NCT06538194

Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis

Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis: A Prospective Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Haydarpasa Numune Training and Research Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.

Detailed description

This randomised-controlled single-blind prospective study was carried out at a Physical Medicine and Rehabilitation out-patient clinic. After approval by the Ethics Committee, all participants signed a written informed consent form. The research was conducted in accordance with the Helsinki Declaration. Participants The study will include individuals with lateral epicondylitis who are between the ages of 20 and 60 and have had elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers and tenderness over the lateral epicondyle were required for the diagnosis of lateral epicondylitis. Patients with the following exclusion criteria were not accepted into the study: * Recent upper-extremity surgery, * Recent upper extremity trauma, fracture, or dislocation, * Upper-extremity peripheral neuropathy, * Infectious processes of joint or soft tissues of the upper extremity * Decompensated heart or respiratory failure * Rheumatologic Diseases * Psychiatric Disorders * History of allergy to ingredients of injection solution Demographic informations were recorded. Severity of elbow pain in resting, activity and if present night pain were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash) and Oxford Elbow Score. Following clinical assessment, patients were divided into three treatment groups randomly. Mesotherapy, Prolotherapy and Control groups. Exercise and resting wrist splints were recommended for all groups. The first group received mesotherapy: For this group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 with saline will be made. A 30 gauge, 4 mm mesotherapy injector will be used for the application. The lateral epicondyle will be the site of an intradermal injection. Of that amount, 2.5 cc will be applied point-by-point at intervals of 1-2 cm, and the remaining 2.5 cc will be applied using the napage method, 0.1 cc of solution were given with each injection. Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals. Only exercise and resting wrist splints will be administered to the third group, which is the control group. All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
PROCEDURE	Mesotherapy	For 1. group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 with saline will be made. A 30 gauge, 4 mm mesotherapy injector will be used for the application. The lateral epicondyle will be the site of an intradermal injection. Of that amount, 2.5 cc will be applied point-by-point at intervals of 1-2 cm, and the remaining 2.5 cc will be applied using the napage method, 0.1 cc of solution were given with each injection. This injection will be applied once a week for a total of 4 sessions. Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2024-08-05
• Last updated: 2025-04-02

Locations

1 site across 1 country: Turkey (Türkiye)