Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001122448
Ethics application status
Approved
Date submitted
30/05/2016
Date registered
18/08/2016
Date last updated
28/02/2023
Date data sharing statement initially provided
24/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a stretching program on shoulder pain and flexibility
Scientific title
Effects of a stretching program on anterior humeral head translation and acromio humeral distance: A Randomised Controlled Trial
Secondary ID [1] 289270 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 298853 0
shoulder flexibility 298854 0
Condition category
Condition code
Musculoskeletal 298921 298921 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298922 298922 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This particular study will require the participants to perform one of two stretches on the dominant side over a 3 weeks period . Participants will be taught the correct technique for performing the stretches by the investigator carrying out the measures. They will be instructed to hold the stretch for 30 seconds for 5 repetitions each session. Following this the therapist will inspect the performance of the stretch and ensure a correct technique .The stretch will be able to be performed on the floor,yoga mat or carpet /rug. Participants will be given an information sheet with instructions and pictures of the stretch and told to contact the researcher if they have any questions about the stretch during the study. Stretching is to be performed twice a day and it is recommended that this occur once in the morning and once in the evening before bed. Participants in both groups will be instructed to perform their respective stretches both morning and night, 7 days a week for 3 weeks. Before starting the stretch it is recommended to do some gentle warm up movements of the shoulder such as large slow circles of the arms.
The participant should perform 5 repetitions of the stretch in the morning and 5 repetitions in the afternoon.
1. Modified sleeper stretch - the participant should be lying on a firm surface (floor with yoga mat, carpet) on their dominant side, With their trunk rotated slightly backwards. Using the non-dominant arm, the participant gently should pull the forearm down to the floor until they feel the stretch at the back of their shoulder. The participant should not feel any pain with the stretch.
2. The participant positions him/her self in sitting with feet flat on the floor. He/she raises the dominant arm to 90 degrees of forward flexion. Using the non-dominant arm the participant pulls the throwing arm across the body towards the opposite shoulder as shown in the photo in the Instruction sheet. The stretch should be felt across the back of the shoulder.
Participants will be required to fill in a diary recording completion of the stretching program in the morning and at night. It will be made clear to the participants that accurate recollection is essential to the study and there will be no consequences for a lack of adherence to the stretching program.
Intervention code [1] 294819 0
Rehabilitation
Comparator / control treatment
There is no control treatment
This trial is a comparison between two interventions described above
Control group
Active

Outcomes
Primary outcome [1] 298434 0
Measure of acromio-humeral distance with diagnostic ultrasound.

The participant will be seated and the ultrasound head placed on the anterior aspect of the shoulder in anterior -posterior direction ( Refer to Mc Creesh et al 2016)
Timepoint [1] 298434 0
All pre-measures - post screening and acceptance into the study and prior to teaching/demonstration of stretch
Post-measures - 3 weeks post stretch programme
Secondary outcome [1] 324124 0
ROM glenohumeral internal rotation (IR) at 90 degrees shoulder abduction.
The participant is positioned supine with dominant upper arm positioned at 90 degrees of abduction resting on the bed. A small folded towel will be placed under the upper arm to ensure the arm is level with the shoulder - not extended.
A digital inclinometer will be used to measure range of internal rotation (IR) of the dominant shoulder. This will be placed on the participant's forearm at the level of the lateral epicondyle. It will be held in place by a small piece of tape. an initial reading will be recorded.
Commencing at the mid point of IR/ER ( designated 90 degrees to the total range of IR will be measured.
The investigator will palpate the humeral head with one finger and the other finger will be placed on the coracoid process of the scapula. This point is considered to be the point when the scapula starts to move with the humeral head (i.e. the limit of glenohumeral IR. This measure will be repeated three(3) times and the range on the inclinometer recorded by an assistant

The other side will then be tested in the same manner.
Timepoint [1] 324124 0
Pre-measures - post-screening and acceptance into the study /pre teaching/demonstration of stretch
Post-measures at the end of the three (3) weeks stretching programme
Secondary outcome [2] 324125 0
Measure of shoulder horizontal adduction.
The participant will be seated with feet flat on the floor .He/she will be asked to lift the dominant arm to 90 degrees of flexion and then move the arm across their chest as far as possible to the point of a feeling of stretch in the posterior aspect of their shoulder. This range will be measured with a universal goniometer placed on the superior aspect of the shoulder with the movable arm aligned along the arm. This measure will be repeated three(3) times.
The other arm will then be tested for comparison
Timepoint [2] 324125 0
Pre- measures- Post screening and acceptance into the study /pre-teaching/demonstration of stretch.
Post-measures -at the end of the three (3) weeks stretching programme

Eligibility
Key inclusion criteria
- Sex: males and females
- Ages: 18-35
- Population: overhead throwing athletes: cricketers, baseballers, tennis players, volleyballers
- Minimum 2 hours overhead throwing per week
- Posterior shoulder tightness identified through:
- Greater than 10 degrees asymmetry between the dominant arm and non- dominant arm in shoulder internal rotation
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Undergoing current treatment for shoulder pain
- Intending to seek treatment for shoulder pain in the next 3 weeks
- Previous shoulder injury in the last 3 months
- Shoulder surgery in the last 6 months
- Shoulder dislocation/ recurrent dislocation
- Cervical spine pain or disorders
- Previous recent history of fracture to the humerus

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)
Participants will be randomly allocated into their group using numbered, sealed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA.
A sample size of 22 participants in each group will provide the power to detect a 1 standard deviation effect size in (the outcome) between the groups. This power calculation is based on a superiority design and a continuous outcome variable (power=90%, significance 5%)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/08/2016
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
22
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 13289 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 293679 0
University
Name [1] 293679 0
Australian Catholic University
Country [1] 293679 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road Banyo Brisbane Qld 4014
Country
Australia
Secondary sponsor category [1] 292512 0
None
Name [1] 292512 0
Address [1] 292512 0
Country [1] 292512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295119 0
Australian Catholic University Ethics Committee
Ethics committee address [1] 295119 0
Ethics committee country [1] 295119 0
Australia
Date submitted for ethics approval [1] 295119 0
16/05/2016
Approval date [1] 295119 0
23/06/2016
Ethics approval number [1] 295119 0

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

Contacts
Principal investigator
Name 66078 0
Ms Pam Teys
Address 66078 0
Office TB 25
Australian Catholic University 1100 Nudgee Road
Banyo Brisbane QLD 4014
Country 66078 0
Australia
Phone 66078 0
+6136237689
Fax 66078 0
+6136237650
Email 66078 0
[email protected]
Contact person for public queries
Name 66079 0
Pam Teys
Address 66079 0
Office TB 25
Australian Catholic University 1100 Nudgee Road
Banyo Brisbane QLD 4014
Country 66079 0
Australia
Phone 66079 0
+6136237689
Fax 66079 0
+6136237650
Email 66079 0
[email protected]
Contact person for scientific queries
Name 66080 0
Pam Teys
Address 66080 0
Office TB 25
Australian Catholic University 1100 Nudgee Road
Banyo Brisbane QLD 4014
Country 66080 0
Australia
Phone 66080 0
+6136237689
Fax 66080 0
+6136237650
Email 66080 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.