Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.

Menoufia University

Status: Completed

Conditions: Degenerative Spondylolisthesis G1

Treatments: Procedure: fixation surgical procedure; Other: PRP injection.

Study type: Interventional

Funder types: Other

Identifiers

NCT04808336

19719NEUS6

Details and patient eligibility

About

Spondylolisthesis is a serious health condition that is often treated with surgery or pain-relieving lumbar epidural steroids. Patients with persistent and debilitating symptoms who have failed to respond to conservative treatment should consider surgery.

Objectives: The aim of this study was to compare the therapeutic efficacy of three ultrasound guided PRP injections of the facet joint capsule to surgical procedures in patients with degenerative spondylolisthesis G1 and their effect on neurogenic pain relief and functional improvement over a one-year follow-up period.

Methods:

A one-year prospective randomised comparative clinical trial was performed on 60 patients with degenerative spondylolisthesis G1 who were randomly assigned to one of two groups: Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals, and Group 2: thirty patients underwent surgery. They were exposed to clinical neuropsychological testing.They were assessed for pain and function using clinical neurological assessments, VAS (Visual Analogue Scale), FRI (Functional Rating Index), Roland Morris, and ODI.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with degenerative spondylolithesis Grade 1 were diagnosed based on their clinical and radiological image.
• Patients complained of extreme pain and received medical treatment (NSAIDS) without improvement.

Exclusion criteria

• Patients with more than two-level pathological lesions and those who had previously
• Patients undergone lumbar surgery,
• HCV, HBV infected patients,
• patients with local abscesses,
• diabetes mellitus,
• malignancy, pregnancy,
• blood disorders (coagulopathy, thrombocytopenia),
• patients who had previously received local injection of steroid within past 3 weeks
• Patients who had undergone lumbar surgery,
• patients with advanced spondylolithesis, disc prolapse,
• inflammatory or musculoskeletal disorders of the spine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

PRP injection group

Active Comparator group

Description:

Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals,

Treatment:

Other: PRP injection.

surgical group..

Active Comparator group

Description:

Group 2: thirty patients underwent surgery

Treatment:

Procedure: fixation surgical procedure