Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757740
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2021-02-14
Brief Title:
Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction Randomized Comparative Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Gaenslens test Patricks 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 0no 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 23minutes 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 25 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 01 ml of sterile water will be injected to ensure spread into sacroiliac joint by unidirectional flow with Color Doppler box then the 35 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 25 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
History taking physical examination provocation tests Gaenslens test Patricks 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 0no 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 23minutes 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 25 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 01 ml of sterile water will be injected to ensure spread into sacroiliac joint by unidirectional flow with Color Doppler box then the 35 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 25 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None