Trial Review

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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
Scientific title
Living with a Frozen Shoulder – a Qualitative Study Exploring the Experience of People with Adhesive Capsulitis
Secondary ID [1] 301142 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frozen Shoulder 317256 0
Adhesive Capsulitis 317257 0
Condition category
Condition code
Musculoskeletal 315390 315390 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 317447 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323635 0
Exploring the lived experience of frozen shoulder determined during semi-structured qualitative interview
Timepoint [1] 323635 0
During a once off interview
Secondary outcome [1] 382444 0
The impact of living with frozen shoulder on a person's emotions, identified during qualitative interview
Timepoint [1] 382444 0
During a once off interview
Secondary outcome [2] 383290 0
The impact of living with frozen shoulder on a person's professional work, identified during qualitative interview
Timepoint [2] 383290 0
During a once off interview
Secondary outcome [3] 383291 0
The impact of living with frozen shoulder on interpersonal relationships, identified during qualitative interview
Timepoint [3] 383291 0
During a once off interview

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Of those involved in the prior study we believe none will need to be excluded from this project

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/06/2020
Date of last participant enrolment
Anticipated
30/07/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16587 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30176 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305585 0
University
Name [1] 305585 0
Flinders University
Country [1] 305585 0
Australia
Primary sponsor type
Individual
Name
Professor Michael Shanahan
Address
Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 305998 0
None
Name [1] 305998 0
none
Address [1] 305998 0
none
Country [1] 305998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305885 0
The Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 305885 0
The Southern Adelaide Clinical Human Research Ethics Committee
Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Ethics committee country [1] 305885 0
Australia
Date submitted for ethics approval [1] 305885 0
06/04/2020
Approval date [1] 305885 0
30/04/2020
Ethics approval number [1] 305885 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101934 0
Prof Michael Shanahan
Address 101934 0
Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 101934 0
Australia
Phone 101934 0
+61 88204 6429
Fax 101934 0
Email 101934 0
Michael.Shanahan@sa.gov.au
Contact person for public queries
Name 101935 0
Dr Suellen Lyne
Address 101935 0
Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 101935 0
Australia
Phone 101935 0
+61 88204 6429
Fax 101935 0
Email 101935 0
suellen.lyne@sa.gov.au
Contact person for scientific queries
Name 101936 0
Dr Suellen Lyne
Address 101936 0
Rheumatology Department
Level 2, Flinders Medical Centre
Flinders Drive, Bedford Park, SA 5042
Country 101936 0
Australia
Phone 101936 0
+61 88204 6429
Fax 101936 0
Email 101936 0
suellen.lyne@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given the qualitative nature of the study, IPD will be difficult to share publicly


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form  Suellen.Lyne@sa.gov.au Contact study contact to access PCIF Suellen Lyn... [More Details]


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLiving with a frozen shoulder - a phenomenological inquiry.2022https://dx.doi.org/10.1186/s12891-022-05251-7
N.B. These documents automatically identified may not have been verified by the study sponsor.