Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

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.

Conditions

• Tennis Elbow

Interventions

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.

Sponsors & Collaborators

• CM Chungmu Hospital

  lead OTHER

Principal Investigators

• Sang-Hoon Lhee, MD PhD · CM Chungmu Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2012-09-30

Completion

2012-09-30

Countries

• South Korea

Study Locations