Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
intra-articular Platelet rich fibrin and lidocaine
methylprednisolone acetate and lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring sacroiliac joint, platelet rich fibrin, ultrasound-guided
Eligibility Criteria
Inclusion Criteria:
- Patient aged >18 years with Low back pain > 6 months.
- Failure of conservative treatment for 3 months.
- Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression & distraction test.
- Positive diagnostic injection (pain reduction >80% after injection).
Exclusion Criteria:
- Patient refusal.
- Disorders in the hip joint.
- Signs of lumbar radiculopathy.
- Bleeding disorders including anticoagulation medications.
- Positive response to Kemp's test (pain provocation test for sciatica).
- Infection at site of injection.
- Psychiatric problems as prevent completion of the study related questionnaires.
- Morbid obesity BMI > 40.
- Severe cardiac and respiratory disorders.
Sites / Locations
- Fayoum University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Platelet rich fibrin Group
Methylprednisolone acetate
Arm Description
Platelet rich fibrin. Group P
Group S
Outcomes
Primary Outcome Measures
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Secondary Outcome Measures
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Modified Oswestry Disability Index
to assess level of disability.
Modified Oswestry Disability Index
to assess level of disability.
Patient satisfaction with procedure
Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)
patient discomfort with procedure
yes or no question
hematoma
procedure related complication
Allergy
procedure related complication
Age
In years
weight
In kilograms
Height
In meters
BMI
In kilogram per square meter
Analgesic requirement after injection
analgesic dose needed after procedure
Full Information
NCT ID
NCT04757740
First Posted
February 14, 2021
Last Updated
July 25, 2022
Sponsor
Fayoum University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04757740
Brief Title
Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction
Official Title
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population.
The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks.
Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided.
Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities.
Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint.
Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process.
The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets.
Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint.
Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.
Detailed Description
Patient preparation:
History taking, physical examination, provocation tests (Gaenslen's test, Patrick's test, and Compression & distraction test), and investigations will be done according to the local protocol designed to evaluate these patients. This includes complete blood count, random blood glucose, serum creatinine & electrolytes, liver function tests, coagulation profile, and electrocardiogram (ECG).
Before the intervention, the participants will be informed about the visual analog scale (VAS) pain score (0-100 mm) (where 0=no pain and 100 = worst comprehensible pain) and the details of the procedures.
The patient will receive Midazolam 2 mg intravenous (IV) as a premedication. Intravenous access will be obtained with a 20-gauge intravenous (IV) cannula and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure) will be applied.
We will use a high-frequency ultrasound probe .and a 22-gauge, 50 mm echogenic needle for performing the injection.
Injectable platelet-rich fibrin (iPRF) preparation:
blood collection will be done from the patient on the day of intervention in a 9 ml blank tube. Within maximum 2:3minutes from sampling, it will be placed in the horizontal centrifuge for a low-speed centrifuge for 8 minutes at 600 rpm 44 g. Upon termination of this process, the Orange color area in the tube (i-PRF) and the remaining blood materials below will be noticed. Then, the tubes will be opened cautiously to avoid remixing, 2.5 ml of i-PRF will be collected from the tubes using a 5ml syringe.
Ultrasound-guided technique:
The patient will be positioned in a prone position over a cushion and after -sterilization with povidone-iodine and draping, the probe will be positioned transversely over the 5th lumber spinous process then moving the probe downwards until sacrum can be identified. Then moving the probe slightly lateral till identifying the 1st posterior sacral foramina (seen as a break in the hyperechoic contour of the sacral wing) then moving the probe downwards till the 2nd posterior sacral foramina will be identified. Tilting the lateral part of the probe slightly upwards and visualizing lateral sacral crest, sacroiliac joint, and iliac bone. Using color Doppler to ensure the absence of vascularization at the injection site of the joint (if present moving the probe cranially or caudally until disappearance). after anesthetizing the skin with 2 ml of 2% lidocaine, the needle will be advanced in-plane to the joint and 0.1 ml of sterile water will be injected to ensure spread into sacroiliac joint by unidirectional flow with Color Doppler box then the 3.5 ml of 1% lidocaine and PRF mixture will be injected in the group (P) or 40 mg of methylprednisolone acetate (Depo-Medrol, Pfizer) (1 ml) and 1% lidocaine (2.5 ml) in the group (S).
Post-procedural care:
The Patient will be transferred to post-intervention care unit for 2 hours after the procedure monitoring heart rate, oxygen saturation, and any possible adverse effect then patients will be discharged to home with a prescription of Diclofenac potassium 50 mg tab three times daily (TID), diclofenac diethylamine gel topically TID and baclofen 10 mg tab TID.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
sacroiliac joint, platelet rich fibrin, ultrasound-guided
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich fibrin Group
Arm Type
Active Comparator
Arm Description
Platelet rich fibrin. Group P
Arm Title
Methylprednisolone acetate
Arm Type
Active Comparator
Arm Description
Group S
Intervention Type
Biological
Intervention Name(s)
intra-articular Platelet rich fibrin and lidocaine
Other Intervention Name(s)
Platelet rich fibrin Group
Intervention Description
intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.
Intervention Type
Drug
Intervention Name(s)
methylprednisolone acetate and lidocaine
Other Intervention Name(s)
Steroid group
Intervention Description
intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid
Primary Outcome Measure Information:
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
1 month after procedure
Secondary Outcome Measure Information:
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
5 minutes after procedure
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
1 week after procedure
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
3 month after procedure
Title
Pain assessment by VAS score
Description
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Time Frame
6 month after procedure
Title
Modified Oswestry Disability Index
Description
to assess level of disability.
Time Frame
1 month after procedure
Title
Modified Oswestry Disability Index
Description
to assess level of disability.
Time Frame
6 month after procedure
Title
Patient satisfaction with procedure
Description
Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)
Time Frame
1 month after procedure
Title
patient discomfort with procedure
Description
yes or no question
Time Frame
5 minutes after procedure
Title
hematoma
Description
procedure related complication
Time Frame
5 minutes after procedure
Title
Allergy
Description
procedure related complication
Time Frame
10 minutes after procedure
Title
Age
Description
In years
Time Frame
5 minutes before procedure
Title
weight
Description
In kilograms
Time Frame
5 minutes before procedure
Title
Height
Description
In meters
Time Frame
5 minutes before procedure
Title
BMI
Description
In kilogram per square meter
Time Frame
5 minutes before procedure
Title
Analgesic requirement after injection
Description
analgesic dose needed after procedure
Time Frame
1 day after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged >18 years with Low back pain > 6 months.
Failure of conservative treatment for 3 months.
Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression & distraction test.
Positive diagnostic injection (pain reduction >80% after injection).
Exclusion Criteria:
Patient refusal.
Disorders in the hip joint.
Signs of lumbar radiculopathy.
Bleeding disorders including anticoagulation medications.
Positive response to Kemp's test (pain provocation test for sciatica).
Infection at site of injection.
Psychiatric problems as prevent completion of the study related questionnaires.
Morbid obesity BMI > 40.
Severe cardiac and respiratory disorders.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr H Mahmoud, Msc
Phone
00201004349592
Email
Ah1240@FAYOUM.EDU.EG
First Name & Middle Initial & Last Name or Official Title & Degree
Maged L Bolous, MD
Phone
00201222468054
Email
mlb00@fayoum.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Alsaeid, MD
Organizational Affiliation
Fayoum University Hospitals
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University hospital
City
Madīnat al Fayyūm
State/Province
Faiyum Governorate
ZIP/Postal Code
63514
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Yassin, MD.
Phone
1111363602
Ext
+20
Email
hmy00@fayoum.edu.eg
First Name & Middle Initial & Last Name & Degree
Yasser S Mostafa, M.Sc.
Phone
1010509735
Ext
+20
Email
ysm03@fayoum.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction
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