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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder instability

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

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]

Acromiohumeral distance

Timepoint [1]

Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [1]

Glenohumeral distance

Timepoint [1]

Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [2]

Resisted external rotation strength

Timepoint [2]

Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [3]

Scapular upward rotation angle

Timepoint [3]

Intervention 1 - Taping: Immediately after tape application
Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [4]

Shoulder function

Timepoint [4]

Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [5]

Shoulder function

Timepoint [5]

Intervention 2 - Rehabilitation: after 12 weeks of rehabilitation

Secondary outcome [6]

Kinesiophobia

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

Plenty Road and, Kingsbury Dr, Bundoora VIC 3086

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Plenty Road and, Kingsbury Dr, Bundoora VIC 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe Human Research Ethics Committee

Ethics committee address [1]

La Trobe University, Plenty Road and, Kingsbury Dr, Bundoora VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/03/2022

Approval date [1]

19/09/2022

Ethics approval number [1]

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

Mr Daniel Verdon

Address

Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181

Country

Australia

Phone

+61 3 9228 0911

Fax

+61 3 9228 0913

[email protected]

Contact person for public queries

Name

Daniel Verdon

Address

Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181

Country

Australia

Phone

+61 3 9228 0911

Fax

+61 3 9228 0913

[email protected]

Contact person for scientific queries

Name

Daniel Verdon

Address

Melbourne Shoulder Group, 305 High Street, Prahran, VIC, 3181

Country

Australia

Phone

+61 3 9228 0911

Fax

+61 3 9228 0913

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
20757	Ethical approval					386789-(Uploaded-26-10-2023-13-47-46)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically