Lumbar Facet Joint SyndromePhase 3PRPNCT04860531
The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease
A Phase 3 study testing Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma and Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone in people with Lumbar Facet Joint Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Lumbar Facet Joint Syndrome
- What is being tested?
- Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma and Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2019to 22 Jan 2021
- Phase
- Phase 3
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Continuous or intermittent gradually progressive back pain for more than 3 months not significantly improving on medical treatment and/or physical modalities.
- Patients age between 20 and 40 years.
- Local / paraspinal pain or tenderness with or without radiation to buttock , groin or thigh.
- Increase of pain on extension , rotation or lateral bending .
- MRI detected synovitis of the facet joint as defined and graded by Czervionke and Fenton, 2008.
Who cannot join
- • Acute low back trauma, fractures, malignancies and inflammatory diseases.
- Pain score of < 4 at rest on visual analog scale.
- Radicular neurologic complaints.
- X-ray findings of long standing facet joint disease as; marked joint space narrowing, subchondral sclerosis or bone deformity/ sponylolithesis.
- Evident disc herniation by MRI.
- Prior surgery on the spine.
Show all 12Show fewer
- Prior interventional treatment on lumbar facet joints
- Known hypersenstivity to local anesthesia, corticosteroid, contrast medium or blood derivatives.
- Local or systemic infection or spinal infection.
- Uncorrectable coagulopathy
- Diabetes Mellitus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Intra-articular Injection of Autologous Platelet Rich Plasma Versus Corticosteriods in Treatment of Synovitis in Lumbar Facet Joint Disease
Low back pain is an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.
Read the detailed description
The study is conducted upon Thirty patients who present to Ain Shams University hospitals outpatient clinic complaining of chronic low back pain diagnosed to have potential lumbar facet joint syndrome.
Intervention
After taking informed written consent the recruited patients will be subjected to the following:
- History:
- Clinical Examination:
- Full history taking
- Thorough clinical examination to exclude radicular or neurological manifestation (motor weakness, incontinence, etc.)
- Analysis of pain using:
- low back pain visual analogue scale (VAS) at rest: VAS is a subjective numerical pain rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain ever experienced.
- Roland-Morris Disability Questionnaire (RMQ), as experienced by the patient in the last 24 hours, of a total score of 24, where a score of 0 represented no disability and a score of 24 represented the maximum disability .
- - Oswestry Disability Index (ODI), ODI is currently considered as the gold standard for measuring degree of disability and estimating quality of life in a patient with low back pain. The ODI is comprised of 10 items which reflect the patient's ability to manage their everyday life while dealing with their pain. Each item in the ODI had 6 options to represent a score from 0 to 5, where choice of the first option of the 6 scores 0 and the last scores 5. A percentage score is calculated: total score of the patient/ max score possible x 100%. A 10% change has been identified as being clinically meaningful. The result had 5 levels:
- minimal disability (0% - 20%)
- moderate disability (21% - 40%)
- severe disability (41% - 60%)
- crippled (61% - 80%)
- bed-bound or exaggerating symptoms (81% - 100%)(Fairbank et al., 1980). II. Radiological investigation.
Magnetic Resonance Imaging : Done by a single consultant radiologist to detect and grade facet joint synovitis according to the following grading system :
0 : No signal abnormality
- : Signal abnormality confined to joint capsule
- : Periarticular signal abnormality involving less than 50 % of the perimeter of the joint*
- : Periarticular signal abnormality involving more than 50 % of the perimeter of the joint *
- : Grade 3 with extension of signal abnormality into the intervertebral foramen, ligamentum flavum, pedicle, transverse process, or vertebral body.
- Signal abnormality may extend into the articular pillar or lamina but does not contribute to the definition of the grade
- The participants will be randomly assigned for intra-articular injection to either; Group (I) (n =15) to be injected with autologous platelet rich plasma and Group (II) (n=15) to be injected with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
III. Preparation of Autologous PRP
Under sterile conditions, about 20 ml of peripheral venous blood will be collected with addition of sodium citrate to the test tube. The PRP will be prepared based on the standard 2-step centrifugation method:
- . The sample is first centrifuged at 1800 rpm for 15 min to separate erythrocytes.
- Serum supernatant is subjected to the second centrifugation at 3500 rpm for 10 minutes to remove part of the platelet poor plasma and concentrate the platelets.
Finally, approximately 2 to 4 mL of buffy coat autologous PRP is collected in a clear syringe for fluoroscopy guided injection as soon as possible.
IV. Lumbar Facet Joint Injection Injection will be performed under supervision of an experienced pain physician, X-ray guided under fluoroscopy. The site for needle penetration will be marked at the intersection of the beam of a C-arm - a device used to guide the needle to a specific area while watching that needle on a live x-ray screen- and the skin.
Standard antisepsis of the skin will be applied, local anesthesia with 0.5% lidocaine will be administered followed by a 21-G spinal needle insertion into the facet joint space under fluoroscopic control, then the targeted joint will be injected with approximately 0.5 mL of autologous PRP in the first group and with 0.5 to 1 ml of a mixture of 0.5% lidocaine and 5mg/ml of betamethasone in the second group. Multiple joints can be injected in the same setting according to our decision depending on clinical examination and MRI findings.
- Follow-up and Clinical Evaluation All the patients will be followed at 3 months after the injection and no anti-inflammatory treatment will be given to the patients during the follow up period.
- Clinical evaluation: criteria and scales:
- low back pain visual analogue scale (VAS) at rest .
- Roland-Morris Disability Questionnaire (RMQ).
- Oswestry Disability Index (ODI).
- Magnetic Resonance Imaging For facet joint synovitis detection and grading in the injected joints
Data Management and Analysis:
The collected data is coded, tabulated, and statistically analyzed using SPSS program (Statistical Package for Social Sciences) software version 17.0.
Descriptive statistics will be done for numerical parametric data as mean +/-SD (standard deviation) and minimum \& maximum of the range and for numerical non parametric data as median and 1st\& 3rd inter-quartile range, while they will be done for categorical data as number and percentage.
Inferential analyses will be done for quantitative variables using independent t-test in cases of two independent groups with parametric data and Mann Whitney U in cases of two independent groups with non parametric data.
Inferential analyses will be done for qualitative data using Chi square test for independent groups. The level of significance will be taken at P value <0.050 is significant, otherwise is non significant. The p-value is a statistical measure for the probability that the results observed in a study could occur by chance.
Ethics:
The study is approved from the Ethical committee of the department of physical medicine , rehabilitation and rheumatology, faculty of medicine, Ain shams university and from the Research Ethical Committee (REC) Ain shams University.
- Conditions
- Lumbar Facet Joint Syndrome
- Being tested
- Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma, Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone
- Keywords
- Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Facet Joints intra-articular injection with Platelet Rich PlasmaDrug
Floroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints
Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasoneDrug
Lumbar Facet Joints intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Group (I) Platelet Rich Plasma | Active comparator | The participants are randomly assigned for intra-articular injection with autologous platelet rich plasma . The treated segments are determined by clinical signs and MRI detected facet joint synovitis . Receives: Drug: Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma |
| Group (II) Corticosteroids | Active comparator | The participants are randomly assigned for intra-articular injection with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis . Receives: Drug: Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of total Number of lumbar facet joints showing tenderness on palpation in each participant documented just before the intervention and at 3 month after the intervention
Measured: at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Maximum active lumber extension measured by goniometer in each participants documented just before the intervention and at 3 month after the intervention
Measured: at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Visual analogue score documented just before the intervention and at 3 month after the intervention where score of 0 denotes absence of pain and score of 10 denotes maximum pain and decrease in the sore denotes improvement as regards low back pain reported by the participants
Measured: at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Roland Morris Disability questionnaire score (RMQ) documented just before the intervention and at 3 month after the intervention, where score 0 denotes absence of any disability and score of 24 denotes maximum disability of the participants and decrease in the score documented denotes improvement
Measured: at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Oswestry Disability Index score (ODI) documented just before the intervention and at 3 month after the intervention, where score of 0% denotes fully functional participants and score of 100% denotes maximum functional affection and decrease of the score by 10% denotes significant improvement
Measured: at 3 month follow up post intervention for each patient
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing number of lumbar facet joints showing synovitis on MRI and/or improving the grade of severity of the synovitis
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of number of lumbar facet joints showing synovitis on MRI and/or improving (decrease in) the grade of severity of the synovitis graded from 0 to 4 according to the extent of lumber facet joint synovitis on MRI documented just before the intervention and at 3 month after the intervention
Measured: at 3 month follow up post intervention for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start17 Sep 2019
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lumbar Facet Joint SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants are assigned for intra-articular injection of lumbar facet joint to either; Group (I) to be injected with autologous platelet rich plasma and Group (II) to be injected with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahdan Yousry Abdelmonem Kotb, Ain Shams University
- Investigators
- Nahed Monir, Professor, Study director, Faculty of Medicine Ain Shams UniversityHala Abdelhady, Professor, Study director, Faculty of Medicine Ain Shams UniversitySahar Fathy, Professor, Study director, Faculty of Medicine Ain Shams UniversityHossam Sakr, Study director, Faculty of Medicine Ain Shams UniversityMohamed Taeimah, MD, Study director, Faculty of Medicine Ain Shams UniversityShahdan Kotb, Principal investigator, Faculty of Medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860531
- Sponsor's protocol ID
- FMASU MD 222 / 2017
- Acronym
- PRP
- Status last verified
- May 2021
- First submitted
- 3 Jan 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu J, Du Z, Lv Y, Zhang J, Xiong W, Wang R, Liu R, Zhang G, Liu Q. A New Technique for the Treatment of Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma. Pain Physician. 2016 Nov-Dec;19(8):617-625.
PubMed 27906940Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.
PubMed 27989008Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
PubMed 6450426Czervionke LF, Fenton DS. Fat-saturated MR imaging in the detection of inflammatory facet arthropathy (facet synovitis) in the lumbar spine. Pain Med. 2008 May-Jun;9(4):400-6. doi: 10.1111/j.1526-4637.2007.00313.x.
PubMed 18489631Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
PubMed 17325518Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
PubMed 6222486Sae-Jung S, Jirarattanaphochai K. Outcomes of lumbar facet syndrome treated with oral diclofenac or methylprednisolone facet injection: a randomized trial. Int Orthop. 2016 Jun;40(6):1091-8. doi: 10.1007/s00264-016-3154-y. Epub 2016 Mar 18.
PubMed 26987980Zhang J, Middleton KK, Fu FH, Im HJ, Wang JH. HGF mediates the anti-inflammatory effects of PRP on injured tendons. PLoS One. 2013 Jun 28;8(6):e67303. doi: 10.1371/journal.pone.0067303. Print 2013.
PubMed 23840657Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
PubMed 24665116Maas ET, Juch JN, Ostelo RW, Groeneweg JG, Kallewaard JW, Koes BW, Verhagen AP, Huygen FJ, van Tulder MW. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints. Eur J Pain. 2017 Mar;21(3):403-414. doi: 10.1002/ejp.963. Epub 2016 Oct 10.
PubMed 27723170Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010 Jul-Aug;13(4):E215-64.
PubMed 20648212Kotb SY, Sherif NM, Saleh HA, Ahmed SF, Sakr HM, Taeimah MO. The role of intra-articular injection of autologous platelet-rich plasma versus corticosteroids in the treatment of synovitis in lumbar facet joint disease. Saudi Med J. 2022 Nov;43(11):1200-1208. doi: 10.15537/smj.2022.43.11.20220449.
PubMed 36379530
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intra-articular Injection of Autologous Platelet Rich Plasma Versus Corticosteriods in Treatment of Synovitis in Lumbar Facet Joint Disease
- ClinicalTrials.gov ID
- NCT04860531
- Acronym / sponsor ID
- PRP / FMASU MD 222 / 2017
- Conditions
- Lumbar Facet Joint Syndrome
- Keywords
- Platelet Rich Plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 27 Apr 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 an extremely common health problem and recent studies have shown that nearly up to 52% of patients have low back pain caused by lumbar facet joint syndrome. Intra-articular injection of facet joints has gradually become one of the vital therapeutic methods for lumbar facet joint syndrome, Steroid is one of the most commonly used injected drugs; however, previous studies have indicated that it has limited ability in long-term relief of low back pain. Therefore, it seems meaningful to apply a new injectable drug and to prove its effectiveness and safety for the treatment of lumbar facet joint syndrome. Recent studies indicate that autologous platelet rich plasma(PRP) is an appropriate injectable material with great potential in treating many different musculoskeletal disorders and currently it is not yet used on a wide scale as a treatment for lumbar facet joint synovitis. In this study the investigators compare the efficacy and safety of Intra-articular injection of PRP versus conventional steriods in patients with lumbar facet joint synovitis.
Detailed description
The study is conducted upon Thirty patients who present to Ain Shams University hospitals outpatient clinic complaining of chronic low back pain diagnosed to have potential lumbar facet joint syndrome.
Intervention
After taking informed written consent the recruited patients will be subjected to the following:
- History:
- Clinical Examination:
- Full history taking
- Thorough clinical examination to exclude radicular or neurological manifestation (motor weakness, incontinence, etc.)
- Analysis of pain using:
- low back pain visual analogue scale (VAS) at rest: VAS is a subjective numerical pain rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain ever experienced.
- Roland-Morris Disability Questionnaire (RMQ), as experienced by the patient in the last 24 hours, of a total score of 24, where a score of 0 represented no disability and a score of 24 represented the maximum disability .
- - Oswestry Disability Index (ODI), ODI is currently considered as the gold standard for measuring degree of disability and estimating quality of life in a patient with low back pain. The ODI is comprised of 10 items which reflect the patient's ability to manage their everyday life while dealing with their pain. Each item in the ODI had 6 options to represent a score from 0 to 5, where choice of the first option of the 6 scores 0 and the last scores 5. A percentage score is calculated: total score of the patient/ max score possible x 100%. A 10% change has been identified as being clinically meaningful. The result had 5 levels:
- minimal disability (0% - 20%)
- moderate disability (21% - 40%)
- severe disability (41% - 60%)
- crippled (61% - 80%)
- bed-bound or exaggerating symptoms (81% - 100%)(Fairbank et al., 1980). II. Radiological investigation.
Magnetic Resonance Imaging : Done by a single consultant radiologist to detect and grade facet joint synovitis according to the following grading system :
0 : No signal abnormality
- : Signal abnormality confined to joint capsule
- : Periarticular signal abnormality involving less than 50 % of the perimeter of the joint*
- : Periarticular signal abnormality involving more than 50 % of the perimeter of the joint *
- : Grade 3 with extension of signal abnormality into the intervertebral foramen, ligamentum flavum, pedicle, transverse process, or vertebral body.
- Signal abnormality may extend into the articular pillar or lamina but does not contribute to the definition of the grade
- The participants will be randomly assigned for intra-articular injection to either; Group (I) (n =15) to be injected with autologous platelet rich plasma and Group (II) (n=15) to be injected with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
III. Preparation of Autologous PRP
Under sterile conditions, about 20 ml of peripheral venous blood will be collected with addition of sodium citrate to the test tube. The PRP will be prepared based on the standard 2-step centrifugation method:
- . The sample is first centrifuged at 1800 rpm for 15 min to separate erythrocytes.
- Serum supernatant is subjected to the second centrifugation at 3500 rpm for 10 minutes to remove part of the platelet poor plasma and concentrate the platelets.
Finally, approximately 2 to 4 mL of buffy coat autologous PRP is collected in a clear syringe for fluoroscopy guided injection as soon as possible.
IV. Lumbar Facet Joint Injection Injection will be performed under supervision of an experienced pain physician, X-ray guided under fluoroscopy. The site for needle penetration will be marked at the intersection of the beam of a C-arm - a device used to guide the needle to a specific area while watching that needle on a live x-ray screen- and the skin.
Standard antisepsis of the skin will be applied, local anesthesia with 0.5% lidocaine will be administered followed by a 21-G spinal needle insertion into the facet joint space under fluoroscopic control, then the targeted joint will be injected with approximately 0.5 mL of autologous PRP in the first group and with 0.5 to 1 ml of a mixture of 0.5% lidocaine and 5mg/ml of betamethasone in the second group. Multiple joints can be injected in the same setting according to our decision depending on clinical examination and MRI findings.
- Follow-up and Clinical Evaluation All the patients will be followed at 3 months after the injection and no anti-inflammatory treatment will be given to the patients during the follow up period.
- Clinical evaluation: criteria and scales:
- low back pain visual analogue scale (VAS) at rest .
- Roland-Morris Disability Questionnaire (RMQ).
- Oswestry Disability Index (ODI).
- Magnetic Resonance Imaging For facet joint synovitis detection and grading in the injected joints
Data Management and Analysis:
The collected data is coded, tabulated, and statistically analyzed using SPSS program (Statistical Package for Social Sciences) software version 17.0.
Descriptive statistics will be done for numerical parametric data as mean +/-SD (standard deviation) and minimum \& maximum of the range and for numerical non parametric data as median and 1st\& 3rd inter-quartile range, while they will be done for categorical data as number and percentage.
Inferential analyses will be done for quantitative variables using independent t-test in cases of two independent groups with parametric data and Mann Whitney U in cases of two independent groups with non parametric data.
Inferential analyses will be done for qualitative data using Chi square test for independent groups. The level of significance will be taken at P value <0.050 is significant, otherwise is non significant. The p-value is a statistical measure for the probability that the results observed in a study could occur by chance.
Ethics:
The study is approved from the Ethical committee of the department of physical medicine , rehabilitation and rheumatology, faculty of medicine, Ain shams university and from the Research Ethical Committee (REC) Ain shams University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants are assigned for intra-articular injection of lumbar facet joint to either; Group (I) to be injected with autologous platelet rich plasma and Group (II) to be injected with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis .
| Arm | Type | Receives |
|---|---|---|
| Group (I) Platelet Rich Plasma | Active comparator | Drug: Lumbar Facet Joints intra-articular injection with Platelet Rich PlasmaThe participants are randomly assigned for intra-articular injection with autologous platelet rich plasma . The treated segments are determined by clinical signs and MRI detected facet joint synovitis . |
| Group (II) Corticosteroids | Active comparator | Drug: Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasoneThe participants are randomly assigned for intra-articular injection with corticosteroids(a mixture of 0.5% lidocaine and 5mg/ml of betamethasone) . The treated segments will be determined by clinical signs and MRI detected facet joint synovitis . |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Continuous or intermittent gradually progressive back pain for more than 3 months not significantly improving on medical treatment and/or physical modalities.
Key exclusion criteria (12 listed)
- • Acute low back trauma, fractures, malignancies and inflammatory diseases.
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 |
|---|---|---|
| Lumbar Facet Joints intra-articular injection with Platelet Rich PlasmaFloroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints | Drug | Group (I) Platelet Rich Plasma |
| Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasoneLumbar Facet Joints intra-articular injection | Drug | Group (II) Corticosteroids |
Primary outcome
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of total Number of lumbar facet joints showing tenderness on palpation in each participant documented just before the intervention and at 3 month after the intervention
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Maximum active lumber extension measured by goniometer in each participants documented just before the intervention and at 3 month after the intervention
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Visual analogue score documented just before the intervention and at 3 month after the intervention where score of 0 denotes absence of pain and score of 10 denotes maximum pain and decrease in the sore denotes improvement as regards low back pain reported by the participants
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Roland Morris Disability questionnaire score (RMQ) documented just before the intervention and at 3 month after the intervention, where score 0 denotes absence of any disability and score of 24 denotes maximum disability of the participants and decrease in the score documented denotes improvement
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of Oswestry Disability Index score (ODI) documented just before the intervention and at 3 month after the intervention, where score of 0% denotes fully functional participants and score of 100% denotes maximum functional affection and decrease of the score by 10% denotes significant improvement
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing number of lumbar facet joints showing synovitis on MRI and/or improving the grade of severity of the synovitis
Time frame: at 3 month follow up post intervention for each patient
In patients complaining of low back pain due to lumbar facet joint disease the investigator asses the efficacy of intra-articular injection of Platelet rich plasma compared to corticosteroids based on comparative analysis of number of lumbar facet joints showing synovitis on MRI and/or improving (decrease in) the grade of severity of the synovitis graded from 0 to 4 according to the extent of lumber facet joint synovitis on MRI documented just before the intervention and at 3 month after the intervention
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 4 May 2021.
- Background: PubMed 27906940Wu J, Du Z, Lv Y, Zhang J, Xiong W, Wang R, Liu R, Zhang G, Liu Q. A New Technique for the Treatment of Lumbar Facet Joint Syndrome Using Intra-articular Injection with Autologous Platelet Rich Plasma. Pain Physician. 2016 Nov-Dec;19(8):617-625.
- Background: PubMed 27989008Wu J, Zhou J, Liu C, Zhang J, Xiong W, Lv Y, Liu R, Wang R, Du Z, Zhang G, Liu Q. A Prospective Study Comparing Platelet-Rich Plasma and Local Anesthetic (LA)/Corticosteroid in Intra-Articular Injection for the Treatment of Lumbar Facet Joint Syndrome. Pain Pract. 2017 Sep;17(7):914-924. doi: 10.1111/papr.12544. Epub 2017 Feb 22.
- Background: PubMed 6450426Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
- Background: PubMed 18489631Czervionke LF, Fenton DS. Fat-saturated MR imaging in the detection of inflammatory facet arthropathy (facet synovitis) in the lumbar spine. Pain Med. 2008 May-Jun;9(4):400-6. doi: 10.1111/j.1526-4637.2007.00313.x.
- Background: PubMed 17325518Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
- Background: PubMed 6222486Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.
- Background: PubMed 26987980Sae-Jung S, Jirarattanaphochai K. Outcomes of lumbar facet syndrome treated with oral diclofenac or methylprednisolone facet injection: a randomized trial. Int Orthop. 2016 Jun;40(6):1091-8. doi: 10.1007/s00264-016-3154-y. Epub 2016 Mar 18.
- Background: PubMed 23840657Zhang J, Middleton KK, Fu FH, Im HJ, Wang JH. HGF mediates the anti-inflammatory effects of PRP on injured tendons. PLoS One. 2013 Jun 28;8(6):e67303. doi: 10.1371/journal.pone.0067303. Print 2013.
- Background: PubMed 24665116Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
- Background: PubMed 27723170Maas ET, Juch JN, Ostelo RW, Groeneweg JG, Kallewaard JW, Koes BW, Verhagen AP, Huygen FJ, van Tulder MW. Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints. Eur J Pain. 2017 Mar;21(3):403-414. doi: 10.1002/ejp.963. Epub 2016 Oct 10.
- Background: PubMed 20648212Manchikanti L, Datta S, Gupta S, Munglani R, Bryce DA, Ward SP, Benyamin RM, Sharma ML, Helm S 2nd, Fellows B, Hirsch JA. A critical review of the American Pain Society clinical practice guidelines for interventional techniques: part 2. Therapeutic interventions. Pain Physician. 2010 Jul-Aug;13(4):E215-64.
- Derived from this study: PubMed 36379530Kotb SY, Sherif NM, Saleh HA, Ahmed SF, Sakr HM, Taeimah MO. The role of intra-articular injection of autologous platelet-rich plasma versus corticosteroids in the treatment of synovitis in lumbar facet joint disease. Saudi Med J. 2022 Nov;43(11):1200-1208. doi: 10.15537/smj.2022.43.11.20220449.
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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.
Nahed Monir, Professor study director
Faculty of Medicine Ain Shams University
Hala Abdelhady, Professor study director
Faculty of Medicine Ain Shams University
Sahar Fathy, Professor study director
Faculty of Medicine Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma and Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone in people with Lumbar Facet Joint Syndrome, run by Ain Shams 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 5 inclusion and 12 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 4 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing total number of lumbar facet joints showing tenderness on palpation on clinical examination (time frame: at 3 month follow up post intervention for each patient). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860531, which also lists 12 linked publications.
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 4 May 2021.