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

NCT04757740 | Completed Phase 4

• 1 other identifier: D240
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

sacroiliac joint; platelet rich fibrin; ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Pain assessment by VAS score

  5 minutes after procedure

• Pain assessment by VAS score

  1 week after procedure

• Pain assessment by VAS score

  3 month after procedure

• Pain assessment by VAS score

  6 month after procedure

• Modified Oswestry Disability Index

  1 month after procedure

Study Arms (2)

Platelet rich fibrin Group

ACTIVE COMPARATOR

Platelet rich fibrin. Group P

Biological: intra-articular Platelet rich fibrin and lidocaine

Methylprednisolone acetate

ACTIVE COMPARATOR

Group S

Drug: methylprednisolone acetate and lidocaine

Interventions

intra-articular Platelet rich fibrin and lidocaine BIOLOGICAL

intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.

Also known as: Platelet rich fibrin Group

Platelet rich fibrin Group

methylprednisolone acetate and lidocaine DRUG

intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid

Also known as: Steroid group

Methylprednisolone acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Lidocaine; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohamed A Alsaeid, MD

  Fayoum University Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

EG (1)