A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis
Condition: Tennis Elbow; Epicondylitis, Lateral Humeral
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Lateral epicondylitis, is a common problem encountered in the orthopaedic practice.
      Histopathological reports have shown that lateral epicondylitis is not an inflammatory
      process but a degenerative condition termed 'tendinosis'. Beneficial effects of local
      corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens
      show lack of any inflammatory process. Recently an injection of "autologous blood injection"
      has been reported to be effective for both intermediate and long term outcomes. It is
      hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis
      and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate
      and specialize and have been found to induce healing cascade. The objective of the study is
      to evaluate the efficacy of autologous blood injection versus local corticosteroid injection
      in the management of lateral epicondylitis.
    

Detailed description: 
      Much controversy has been there over the pathophysiology and there is not enough scientific
      evidence to favour any particular type of treatment for acute lateral epicondylitis.
      Currently degeneration of the origin of the extensor carpi radialis brevis (ECRB), repeated
      micro trauma and incomplete healing response has been accepted as the cause of lateral
      epicondylitis by most of the researchers.

      Histopathological reports have shown that lateral epicondylitis is not an inflammatory
      process but a degenerative condition termed 'tendinosis'. There are numerous treatment
      modalities for lateral epicondylitis both conservative and operative. Most conservative
      modalities such as local corticosteroid injection have focused on suppressing inflammatory
      process that does not actually exist. A recent review article concluded that for short term
      outcomes (6 weeks), statistically significant and clinically relevant differences were found
      on pain and global improvement with corticosteroid injection compared to placebo, local
      anaesthetic, or other conservative treatments. For intermediate (6 weeks to 6 months) and
      long term outcomes (more than 6 months), no statistically significant or clinically relevant
      results in favour of corticosteroid injections were found. So it is not possible to draw a
      firm conclusion on the effectiveness of corticosteroid injection.

      Recently an injection of autologous blood has been reported to be effective for both
      intermediate and long term outcomes for the treatment of lateral epicondylitis. There was a
      significant decrease in pain. It is hypothesized that mitogens such as platelet derived
      growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming
      growth factor cause fibroblasts to migrate and specialize and have been found to cause
      angiogenesis. A specific humoral mediator may promote the healing cascade in the treatment of
      tendinosis as well. These growth factors trigger stem cell recruitment, increase local
      vascularity and directly stimulate the production of collagen by tendon sheath fibroblasts.

      Autologous blood was selected as the medium for injection because (1) its application is
      minimally traumatic, (2) it has a reduced risk for immune-mediated rejection, devoid of
      potential complications such as hypoglycemia, skin atrophy, tendon tears associated with
      corticosteroid injection (3) it is simple to acquire and prepare, easy to carry out as
      outpatient procedure and (4) it is inexpensive.

      There are very few studies done to evaluate injection of autologous blood for lateral
      epicondylitis as treatment modality. Hence it is evaluated by comparing with the
      corticosteroid injection which is a commonly practiced conservative treatment modality.
    

Intervention name(s): Autologous blood injection; Local corticosteroid injection
Intervention type(s): Biological; Drug
Intervention description(s): Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique.; Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique
Other intervention name(s): autologous blood drawn from peripheral vein.; Methyl prednisolone acetate 80mg
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tennis Elbow; Epicondylitis, Lateral Humeral