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Trial registered on ANZCTR


Registration number
ACTRN12623001284651
Ethics application status
Approved
Date submitted
26/10/2023
Date registered
11/12/2023
Date last updated
11/12/2023
Date data sharing statement initially provided
11/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound measurement of unstable shoulders before and after taping and rehabilitation treatment
Scientific title
Effect of taping and rehabilitation on humeral head position and translation in unstable shoulders: an ultrasound study
Secondary ID [1] 310849 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder instability 331882 0
Condition category
Condition code
Musculoskeletal 328603 328603 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves 2 interventions (taping and rehabilitation. All participants will be offered to be part of the taping group and the rehabilitation group. They can decide whether to be part of one, the other, or both. This design may be classified as a before-and-after study involving two interventions.

Intervention 1 - Taping
Fixomul hypoallergenic tape and rigid sports tape.
Scapular taping into upward rotation.
Experienced physiotherapist with over 10 years of experience.
Individual face-to-face treatment.
One treatment session - the tape application takes less than 5 minutes.
Administered at a private physiotherapy clinic in Melbourne, Australia.
Adherence will not be monitored as follow-up data is taken immediately after the tape application.

Intervention 2 - Rehabilitation
Rehabilitation will be overseen by the participants' treating physiotherapist who has been trained in the Watson Instability Program (Watson, et al., 2016, 2017). Progression through the program is determined by the treating physiotherpist and typically occurs in the treatment sessions.
Exercises are typically of low-moderate intensity and focus on low-load, high repitition dosages. E.g. shoulder shrug against red theraband 1-3 sets, 20 reps, 5 secs, 1-3 x daily. Other exercises may include, but may not be limited to:
- row (low/high)
- external rotation (low/high)
- internal rotation (low/high)
- pushing (low/high)
- lateral raise (low/high)
Treatment may be individualised/tailored as determined by the treating physiotherapist. Treatments may include, but are not limited to: Exercise prescription/progression, massage, stretching, joint mobilisation, and taping.
Equipment may include therabands, handweights, and gym equipment as deemed necessary by the treating physiotherapist.
Treatment may be delivered face-to-face, or via telehealth, or via a mixture as determined by the treating physiotherapist
The number/frequency of sessions over a twelve week period will be determined by the treating physiotherapist but typically last 20-30 minutes, once per week (13 sessions).
Treatments will be administed through a private physiotherapy clinic in Melbourne, Australia. Adherence will be overseen by the treating physiotherapist and may include strategies such as patient education, booking appointments ahead of time, and follow-up contact where appropriate. Attendence will be recorded by the treating physiotherpist in the clinic's practice management software.

REFERENCES:
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
Intervention code [1] 327261 0
Treatment: Other
Intervention code [2] 327262 0
Rehabilitation
Comparator / control treatment
This study involves 2 interventions (taping and rehabilitation. All participants will be offered to be part of the taping group and the rehabilitation group. They can decide whether to be part of one, the other, or both. The two interventions are not being compared to one another, rather, the effect of each intervention is being assessed before and after.

Intervention 1 - Taping: No comparator as this is a before-and-after intervention design.
Intervention 2 - Rehabilitation: No comparator as this is a before-and-after intervention design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336408 0
Acromiohumeral distance
Timepoint [1] 336408 0
Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [1] 428183 0
Glenohumeral distance
Timepoint [1] 428183 0
Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [2] 428184 0
Resisted external rotation strength
Timepoint [2] 428184 0
Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [3] 428185 0
Scapular upward rotation angle
Timepoint [3] 428185 0
Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [4] 428186 0
Shoulder function
Timepoint [4] 428186 0
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [5] 429477 0
Shoulder function
Timepoint [5] 429477 0
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation
Secondary outcome [6] 429478 0
Kinesiophobia
Timepoint [6] 429478 0
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Eligibility
Key inclusion criteria
- Symptomatic subluxation or dislocation inferiorly +/- anterior or posterior direction
- Positive sulcus test
- Improvement in range of motion in abduction by >20 degrees, OR improvement of pain or guarding in abduction, OR improvement in strength on an isometric test
- Intervention 2 - Rehabilitation: Participants must be enrolled in a rehabilitation
program with a practitioner trained to implement the Watson Instability Program (WIP)
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of significant trauma to the shoulder
- History of surgery on the affected shoulder
- Unable to understand or follow instructions in English
- Known neurological pathology creating motor deficit
- Known upper or lower motor neurone disease
- Known connective tissue disorder (Ehlers Danlos / Marfan syndrome)
- Presence of cervical radiculopathy

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
15
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315098 0
University
Name [1] 315098 0
La Trobe University
Country [1] 315098 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road and, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 317120 0
None
Name [1] 317120 0
Address [1] 317120 0
Country [1] 317120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314040 0
La Trobe Human Research Ethics Committee
Ethics committee address [1] 314040 0
La Trobe University, Plenty Road and, Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 314040 0
Australia
Date submitted for ethics approval [1] 314040 0
24/03/2022
Approval date [1] 314040 0
19/09/2022
Ethics approval number [1] 314040 0
HEC22126

Summary
Brief summary
This is the second component of a masters project that is investigating humeral head position and translation in unstable shoulders. In this pre- and post-intervention study, we aim to investigate the effect of taping and rehabilitation on humeral head position and/or translation in unstable shoulders. We hypothesise that humeral head inferior position/translation will reduce and that these findings will correlate with other measured improvements of shoulder position, strength, pain, and function.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130214 0
Mr Daniel Verdon
Address 130214 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 130214 0
Australia
Phone 130214 0
+61 3 9228 0911
Fax 130214 0
+61 3 9228 0913
Email 130214 0
[email protected]
Contact person for public queries
Name 130215 0
Daniel Verdon
Address 130215 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 130215 0
Australia
Phone 130215 0
+61 3 9228 0911
Fax 130215 0
+61 3 9228 0913
Email 130215 0
[email protected]
Contact person for scientific queries
Name 130216 0
Daniel Verdon
Address 130216 0
Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181
Country 130216 0
Australia
Phone 130216 0
+61 3 9228 0911
Fax 130216 0
+61 3 9228 0913
Email 130216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20757Ethical approval    386789-(Uploaded-26-10-2023-13-47-46)-Study-related document.pdf



Results publications and other study-related documents

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