Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      The purpose of this study is to find the optimal treatment method for chronic lateral
      epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated
      tendon.The hypothesis is that there will be significant difference between treatment groups
      and control group (physiotherapy) and also there will be significant difference among
      treatment groups.
    

Detailed description: 
      231 patients were randomized using a Random Sequence Generator (Random.org) into 4 groups:
      Group A (physiotherapy as a control, n=58), Group B (ESWT, n=62), Group C (Prolotherapy,
      n=56) and Group D (PRP, n=55). In group A, patients were educated to do stretching and
      eccentric strengthening exercise of wrist extensor muscles. In group B patients were treated
      with 3 sessions of high-energy shock wave therapy ESWT (Evotron, Switech medical,
      Kreuzlingen, CH) in 2 weeks interval. Total energy flux density ranged from 0.1 to 0.14
      mJ/mm2 (1500 impulses). Shockwave was targeted over lateral epicondyle where maximum
      tenderness was located. In group C, injection of 20% dextrose (3cc mixed with 0.3cc of
      lidocaine) to ECRB tendon was done under ultrasound guidance and in group D, 3 cc of PRP
      (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected
      into ECRB tendon under ultrasound guidance. 22G needle was used for injection in group C and
      D. The primary outcome measure is DASH scoring system which is recorded on the initial, 3rd,
      6th, 18th and 24th month. Secondary outcome measures were ultrasonography (measured on
      initial, 6th and 24th month) and SSS (Subjective Satisfaction Score) measured on initial and
      24th month. After 24 months from the last procedure, all serial questionnaires and
      physician-filled-SSS sheets were gathered and analyzed by a one-way analysis of variance and
      Scheffe post-test. A value of p<0.01 was considered statistically significant.
    

Intervention name(s): physiotherapy; extracorporeal shockwave therapy; prolotherapy; platelet-rich plasma
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Physiotherapy is the treatment of a wide range of conditions and injuries to the body through the use of various forms of passive mobilisation, massage, electrotherapy and exercises.; Extracorporeal shockwave therapy (ESWT) is noninvasive procedure, and has been shown to be effective in the treatment of chronic tendon pathology in the elbow, shoulder and plantar fascia. Shock wave therapy is traditionally categorized as either low energy (<0.2 mJ/mm2) or high energy (>0.2 mJ/mm2). Rompe, et al have hypothesized that there is an overstimulation of nerve fibers, resulting in an immediate analgesic effect (hyperstimulation analgesia). Physical effects on cell permeability and induction of diffusible radicals have also been postulated to cause disruption of the tendon tissue, resulting in induction of a healing process.; Prolotherapy has been defined as the iatrogenic stimulation of wound healing and tissue repair through the injection of an irritant solution into damaged ligaments and tendons. Prolotherapy solutions are purported to initiate an inflammatory cascade at the site of injection, which induces fibroblast proliferation and subsequent collagen synthesis, resulting in a tighter and stronger ligament or tendon. The primary mechanism of action of prolotherapy is to induce a small inflammatory response to promote adequate healing or more viable scar tissue formation that results in stronger fibrous tissue at the lateral epicondyle, which leads to improved function and reduced pain.; Platelet-rich plasma (PRP) is defined as an autologous concentration of human platelets in a small volume of plasma which is mechanically treated to increase the concentration of platelets compared to whole blood. The supraphysiological concentration of platelets will provide a locally increased concentration of growth factors and cytokines that are contained within the platelets themselves.Based on these concepts, it is believed that PRP can augment or stimulate healing with the same biologic healing process that normally occurs in the human body after injury.
Other intervention name(s): Physical Therapy; Rehabilitation; ESWT; PRP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tennis Elbow; lateral epicondylosis; lateral epicondylitis; Platelet-Rich Plasma; Extracorporeal Shockwave Therapy; Prolotherapy; Physiotherapy