Functional and Electromyographical Changes After PRP or Dextrose Injection in Chronic Lateral Epicondylitis

Study Overview
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Brief Summary
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The purpose of this study is to find out functional and electromyographical changes after platelet rich plasma and dextrose injection in chronic lateral epicondylitis.

Detailed Description
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Both platelet rich plasma (PRP) and dextrose treat chronic lateral epicondylalgia (CLE), mechanically by enhancing tendon cell proliferation, differentiation, and maturation. In fact, hypertonic glucose injection is much cost-effective as compared to PRP. Hence, it is of clinical value to compare the recovery of extensor carpi radialis breveis (ECRB) muscular structure and muscular function between PRP and hypertonic glucose injection. The investigators will measure functional outcome and force gradation after PRP and glucose injection in CLE patients using multi-electromyography, functional score (Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE)) and force (gripping power and maximal voluntary contraction (MVC) during wrist extension) before and 12 weeks after injection. The hypotheses of this study are 1) lower MVC and greater force fluctuations of a force task in the affected muscle in individuals with CLE; 2) lower discharge rate and higher discharge variability of motor units of a force task in the affected muscle in individuals with CLE than those in the contralateral sound side; 3) the PRP group shows a greater improvement in a visual analog scale (VAS), DASH, PRTEE score, MVC, and the size of force fluctuations than the glucose group after treatment. 4) the PRP group shows a greater discharge rate and lower discharge variability for a force task than the glucose group after treatment.

Official Title
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Functional and Electromyographical Changes After Platelet Rich Plasma or Dextrose Injection in Chronic Lateral Epicondylitis

Conditions
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Tennis Elbow

Intervention / Treatment
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* Drug: Platelet Rich Plasma
* Drug: Dextrose 50%


Participation Criteria
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Eligibility Criteria
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The control group Inclusion criteria: 1. The ages of 20-65 years without any neurological or muscular disease. Exclusion criteria: 1. Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis The treatment group (Experimental group) Inclusion Criteria: Patients with lateral epicondylitis in the elbow (age: 20-65 years old) Pain unresponsive to 1 of 3 conventional therapy programs (local steroid injections, physical/occupational therapy, nonsteroidal anti-inflammatory medications) History of elbow pain for at least 3 months Elbow pain at least 50 mm/100 mm using a visual analog scale (VAS) Exclusion Criteria: Healthy population between the ages of 20-65 years Pregnancy History of bleeding disorder, anemia, or any blood disorder (such as Hemoglobin <11 g/dL; Hematocrit <33%; Platelet count outside of the normal range of 150 to 400 x1000/u) Active bilateral elbow tendinosis within 4 weeks, previous surgery for elbow tendinosis or fracture of the affected elbow History of arthritis or, cervical radiculopathy, carpal tunnel syndrome on the affected side within 1 year before randomization Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis Uncooperative patient or patient with neurological disorders who is incapable of following directions or who is predictably unwilling to return for follow-up examinations Hypothyroidism Received local steroid injections within 6 weeks, physical/occupational therapy within 4 weeks, or non- steroidal anti-inflammatory medications within 1 week Intolerance to acetaminophen

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: platelet rich plasma group<br>Preparing 2 mL of PRP with concentration of 4-6 times the average normal values, 20mL of blood will be first collected from the patient's upper limb cubital vein using an 18G needle. | Drug: Platelet Rich Plasma<br>* Preparing 2 mL of PRP with concentration of 4-6 times the average normal values, 20mL of blood will be first collected from the patient's upper limb cubital vein using an 18G needle. A local subcutaneous anesthesia (2 ml of 1% lidocaine) will be finished by the orthopedist.<br>|
| Active Comparator: dextrose group<br>4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe). | Drug: Dextrose 50%<br>* The group will use 4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).<br>|
| No Intervention: Placebo (the control group)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on a visual analog scale (VAS) | a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain) | 12 weeks | 
| Disabilities of the Arm, Shoulder and Hand (DASH) score | scored 0 (no disability) to 100 | 12 weeks | 
| Patient-Rated Tennis Elbow Evaluation (PRTEE) score | pain and disability from 0 to 10(0 = no difficulty, 10 = unable to do) | 12 weeks | 
| Level of force | extension of maximal voluntary contraction | 12 weeks | 
| Level of force | gripping power | 12 weeks | 
| The gradation of muscle force(the surface electromyogram) | the number of motor units active | 12 weeks |