Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis

Официальное название

Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis: A Prospective Randomised Controlled Trial

Обзор

The goal of this clinical trial is to investigate the efficacy of mesotherapy in patients with lateral epicondylitis and to determine whether it is as effective as extracorporeal shock wave therapy (ESWT). Is mesotherapy an effective method in patients with lateral epicondylitis? Researchers will compare Mesotherapy to extracorporeal shock wave therapy (ESWT) in patient with Lateral epicondylitis. Patients will be randomly assigned to either the Mesotherapy group or the ESWT group using a closed envelope method. * Group 1 (Mesotherapy group): Patients will receive a total of 5 sessions of mesotherapy, with one session every 7 days. * Group 2 (ESWT group): Patients will receive a total of 5 sessions of Extracorporeal Shock Wave Therapy (ESWT), with one session every 7 days. Patients will be assessed at three time points: before treatment, 30 minutes after the completion of the treatment, and 12 weeks after the completion of the treatment

Подробное описание

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 18 and 65 and have had elbow pain for at six weeks. 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:

* Receiving an interventional injection in the elbow region within the last 3 months * Receiving physical therapy in the last 3 months * Receiving regular nonsteroidal anti-inflammatory drug (NSAID) treatment in the last 2 weeks * History of fracture or surgery in the affected elbow region * Chronic inflammatory diseases * Acute infection * History of malignancy * Coagulation disorders * Pregnancy * Presence of a pacemaker or electronic implants * Cervical radiculopathy and entrapment neuropathy * Drug allergies * BMI \> 35

Demographic informations were recorded. Severity of elbow pain in activity were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with The Patient-Rated Tennis Elbow Evaluation , Short-Form-Health-Survey-12 (SF-12 )

Following clinical assessment, patients were divided into two treatment groups randomly. Mesotherapy and Extracorporeal Shock wave Therapy . 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, thiocolchicoside, and meloxicam diluted ¼ 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 Extracorporeal Shock Wave Therapy will be applied to the lateral epicondyle area at 10-15 Hz frequency, 1.5-2.5 bar energy density, and 2000 pulses. Patients will receive a total of 5 sessions of Extracorporeal Shock Wave Therapy (ESWT), with one session every 7 days.

All measures were conducted at baseline, after treatment, at 12 weeks follow-ups.

Вмешательства

• Устройство Extracorporeal Shock Wave Therapy
  For patients in Group 2, Extracorporeal Shock Wave Therapy will be applied to the lateral epicondyle area at 10-15 Hz frequency, 1.5-2.5 bar energy density, and 2000 pulses. Patients will receive a total of 5 sessions of Extracorporeal Shock Wave Therapy (ESWT), with one session every 7 days.
• Процедура Mesotherapy
  Intradermal mesotherapy involving lidocaine, pentoxifylline, meloxicam, and thiocolchicoside will be applied to painful elbow points using a 4 mm, 30G needle in a point-by-point technique at a 90° angle (0.1 cc per point). A nappage technique at a 45° angle will then be applied around the common extensor tendon. A total of five sessions will be administered, one every 7 days.

Первичные конечные точки

• VAS [Срок оценки: All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up]
• Patient-Rated Tennis Elbow Evaluation [Срок оценки: All measures were conducted at baseline, At the end of treatment (Week 5), at 12th weeks follow-ups]
• SF-12 Health Survey [Срок оценки: All measures were conducted at baseline,At the end of treatment (Week 5) , 12th weeks follow-ups]

Вторичные конечные точки (2)

• Algometer Measurement of Pressure-Pain Threshold [Срок оценки: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.]
• Hand Dynamometer for Grip Strength [Срок оценки: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.]

Критерии участия

Критерии включения

• Aged between 18 and 65 years
• Pain and tenderness in the unilateral lateral epicondyle for ≥6 weeks
• Clinically diagnosed with Lateral Epicondylitis
• Patients without cognitive deficits who can follow verbal instructions Exclusion Criteria
• Receiving an interventional injection in the elbow region within the last 3 months
• Receiving physical therapy in the last 3 months
• Receiving regular nonsteroidal anti-inflammatory drug (NSAID) treatment in the last 2 weeks
• History of fracture or surgery in the affected elbow region
• Chronic inflammatory diseases
• Acute infection
• History of malignancy
• Coagulation disorders
• Pregnancy
• Presence of a pacemaker or electronic implants
• Cervical radiculopathy and entrapment neuropathy
• Drug allergies
• BMI > 35

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Health Science University Haydarpasa Numune Research and Training Hospital, Istanbul, Usku — Istanbul

Публикации

• Mammucari M, Gatti A, Maggiori S, Sabato AF. Role of mesotherapy in musculoskeletal pain: opinions from the italian society of mesotherapy. Evid Based Complement Alternat Med. 2012;2012:436959. doi: 10.1155/2012/436959. Epub 2012 May 13. PMID 22654954

Идентификаторы

NCT: NCT07043335 · IMU-GETAT-KAEK/27.03.2024/04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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