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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaydarpasa Numune Training and Research Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group 1 (Mesotherapy group)Active comparator 1 intervention
Group B: Group 2 (ESWT group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

VAS

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.

Time frame
All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up
2

Patient-Rated Tennis Elbow Evaluation

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.

Time frame
All measures were conducted at baseline, At the end of treatment (Week 5), at 12th weeks follow-ups
3

SF-12 Health Survey

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

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

Secondary outcomes

1

Algometer Measurement of Pressure-Pain Threshold

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

Time frame
All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.
2

Hand Dynamometer for Grip Strength

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

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

Other outcomes

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