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

NCT05326763 | Unknown Phase 3

• 1 other identifier: SLH-M109-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

platelet rich plasma group

ACTIVE COMPARATOR

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

dextrose group

ACTIVE COMPARATOR

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

Drug: Dextrose 50%

Placebo (the control group)

NO INTERVENTION

Interventions

Platelet Rich Plasma 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.

platelet rich plasma group

Dextrose 50% DRUG

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

dextrose group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Systemic disorders such as diabetes, rheumatoid arthritis, or hepatitis
• The treatment group (Experimental group)
• 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)
• 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

Sponsors & Collaborators

• Chen Yueh: lead

Study Sites (1)

Chen Yueh

Tainan, 72152, Taiwan

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Yueh Chen

  Madou Sin-Lau Hosptial, the Presbyterian Church in Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh Chen

CONTACT

+886 921569617; b1729kimo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: April 14, 2022
• Study Start: May 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

TW (1)