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

NCT04808336 | Completed

• 1 other identifier: 19719NEUS6
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 1-Visual analogue scale. ,

  VAS Visual analogue scale: According to the VAS, the pain severity was calculated by the patients on a scale of 0 (no pain) to 10 (agonising pain)

  12 months

• 2-The Persian Functional Rating Index (FRI )

  The Persian Functional Rating Index (FRI ), which is an accurate and valid instrument that contains 10 items that measure both pain and function, with an impairment score ranging from 0% (no disability) to 100% (severe disability) 2- The Persian Functional Rating Index (FRI ), which is an accurate and valid instrument that contains 10 items that measure both pain and function, with an impairment score ranging from 0% (no disability) to 100% (severe disability)

  12 months

Secondary Outcomes (2)

• Oswestry Disability Index (ODI) for low back pain

  12 months

• The Roland-Morris questionnaire

  12 months

Study Arms (2)

PRP injection group

ACTIVE COMPARATOR

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

Other: PRP injection.

surgical group..

ACTIVE COMPARATOR

Group 2: thirty patients underwent surgery

Procedure: fixation surgical procedure

Interventions

PRP injection. 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,

PRP injection group

fixation surgical procedure PROCEDURE

Group 2: thirty patients underwent surgery

surgical group..

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Dalia Saif

Shebien Elkom, 11311, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Rheumatology at faculty of medicine Menoufia University

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 22, 2021
• Study Start: March 26, 2019
• Primary Completion: May 2, 2020
• Study Completion: May 26, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

EG (1)