Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04757740 |
| Other study ID # |
D240 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Fayoum University Hospital |
| Contact |
Amr H Mahmoud, Msc |
| Phone |
00201004349592 |
| Email |
Ah1240[@]FAYOUM.EDU.EG |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
