Steroid Versus Platelet Rich Plasma Injection for Chronic Low Back Pain
Condition: Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      Chronic low back pain, with or without lower extremity pain, which arises from various
      structures of the spine constitutes a majority of pain complaints. The sacroiliac joint (SIJ)
      has been implicated as the primary source of pain in 10% to 27% of patients with mechanical
      low back pain below L5 vertebra. The common causes of SIJ pain include a trauma like direct
      fall on the buttocks, a rear-end or broad-side type motor vehicle accident, and an
      unanticipated step into a hole or from a miscalculated height, fusion surgery, anterior
      dislocation, inflammatory and degenerative sacroiliac joint disease and idiopathic. The
      treatment of SIJ pain remains a therapeutic challenge. Besides physiotherapy and systemic
      therapies including non-steroidal anti-inflammatory drugs (NSAIDs) and biologic agents,
      intra-articular and peri articular injections of SIJ, radiofrequency neurotomy and surgical
      fusion are often performed for pain relief. However, the success of these interventions has
      been determined according to the therapeutic efficacy and correct placement of the drug. The
      image guidance of SIJ injections seems to be important due to the complex anatomy of the
      joint causing a low accuracy when performed according to clinical judgement only. The
      feasibility of ultrasound (USG) guided injection of SIJ has recently been demonstrated
      resulting in very high success rates up to 90%. Various agents being used in SIJ injections
      include local anaesthetics, corticosteroid, botulinum toxin-A, 12.5% dextrose,
      phenol-glycerine-glucose (P2G) and sodium morrhuate (cod liver oil extract). SIJ steroid
      injection is commonly used technique and has been found to be effective to treat SIJ pain.
      However, the main drawback is short term effect. Borowsky et al reported improvement in
      visual analog score (VAS) of 14.1% and reduction of VAS ≥ 50% in only 12.50% patients at 3
      months after intra-articular steroid (2 mL 0.5% bupivacaine plus 40 mg methylprednisolone)
      SIJ injection. Treatment modalities being currently used do not, in general, address the
      disease process itself, there is clearly a need to investigate treatments that are more
      widely applicable for symptom management and which may also directly address the disease
      process itself. Current research efforts aim at modifying the rate of healing of joint by
      using biological healing factors which are various growth factors (transforming growth
      factor, vascular endothelial growth factor, fibroblast growth factor, epidermal growth
      factor, platelet derived growth factor etc.) found abundantly in the human blood especially
      in platelets. The platelet rich plasma (PRP) is an ideal autologous biological blood-derived
      product, which can be exogenously applied to various tissues where it releases high
      concentrations of platelet derived growth factors that enhance the body's natural healing
      response. In addition PRP possesses antimicrobial properties that may contribute to the
      prevention of infections. PRP is now being widely tested in different fields of medicine for
      its possibilities in aiding the regeneration of tissue with low healing potential. Local
      injection of PRP is a new modality which has been effectively used for the treatment of
      Achilles tendon injury in athletes, chronic epicondylar tendinopathy, chronic patellar
      tendinosis, rotator cuff tear, anterior cruciate ligament injury, gonoarthrosis and plantar
      fasciitis. The intra-articular injection of PRP into knee joint has been found to reduce the
      incidence of local inflammatory changes in early knee osteoarthritis. Recently, PRP has been
      used for low back pain caused by SIJ laxity showing significant improvement in pain scores.
      However, there is no study at present comparing the efficacy of intra-articular injection of
      PRP with corticosteroids for the treatment of chronic SIJ pain. Considering the vast
      potential of PRP and its safety, this study aimed at studying the efficacy of ultrasound
      guided intra-articular SIJ injection of leukocyte free PRP for chronic low back pain due to
      SIJ pathology. In the current study, we tested the hypothesis that the SIJ injection of
      leukocyte-free PRP may be more effective for the treatment of sacroiliac joint pain as
      compared with steroid injection.
    


Intervention name(s): Platelet Rich Plasma; methylprednisolone
Intervention type(s): Biological; Biological
Intervention description(s): single intraarticular injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml); single injection 1.5 ml of methylprednisolone (40mg/ml) and 1.5 ml of 2% lidocaine (20mg/ml) with 0.5 ml of saline (total volume 3.5 ml)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment