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

Tennis Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326763
• Other study ID #: SLH-M109-01
• Status: Recruiting
• Phase: Phase 3
• Start date: May 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Sin-Lau Hospital
• Contact: Yueh Chen
• Phone: +886 921569617
• Email: b1729kimo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Drug:
• 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. A local subcutaneous anesthesia (2 ml of 1% lidocaine) will be finished by the orthopedist.
• Dextrose 50%
The group will use 4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).

Locations

Country	Name	City	State
Taiwan	Chen Yueh	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chen Yueh

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) score	scored 0 (no disability) to 100	12 weeks
Primary	Patient-Rated Tennis Elbow Evaluation (PRTEE) score	pain and disability from 0 to 10(0 = no difficulty, 10 = unable to do)	12 weeks
Primary	Level of force	extension of maximal voluntary contraction	12 weeks
Primary	Level of force	gripping power	12 weeks
Primary	The gradation of muscle force(the surface electromyogram)	the number of motor units active	12 weeks