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

NCT ID: NCT05326763

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2022-12-31

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.

Conditions

Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Platelet Rich Plasma

Intervention Type: DRUG

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 group

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

Group Type: ACTIVE_COMPARATOR

Dextrose 50%

Intervention Type: DRUG

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

Placebo (the control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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. Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis

The treatment group (Experimental group)

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chen Yueh

OTHER

Sponsor Role: lead

Responsible Party

Chen Yueh

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yueh Chen

Role: PRINCIPAL_INVESTIGATOR

Madou Sin-Lau Hosptial, the Presbyterian Church in Taiwan

Locations

Chen Yueh

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yueh Chen

Role: CONTACT

b1729kimo@gmail.com

+886 921569617

Facility Contacts

Yueh Chen

Role: primary

b1729kimo@gmail.com

+886 921569617

Other Identifiers

SLH-M109-01

Identifier Type: -

Identifier Source: org_study_id