Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000618752
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
26/04/2022
Date last updated
26/04/2022
Date data sharing statement initially provided
26/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Steroid versus platelet-rich plasma (PRP) injection for frozen shoulder (STIFF) Trial
Scientific title
Patient-reported outcomes following platelet-rich plasma (PRP) compared to corticosteroid intra-articular injection for treatment of adhesive capsulitis: A randomised controlled trial
Secondary ID [1] 306536 0
nil
Universal Trial Number (UTN)
Trial acronym
STIFF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adhesive capsulitis shoulder (frozen shoulder) 325420 0
Condition category
Condition code
Musculoskeletal 322811 322811 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intra-articular platelet-rich plasma injection
6mL of PRP (centrifuged at 580 g, 2000 RPM for 8 minutes) combined with 0.25mL calcium chloride for platelet activation.
Administered once, except in the case of ongoing pain (>50% baseline pain at 6 weeks) when repeat injection may be offerred up to 12 weeks later. In case of ongoing pain beyond the repeat injection, participants will be offered blinded crossover treatment at 6 months.
Intervention code [1] 322962 0
Treatment: Other
Comparator / control treatment
Intra-articular corticosteroid injection
1 mL of 40 mg Triamcinalone + 5mL saline
Administered once, except in the case of ongoing pain (>50% baseline pain at 6 weeks) when repeat injection may be offerred up to 12 weeks later. In case of ongoing pain beyond the repeat injection, participants will be offered blinded crossover treatment at 6 months.
Control group
Active

Outcomes
Primary outcome [1] 330593 0
Disabilities of the Arm, Shoulder and Hand shortened version (QuickDASH) Score
Timepoint [1] 330593 0
2 weeks, 12 weeks, 6 months and 1 year (primary timepoint) post-injection.
Primary outcome [2] 330594 0
Visual Analogue Score (VAS) for Pain
Timepoint [2] 330594 0
2 weeks, 12 weeks, 6 months and 1 year (primary timepoint) post-injection.
Primary outcome [3] 330595 0
Shoulder Pain and Disability Index (SPADI) Total Score.
Timepoint [3] 330595 0
2 weeks, 12 weeks, 6 months and 1 year (primary timepoint) post-injection.
Secondary outcome [1] 406863 0
VAS (Visual Analogue Score) for Normal feeling
Timepoint [1] 406863 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [2] 406864 0
Shoulder Pain and Disability Index (SPADI) Pain subscale score
Timepoint [2] 406864 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [3] 406865 0
Shoulder Pain and Disability Index (SPADI) Disability subscale score
Timepoint [3] 406865 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [4] 406866 0
Disabilities of the Arm, Shoulder and Hand shortened version (QuickDASH) Symptoms score
Timepoint [4] 406866 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [5] 406867 0
Disabilities of the Arm, Shoulder and Hand shortened version (QuickDASH) Function score
Timepoint [5] 406867 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [6] 406868 0
Socrates Patient Satisfaction Total Score
Timepoint [6] 406868 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [7] 406871 0
Response (4-point scale) to Socrates Patient Satisfaction questionnaire item "Would you have the operation or treatment again if needed on another joint?"
Timepoint [7] 406871 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [8] 406873 0
Analgesia use
Patients are given paracetamol +/- codeine but no NSAIDs. Patients to keep a
logbook of their medication use.
Information from logbook/diary collected monthly by email or telephone/teleconference interview (according to patient preference). Primary source logbooks returned at the end of the study.
Timepoint [8] 406873 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.
Secondary outcome [9] 406876 0
Adverse events or complications
Patients keep a logbook of any adverse symptoms or events that might be
associated with the procedure.
Information from logbook/diary collected monthly by email or telephone/teleconference interview (according to patient preference). Primary source logbooks returned at the end of the study.
Recognised risks of shoulder injection (both corticosteroid and PRP) include:
*infection – mitigated by excluding patients with evidence of potential injection. By using
chlorhexidine skin prep, sterile field using dressing packs on surgical trolley, aseptic no-touch technique
• allergy – mitigated by asking for PMHx and having adrenaline and resuscitation equipment on site
• bleeding – ensure patient not anticoagulated or diagnosed with a bleeding diathesis,
• iatrogenic injury to surrounding structures – injections performed by trained clinicians using ultrasound guidance and through the posterior approach for safety and consistency.
Recognised risks of corticosteroid injection therapy also include:
• fat atrophy and skin depigmentation – mitigated by using USS to ensure CSI is given intraarticularly and not subcutaneously.
• hyperglycaemia – 48 hour close BGL monitoring and patient education.
Timepoint [9] 406876 0
2 weeks, 12 weeks, 6 months and 1 year post-injection.

Eligibility
Key inclusion criteria
• Patients aged 18 years or over living in Auckland region
• Specialist-confirmed diagnosis of adhesive capsulitis
• Shoulder pain and restricted range of motion in shoulder
• Symptoms between 1-12 months
• Shoulder radiograph and ultrasound scan. Radiology will document capsular thickness, bursal thickness, prevalence of co-existing calcific tendonitis, rotator cuff tendinopathy/minor tear or joint effusion. These findings are not exclusion criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Serious orthopaedic or medical co-morbidity including osteoarthritis, fracture, dislocation, massive rotator cuff tear, infection, malignancy, haematological disorder, chronic regional pain syndrome of the shoulder, crystal arthropathy of shoulder confirmed on previous aspirate, previous shoulder injection within 3 months
• Participants need to avoid steroids and non-steroidal anti-inflammatories (NSAID) in the week prior and week after their injection. This will be screened for during the consent process and immediately before the procedure. Patients using these medications will be deferred to a later procedure day when they haven’t used them for over one week prior.

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)
Allocation involves contacting the holder of the allocation schedule who is "off-site" upon confirmation of eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation (20 per block) using online randomisation (random.org) schedule generated prior to study onset and stored with patient names and study numbers in a password protected document within secured server, This is accessed off-site using virtual private network (VPN) access.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Opaque syringes prepared by clinical assistant who is not in contact with participants. The are labelled with participant study number only. Clinician checks participant study number on syringe against patient name before injecting.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Demographic & health data:
The following patient demographic data will be collected:
• Age, gender, BMI, ethnicity, duration of disease/symptoms (average months, <6months >6months), involved side (right/left, dominant/non dominant), stage of frozen shoulder (1/2), smoker, diabetes (yes/no), occupation (employed/unemployed, heavy/light), previous physiotherapy (yes/no), previous shoulder injection (yes/no), previous Steroid/NSAID use (yes/no), funding.
• Relevant previous medical history, comorbidities/diagnoses

Imaging data:
Imaging evaluations and findings are being collected prior to the intervention to assist in diagnosis and screening. Summary data will be incorporated into study variables and it could be associated with treatment prognosis.

Primary & secondary outcomes:
The primary outcomes are QuickDASH, VAS pain and SPADI total score changes. Secondary outcomes include changes in VAS normal feeling, SPADI pain and disability subscale scores, QuickDASH symptoms and function scores, and follow-up time point measures of patient satisfaction total score and relating to whether the patient would repeat the procedure on their other shoulder if required, and analgesia use. Adverse events, including post-intervention complications, are logged to record any differences in terms of safety outcomes and categorised as minor or serious.
Changes in primary outcome measures, and single time-point patient satisfaction will be compared between groups using equivalence statistical tests using two 1-sided t-test procedures for both equivalence limits, equivalent to a 90% confidence interval.
The equivalence tests will be supported by traditional difference statistical tests, reporting 95% confidence intervals for the difference between PRPI and CSI, to allow for the possibility that a clear difference between treatments might be observed. Traditional statistical analysis would utilise analysis of variance (ANOVA) for differences between PRPI and CSI in score changes over time, independent samples t-test for overall patient satisfaction score at each time point and total analgesia use throughout the study period, and Mann-Whitney test for patient satisfaction ‘have procedure again?’ score at each time-point. Differences between PRPI and CSI in occurrence of minor or serious adverse events will be determined by chi-square analysis. A preliminary cost benefit analysis of PRPI and CSI treatment will also be undertaken.

Stopping rules:
Interim difference statistical tests for primary outcome variables will be undertaken when 40, 60, and 80 participants have reached 12 week and 1 year follow-up points. A statistically significant between-group difference in at least 2 of the 3 primary outcome measures will result in the trial being terminated due to lost equipoise.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/05/2022
Actual
Date of last participant enrolment
Anticipated
29/09/2023
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 24621 0
New Zealand
State/province [1] 24621 0

Funding & Sponsors
Funding source category [1] 310876 0
Charities/Societies/Foundations
Name [1] 310876 0
The Wishbone Trust
Country [1] 310876 0
New Zealand
Primary sponsor type
Individual
Name
Dr Matthew Brick
Address
Orthosports North Harbour Limited
AUT Millennium
17 Antares Place
Rosedale
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 312147 0
None
Name [1] 312147 0
Address [1] 312147 0
Country [1] 312147 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310437 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310437 0
Ethics committee country [1] 310437 0
New Zealand
Date submitted for ethics approval [1] 310437 0
18/11/2021
Approval date [1] 310437 0
22/12/2021
Ethics approval number [1] 310437 0
2021 FULL 11764

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

Contacts
Principal investigator
Name 117666 0
Dr Jordan Davis
Address 117666 0
Orthosports North Harbour Limited
Orthopaedics and Musculoskeletal Medicine
AUT Millennium
17 Antares Place
Rosedale
Auckland 0632
Country 117666 0
New Zealand
Phone 117666 0
+64 21 0233 0501
Fax 117666 0
Email 117666 0
[email protected]
Contact person for public queries
Name 117667 0
Jordan Davis
Address 117667 0
Orthosports North Harbour Limited
Orthopaedics and Musculoskeletal Medicine
AUT Millennium
17 Antares Place
Rosedale
Auckland 0632
Country 117667 0
New Zealand
Phone 117667 0
+64 21 0233 0501
Fax 117667 0
Email 117667 0
[email protected]
Contact person for scientific queries
Name 117668 0
Jordan Davis
Address 117668 0
Orthosports North Harbour Limited
Orthopaedics and Musculoskeletal Medicine
AUT Millennium
17 Antares Place
Rosedale
Auckland 0632
Country 117668 0
New Zealand
Phone 117668 0
+64 21 0233 0501
Fax 117668 0
Email 117668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Fully deidentified data that uses a study number code, generated consecutively at recruitment, for unique identification. Primary and secondary outcomes measures at all time points and basic demographic information that limits the possibility of any individual being identified or linked with other data sets.
When will data be available (start and end dates)?
Approximately January 2025 to December 2035.
Available to whom?
People representing other research organisations.
Available for what types of analyses?
Non commercial scientific review or meta-analysis.
How or where can data be obtained?
Principal Investigator or Sponsor.
[email protected] OR
[email protected]


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.