The Role of Intra-articular Injection of PRP Versus Corticosteriods in Treatment of Lumbar Facet Disease
Condition: Lumbar Facet Joint Syndrome
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): 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
Intervention type(s): Drug; Drug
Intervention description(s): Floroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints; Lumbar Facet Joints intra-articular injection
Intervention MeSH terms: Betamethasone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
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 .
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet Rich Plasma