Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000228482
Ethics application status
Approved
Date submitted
22/01/2025
Date registered
28/03/2025
Date last updated
28/03/2025
Date data sharing statement initially provided
28/03/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry Needling for Glenohumeral Internal Rotation Deficit syndrome
Scientific title
Short term effects of Dry Needling on infraspinatus on throwing sports athlete with Glenohumeral Internal Rotation Deficit syndrome
Secondary ID [1] 313785 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glenohumeral Internal Rotation Deficit syndrome 336416 0
Condition category
Condition code
Musculoskeletal 332938 332938 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dry needling in the infraspinatus muscle with a 0.30×40 mm needle inserted perpendicular to the scapula, applying the Hong technique, involving rapid entry and exit during 1-2 minutes, aiming to provoke four spasms.

This technique will be performed two days by a kinesiotherapist, separated by one week.
Intervention code [1] 330373 0
Rehabilitation
Comparator / control treatment
Sham needling in the infraspinatus muscle, without penetrating the myofascial trigger point, over a period of 1 minute.
This technique will be performed two days by a kinesiotherapist, separated by one week.
Control group
Placebo

Outcomes
Primary outcome [1] 340471 0
Total rotation range of motion of the shoulder
Timepoint [1] 340471 0
Baseline (T0), before the second intervention (T1, day 8 post-baseline), and after the final intervention (T2, day 15 post-baseline).
Secondary outcome [1] 444189 0
Pain intensity at digital compression at the infraspinatus muscle
Timepoint [1] 444189 0
Baseline (T0), before the second intervention (T1, day 8 post-baseline), and after the final intervention (T2, day 15 post-baseline).

Eligibility
Key inclusion criteria
Handball and volleyball players (male or female) aged 18–35 years with a diagnosis of pathological Glenohumeral Internal Rotation Deficit (confirmed by two expert physiotherapists), engaged in a minimum of two training sessions per week and one competitive game.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Needle phobia (belonephobia), history of surgery in the affected area, presence of other injuries or systemic diseases, cardiovascular conditions, pregnancy, or inability to attend all treatment sessions.

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
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
Statistical methods / analysis
A two-way ANOVA will be perfomed to evaluate the efficacy of the intervention

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
6/05/2025
Actual
Date of last data collection
Anticipated
14/05/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26840 0
Spain
State/province [1] 26840 0

Funding & Sponsors
Funding source category [1] 318251 0
Self funded/Unfunded
Name [1] 318251 0
Country [1] 318251 0
Primary sponsor type
Individual
Name
Guillermo García-Pérez-de-Sevilla- Universidad Europea de Madrid
Address
Country
Spain
Secondary sponsor category [1] 320637 0
None
Name [1] 320637 0
Address [1] 320637 0
Country [1] 320637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316892 0
Hospital de Getafe Ethical Committee
Ethics committee address [1] 316892 0
Ethics committee country [1] 316892 0
Spain
Date submitted for ethics approval [1] 316892 0
04/12/2023
Approval date [1] 316892 0
29/02/2024
Ethics approval number [1] 316892 0
Registration Number: CEIm24/40

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

Contacts
Principal investigator
Name 139338 0
Dr Guillermo García-Pérez-de-Sevilla
Address 139338 0
Universidad Europea de Madrid, Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139338 0
Spain
Phone 139338 0
+34629207357
Fax 139338 0
Email 139338 0
[email protected]
Contact person for public queries
Name 139339 0
Guillermo García-Pérez-de-Sevilla
Address 139339 0
Universidad Europea de Madrid, Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139339 0
Spain
Phone 139339 0
+34629207357
Fax 139339 0
Email 139339 0
[email protected]
Contact person for scientific queries
Name 139340 0
Guillermo García-Pérez-de-Sevilla
Address 139340 0
Universidad Europea de Madrid, Calle Tajo s/n 28670 Villaviciosa de Odón
Country 139340 0
Spain
Phone 139340 0
+34629207357
Fax 139340 0
Email 139340 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.