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

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

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

Study Overview

• Status: Recruiting
• Conditions: Tennis Elbow
• Intervention / Treatment: Drug: Platelet Rich Plasma; Drug: Dextrose 50%

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yueh Chen; Phone Number: +886 921569617; Email: b1729kimo@gmail.com

Study Locations

• Taiwan
  • Tainan, Taiwan, 72152
    • Recruiting
    • Chen Yueh
    • Contact: Yueh Chen; Phone Number: +886 921569617; Email: b1729kimo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: platelet rich plasma group; 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; 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.
Active Comparator: dextrose group; 4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).	Drug: 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).
No Intervention: Placebo (the control group)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chen Yueh
• Investigators: Principal Investigator: Yueh Chen, Madou Sin-Lau Hosptial, the Presbyterian Church in Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: SLH-M109-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No