Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000856516
Ethics application status
Approved
Date submitted
21/04/2024
Date registered
11/07/2024
Date last updated
11/07/2024
Date data sharing statement initially provided
11/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Corticosteroid versus Platelet Rich Plasma (PRP) in Sacroilitis
Scientific title
Comparative Efficacy of Intra-articular Corticosteroid vs. Autologous Platelet-Rich Plasma Injections for Sacroiliitis: A Randomized Controlled Trial
Secondary ID [1] 311837 0
Nil Known
Universal Trial Number (UTN)
U1111-1306-2039
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sacroilitis 333368 0
Backache 333369 0
Condition category
Condition code
Musculoskeletal 330055 330055 0 0
Other muscular and skeletal disorders
Anaesthesiology 330590 330590 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a comparative randomized controlled trial study,aim to compare the effectiveness of intra-articular corticosteroid injection with autologous platelet-rich plasma (PRP) injection among patients with sacroilitis. The patients will be divided into two groups that is Group A and Group B by lottery method. Group A will receive the Intraarticular Corticosteroid Injection and will be considered as control where as the Group B will receive the Autologus Platelet Rich Plasma Injection and will be considered as Intervention group.

Patient in each group will be given appointment for the day of procedure to be performed.
Group B Patients will receive Intraarticular Platelet Rich Plasma Injection. Before procedure patient's Platelets count will be checked and other heamotology related conditions including bleeding disorders will be ruled out. On the day of procedure, patient's vitals will be checked. After that Nursing Assistant will preload the Collecting Syringe with 1 ml Acid Citrate Dextrose. After adopting aseptic technique including wearing gloves and skin cleansing with Pyodine, 15 ml blood will be collected from the patient. Blood will be placed in Centrifuge machine. 1st soft spin will be given and then the hard spin. The heamatologist will collect the lower level of plasma along with buffy coat. Patient's Painful Sacroiliac joint will again be identified. Ligocaine gel will applied for 5 minutes. The aseptic techniques including the drapping and skin cleansing will follow. Patient will receive the Platelet Rich Plasma in affected joint only. The procedure will be performed by Consultant Doctor Physical Medicine and Rehabilitation. Patient will be retained in the Hospital fro next 30 minutes. The whole procedure starting from Patients in Group B reporting to hospital till allowing to leave will take 90 minutes.
Also all the processes will be performed under the supervision of researcher.
Intervention code [1] 328294 0
Treatment: Other
Comparator / control treatment
In Control group that is Group A, Patient will receive 40 mg Traimcinolone Acetate. Lignocaine gel will be applied for 5 minutes before the procedure performed. The procedure will be performed only once and it will take 45 minutes including the post injection 15 minutes rest time. The procedure will be performed by Consultant Physical Medicine and Rehabilitation.
Group A patients will receive Ultrasound guided Intra-articular Traimcinolone Acetate Injection, Before the procedure patient will be screen out for any blood disorder. After reporting patient's vitals will be checked. The painful Sacroiliac Joint will be identified and marked. Lignocaine gel will be applied for 5 minutes. Patient will drapped and aseptic measures have been taken including the skin preparation with Pyodine. Patient will injected with 40mg Traimcinolone Acetate with 27 guage Spinal Needle. Patient will be rested in the prone position for 30 minutes. The procedure for each patient in Group A will take 60 minutes.
Control group
Active

Outcomes
Primary outcome [1] 337837 0
Patient's perception of pain will be assessed using Numerical Rating Scale
Timepoint [1] 337837 0
Baseline (Pre Injection), 1 ,3 and 6 Months (Post Injection)
Primary outcome [2] 338740 0
Patient's Functional Level will be assessed using Oswestry Disability Index
Timepoint [2] 338740 0
Baseline (Pre Injection), 1 ,3 and 6 Months (Post Injection)
Secondary outcome [1] 437253 0
Patient quality of life assessed using 12-Item Short Form Survey (SF-12) questionnaire
Timepoint [1] 437253 0
Baseline (Pre Injection), 1 ,3 and 6 Months (Post Injection)

Eligibility
Key inclusion criteria
1. The diagnosis of sacroiliac joint dysfunction-related pain involved a combination of clinical assessments, imaging, and the exclusion of other potential pain sources alongside positive findings in at least three provocative tests, including Patrick’s test, compression test, distraction test, Gaenslen’s test, thigh thrust test, and pain upon applying pressure to the SI joint.
2. Age group from 18 to 70 years
3. Patients of both genders.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Sacroiliac joint dysfunction can be related to inflammatory and septic conditions or linked with spinal deformities such as scoliosis and kyphosis. Additionally, other spinal pathologies are ruled out during diagnosis.
2. Overlying soft tissue infection.
3. Uncontrolled diabetes mellitus.
4. Coagulation disorders
5. Patients Using Warfarin and Heparin
6. Inflammatory/Septic Arthritis

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 Concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 26225 0
Pakistan
State/province [1] 26225 0
Khyberpakhtunkhwa

Funding & Sponsors
Funding source category [1] 316184 0
Hospital
Name [1] 316184 0
Combined Military Hospital Kohat
Country [1] 316184 0
Pakistan
Primary sponsor type
Hospital
Name
Combined Military Hospital Kohat
Address
Country
Pakistan
Secondary sponsor category [1] 318368 0
None
Name [1] 318368 0
Address [1] 318368 0
Country [1] 318368 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315003 0
Ethical Review Committee, Combined Military Hospital, Kohat, Pakistan
Ethics committee address [1] 315003 0
Ethics committee country [1] 315003 0
Pakistan
Date submitted for ethics approval [1] 315003 0
01/11/2023
Approval date [1] 315003 0
15/12/2023
Ethics approval number [1] 315003 0
E-2005/A/115

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

Contacts
Principal investigator
Name 133390 0
Dr Syed Tameem Ul Hassan
Address 133390 0
Department of Physical Medicine and Rehabilitation, CHM, Cantt Rd, Kohat, Khyber Pakhtunkhwa 26280, Pakistan
Country 133390 0
Pakistan
Phone 133390 0
+923368885877
Fax 133390 0
Email 133390 0
[email protected]
Contact person for public queries
Name 133391 0
Syed Tameem Ul Hassan
Address 133391 0
DDepartment of Physical Medicine and Rehabilitation, CHM, Cantt Rd, Kohat, Khyber Pakhtunkhwa 26280, Pakistan
Country 133391 0
Pakistan
Phone 133391 0
+923368885877
Fax 133391 0
Email 133391 0
[email protected]
Contact person for scientific queries
Name 133392 0
Syed Tameem Ul Hassan
Address 133392 0
Department of Physical Medicine and Rehabilitation, CHM, Cantt Rd, Kohat, Khyber Pakhtunkhwa 26280, Pakistan
Country 133392 0
Pakistan
Phone 133392 0
+923368885877
Fax 133392 0
Email 133392 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?
Results and Outcomes
When will data be available (start and end dates)?
1-1-2026 to 1-1-2027
Available to whom?
Researchers and Doctors
Available for what types of analyses?
For comparison and Verification of results
How or where can data be obtained?
Data could be obtained via email to author that is via [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22017Ethical approval    387583-(Uploaded-21-04-2024-17-12-33)-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.