Clinical trial NCT04860531: The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease
Official title: The Role of Intra-articular Injection of Autologous Platelet Rich Plasma Versus Corticosteriods in Treatment of Synovitis in Lumbar Facet Joint Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lumbar Facet Joint Syndrome
Keywords: Platelet Rich Plasma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 .
Primary purpose: TREATMENT

Brief 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 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:

1. History:

I. Clinical Examination:

1. Full history taking
2. Thorough clinical examination to exclude radicular or neurological manifestation (motor weakness, incontinence, etc.)
3. 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

1. : Signal abnormality confined to joint capsule
2. : Periarticular signal abnormality involving less than 50 % of the perimeter of the joint\*
3. : Periarticular signal abnormality involving more than 50 % of the perimeter of the joint \*
4. : 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:

1. . The sample is first centrifuged at 1800 rpm for 15 min to separate erythrocytes.
2. 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.

V. 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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.
  * 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

Primary outcomes:
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
timeFrame: at 3 month follow up post intervention for each patient
measure: The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing maximum active lumber extension angle measured by goniometer
timeFrame: at 3 month follow up post intervention for each patient
measure: The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing the Visual analogue score (VAS)
timeFrame: at 3 month follow up post intervention for each patient
measure: The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Roland Morris Disability questionnaire score (RMQ)
timeFrame: at 3 month follow up post intervention for each patient
measure: The Efficacy of lumbar facet joints intra-articular injection of PRP versus conventional Corticosteroids in changing Functional questionnaire score - Oswestry Disability Index ODI
timeFrame: at 3 month follow up post intervention for each patient
measure: 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
timeFrame: at 3 month follow up post intervention for each patient
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Nahed Monir, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Ain Shams University
name: Hala Abdelhady, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Ain Shams University
name: Sahar Fathy, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Ain Shams University
name: Hossam Sakr
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Ain Shams University
name: Mohamed Taeimah, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Ain Shams University
name: Shahdan Kotb
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kotb 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.