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

Phase 3

• Conditions: Tennis Elbow
• Interventions: Drug: Dextrose 50%; Drug: Platelet Rich Plasma

• Registration Number: NCT05326763
• Lead Sponsor: Chen Yueh

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-05-25
• Study First Submitted: 2021-09-13
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients with lateral epicondylitis in the elbow (age: 20-65 years old)
2. Pain unresponsive to 1 of 3 conventional therapy programs (local steroid injections, physical/occupational therapy, nonsteroidal anti-inflammatory medications)
3. History of elbow pain for at least 3 months
4. Elbow pain at least 50 mm/100 mm using a visual analog scale (VAS)

Exclusion Criteria

1. Healthy population between the ages of 20-65 years
2. Pregnancy
3. 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)
4. Active bilateral elbow tendinosis within 4 weeks, previous surgery for elbow tendinosis or fracture of the affected elbow
5. History of arthritis or, cervical radiculopathy, carpal tunnel syndrome on the affected side within 1 year before randomization
6. Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis
7. Uncooperative patient or patient with neurological disorders who is incapable of following directions or who is predictably unwilling to return for follow-up examinations
8. Hypothyroidism
9. Received local steroid injections within 6 weeks, physical/occupational therapy within 4 weeks, or non- steroidal anti-inflammatory medications within 1 week
10. Intolerance to acetaminophen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dextrose group	Dextrose 50%	4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).
platelet rich plasma group	Platelet Rich Plasma	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chen Yueh; 🇨🇳 Tainan, Taiwan