Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis
1 other identifier
interventional
50
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2026
CompletedFebruary 18, 2026
February 1, 2026
8 months
December 19, 2024
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up
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.
All measures were conducted at baseline, At the end of treatment (Week 5), at 12th weeks follow-ups
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.
All measures were conducted at baseline,At the end of treatment (Week 5) , 12th weeks follow-ups
Secondary Outcomes (2)
Algometer Measurement of Pressure-Pain Threshold
All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.
Hand Dynamometer for Grip Strength
All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.
Study Arms (2)
Group 1 (Mesotherapy group)
ACTIVE COMPARATORThe intradermal mesotherapy will be applied to the painful points in the elbow using a 4 mm long, 30G needle with a point-by-point technique at a 90-degree angle. The injection volume per point will be 0.1 cc. Following this, a "nappage" technique with a 45-degree angle will be applied around the common extensor tendon.Mesotherapy solution will contain 1 cc 0.1% lidocaine, 1 cc pentoxifylline, 1 cc thiocolchicoside, 1 cc meloxicam 1⁄4 diluted with 0.9% physiological isotonic saline. Patients will receive a total of 5 sessions of mesotherapy, with one session every 7 days.
Group 2 (ESWT group)
ACTIVE COMPARATORFor 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Aged between 18 and 65 years
- Pain and tenderness in the unilateral lateral epicondyle for ≥6 weeks
- Clinically diagnosed with Lateral Epicondylitis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Science University Haydarpasa Numune Research and Training Hospital, Istanbul, Uskudar 34668
Istanbul, Turkey (Türkiye)
Related Publications (1)
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: 22654954BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- Specialist Physician
Study Record Dates
First Submitted
December 19, 2024
First Posted
June 29, 2025
Study Start
July 1, 2025
Primary Completion
February 15, 2026
Study Completion
February 20, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- starting 6 months after publication
all IPD