Degenerative Spondylolisthesis G1 Clinical Trial
Official title:
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
| NCT number | NCT04808336 |
| Other study ID # | 19719NEUS6 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 26, 2019 |
| Est. completion date | May 26, 2020 |
| Verified date | March 2021 |
| Source | Menoufia University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | May 26, 2020 |
| Est. primary completion date | May 2, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Dalia Saif | Shebien Elkom |
| Lead Sponsor | Collaborator |
|---|---|
| Menoufia University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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 | 12 months | |
| Secondary | 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) | 12 months |