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

Primary Purpose

Degenerative Spondylolisthesis G1

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PRP injection.
fixation surgical procedure
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Spondylolisthesis G1

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dalia Saif

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PRP injection group

surgical group..

Arm 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,

Group 2: thirty patients underwent surgery

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Oswestry Disability Index (ODI) for low back pain
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
The Roland-Morris questionnaire
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)

Full Information

First Posted
March 14, 2021
Last Updated
March 18, 2021
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04808336
Brief Title
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
Official Title
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
May 2, 2020 (Actual)
Study Completion Date
May 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Spondylolisthesis G1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP injection group
Arm Type
Active Comparator
Arm 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,
Arm Title
surgical group..
Arm Type
Active Comparator
Arm Description
Group 2: thirty patients underwent surgery
Intervention Type
Other
Intervention Name(s)
PRP injection.
Intervention 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,
Intervention Type
Procedure
Intervention Name(s)
fixation surgical procedure
Intervention Description
Group 2: thirty patients underwent surgery
Primary Outcome Measure Information:
Title
1-Visual analogue scale. ,
Description
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)
Time Frame
12 months
Title
2-The Persian Functional Rating Index (FRI )
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI) for low back pain
Description
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
Time Frame
12 months
Title
The Roland-Morris questionnaire
Description
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)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dalia Saif
City
Shebien Elkom
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

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

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