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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Extracorporeal Shock Wave Therapy
DeviceFor 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/SurgeryIntradermal 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
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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