34666691146
Fax 62310 0
Email 62310 0
[email protected]
Contact person for public queries
Name 62311 0
Jenny Patricia Solano Quiroga
Address 62311 0
Maria Escribano Fisioterapia: 51 Juan Laso St, El Casar, 19170 (Guadalajara)
Country 62311 0
Spain
Phone 62311 0
+34666691146
Fax 62311 0
Email 62311 0
[email protected]
Contact person for scientific queries
Name 62312 0
Jenny Patricia Solano Quiroga
Address 62312 0
Maria Escribano Fisioterapia: 51 Juan Laso St, El Casar, 19170 (Guadalajara)
Country 62312 0
Spain
Phone 62312 0
+34666691146
Fax 62312 0
Email 62312 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
EmbaseEffects of dry needling on neuromuscular control of ankle stabilizer muscles and center of pressure displacement in basketball players with chronic ankle instability: A single-blinded randomized controlled trial.2021https://dx.doi.org/10.3390/ijerph18042092
N.B. These documents automatically identified may not have been verified by the study sponsor.