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

Primary Purpose

Tennis Elbow

Status

Recruiting

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Platelet Rich Plasma

Dextrose 50%

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Chen YuehRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

platelet rich plasma group

dextrose group

Placebo (the control group)

Arm Description

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.

4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).

Outcomes

Primary Outcome Measures

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)

Disabilities of the Arm, Shoulder and Hand (DASH) score

scored 0 (no disability) to 100

Patient-Rated Tennis Elbow Evaluation (PRTEE) score

pain and disability from 0 to 10(0 = no difficulty, 10 = unable to do)

Level of force

extension of maximal voluntary contraction

Level of force

gripping power

The gradation of muscle force(the surface electromyogram)

the number of motor units active

Secondary Outcome Measures

Full Information

NCT ID

NCT05326763

First Posted

September 13, 2021

Last Updated

April 11, 2022

Sponsor

Chen Yueh

1. Study Identification

Unique Protocol Identification Number

NCT05326763

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 25, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chen Yueh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tennis Elbow

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

platelet rich plasma group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

dextrose group

Arm Type

Active Comparator

Arm Description

4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).

Arm Title

Placebo (the control group)

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Platelet Rich Plasma

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dextrose 50%

Intervention Description

The group will use 4 ml of PRP + 4 ml of 0.9% saline -h 2 ml of 1% lidocaine (10-ml syringe).

Primary Outcome Measure Information:

Title

Pain score on a visual analog scale (VAS)

Description

a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain)

Time Frame

12 weeks

Title

Disabilities of the Arm, Shoulder and Hand (DASH) score

Description

scored 0 (no disability) to 100

Time Frame

12 weeks

Title

Patient-Rated Tennis Elbow Evaluation (PRTEE) score

Description

pain and disability from 0 to 10(0 = no difficulty, 10 = unable to do)

Time Frame

12 weeks

Title

Level of force

Description

extension of maximal voluntary contraction

Time Frame

12 weeks

Title

Level of force

Description

gripping power

Time Frame

12 weeks

Title

The gradation of muscle force(the surface electromyogram)

Description

the number of motor units active

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yueh Chen

Phone

+886 921569617

b1729kimo@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yueh Chen

Organizational Affiliation

Madou Sin-Lau Hosptial, the Presbyterian Church in Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chen Yueh

City

Tainan

ZIP/Postal Code

72152

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yueh Chen

Phone

+886 921569617

b1729kimo@gmail.com

12. IPD Sharing Statement

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

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