UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056603 |
|---|---|
| Receipt number | R000064471 |
| Scientific Title | Prolotherapy Injection Using Platelet-Rich Plasma for Patients Suffering from Chronic Sacroiliac Pain |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2024/12/30 00:44:22 |
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Basic information
Public title
Prolotherapy Injection Using Platelet-Rich Plasma for Patients Suffering from Chronic Sacroiliac Pain
Acronym
Platelet-Rich Plasma for Sacroiliac Pain
Scientific Title
Prolotherapy Injection Using Platelet-Rich Plasma for Patients Suffering from Chronic Sacroiliac Pain
Scientific Title:Acronym
Platelet-Rich Plasma for Sacroiliac Pain
Region
| Africa |
Condition
Condition
Completed
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial was to compare the effectiveness of prolotherapy using platelet-rich plasma (PRP) versus Dextrose 25% in the management of chronic sacroiliac (SI) pain.
The primary outcome measure was the numerical pain scale (NPS) after prolotherapy injection of the conventional regimen and PRP. A 50% reduction in pain from the baseline measurement was taken as the cutoff indicator of pain relief.
Secondary outcomes that were measured during this study include physical functioning through the Oswestry Disability Index (ODI), rescue analgesic consumption, and the economic cost of SI pain management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The numerical pain scale (NPS) is the primary target outcome, which will be measures as baseline during the first interview, 1.5 months, 3 months and 6 months after injection.
Key secondary outcomes
Oswestry Disability Index (ODI), rescue analgesic consumption, and the economic cost.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Platelet-rich plasma
Interventions/Control_2
Dextrose 25%
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Target patients were those in whom the sacroiliac joint was the prominent source of low back pain.
Key exclusion criteria
Patients under the age of 30 years and those over the age of 90 years
Local infection in the sacroiliac joint region
Coagulation disorder
Poorly controlled diabetes mellitus
Autoimmune disorders
Mental and psychiatric disorders
Lost to follow-up
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mahmoud |
| Middle name | Abdel-Qawy |
| Last name | Al-Abd |
Organization
Faculty of Medicine, Menoufia University
Division name
Department of Anesthesiology, Intensive care and Pain management
Zip code
32511
Address
Egypt, Menofia Governorate, Shebin El-Kom city
TEL
+201098223176
mahmoud.kawy.abd@gmail.com
Public contact
Name of contact person
| 1st name | Mahmoud |
| Middle name | Abdel-Qawy |
| Last name | Al-Abd |
Organization
Faculty of Medicine, Menoufia University
Division name
Department of Anesthesiology, Intensive care and Pain management
Zip code
32511
Address
Egypt, Menofia Governorate, Shebin El-Kom city
TEL
+201098223176
Homepage URL
mahmoud.kawy.abd@gmail.com
Sponsor or person
Institute
Faculty of Medicine, Menoufia University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Menoufia University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Menoufia University
Address
Egypt, Menofia Governorate, Shebin El-Kom city, Yassin Abdel Ghaffar St- from Gamal Abdel Anasar St
Tel
0482330325
medcine@menofia.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064471
