Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000553572
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
29/05/2015
Date last updated
9/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Muscle activity of the rotator cuff and shoulder girdle musculature during common rehabilitation exercises
Scientific title
Muscle activity of the rotator cuff and shoulder girdle musculature during common rehabilitation exercises in healthy participants
Secondary ID [1] 286679 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder kinematics in healthy participants for rehabilitation intervention in patients with rotator cuff tears 294973 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295235 295235 0 0
Other physical medicine / rehabilitation
Musculoskeletal 295236 295236 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will explore EMG activation of rotator cuff and shoulder girdle musculature, in healthy participants during rehabilitation exercises commonly prescribed for patients with massive rotator cuff tears, and early stage post rotator cuff surgery. Based on the data we observe, we will look to develop a rehabilitation protocol for patients with massive rotator cuff tears, and post shoulder replacement. The information we gather from this study will provide information for postoperative regimes for other surgeries such as rotator cuff repair and subacromial decompression. The implications from these studies will advance the clinical knowledge and practical application of exercise rehabilitation for patients with rotator cuff disease to enhance outcomes and prevent recurrence of symptoms.

Electromyographic data will be collected simultaneously from seven shoulder muscles using a combination of surface and intramuscular fine-wire electrodes. Pre-gelled and self-adhering silver/silver-chloride bipolar dual surface electrodes will be used to measure the muscle activity of the following muscles on the participant’s right side: upper trapezius, anterior deltoid, middle deltoid and posterior deltoid. The surface electrodes are to be placed on the target muscles over the belly of the muscle in line with the direction of the muscle fibres with an inter-electrode distance of approximately 20 mm. Prior to application of the surface electrodes, the skin will be cleansed and shaved (if required).

Intramuscular electrodes will be used for muscles that underlie more superficial muscles (supraspinatus, subscapularis), or for muscles that shift markedly with respect to the overlying soft tissue during shoulder movement (infraspinatus). A medically trained investigator (RP) will insert all intramuscular fine wire electrodes will via a sterile 30mm, 27-gauge hypodermic needle with a pair of 0.051 mm, insulated, bent end Teflon coated stainless steel wires and 200mm tail with 5mm bare-wire terminations (Chalgren Enterprises, USA). The insertion site will be prepared using aseptic technique, via a chlorohexidine solution. Depth of the insertion will be determined using ultrasound and confirmed by visualisation of the EMG signal during maximal voluntary isometric contraction (MVIC).

Surface EMG electrode placement will be attained initially through surface palpation and isometric contraction, and confirmed through visualisation of the EMG signal during MVIC (MYON m320 Telemyo system sampling at 2000Hz) via manual muscle testing. Two trials of 5-second MVICs will be performed, and will represent 100% EMG activity to be used as a standardised, within-subject reference for the data collected during the rehabilitation exercises. Verbal encouragement will be given during all trials. Electrodes will remain in place until the completion of the testing session. Passive, active and resisted movements will be performed to determine participant comfort and quality of EMG data. Muscle activation magnitude will be captured with VICON NEXUS software and post-processing will be filtered/normalised in MATLAB software (The Mathworks, Natick, MS, USA). An additional surface electrode will be placed over the clavicle to serve as a reference electrode for all surface muscles and a large ground electrode was used as a reference electrode for all intramuscular electrodes.

The testing protocols will be conducted in the presence of one or more of the investigators, who are qualified Accredited Exercise Physiologists, to ensure correct body positioning and exercise technique, without excess movements during data collection. The session will last approximately 2 hours, and will require participants to undertake 11 shoulder rehabilitation exercises representing typical active ROM (AROM), active-assisted ROM (AAROM) and resistance exercises employed in clinical practice for rotator cuff disease. AAROM exercises will include: 1) shoulder elevation using a rope and pulley and 2) shoulder elevation using a broomstick, 3) wall slide exercise for elevation, 4) forward bow exercise, 5) external rotation using a broomstick both standing upright and seated, 6) the shoulder "pendulum" ROM exercise and 7) “Rock the Baby” gravity-eliminated pendulum exercise. Active exercises will include: 8) standing external humeral rotation, 9) side-lying external humeral rotation, 10) shoulder abduction, and 11) shoulder flexion. Each participant will perform 10 repetitions of each exercise at a standardised tempo matching the beat of a metronome set to 60 beats per min (2 s per concentric and 2 s per eccentric contraction). The order of exercises and loadings will be block randomised for each participant, and each set of exercise will be initiated every 2 min. Immediately after each set of exercise, the Borg CR10 scale, which has anchor points of 0 = “no exertion”, through to 10 = “extreme exertion”, will be used to rate perceived loading of the respective muscle groups during the exercise and will be carefully explained to each individual prior to testing.
Intervention code [1] 291788 0
Rehabilitation
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294989 0
Muscle activity as assessed by electromyography (EMG) Intramuscular EMG Supraspinatus, Infraspinatus, Subscapularis, Anterior Deltoid, Middle Deltoid, Posterior Deltoid.
Timepoint [1] 294989 0
Baseline during no movement, and throughout the duration of task
Secondary outcome [1] 314512 0
Perceived loading of the rotator cuff and shoulder girdle musculature, self-assessed by participant on the Borg 10 Scale
Timepoint [1] 314512 0
At the immediate completion of each task

Eligibility
Key inclusion criteria
Participants will be enrolled in the study if they meet the following criteria: 1.) Right-hand dominant, 2.) No history of shoulder or neck injury or pain requiring treatment (i.e. no medication, physical therapy intervention or surgery) for either shoulder, 3.) Full, pain-free, bilateral shoulder range of motion, and 4.) No contraindications to fine-wire placement or completion of shoulder rehabilitation exercises.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of shoulder or neck injury or pain requiring treatment
- Over the age of 40
- Do not read and speak English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
A power analysis using G power software was performed to calculate the sample size required for the two studies. Activity levels of 10% MVC are commonly considered to represent minimal activity. Therefore assuming a standard power of 0.8, a significance level of .05, and the difference of the means among exercises must be at least 10% of MVIC to be clinically relevant with a SD of 15%, 20 participants (10 male and 10 female) will be required for this study which we consider conservative.

One-way repeated measures ANOVA will be used to assess differences in EMG level of peak and average muscle activation observed between each task. Significant main effects will be further examined using Bonferroni post-hoc test. Spearman’s correlation coefficient will be used to measure the relationship between EMG activation and RPE.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
25/06/2016
Date of last data collection
Anticipated
Actual
25/06/2016
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291253 0
University
Name [1] 291253 0
University of Western Australia
Country [1] 291253 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Sport Science, Exercise and Health (M408)
The University of Western Australia
35 Stirling Highway
Crawley Perth
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 289929 0
None
Name [1] 289929 0
N/A
Address [1] 289929 0
N/A
Country [1] 289929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292817 0
Human Research Ethics Committee (HREC) University of Western Australia
Ethics committee address [1] 292817 0
Ethics committee country [1] 292817 0
Australia
Date submitted for ethics approval [1] 292817 0
18/02/2016
Approval date [1] 292817 0
19/02/2016
Ethics approval number [1] 292817 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 449 449 0 0
/AnzctrAttachments/368486-Rotator Cuff Research Plan 1 & 2.docx
Attachments [2] 450 450 0 0
/AnzctrAttachments/368486-Participant Information Sheet RC Study 1 & 2.doc

Contacts
Principal investigator
Name 57002 0
Mr Peter Edwards
Address 57002 0
Hollywood Functional Rehabilitation Clinic
PO Box 7273
Shenton Park, Western Australia, 6008
Country 57002 0
Australia
Phone 57002 0
+61422370913
Fax 57002 0
Email 57002 0
[email protected]
Contact person for public queries
Name 57003 0
Peter Edwards
Address 57003 0
Hollywood Functional Rehabilitation Clinic
PO Box 7273
Shenton Park, Western Australia, 6008
Country 57003 0
Australia
Phone 57003 0
+61422370913
Fax 57003 0
Email 57003 0
[email protected]
Contact person for scientific queries
Name 57004 0
Peter Edwards
Address 57004 0
Hollywood Functional Rehabilitation Clinic
PO Box 7273
Shenton Park, Western Australia, 6008
Country 57004 0
Australia
Phone 57004 0
+61422370913
Fax 57004 0
Email 57004 0
[email protected]

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

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