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Trial registered on ANZCTR


Registration number
ACTRN12617000518369
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
10/04/2017
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a physiotherapy technique on shoulder joint position using diagnostic ultrasound
Scientific title
Evaluation of the effect of glenohumeral mobilisation-with-movement on acromiohumeral distance and humeroglenoid distance in healthy subjects using diagnostic ultrasound
Secondary ID [1] 291544 0
Nil known
Universal Trial Number (UTN)
U1111-1194-7381
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal condition 302632 0
Shoulder pain 302633 0
Condition category
Condition code
Musculoskeletal 302152 302152 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobilisation With Movement (MWM) Intervention
Each subject will asked to attend for a single treatment session at the Research laboratory of the Australian Catholic University Nudgee Road Banyo QLD.
Each session will take approximately 75 minutes.
Each subject will have pre and post intervention measures of acromiohumeral distance at 0 degrees and 60 degrees of shoulder abduction and humeroglenoid distance at 0 degrees at rest and with contraction of the shoulder muscles. Three repetitions of each measure will be taken. Each subject will then receive both a sham and a MWM treatment - sham to one shoulder and MWM to the other shoulder. The selection of which shoulder will receive the Sham or the MWM will be randomised. A person not involved in the study will randomly allocate the right and left shoulder to either the sham or MWM and place the order in sealed opaque envelopes
The supervising physiotherapist will choose a numbered envelope with the order of treatment in and then apply the glenohumeral MWM technique to the allocated shoulder as described by Mulligan as designated by the numbered participant’s random allocation. The participant will be seated with an erect posture and feet flat on the floor. The therapist will stand on the opposite side of the shoulder to be treated and place one hand over the scapula posteriorly and the thenar eminence of the other hand over the anterior aspect of the head of the humerus. The therapist will apply a sustained posterolateral glide whilst the subject raises their arm along the plane of the scapula as far as possible. Three sets of 10 repetitions will be applied, with a 30 second interval between each set. The participant will be instructed that the entire application of the technique should be pain-free.

Intervention code [1] 297611 0
Treatment: Other
Comparator / control treatment
Sham Condition
The sham condition will replicate the MWM intervention except for hand positioning. The therapist will stand on the opposite side of the designated shoulder and place one hand over the scapula posteriorly and the thenar eminence of the other hand over the anterior aspect of the clavicle and acromioclavicular joint. Minimal pressure will be applied, and no movement of the humeral head will occur from the manual contact of the therapist. The repetitions, sets and rest intervals will be identical to the MWM intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 301574 0
Diagnostic ultrasound images will be taken of the acromiohumeral distance (AHD) at 0 degrees of abduction on both shoulders
Timepoint [1] 301574 0
Baseline and immediate post intervention
Primary outcome [2] 301575 0
Diagnostic ultrasound images will be taken of the acromiohumeral distance (AHD) at 60 degrees of abduction on both shoudlers
Timepoint [2] 301575 0
Baseline and immediately post intervention
Primary outcome [3] 301577 0
Diagnostic ultrasound images will be taken of the acromiohumeral distance (AHD) at 60 degrees of abduction with muscle activation on both shoudlers
Timepoint [3] 301577 0
Baseline and immediatley post intervention
Secondary outcome [1] 333145 0
Diagnostic ultrasound images will be taken of the Humeroglenoid distance (HGD) in an anterior-posterior direction on both shoulders at 0 degrees of abduction.
Timepoint [1] 333145 0
Baseline and immediatley post intervention
Secondary outcome [2] 333146 0
Diagnostic ultrasound images will be taken of the Humeroglenoid distance (HGD) in an anterior-posterior direction on both shoulders at 60 degrees of abduction.
Timepoint [2] 333146 0
Baseline and immediatley post intervention
Secondary outcome [3] 333147 0
Diagnostic ultrasound images will be taken of the Humeroglenoid distance (HGD) in an anterior-posterior direction on both shoulders at 60 degrees of abduction with muscle activation.
Timepoint [3] 333147 0
Baseline and immediately post intervention

Eligibility
Key inclusion criteria
Healthy males and females between 18 – 65 years old

Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or past musculoskeletal or neuromuscular pathology related to cervical spine, shoulders or arms
Current or past history of injury, surgery or prolonged pain involving the cervical spine, shoulders or arms
Current or past history of connective tissue disorders, hypermobility or hypermobility-related disorders.
Current or recent steroid use
Cervical spine or shoulder range of movement outside the normal ranges as indicated by Palmer and Epler
Unable to speak English or reduced cognition
Current or past history of cancer
Diabetes
Systemic illnesses including rheumatoid arthritis and other autoimmune disorders

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)
An administration assistant will manually allocate subjects to receive glenohumeral MWM to the right shoulder and sham to the left shoulder and vice versa. Single pieces of paper identifying one of these allocations (equal numbers of each) will be shuffled and placed in sealed opaque envelopes and then numbered consecutively. Subjects will be assigned the successively numbered envelope after their physical screening and pre- measures taken. The physiotherapist performing MWM and sham will be blinded to the allocation procedure and will only discover the subject's allocated order of treatment upon opening their envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin tossing
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
Other
Other design features
Subjects will randomly receive either treatment or sham on one shoulder and the opposite on the other shoulder.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2017
Actual
Date of last participant enrolment
Anticipated
29/05/2017
Actual
Date of last data collection
Anticipated
29/05/2017
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 15656 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 296033 0
University
Name [1] 296033 0
Australian Catholic University
Country [1] 296033 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road Banyo QLd 4014
Country
Australia
Secondary sponsor category [1] 294921 0
None
Name [1] 294921 0
Address [1] 294921 0
Country [1] 294921 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297292 0
Australian Catholic University Ethics Committe
Ethics committee address [1] 297292 0
Ethics committee country [1] 297292 0
Australia
Date submitted for ethics approval [1] 297292 0
Approval date [1] 297292 0
29/09/2015
Ethics approval number [1] 297292 0
2016-63H

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

Contacts
Principal investigator
Name 73606 0
Dr Pamela Teys
Address 73606 0
Room 212.01.25
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 73606 0
Australia
Phone 73606 0
+61736237689
Fax 73606 0
+61736237650
Email 73606 0
Pamela.Teys@acu.edu.au
Contact person for public queries
Name 73607 0
Pamela Teys
Address 73607 0
Room 212.01.25
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 73607 0
Australia
Phone 73607 0
+61 736237689
Fax 73607 0
+61 732637650
Email 73607 0
Pamela.Teys@acu.edu.au
Contact person for scientific queries
Name 73608 0
Pamela Teys
Address 73608 0
Room 212.01.25
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 73608 0
Australia
Phone 73608 0
+61 736237689
Fax 73608 0
+61 736237650
Email 73608 0
Pamela.Teys@acu.edu.au

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
No additional documents have been identified.