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

Sponsor

Chen Yueh (Other)

Overall Status

Recruiting

CT.gov ID

NCT05326763

Collaborator

(none)

Enrollment

Location

Arms

19.2

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tennis Elbow	Drug: Platelet Rich Plasma Drug: Dextrose 50%	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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)
Level of force [12 weeks]
extension of maximal voluntary contraction
Level of force [12 weeks]
gripping power
The gradation of muscle force(the surface electromyogram) [12 weeks]
the number of motor units active

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

The control group

Inclusion criteria:

The ages of 20-65 years without any neurological or muscular disease.

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chen Yueh	Tainan		Taiwan	72152

Sponsors and Collaborators

Chen Yueh

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Yueh, Principal Investigator, Sin-Lau Hospital

ClinicalTrials.gov Identifier:

NCT05326763

Other Study ID Numbers:

SLH-M109-01

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tennis Elbow

Study Results

No Results Posted as of Apr 14, 2022