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Completed

NCT Number: NCT04808336

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

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.

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Key information

Conditions

Degenerative Spondylolisthesis G1

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dalia Saif

Shebien Elkom, 11311, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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,

fixation surgical procedure

Procedure

Group 2: thirty patients underwent surgery

Primary outcomes

  1. 1-Visual analogue scale. ,

    Time frame: 12 months

    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)

  2. 2-The Persian Functional Rating Index (FRI )

    Time frame: 12 months

    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)

Secondary outcomes

  1. Oswestry Disability Index (ODI) for low back pain

    Time frame: 12 months

    Assessment of pain-related disability using the Oswestry Disability Index (ODI) for low back pain, which categorises disability as minimal (0-20), mild (20-40), extreme (40-60), ODI of 60-80 suggests that the patient is crippled, and ODI of 80-100 implies that the patient is either bed-ridden or exaggerating his or her complaints

  2. The Roland-Morris questionnaire

    Time frame: 12 months

    The Roland-Morris questionnaire is a 24-item self-report checklist that assesses the extent at which low-back pain affects daily activities. Since each question is implies one point, scores will range from 0 (no disability) to 24 (severe disability)

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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