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Trial registered on ANZCTR


Registration number
ACTRN12618000726257
Ethics application status
Approved
Date submitted
26/04/2018
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring the effects shoulder mobilization on scapular and shoulder muscle activities
Scientific title
Exploring the effects shoulder mobilization on scapular and shoulder muscle activities: a repeated measures study in a group of asymptomatic individuals
Secondary ID [1] 294700 0
Nil known
Universal Trial Number (UTN)
U1111-1212-8041
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder disorders 307561 0
Condition category
Condition code
Physical Medicine / Rehabilitation 306637 306637 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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, three sets of 60 seconds, with 30 seconds interval between sets) is commonly used clinically.

Two different shoulder mobilizations will be performed (each mobilization will be performed on a different day).Data collection will take place in two sessions. The second session must occur within 10 days of the first session, and with at least 24 hours interposed.

For each experimental condition, the participants’ shoulder will be positioned such that the gleno-humeral capsule and ligaments are lengthened. Thus, when the humerus is mobilized, the gleno-humeral capsule and ligaments will be repetitively stretched through passive mobilization. Each mobilization will be performed on a different day, and the order of the mobilization will be randomized. The inferior mobilization will consist of repeated glides applied at the shoulder, with the participant’s arm positioned at 120 degrees of shoulder abduction. The posterior mobilization will consist of repeated posterior glides applied at the shoulder, with the participant arm positioned in horizontal flexion.
Intervention code [1] 300993 0
Rehabilitation
Comparator / control treatment
Posterior mobilization condition.
Control group
Active

Outcomes
Primary outcome [1] 305686 0
Anterior deltoid muscle activity levels will be considered as primary outcome measures for assessing the effect of posterior mobilization on muscle activity levels.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [1] 305686 0
Baseline (prior to mobilization), and follow-up (immediately after mobilization).
Primary outcome [2] 305715 0
Middle deltoid muscle activity levels will be considered as primary outcome measures for assessing the effect of inferior mobilization on muscle activity levels.
Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [2] 305715 0
Baseline (prior to mobilization), and follow-up (immediately after mobilization).
Secondary outcome [1] 345976 0
When assessing the effect of posterior mobilization, infraspinatus muscle will be considered as secondary outcome.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [1] 345976 0
Baseline (prior to mobilization), and follow-up (immediately after mobilization).
Secondary outcome [2] 345977 0
When assessing the effect of posterior mobilization, latissimus dorsi muscle will be considered as secondary outcome.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [2] 345977 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).
Secondary outcome [3] 346182 0
When assessing the effect of posterior mobilization, posterior deltoid muscle will be considered as secondary outcome.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [3] 346182 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).
Secondary outcome [4] 346184 0
When assessing the effect of inferior mobilization, latissimus dorsi muscle will be considered as secondary outcome.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [4] 346184 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).
Secondary outcome [5] 346185 0
When assessing the effect of inferior mobilization, pectoralis major muscle will be considered as secondary outcome.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [5] 346185 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).
Secondary outcome [6] 346229 0
Pectoralis major muscle activity levels will be considered as primary outcome measures for assessing the effect of posterior mobilization on muscle activity levels.

Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [6] 346229 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).
Secondary outcome [7] 346230 0
Supraspinatus muscle activity levels will be considered as primary outcome measures for assessing the effect of inferior mobilization on muscle activity levels.
Muscle activity levels will be measured using surface electromyography, with a frequency sample of 3000 Hz.
Timepoint [7] 346230 0
Baseline (prior to mobilization) and follow-up (immediately after mobilization).

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
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they present any positive response to the cervical and shoulder screening tests.

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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10343 0
New Zealand
State/province [1] 10343 0

Funding & Sponsors
Funding source category [1] 299306 0
University
Name [1] 299306 0
University of Otago Research Grant
Address [1] 299306 0
University of Otago - Centre for Innovation, 87 St David St, Dunedin, 9016
Country [1] 299306 0
New Zealand
Primary sponsor type
University
Name
School of Physiotherapy - University of Otago
Address
325 Great King Street, Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 298615 0
None
Name [1] 298615 0
Address [1] 298615 0
Country [1] 298615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300215 0
University of Otago Ethics Committee
Ethics committee address [1] 300215 0
University of Otago Human Ethics Committee (Health), Clock Tower Building, Dunedin, 9054
Ethics committee country [1] 300215 0
New Zealand
Date submitted for ethics approval [1] 300215 0
Approval date [1] 300215 0
17/05/2017
Ethics approval number [1] 300215 0

Summary
Brief summary
Joint mobilizations are used for treating patients with shoulder pain, and are performed in different directions. Mobilizations lengthen capsule-ligament structures, impacting on activity of shoulder muscles. Our previous research suggests low intensity mobilizations lead to small changes in shoulder muscle activity. This project will explore whether: (1) shoulder mobilizations lead to changes in shoulder muscle activity; (2) muscle responses vary according to the direction of mobilization.
This is a repeated-measures, two-treatment crossover, randomized trial, to assess the effect of shoulder mobilization on shoulder muscle activity levels. The inferior mobilization will consist of repeated glides applied at the shoulder, with the participant’s arm positioned at the end of shoulder abduction range. The posterior mobilization will consist of repeated posterior glides applied at the shoulder, with the participant arm placed at 120 degrees of shoulder abduction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82942 0
Dr Daniel Cury Ribeiro
Address 82942 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 82942 0
New Zealand
Phone 82942 0
+64 03 479 74 55
Fax 82942 0
Email 82942 0
daniel.ribeiro@otago.ac.nz
Contact person for public queries
Name 82943 0
Dr Daniel Cury Ribeiro
Address 82943 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 82943 0
New Zealand
Phone 82943 0
+64 03 479 74 55
Fax 82943 0
Email 82943 0
daniel.ribeiro@otago.ac.nz
Contact person for scientific queries
Name 82944 0
Dr Daniel Cury Ribeiro
Address 82944 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin
Country 82944 0
New Zealand
Phone 82944 0
+64 03 479 74 55
Fax 82944 0
Email 82944 0
daniel.ribeiro@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary