Low Back PainPhase 4NCT04757740
Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction
A Phase 4 study testing intra-articular Platelet rich fibrin and lidocaine and methylprednisolone acetate and lidocaine in people with Low Back Pain, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- intra-articular Platelet rich fibrin and lidocaine and methylprednisolone acetate and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 1 Mar 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged >18 years with Low back pain > 6 months.
- Failure of conservative treatment for 3 months.
- Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression \& distraction test.
- Positive diagnostic injection (pain reduction >80% after injection).
Who cannot join
- Patient refusal.
- Disorders in the hip joint.
- Signs of lumbar radiculopathy.
- Bleeding disorders including anticoagulation medications.
- Positive response to Kemp's test (pain provocation test for sciatica).
- Infection at site of injection.
Show all 9Show fewer
- Psychiatric problems as prevent completion of the study related questionnaires.
- Morbid obesity BMI > 40.
- Severe cardiac and respiratory disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study)
Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population.
The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks.
Read more
Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided.
Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities.
Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint.
Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process.
The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets.
Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint.
Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.
Read the detailed description
Patient preparation:
History taking, physical examination, provocation tests (Gaenslen's test, Patrick's test, and Compression \& distraction test), and investigations will be done according to the local protocol designed to evaluate these patients. This includes complete blood count, random blood glucose, serum creatinine \& electrolytes, liver function tests, coagulation profile, and electrocardiogram (ECG).
Before the intervention, the participants will be informed about the visual analog scale (VAS) pain score (0-100 mm) (where 0=no pain and 100 = worst comprehensible pain) and the details of the procedures.
The patient will receive Midazolam 2 mg intravenous (IV) as a premedication. Intravenous access will be obtained with a 20-gauge intravenous (IV) cannula and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure) will be applied.
We will use a high-frequency ultrasound probe .and a 22-gauge, 50 mm echogenic needle for performing the injection.
Injectable platelet-rich fibrin (iPRF) preparation:
blood collection will be done from the patient on the day of intervention in a 9 ml blank tube. Within maximum 2:3minutes from sampling, it will be placed in the horizontal centrifuge for a low-speed centrifuge for 8 minutes at 600 rpm 44 g. Upon termination of this process, the Orange color area in the tube (i-PRF) and the remaining blood materials below will be noticed. Then, the tubes will be opened cautiously to avoid remixing, 2.5 ml of i-PRF will be collected from the tubes using a 5ml syringe.
Ultrasound-guided technique:
The patient will be positioned in a prone position over a cushion and after -sterilization with povidone-iodine and draping, the probe will be positioned transversely over the 5th lumber spinous process then moving the probe downwards until sacrum can be identified. Then moving the probe slightly lateral till identifying the 1st posterior sacral foramina (seen as a break in the hyperechoic contour of the sacral wing) then moving the probe downwards till the 2nd posterior sacral foramina will be identified. Tilting the lateral part of the probe slightly upwards and visualizing lateral sacral crest, sacroiliac joint, and iliac bone. Using color Doppler to ensure the absence of vascularization at the injection site of the joint (if present moving the probe cranially or caudally until disappearance). after anesthetizing the skin with 2 ml of 2% lidocaine, the needle will be advanced in-plane to the joint and 0.1 ml of sterile water will be injected to ensure spread into sacroiliac joint by unidirectional flow with Color Doppler box then the 3.5 ml of 1% lidocaine and PRF mixture will be injected in the group (P) or 40 mg of methylprednisolone acetate (Depo-Medrol, Pfizer) (1 ml) and 1% lidocaine (2.5 ml) in the group (S).
Post-procedural care:
The Patient will be transferred to post-intervention care unit for 2 hours after the procedure monitoring heart rate, oxygen saturation, and any possible adverse effect then patients will be discharged to home with a prescription of Diclofenac potassium 50 mg tab three times daily (TID), diclofenac diethylamine gel topically TID and baclofen 10 mg tab TID.
- Conditions
- Low Back Pain
- Being tested
- intra-articular Platelet rich fibrin and lidocaine, methylprednisolone acetate and lidocaine
- Keywords
- sacroiliac joint, platelet rich fibrin, ultrasound-guided
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular Platelet rich fibrin and lidocaineBiological
Also called Platelet rich fibrin Group
intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.
methylprednisolone acetate and lidocaineDrug
Also called Steroid group
intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich fibrin Group | Active comparator | Platelet rich fibrin. Group P Receives: Biological: intra-articular Platelet rich fibrin and lidocaine |
| Methylprednisolone acetate | Active comparator | Group S Receives: Drug: methylprednisolone acetate and lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Measured: 1 month after procedure
Secondary outcomes (15)
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Measured: 5 minutes after procedure
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Measured: 1 week after procedure
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Measured: 3 month after procedure
Pain assessment by VAS score
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
Measured: 6 month after procedure
Modified Oswestry Disability Index
to assess level of disability.
Measured: 1 month after procedure
Modified Oswestry Disability Index
to assess level of disability.
Measured: 6 month after procedure
Patient satisfaction with procedure
Will be evaluated according to a satisfaction score (poor = 0; fair = 1; good = 2; excellent= 3)
Measured: 1 month after procedure
patient discomfort with procedure
yes or no question
Measured: 5 minutes after procedure
hematoma
procedure related complication
Measured: 5 minutes after procedure
Allergy
procedure related complication
Measured: 10 minutes after procedure
Age
In years
Measured: 5 minutes before procedure
weight
In kilograms
Measured: 5 minutes before procedure
Height
In meters
Measured: 5 minutes before procedure
BMI
In kilogram per square meter
Measured: 5 minutes before procedure
Analgesic requirement after injection
analgesic dose needed after procedure
Measured: 1 day after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr hamdy Mahmoud, Fayoum University Hospital
- Investigators
- Mohamed A Alsaeid, MD, Study director, Fayoum University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757740
- Sponsor's protocol ID
- D240
- Status last verified
- Jul 2024
- First submitted
- 14 Feb 2021
- Last updated
- 9 Jul 2024
- 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 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet Rich Fibrin Versus Steroid in Ultrasound-Guided Sacroiliac Joint Injection for Joint Dysfunction (Randomized Comparative Study)
- ClinicalTrials.gov ID
- NCT04757740
- Acronym / sponsor ID
- D240
- Conditions
- Low Back Pain
- Keywords
- sacroiliac joint, platelet rich fibrin, ultrasound-guided
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 17 Feb 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.
Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population.
The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks.
Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided.
Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities.
Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint.
Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process.
The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets.
Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint.
Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.
Detailed description
Patient preparation:
History taking, physical examination, provocation tests (Gaenslen's test, Patrick's test, and Compression \& distraction test), and investigations will be done according to the local protocol designed to evaluate these patients. This includes complete blood count, random blood glucose, serum creatinine \& electrolytes, liver function tests, coagulation profile, and electrocardiogram (ECG).
Before the intervention, the participants will be informed about the visual analog scale (VAS) pain score (0-100 mm) (where 0=no pain and 100 = worst comprehensible pain) and the details of the procedures.
The patient will receive Midazolam 2 mg intravenous (IV) as a premedication. Intravenous access will be obtained with a 20-gauge intravenous (IV) cannula and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure) will be applied.
We will use a high-frequency ultrasound probe .and a 22-gauge, 50 mm echogenic needle for performing the injection.
Injectable platelet-rich fibrin (iPRF) preparation:
blood collection will be done from the patient on the day of intervention in a 9 ml blank tube. Within maximum 2:3minutes from sampling, it will be placed in the horizontal centrifuge for a low-speed centrifuge for 8 minutes at 600 rpm 44 g. Upon termination of this process, the Orange color area in the tube (i-PRF) and the remaining blood materials below will be noticed. Then, the tubes will be opened cautiously to avoid remixing, 2.5 ml of i-PRF will be collected from the tubes using a 5ml syringe.
Ultrasound-guided technique:
The patient will be positioned in a prone position over a cushion and after -sterilization with povidone-iodine and draping, the probe will be positioned transversely over the 5th lumber spinous process then moving the probe downwards until sacrum can be identified. Then moving the probe slightly lateral till identifying the 1st posterior sacral foramina (seen as a break in the hyperechoic contour of the sacral wing) then moving the probe downwards till the 2nd posterior sacral foramina will be identified. Tilting the lateral part of the probe slightly upwards and visualizing lateral sacral crest, sacroiliac joint, and iliac bone. Using color Doppler to ensure the absence of vascularization at the injection site of the joint (if present moving the probe cranially or caudally until disappearance). after anesthetizing the skin with 2 ml of 2% lidocaine, the needle will be advanced in-plane to the joint and 0.1 ml of sterile water will be injected to ensure spread into sacroiliac joint by unidirectional flow with Color Doppler box then the 3.5 ml of 1% lidocaine and PRF mixture will be injected in the group (P) or 40 mg of methylprednisolone acetate (Depo-Medrol, Pfizer) (1 ml) and 1% lidocaine (2.5 ml) in the group (S).
Post-procedural care:
The Patient will be transferred to post-intervention care unit for 2 hours after the procedure monitoring heart rate, oxygen saturation, and any possible adverse effect then patients will be discharged to home with a prescription of Diclofenac potassium 50 mg tab three times daily (TID), diclofenac diethylamine gel topically TID and baclofen 10 mg tab TID.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich fibrin Group | Active comparator | Biological: intra-articular Platelet rich fibrin and lidocainePlatelet rich fibrin. Group P |
| Methylprednisolone acetate | Active comparator | Drug: methylprednisolone acetate and lidocaineGroup S |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged >18 years with Low back pain > 6 months.
- Failure of conservative treatment for 3 months.
- Positive findings on at least one of three provocation tests for sacroiliac joint pain: Gaenslen's test, Patrick's test, and compression \& distraction test.
- Positive diagnostic injection (pain reduction >80% after injection).
Key exclusion criteria (9 listed)
- Patient refusal.
- Disorders in the hip joint.
- Signs of lumbar radiculopathy.
- Bleeding disorders including anticoagulation medications.
- Positive response to Kemp's test (pain provocation test for sciatica).
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 |
|---|---|---|
| intra-articular Platelet rich fibrin and lidocaineAlso: Platelet rich fibrin Groupintra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture. | Biological | Platelet rich fibrin Group |
| methylprednisolone acetate and lidocaineAlso: Steroid groupintra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid | Drug | Methylprednisolone acetate |
Primary outcome
Pain assessment by VAS score
Time frame: 1 month after procedure
the quality of analgesia between (0-100 mm) where 0=no pain and 100 = worst comprehensible pain
15 secondary outcomes
Pain assessment by VAS score
Time frame: 5 minutes after procedure
Pain assessment by VAS score
Time frame: 1 week after procedure
Pain assessment by VAS score
Time frame: 3 month after procedure
Pain assessment by VAS score
Time frame: 6 month after procedure
Modified Oswestry Disability Index
Time frame: 1 month after procedure
Modified Oswestry Disability Index
Time frame: 6 month after procedure
Patient satisfaction with procedure
Time frame: 1 month after procedure
patient discomfort with procedure
Time frame: 5 minutes after procedure
hematoma
Time frame: 5 minutes after procedure
Allergy
Time frame: 10 minutes after procedure
Age
Time frame: 5 minutes before procedure
weight
Time frame: 5 minutes before procedure
Height
Time frame: 5 minutes before procedure
BMI
Time frame: 5 minutes before procedure
Analgesic requirement after injection
Time frame: 1 day after procedure
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 9 Jul 2024.
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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.
Mohamed A Alsaeid, MD study director
Fayoum University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intra-articular Platelet rich fibrin and lidocaine and methylprednisolone acetate and lidocaine in people with Low Back Pain, run by Fayoum University Hospital 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 4 inclusion and 9 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 9 Jul 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain assessment by VAS score (time frame: 1 month after procedure). 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 9 Jul 2024.