Degenerative Spondylolisthesis G1NCT04808336
Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
A study testing PRP injection. and fixation surgical procedure in people with Degenerative Spondylolisthesis G1, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Degenerative Spondylolisthesis G1
- What is being tested?
- PRP injection. and fixation surgical procedure
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2019to 26 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- PRP injection., fixation surgical procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 procedureProcedure or surgery
Group 2: thirty patients underwent surgery
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Other: PRP injection. |
| surgical group.. | Active comparator | Group 2: thirty patients underwent surgery Receives: Procedure: fixation surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start26 Mar 2019
- Primary completion2 May 2020
- Study completion26 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Spondylolisthesis G1Studies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Salah Saif, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808336
- Sponsor's protocol ID
- 19719NEUS6
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma Injection Versus Surgical Fixation Procedure in Management of Spondylolisthesis grade1.
- ClinicalTrials.gov ID
- NCT04808336
- Acronym / sponsor ID
- 19719NEUS6
- Conditions
- Degenerative Spondylolisthesis G1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP injection group | Active comparator | Other: 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, |
| surgical group.. | Active comparator | Procedure: fixation surgical procedureGroup 2: thirty patients underwent surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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, | Other | PRP injection group |
| fixation surgical procedureGroup 2: thirty patients underwent surgery | Procedure or surgery | surgical group.. |
Primary outcome
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-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)
2 secondary outcomes
Oswestry Disability Index (ODI) for low back pain
Time frame: 12 months
The Roland-Morris questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
Related trials for Degenerative Spondylolisthesis G1
Active, not recruiting
Multicenter Clinical Randomized Controlled Trial of Unilateral Biportal Endoscopic Spinal Surgery for Degenerative Grade 1 Spondylolisthesis Complicated With Lumbar Spinal Stenosis
Lumbar Spinal Stenosis (LSS), Degenerative Spondylolisthesis G1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection. and fixation surgical procedure in people with Degenerative Spondylolisthesis G1, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Visual analogue scale. , (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.