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

NCT ID: NCT04808336

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-26
• Study Completion Date: 2020-05-26

Brief Summary

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.

Conditions

Degenerative Spondylolisthesis G1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PRP injection group

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

Group Type: ACTIVE_COMPARATOR

PRP injection.

Intervention Type: OTHER

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

surgical group..

Group 2: thirty patients underwent surgery

Group Type: ACTIVE_COMPARATOR

fixation surgical procedure

Intervention Type: PROCEDURE

Group 2: thirty patients underwent surgery

Interventions

PRP injection.

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

Intervention Type: OTHER

fixation surgical procedure

Group 2: thirty patients underwent surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Salah Saif

lecturer of Rheumatology at faculty of medicine Menoufia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dalia Saif

Shebien Elkom, , Egypt

Countries

Egypt

Other Identifiers

19719NEUS6

Identifier Type: -

Identifier Source: org_study_id