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Trial registered on ANZCTR


Registration number
ACTRN12620000335998
Ethics application status
Approved
Date submitted
27/02/2020
Date registered
10/03/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
10/03/2020
Date results information initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise based management for atraumatic instability of the shoulder in circus arts performers
Scientific title
The effect of an exercise rehabilitation program on pain, strength and function in circus arts performers with atraumatic instability of the shoulder: a longitudinal prospective cohort study with quasi experimental design.
Secondary ID [1] 300644 0
Nil known
Universal Trial Number (UTN)
U1111-1248-7583
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atraumatic Shoulder Instability 316428 0
Condition category
Condition code
Musculoskeletal 314688 314688 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise-based rehabilitation for circus arts performers with atraumatic instability of the shoulder: a longitudinal prospective cohort study with quasi experimental design.

Why/Rationale:
Clinically diagnosed atraumatic instability of the shoulder involves symptomatic instability (aberrant humeral head movement) in at least 1 direction, accompanied by shoulder discomfort, pain, apprehension or guarding. This is a common presentation to the medical team at the National Institute of Circus Arts. The projects aim is to determine the effects of a rehabilitation exercise program on pain, strength and function in circus artists with clinically diagnosed atraumatic instability of the shoulder.

What: The rehabilitation program is primarily based around maintaining good scapula and humeral head control through all ranges of shoulder motion. It is reported to be more effective than standard physiotherapy in people with multi-directional instability of the shoulder (Warby et al., 2018) but has not been tested in people with all types of atraumatic instability (uni-directional and multi-directional), or in circus arts performers.

Warby, S. A., Ford, J. J., Hahne, A. J., Watson, L., Balster, S., Lenssen, R., & Pizzari, T. (2018). Comparison of 2 Exercise Rehabilitation Programs for Multidirectional Instability of the Glenohumeral Joint: A Randomized Controlled Trial. American Journal of Sports Medicine, 46(1), 87-97. doi:10.1177/0363546517734508

Materials: Participants will be provided with the necessary equipment (dumbells, rubber bands/Theratubing) to perform the intervention exercise-based rehabilitation program.

Procedures:
The rehabilitation exercise program is identical to the Watson Protcol presented in the trial registered ACTRN12613001240730. This rehabilitation program will be performed for 12-weeks at home and during already timetabled rehabilitation sessions within the National Institute of Circus Arts scheduled rehabilitation sessions (currently scheduled into their curriculum).

The program has previously been published:
Watson, L., Warby, S., Balster, S., Lenssen, R., & Pizzari, T. (2016). The treatment of multidirectional instability of the shoulder with a rehabilitation program: Part 1. Shoulder Elbow, 8(4), 271-278. doi:10.1177/1758573216652086
Watson, L., Warby, S., Balster, S., Lenssen, R., & Pizzari, T. (2017). The treatment of multidirectional instability of the shoulder with a rehabilitation programme: Part 2. Shoulder Elbow, 9(1), 46-53. doi:10.1177/1758573216652087

A summary of the stages of the exercise program are as follows (can also be seen under ACTRN12613001240730):
Stage 1- Coronel Plane Strengthening 0 to 45 degrees Abduction:
Scapula upward rotation and tilting
Internal Rotation/External Rotation from 0 to 45 abduction with theraband
Standing/bent over rows 0 to 45 degrees abduction

Stage 2- Building Posterior Musculature
Bent over rows
Side lie external rotation
Standing rows

Stage 3: Flexion Drills
Flexion Drills from 0 to 45 degrees Abduction

Stage 4: Coronal Plane Strengthening 45 to 90 degrees Abduction
Internal Rotation/External Rotation from 45 to 90 degrees abduction with theraband
Standing/bent over rows 0 to 45 degrees abduction
Flexion to 90 degrees abduction

Stage 5: Specific Strength Drills
Bent over rows (Posterior deltoid)
Supine and sitting flexion (Anterior deltoid)
Lateral Raises (Middle deltoid)

Stage 6: Sports Specific and Functional Specific Drills
Drills determined by the requirements of the patient.
Load and progressed to allow for return to sport or function.

Provision of services: Physiotherapists with >5 years clinical experience and trained in the protocol will be prescribing the intervention exercise program.

How: Participants will have one physiotherapist session each week to assess their shoulder and progress their rehabilitation program as appropriate for their shoulder condition. The trial physiotherapists will ensure that participants can perform these exercises correctly and then they will be asked to perform them at home and in the National Institute of Circus Arts gymnasium during their scheduled rehabilitation exercise sessions (normal part of the student curriculum). Standard protocol at NICA is for a physiotherapist to be present during these timetabled exercise sessions, so this will ensure correct exercise technique is performed.

Where: Physiotherapy appointments will occur at the National Institute of Circus Arts, Melbourne, Australia.

When and how much: The exercise program will incorporate between 3 and 7 exercises to strengthen the muscles around the shoulder and shoulder blade, using rubber bands (Theratubing) and weights. The exercise program will take between 15 and 20 minutes to complete and will be performed two to three times a day (muscle recruitment exercises); to once every two days (muscle strength exercises), depending on the phase of the program.

Adherence: Adherence will be measured through a participant exercise diary. This will be assessed each week at the physiotherapy appointment, but also formally at the 6-week and 12-week follow up post commencement of the intervention. At each physiotherapy treatment appointment, the physiotherapist will encourage the participant to adhere to the exercise protocol.

Tailoring: The program will be personalised to the individual and only progressed according to the weekly assessment during the physiotherapy session.
Intervention code [1] 316977 0
Rehabilitation
Intervention code [2] 317049 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323030 0
The Western Ontario Shoulder Instability Index (WOSI)
- a self-administered tool, with 21 items over the four domains of physical symptoms, sport/recreation/work, lifestyle function and emotional function.
Timepoint [1] 323030 0
Baseline, 6-weeks, 12-weeks [primary timepoint], 6 months and 12-months post baseline measures
Primary outcome [2] 323031 0
The Melbourne Instability Shoulder Scale (MISS)
- a self-administered tool, with a total of 100 points, divided into four categories that assess pain, instability, function, and occupational and sporting demands.
Timepoint [2] 323031 0
Baseline, 6-weeks, 12-weeks [primary timepoint], 6-months and 12-months post baseline measures
Secondary outcome [1] 380541 0
Shoulder strength measured using hand held dynamometry
- Shoulder external rotation and internal rotation at 0degrees of shoulder abduction
- Shoulder external rotation and internal rotation at 90degrees of shoulder abduction
- Scapula upward rotation/elevation
- Shoulder external rotation and internal rotation in horizontal flexion at 90deg flexion
- Abduction at 45degrees
- Shoulder flexion at 90deg
- Shoulder extension at 90deg
Timepoint [1] 380541 0
Baseline and 12-weeks post baseline measures
Secondary outcome [2] 380542 0
Handstand stability
- Accelerometers will be used to detect movement in handstand position
- If the physiotherapist completing entry clinical assessment deems a handstand to be unsafe to perform, this element of testing will not be completed.
Timepoint [2] 380542 0
Baseline and 12-weeks post baseline measures
Secondary outcome [3] 380543 0
Tampa Scale
- assesses for kinesiophobia (fear of pain due to movement)
Timepoint [3] 380543 0
Baseline, 6-weeks, 12-weeks, 6-months and 12-months post baseline measures
Secondary outcome [4] 380544 0
Orebro (short-form) questionnaire
- questionnaire that indicates risk of slow recovery or longer term disability and potential failure to return to pre-injury capacity such as work or daily activity due to personal, social psychological and environmental factors.
Timepoint [4] 380544 0
Baseline, 6-weeks, 12-weeks, 6-months and 12-months post baseline measures
Secondary outcome [5] 380545 0
Global rating of change will be measured using a 7-point Likert scale.
Timepoint [5] 380545 0
6-weeks, 12-weeks, 6-months and 12-months post baseline measures
Secondary outcome [6] 380546 0
Scapula angles.
- Angle of scapula upward rotation at rest and through abduction range of motion will be measured with an inclinometer on the superior scapula spine.
Timepoint [6] 380546 0
Baseline and 12-weeks post baseline measures
Secondary outcome [7] 380547 0
Adherence to the program
- participant exercise diaries will be used to determine adherence to the exercise program
Timepoint [7] 380547 0
Exercise diary weeks 1-12.
Secondary outcome [8] 380548 0
Adverse events will be assessed by the trial physiotherapist with closed and open ended questions in every treatment session. Questions included will be:
"Have you had any pain associated with the exercise program? If yes, please describe."
Have you had any pain or increase in pain NOT associated with the exercise program? If yes, please describe."

Examples of adverse events include: pain increase attributed to the home exercise program, episode of shoulder subluxation attributed to the home program, any other injury attributed to the home exercise program (i.e: back injury).
Timepoint [8] 380548 0
Recorded in the clinical notes for every session and formally assessed at 6 weeks, 12 weeks, 24 weeks and 52 weeks post randomisation.

Eligibility
Key inclusion criteria
Report of shoulder region discomfort, pain or apprehension/guarding with movement
Willing to participate in 12-week exercise program
Clinically diagnosed symptomatic atraumatic shoulder instability in one or more directions.
Amenable to correction (symptomatically improve a participant’s abduction or flexion range of motion by a minimum of 20°, or, significantly reduce a participant’s pain or guarding in any objective measure, or, improve a participant’s strength on an isometric test).
Minimum age
15 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of significant trauma defined as contact with an external object (such as a fall, impact with another body or surface) with lock out of the glenohumeral joint and conscious awareness by the patient of a sudden onset of pain.
History of glenohumeral dislocation that requires relocation
Prior surgical history of the affected shoulder(s)
Non-correctable volitional instability
Inability to complete 5 repetitions of a 5 second duration shoulder shrug with no weight
Non-compliance
Neurological motor deficit
Instability due to UMN or LMN lesion
Ehlers-Danlos syndrome/Marfan’s syndrome
Shoulder pain that is predominantly due to cervical dysfunction including:
- Cervical spine somatic referred pain
- Cervical spine radicular pain
- Cervical spine radiculopathy
- Thoracic outlet syndrome

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective longitudinal cohort intervention study with quasi-experimental design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a moderate effect size of 0.5, a sample size of 22 is required for this study. Data analysis will focus on within-group treatment effects (with effect sizes and confidence intervals) at each of the follow up timepoints. Linear mixed models or repeated measures ANCOVA will be used to analyse outcome measures including questionnaires (MISS, WOSI, Orebro, Tampa scale, global rating of change), strength, scapula measures and handstand stability data. Adverse events and participant adherence to the study protocol will also be recorded.

Recruitment
Recruitment status
Active, not recruiting
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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305068 0
University
Name [1] 305068 0
National Institute of Circus Arts
Address [1] 305068 0
39-59 Green St, Prahran VIC 3181
Country [1] 305068 0
Australia
Funding source category [2] 305176 0
University
Name [2] 305176 0
Swinburne University of Technology
Address [2] 305176 0
John St, Hawthorn VIC 3122
Country [2] 305176 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Swinburne University of Technology
John St, Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 305461 0
University
Name [1] 305461 0
National Institute of Circus Arts
Address [1] 305461 0
39-59 Green St, Prahran VIC 3181
Country [1] 305461 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305458 0
Swinburne University of Technology Ethics Human Research Ethics Committee
Ethics committee address [1] 305458 0
Swinburne University of Technology
John St, Hawthorn VIC 3122
Ethics committee country [1] 305458 0
Australia
Date submitted for ethics approval [1] 305458 0
Approval date [1] 305458 0
05/02/2020
Ethics approval number [1] 305458 0

Summary
Brief summary
The projects aim is to determine the effects of a shoulder rehabilitation exercise program in circus artists with all forms of atraumatic shoulder instability. The program used in this study has already been shown to be superior to one other exercise intervention (Rockwood exercise program) in people with multi-directional instability at 12 and 24-weeks, however, it has not been tested in all forms of atraumatic instability (including uni-directional) or in circus performers, a population that requires optimal shoulder stability for their art form.

The hypothesis is that the implementation of the exercise-based rehabilitation protocol should result in a statistically significant increase in shoulder strength, and an improvement in the MISS, WOSI and Orebro scores from baseline to post intervention timepoints (Warby et al., 2018). Similarly, there should be an improvement in the Tampa Scale, but this is unlikely to be statistically significant as the population being studied are very active individuals participating in a high a risk sport (circus). If improvements are identified in questionnaires, scapular measures and strength measures, an increase in stability or change in pattern of handstand stability should be found.
Trial website
Trial related presentations / publications
Public notes
In the situation that NICA is forced to close for a period of time due to the Covid-19 pandemic, physiotherapy services will be provided online through a teleconsultation and exercises will be performed at the participants home with provided equipment, until classes resume at NICA.

References:
Warby, S. A., Ford, J. J., Hahne, A. J., Watson, L., Balster, S., Lenssen, R., & Pizzari, T. (2018). Comparison of 2 Exercise Rehabilitation Programs for Multidirectional Instability of the Glenohumeral Joint: A Randomized Controlled Trial. American Journal of Sports Medicine, 46(1), 87-97. doi:10.1177/0363546517734508

Watson, L., Warby, S., Balster, S., Lenssen, R., & Pizzari, T. (2016). The treatment of multidirectional instability of the shoulder with a rehabilitation program: Part 1. Shoulder Elbow, 8(4), 271-278. doi:10.1177/1758573216652086

Watson, L., Warby, S., Balster, S., Lenssen, R., & Pizzari, T. (2017). The treatment of multidirectional instability of the shoulder with a rehabilitation programme: Part 2. Shoulder Elbow, 9(1), 46-53. doi:10.1177/1758573216652087

Contacts
Principal investigator
Name 100446 0
Dr Charlotte Ganderton
Address 100446 0
Swinburne University of Technology
John St, Hawthorn VIC 3122
Country 100446 0
Australia
Phone 100446 0
+61 3 92143539
Fax 100446 0
Email 100446 0
cganderton@swin.edu.au
Contact person for public queries
Name 100447 0
Dr Charlotte Ganderton
Address 100447 0
Swinburne University of Technology
John St, Hawthorn VIC 3122
Country 100447 0
Australia
Phone 100447 0
+61 3 92143539
Fax 100447 0
Email 100447 0
cganderton@swin.edu.au
Contact person for scientific queries
Name 100448 0
Dr Charlotte Ganderton
Address 100448 0
Swinburne University of Technology
John St, Hawthorn VIC 3122
Country 100448 0
Australia
Phone 100448 0
+61 3 92143539
Fax 100448 0
Email 100448 0
cganderton@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants are performers within an elite training institution (National Institute of Circus Arts, Australia)
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary