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

NCT06538194 | Completed

• 1 other identifier: IMU-GETAT-KAEK/27.03.2024/06
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; mesotherapy; prolotherapy; elbow pain

Outcome Measures

Primary Outcomes (3)

• VAS

  Measurement of Pain Severity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.

• short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash)

  Measurement of Functional Disability. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. The DASH score is one of the most established questionnaires for disorders of the upper limb.

  All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.

• Oxford Elbow Score

  Measurement of Functional Disability. The outcome can be interpreted based on a 48-point scale: 0-19, poor; 20-29, fair; 30-39, good; and 40-48, excellent

  All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.

Study Arms (3)

Mesotherapy

ACTIVE COMPARATOR

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.

Procedure: Mesotherapy

Prolotherapy

ACTIVE COMPARATOR

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.

Procedure: Mesotherapy

Control

ACTIVE COMPARATOR

Only exercise and resting wrist splints will be administered to the third group, which is the control group.

Procedure: Mesotherapy

Interventions

Mesotherapy PROCEDURE

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.

Also known as: Prolotherapy

Control; Mesotherapy; Prolotherapy

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers Tenderness over the lateral epicondyle

You may not qualify if:

• 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

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (2)

• Arias-Vazquez PI, Castillo-Avila RG, Tovilla-Zarate CA, Quezada-Gonzalez HR, Arcila-Novelo R, Loeza-Magana P. Efficacy of prolotherapy in pain control and function improvement in individuals with lateral epicondylitis: A Systematic Review and Meta-analysis. ARP Rheumatol. 2022 Apr-Jun;1(2):152-167.

  PMID: 35810374 BACKGROUND

• Piraccini E, Biondi G. Prolotherapy: Regenerative Medicine for Lateral Epicondylitis. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):509-510. doi: 10.5152/TJAR.2020.82356. Epub 2020 May 18.

  PMID: 33313593 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Interventions

Mesotherapy; Prolotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: August 5, 2024
• Study Start: April 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

TU (1)