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Trial registered on ANZCTR
Registration number
ACTRN12620000677909
Ethics application status
Approved
Date submitted
28/04/2020
Date registered
15/06/2020
Date last updated
15/06/2020
Date data sharing statement initially provided
15/06/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Living with a Frozen Shoulder – a Study Exploring the Experience of People with Frozen Shoulder
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Scientific title
Living with a Frozen Shoulder – a Qualitative Study Exploring the Experience of People with Adhesive Capsulitis
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Secondary ID [1]
301142
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Frozen Shoulder
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Adhesive Capsulitis
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Condition category
Condition code
Musculoskeletal
315390
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is an observational study, where participants will take part in a semi-structured interview exploring their experience with frozen shoulder. The interview will occur as a once off interview, lasting 60-90 minutes. No further long term follow-up will be required.
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Intervention code [1]
317447
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Exploring the lived experience of frozen shoulder determined during semi-structured qualitative interview
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Assessment method [1]
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Timepoint [1]
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During a once off interview
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Secondary outcome [1]
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The impact of living with frozen shoulder on a person's emotions, identified during qualitative interview
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Assessment method [1]
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Timepoint [1]
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During a once off interview
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Secondary outcome [2]
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The impact of living with frozen shoulder on a person's professional work, identified during qualitative interview
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Assessment method [2]
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Timepoint [2]
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During a once off interview
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Secondary outcome [3]
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The impact of living with frozen shoulder on interpersonal relationships, identified during qualitative interview
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Assessment method [3]
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Timepoint [3]
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During a once off interview
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Eligibility
Key inclusion criteria
Individuals who have had a recently diagnosed frozen shoulder will be invited to participate in the study. They will be selected from those who recently participated in our work on the treatment of the condition.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Of those involved in the prior study we believe none will need to be excluded from this project
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
A qualitative study will be conducted, using semi-structured in-depth phenomenological interviews. The audio-recorded interviews will be transcribed with the permission of the interviewees and then the data will be de-identified.
Interviewing will be continued until no new ideas relating to the phenomenon are revealed, that is interviewees introduced no new perspectives. Saturation will be achieved when no new themes emerge and no further coding is possible. It is expected that 10-15 people will need to be interviewed to achieve the desired outcome.
Units of meaning will be delineated in order to illuminate the research phenomenon taking into account the literal content, the number of times the meaning was mentioned and how the meaning was delivered. Units of meaning will be clustered to form themes to express the essence of the clusters.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
4/06/2020
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Date of last participant enrolment
Anticipated
30/07/2020
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
15
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
16587
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
30176
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Flinders University
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Address [1]
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Flinders University
Sturt Rd, Bedford Park SA 5042
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Michael Shanahan
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Address
Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
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none
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Country [1]
305998
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305885
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The Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
305885
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The Southern Adelaide Clinical Human Research Ethics Committee
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Ethics committee country [1]
305885
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Australia
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Date submitted for ethics approval [1]
305885
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06/04/2020
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Approval date [1]
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30/04/2020
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Ethics approval number [1]
305885
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Summary
Brief summary
Frozen shoulder or adhesive capsulitis is a relatively common condition which results in significant pain and loss of function. Despite its prevalence it is poorly understood. The cause of frozen shoulder is unknown, and treatment options are limited. Additionally the impact on individuals suffering from a frozen shoulder is poorly characterised. Anecdotally the impact of this condition can be severe with marked pain experience and prolonged loss of function, potentially resulting in significant psychological and socioeconomic impacts for individuals effected by the condition.
This study aims to better understand the impact of frozen shoulder on people who have recently suffered from the condition. By interviewing individuals using a phenomenological approach we aim to get a deeper understanding of the lived experience of people who have recently suffered from this poorly understood disease.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Michael Shanahan
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Address
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Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
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Australia
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Phone
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+61 88204 6429
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Suellen Lyne
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Address
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Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
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Australia
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Phone
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+61 88204 6429
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Suellen Lyne
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Address
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Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
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Country
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Australia
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Phone
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+61 88204 6429
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Given the qualitative nature of the study, IPD will be difficult to share publicly
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7809
Informed consent form
[email protected]
Contact study contact to access PCIF Suellen Lyn...
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Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Living with a frozen shoulder - a phenomenological inquiry.
2022
https://dx.doi.org/10.1186/s12891-022-05251-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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