Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001286730p
Ethics application status
Submitted, not yet approved
Date submitted
23/11/2020
Date registered
4/10/2022
Date last updated
4/10/2022
Date data sharing statement initially provided
4/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of c4 and sleeper stretch manipulation on glenohumeral internal rotation déficit (GIRD) and pain in the long portion of the bíceps brachii.
Scientific title
Effects of c4 and sleeper stretch manipulation on glenohumeral internal rotation deficit (GIRD) and pain in the long portion of the biceps brachii in badminton players
Secondary ID [1] 302810 0
none
Universal Trial Number (UTN)
U1111-1261-0012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glenohumeral internal rotation deficit (GIRD) 319817 0
Pain in the long portion of the Biceps Brachii. 319818 0
Condition category
Condition code
Musculoskeletal 317749 317749 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In our Research project we will include:

- Experimental group 1 (G1) will be made up of 25 patients (n = 25) who will undergo the manipulation technique of the 4th cervical vertebra.
- Experimental group 2 (G2) will be made up of 25 patients (n = 25) who will undergo the sleeper stretch technique.
- Experimental group 3 (G3) will be made up of 25 patients (n = 25) who will undergo the manipulation technique of the 4th cervical vertebra and sleeper stretch.
The subjects will be in the groups at random. The randomization method that will be used in the research project is by means of a simple random sampling, for this we will use the SPSS computer program.
The maneuvers to be carried out are: One of them will be the C4 manipulation technique for the subjects belonging to experimental group 1 and 3 together with the sleeper stretch technique that will be performed on experimental group 2 and 3.
A structured notebook will be made to collect information of interest for the study in badminton players, which includes sociodemographic and technical data, as well as physical and ultrasound examination of the dominant shoulder.
A doctor will carry out the physical and ultrasound examination of the different badminton players
The doctor will carry out a new measurement of the internal rotation, as well as the external rotation of the dominant shoulder of each of the players.
For this, a standard plastic goniometer will be used, with a numerical scale where the degrees are increased from 1 to 1.
Pain pressure thresholds will be measured using an electronic algometer, which is used by exerting perpendicular pressure on the muscle fiber.
The measurement with an algometer will be made in the anterior region of the muscle mass of the long head of the biceps brachii, just midway between the shoulder and the elbow. The total number of measurements to be carried out in each patient to see the pain pressure thresholds with an algometer in the PLB will be 3 measurements with a time of 30 seconds between each measurement, using the average of the three results as the value.
The doctor will carry out two post-intervention evaluations, on the first evaluation day and 15 days later, immediately after the player has been manipulated and sleeper stretch."
C4 manipulation technique:
- Patient position: supine position.
- Position of the therapist: Standing at the head of the patient, although a little deviated at the ipsilateral level of the vertebra to be treated, both legs parallel and semiflexed. The center of gravity must be vertical to the lesion to be treated.
- Contacts: The cranial hand is placed by the radial border of the joint distal interphalangeal joint of the index finger at the articular process of C4. the other hand controls the vertebra from the other side and the patient's head.
- Parameters: The cervical spine is in neutral flexoextension, ipsilateral lateroflexion and contralateral rotation.
- Execution: We ask the patient to inspire, and at the end of expiration, the Therapist increases the tension in rotation with both hands and the impulse is performed to manipulate.
Intervention code [1] 319123 0
Treatment: Other
Comparator / control treatment
- Experimental group 1 (G1). manipulation technique of the 4th cervical vertebra.
Control group
Active

Outcomes
Primary outcome [1] 332579 0
The primary outcome is gain in joint range of the glenohumeral joint
Timepoint [1] 332579 0
The doctor will perform the assessment just after performing the manipulation and after the study participants have performed the sleeper stretch exercises for 4 weeks.
Primary outcome [2] 332580 0
pain in the long head of the biceps brachii.
Timepoint [2] 332580 0
The doctor will perform the assessment just after performing the manipulation and after the study participants have performed the sleeper stretch exercises for 4 weeks.
Secondary outcome [1] 413795 0
'joint range' evaluated by goniometer in the first assessment just after performing the manipulation and sleeper stretch.
Timepoint [1] 413795 0
The doctor will carry out the assessment just after having performed the manipulation and stretching of the sleeper on the player in the first assessment.

Eligibility
Key inclusion criteria
o Over 15 years old
o Federated badminton players
o Not having any contraindication for the performance of manipulative techniques
o GIRD presenter. The acronym GIRD refers to the deficit of internal rotation of the glenohumeral joint. To perform the test, the player will lie supine, with a 90º elbow flexion in a neutral position and a 90º horizontal abduction.
The examiner will stabilize the scapula of the shoulder to be explored by applying pressure on the table. Next, the maximum passive external rotation (90º) will be evaluated and then the internal rotation (90º). Following what is agreed in the Consensus of the Pathology of the Shoulder of the pitcher, the player will be considered to have a GIRD when the difference is equal to or greater than 18o in relation to the contralateral.
o Tenosynovitis in the long head of the biceps. The presence of fluid in the tendon sheath of PLB is assessed in the axial axis, considering it positive if the measurement of the anechoic region is greater than 2 mm.
o Hypertrophy of the posterior capsule. A thickening of the posterior capsule has been observed due to the stress overload that it suffers repeatedly, generating a kind of scar tissue
o Anterior Glenohumeral Instability. Anterior shoulder instability is one of the most prevalent pathologies among casts due to the range of motion they perform, which makes them acquire extreme external rotation positions that predispose to instability. The contracture of the posterior capsule, typical of pitchers, also predisposes to an anterior translation.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
o Who have undergone surgery on the shoulder to be evaluated
o That they have been treated in the three months prior to the study
o Taking drugs that may alter the symptoms or results
o That they did not accept participation in the study
o Present contraindications to treatment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We do not know of any studies carried out in badminton players evaluating the rotations and total joint balance of the glenohumeral joint, which is why it is of interest for this study.
But the shoulder studies analyzed in preparation make us think that with a sample of 75 participants we will get the information we need.
The study that we are going to carry out is feasible since we have the necessary means, resources and knowledge to carry it out. For this we will use a goniometer, algometer and ultrasound machine. We will also be able to bring together the patients who are the object of the study through the Andalusian Badminton Federation, the Spanish Badminton Federation and different clubs of the National Badminton League, as well as the collaboration of other healthcare colleagues to carry out the study.
The subjects will be in the groups at random. The randomization method that will be used in the research project is by means of a simple random sampling, for this we will use the SPSS computer program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 23113 0
Spain
State/province [1] 23113 0
Sevilla

Funding & Sponsors
Funding source category [1] 307236 0
Other
Name [1] 307236 0
International Sports Medicine Clinic (ISMEC)
Country [1] 307236 0
Spain
Primary sponsor type
Other
Name
Salud Sport Club
Address
SAN JOSE 11
41300 San José de la Rinconada
SPAIN
Country
Spain
Secondary sponsor category [1] 307841 0
Other
Name [1] 307841 0
Patronato Deportes La Rinconada
Address [1] 307841 0
CALLE JARDIN DE LAS DELICIAS S/N
41300 SAN JOSE DE LA RINCONADA
SPAIN
Country [1] 307841 0
Spain

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308981 0
COMITE ETICO DE LA JUNTA DE ANDALUCIA
Ethics committee address [1] 308981 0
Ethics committee country [1] 308981 0
Spain
Date submitted for ethics approval [1] 308981 0
29/07/2021
Approval date [1] 308981 0
Ethics approval number [1] 308981 0

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

Contacts
Principal investigator
Name 106866 0
Mr Rafael Fernandez Arteaga
Address 106866 0
Rafael Fernández Arteaga
Ismec
calle Arjona 10
41001 Sevilla
Country 106866 0
Spain
Phone 106866 0
+34 627 93 73 41
Fax 106866 0
Email 106866 0
[email protected]
Contact person for public queries
Name 106867 0
Rafael Fernandez Arteaga
Address 106867 0
Rafael Fernández Arteaga
Ismec
calle Arjona 10
41001 Sevilla
Country 106867 0
Spain
Phone 106867 0
+34 627 93 73 41
Fax 106867 0
Email 106867 0
[email protected]
Contact person for scientific queries
Name 106868 0
Rafael Fernandez Arteaga
Address 106868 0
Rafael Fernández Arteaga
Ismec
calle Arjona 10
41001 Sevilla
Country 106868 0
Spain
Phone 106868 0
+34 627 93 73 41
Fax 106868 0
Email 106868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the documents that allow ethics and that are used for this study will be shared
all of the individual participant data collected during the trial will be shared
When will data be available (start and end dates)?
the data will be available from the publication of the study with no specific end date.
Available to whom?
available to the entire scientific community
Available for what types of analyses?
There is no specific type for which they will be available
How or where can data be obtained?
can be obtained by contacting the principal investigator
[email protected]
+34 627 93 73 41


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.