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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05326763
Enrollment
90
Registered
2022-04-14
Start date
2021-05-25
Completion date
2022-12-31
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tennis Elbow

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.

Interventions

DRUGPlatelet 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.

DRUGDextrose 50%

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

Sponsors

Chen Yueh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion 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: 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)

Design outcomes

Primary

MeasureTime frameDescription
Pain score on a visual analog scale (VAS)12 weeksa 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) score12 weeksscored 0 (no disability) to 100
Patient-Rated Tennis Elbow Evaluation (PRTEE) score12 weekspain and disability from 0 to 10(0 = no difficulty, 10 = unable to do)
Level of force12 weeksextension of maximal voluntary contraction
The gradation of muscle force(the surface electromyogram)12 weeksthe number of motor units active

Countries

Taiwan

Contacts

Primary ContactYueh Chen
b1729kimo@gmail.com+886 921569617

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026