Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000020886
Ethics application status
Approved
Date submitted
4/11/2020
Date registered
13/01/2021
Date last updated
5/05/2023
Date data sharing statement initially provided
13/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effects of posterior shoulder mobilization on scapular and shoulder muscle activities
Scientific title
The effect of high dosage shoulder posterior mobilisation on shoulder and scapular muscle activity during resisted shoulder elevation: A repeated-measures study on asymptomatic individuals
Secondary ID [1] 302693 0
Nil known
Universal Trial Number (UTN)
U1111-1260-7563
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder disorders 319608 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317549 317549 0 0
Physiotherapy
Musculoskeletal 317909 317909 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobilization: The participants’ shoulder will be passively mobilized by an experienced musculoskeletal physiotherapist. The mobilizations will consist of 3 sets of 60 seconds of passive movement, at a rate of 2 Hz, with 30 seconds interval between sets. This dosage (grade +IV, 2 Hz, 3 sets of 60 seconds, with 30 seconds interval between sets) is commonly used in the clinical setting. The mobilization will be performed with the shoulder in abduction greater than 90 degrees, so that the gleno-humeral capsule and ligaments are (theoretically) lengthened.

This intervention (i.e. mobilization) will be delivered in one session lasting approximately 5 min. That will be followed by a wash-out period lasting for 10 min.
Intervention code [1] 318973 0
Rehabilitation
Comparator / control treatment
Control: The participant will be positioned in supine, with arms at rest. Participants will remain in this position for the equivalent time spent during the mobilization condition (i.e. 3 sets of 60 seconds, with 30 seconds interval between sets). No mobilization will be performed during the control condition.
Control group
Active

Outcomes
Primary outcome [1] 325593 0
Middle deltoid muscle activity level as measured with surface EMG.
Timepoint [1] 325593 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [1] 388483 0
Upper trapezius muscle activity level as measured with surface EMG.
Timepoint [1] 388483 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [2] 388484 0
Lower trapezius muscle activity level as measured with surface EMG.
Timepoint [2] 388484 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [3] 388485 0
Serratus anterior muscle activity level as measured with surface EMG.
Timepoint [3] 388485 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [4] 388486 0
Pectoralis major muscle activity level as measured with surface EMG.
Timepoint [4] 388486 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [5] 388487 0
Infraspinatus muscle activity level as measured with surface EMG.
Timepoint [5] 388487 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [6] 388488 0
Latissimus dorsi muscle activity level as measured with surface EMG.
Timepoint [6] 388488 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).
Secondary outcome [7] 388489 0
Posterior deltoid muscle activity level as measured with surface EMG.
Timepoint [7] 388489 0
Outcomes (i.e. muscle activity levels) will be measured during the 5 resisted shoulder elevations performed at baseline (prior to experimental conditions - mobilisation or control), and follow-up (after experimental conditions - mobilisation or control).

Eligibility
Key inclusion criteria
Participants will be included if they present no current neck and shoulder injuries.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

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)
The randomisation schedule will be concealed through central randomization. A research administrator will randomise participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer-generated by a research administrator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/01/2021
Actual
4/05/2022
Date of last participant enrolment
Anticipated
1/03/2021
Actual
3/07/2022
Date of last data collection
Anticipated
5/04/2021
Actual
3/07/2022
Sample size
Target
25
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 23087 0
New Zealand
State/province [1] 23087 0

Funding & Sponsors
Funding source category [1] 307129 0
Charities/Societies/Foundations
Name [1] 307129 0
New Zealand Manipulative Physiotherapists Association
Country [1] 307129 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street, Dunedin, 9016
School of Physiotherapy, University of Otago
Country
New Zealand
Secondary sponsor category [1] 307705 0
None
Name [1] 307705 0
Address [1] 307705 0
Country [1] 307705 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307241 0
University of Otago Ethics Committee
Ethics committee address [1] 307241 0
Ethics committee country [1] 307241 0
New Zealand
Date submitted for ethics approval [1] 307241 0
24/10/2019
Approval date [1] 307241 0
30/10/2019
Ethics approval number [1] 307241 0
H19/107

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

Contacts
Principal investigator
Name 106530 0
Dr Daniel Ribeiro
Address 106530 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 106530 0
New Zealand
Phone 106530 0
+6434797455
Fax 106530 0
Email 106530 0
[email protected]
Contact person for public queries
Name 106531 0
Daniel Ribeiro
Address 106531 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 106531 0
New Zealand
Phone 106531 0
+6434797455
Fax 106531 0
Email 106531 0
[email protected]
Contact person for scientific queries
Name 106532 0
Daniel Ribeiro
Address 106532 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 106532 0
New Zealand
Phone 106532 0
+6434797455
Fax 106532 0
Email 106532 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published results only.

What types of analyses could be done with individual participant data?
• IPD meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator (Daniel Ribeiro - e-mail: [email protected]).

Are there extra considerations when requesting access to 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.