NCT02052089

Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

Prospective Randomized Clinical and Radiologic Study for the Treatment of Lateral Epicondylosis; Comparison Among PRP (Platelet-Rich Plasma) , Prolotherapy, Physiotherapy and ESWT (Extracorporeal Shockwave Therapy)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: CM Chungmu Hospital · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tennis Elbow

Interventions

Type	Name	Description
PROCEDURE	physiotherapy	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.
PROCEDURE	extracorporeal shockwave therapy	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.
PROCEDURE	prolotherapy	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.
PROCEDURE	platelet-rich plasma	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2014-01-31
• Last updated: 2014-01-31

Locations

1 site across 1 country: South Korea