Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001123831
Ethics application status
Approved
Date submitted
15/10/2012
Date registered
22/10/2012
Date last updated
29/04/2022
Date data sharing statement initially provided
29/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Frozen Shoulder Treatments – Conservative Approach Study Evaluation (FroST-CASE)
Scientific title
Does receiving regular physiotherapy intervention in frozen shoulder adults affect the rate of change in range of motion and pain?
Secondary ID [1] 281395 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute to subacute adhesive capsulitis 287632 0
Condition category
Condition code
Musculoskeletal 287962 287962 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 287963 287963 0 0
Physiotherapy
Inflammatory and Immune System 287964 287964 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electrical / heat therapy: Therapeutic ultrasound and/or hot pack.
Mobilisation techniques: Manual therapy - Grade III/IV caudal and/or anteroposterior glide(s) with/without combined movements.
Home exercise programme: Progressive range of motion (ROM) exercises.
Patient education on frozen shoulder and management rationale.
These interventions occur in every session.
1 x 30 minutes session per every 2 weeks for 6-12 weeks. Participant who's outcome improvements has stayed in status quo for 2 successive sessions (earlier than 12 weeks) will be considered by the treating physiotherapist to have completed the trial.
Mode: one-on-one sessions with physiotherapist.
Intervention code [1] 285873 0
Rehabilitation
Comparator / control treatment
Electrical therapy: Therapeutic ultrasound
Mobilisation techniques: Manual therapy.
Home exercise programme: Progressive ROM exercises.
Follow-up based on earliest available appointment,
1 x 20 minutes session per every 3 weeks for 6-12 weeks.
This active-control has shorter intervention time and patient education.
Control group
Active

Outcomes
Primary outcome [1] 288176 0
Shoulder range of motion (flexion, abduction, internal /external rotation, hand behind neck and hand behind back) measured with goniometer and prominent bony landmarks.
Timepoint [1] 288176 0
every 2 weeks up to 12th week or earlier (outcomes plateaued and exit from outpatient musculoskeletal service)
Secondary outcome [1] 299545 0
Pain numeric 10-point Likert-scale
Timepoint [1] 299545 0
every 2 weeks up to 12th week or earlier (outcomes plateaued and exit from outpatient musculoskeletal service)

Eligibility
Key inclusion criteria
Community dwelling adults
Diagnosed acute (3 months) and sub-acute (6 months) frozen shoulder
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive disorder
Fracture in healing phase
Cerebral haemorrhage and surgery within the past 3 months
Uncontrolled medical condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are diagnosed by the medical doctors and referred for physiotherapy management. They are allocated a physiotherapist at random by appointment administrators (unaware of the trial).
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
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
3/04/2013
Date of last participant enrolment
Anticipated
Actual
20/03/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
50
Accrual to date
Final
46
Recruitment outside Australia
Country [1] 4600 0
Singapore
State/province [1] 4600 0

Funding & Sponsors
Funding source category [1] 286149 0
Self funded/Unfunded
Name [1] 286149 0
Nil
Country [1] 286149 0
Primary sponsor type
Other Collaborative groups
Name
National Healthcare Group Polyclinics
Address
6 Commonwealth Lane #07-01/02
GMTI Building
S(149547)
Country
Singapore
Secondary sponsor category [1] 284958 0
None
Name [1] 284958 0
Address [1] 284958 0
Country [1] 284958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288205 0
National Healthcare Group DSRB
Ethics committee address [1] 288205 0
Ethics committee country [1] 288205 0
Singapore
Date submitted for ethics approval [1] 288205 0
17/10/2012
Approval date [1] 288205 0
14/03/2013
Ethics approval number [1] 288205 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34831 0
Mr Kwok Boon Chong
Address 34831 0
National Healthcare Group Polyclinics
3 Fusionpolis Link, Nexus@one-north
Singapore 138543
Country 34831 0
Singapore
Phone 34831 0
+65 6896 2289
Fax 34831 0
Email 34831 0
[email protected]
Contact person for public queries
Name 18078 0
Kwok Boon Chong
Address 18078 0
6 Commonwealth Lane #07-01/02
GMTI Building
S(149547)
Country 18078 0
Singapore
Phone 18078 0
+65, 68962289
Fax 18078 0
Email 18078 0
[email protected]
Contact person for scientific queries
Name 9006 0
Kwok Boon Chong
Address 9006 0
6 Commonwealth Lane #07-01/02
GMTI Building
S(149547)
Country 9006 0
Singapore
Phone 9006 0
+65, 68962289
Fax 9006 0
Email 9006 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?

No Supporting Document Provided



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.