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NCT Number: NCT07043335

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science University Haydarpasa Numune Research and Training Hospital, Istanbul, Uskudar 34668

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Berna Gunay M.D

CONTACT

[email protected]

+905354133047

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

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.

Mesotherapy

Procedure

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.

Primary outcomes

  1. VAS

    Time frame: All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up

    Measurement of pain intensity using the Visual Analogue Scale (VAS). The VAS consists of a 10 cm line with endpoints representing 0 ("no pain") and 10 ("pain as bad as it could possibly be").

    Minimum score: 0

    Maximum score: 10

    Higher scores indicate worse pain.

  2. Patient-Rated Tennis Elbow Evaluation

    Time frame: All measures were conducted at baseline, At the end of treatment (Week 5), at 12th weeks follow-ups

    The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (tennis elbow). Scores range from 0 to 100, with higher scores indicating greater pain and disability.

  3. SF-12 Health Survey

    Time frame: All measures were conducted at baseline,At the end of treatment (Week 5) , 12th weeks follow-ups

    A self-reported measure assessing health-related quality of life. Scores range from 0 to 100, with higher scores indicating better health status.

Secondary outcomes

  1. Algometer Measurement of Pressure-Pain Threshold

    Time frame: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.

    Measurement of pressure-pain threshold using an algometer device. Values are measured in kilopascals (kPa). Higher values indicate higher pain tolerance.

  2. Hand Dynamometer for Grip Strength

    Time frame: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.

    Measurement of grip strength using a hand dynamometer. Values are measured in kilograms (kg). Higher values indicate stronger grip strength.

Study contacts

Contact information is provided by the study sponsor or research team.

Berna Gunay, Medical doctor

CONTACT

[email protected]

+905354133047

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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