Lateral EpicondylitisNCT07043335
Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis
A study testing Extracorporeal Shock Wave Therapy and Mesotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Extracorporeal Shock Wave Therapy and Mesotherapy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University Haydarpasa Numune Research and Training Hospital, Istanbul, Uskudar 34668
Istanbul
Berna Gunay M.D, +905354133047, bernagunay@yahoo.com
About this study
Official title: Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis: A Prospective Randomised Controlled 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?
Read more
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
Read the detailed description
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.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Extracorporeal Shock Wave Therapy, Mesotherapy
- Keywords
- elbow pain, mesotherapy, lateral epicondylitis, extracorporeal shock wave therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
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.
MesotherapyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Mesotherapy group) | Active comparator | The 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. Receives: Procedure: Mesotherapy |
| Group 2 (ESWT group) | Active comparator | 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. Receives: Device: Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measurement of pressure-pain threshold using an algometer device. Values are measured in kilopascals (kPa). Higher values indicate higher pain tolerance.
Measured: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.
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.
Measured: All measures were conducted at baseline,At the end of treatment (Week 5) , at 12th weeks follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jul 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Gunay, MD, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043335
- Sponsor's protocol ID
- IMU-GETAT-KAEK/27.03.2024/04
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD
Publications
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.
PubMed 22654954
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07043335
- Acronym / sponsor ID
- IMU-GETAT-KAEK/27.03.2024/04
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- elbow pain, mesotherapy, lateral epicondylitis, extracorporeal shock wave therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Mesotherapy group) | Active comparator | Procedure: MesotherapyThe 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 comparator | Device: Extracorporeal Shock Wave TherapyFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyFor 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. | Device | Group 2 (ESWT group) |
| MesotherapyIntradermal 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. | Procedure or surgery | Group 1 (Mesotherapy group) |
Primary outcome
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.
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.
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 22654954Mammucari 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy and Mesotherapy in people with Lateral Epicondylitis and Tennis Elbow, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Berna Gunay, Medical doctor (+905354133047, bernagunay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: All measures were conducted at baseline, at the end of treatment (Week 5), at 12th weeks follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07043335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.