Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction

Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study)

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Biological: intra-articular Platelet rich fibrin and lidocaine; Drug: methylprednisolone acetate and lidocaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amr H Mahmoud, Msc; Phone Number: 00201004349592; Email: Ah1240@FAYOUM.EDU.EG
• Study Contact Backup: Name: Maged L Bolous, MD; Phone Number: 00201222468054; Email: mlb00@fayoum.edu.eg

Study Locations

• Egypt
  • Faiyum Governorate
    • Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
      • Recruiting
      • Fayoum University Hospital
      • Contact: Hany M Yassin, MD.; Phone Number: +20 1111363602; Email: hmy00@fayoum.edu.eg
      • Contact: Yasser S Mostafa, M.Sc.; Phone Number: +20 1010509735; Email: ysm03@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient aged >18 years with Low back pain > 6 months.
2. Failure of conservative treatment for 3 months.
3. Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression & distraction test.
4. Positive diagnostic injection (pain reduction >80% after injection).

Exclusion Criteria:

1. Patient refusal.
2. Disorders in the hip joint.
3. Signs of lumbar radiculopathy.
4. Bleeding disorders including anticoagulation medications.
5. Positive response to Kemp's test (pain provocation test for sciatica).
6. Infection at site of injection.
7. Psychiatric problems as prevent completion of the study related questionnaires.
8. Morbid obesity BMI > 40.
9. Severe cardiac and respiratory disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet rich fibrin Group; Platelet rich fibrin. Group P	Biological: intra-articular Platelet rich fibrin and lidocaine; intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.; Other Names: Platelet rich fibrin Group
Active Comparator: Methylprednisolone acetate; Group S	Drug: methylprednisolone acetate and lidocaine; intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid; Other Names: Steroid group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment by VAS score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	1 month after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment by VAS score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	5 minutes after procedure
Pain assessment by VAS score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	1 week after procedure
Pain assessment by VAS score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	3 month after procedure
Pain assessment by VAS score	the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain	6 month after procedure
Modified Oswestry Disability Index	to assess level of disability.	1 month after procedure
Modified Oswestry Disability Index	to assess level of disability.	6 month after procedure
Patient satisfaction with procedure	Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)	1 month after procedure
patient discomfort with procedure	yes or no question	5 minutes after procedure
hematoma	procedure related complication	5 minutes after procedure
Allergy	procedure related complication	10 minutes after procedure
Age	In years	5 minutes before procedure
weight	In kilograms	5 minutes before procedure
Height	In meters	5 minutes before procedure
BMI	In kilogram per square meter	5 minutes before procedure
Analgesic requirement after injection	analgesic dose needed after procedure	1 day after procedure

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Study Director: Mohamed A Alsaeid, MD, Fayoum University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound-guided; platelet rich fibrin; sacroiliac joint
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Back Pain; Low Back Pain; Joint Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Lidocaine
• Other Study ID Numbers: D240

Drug and device information, study documents

• 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