Lateral EpicondylitisNCT06538194
Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis
A study testing Mesotherapy in people with Lateral Epicondylitis, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Mesotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers Tenderness over the lateral epicondyle
Who cannot join
- Recent upper-extremity surgery,
- Recent upper extremity trauma, fracture, or dislocation,
- Upper-extremity peripheral neuropathy,
- Infectious processes of joint or soft tissues of the upper extremity
- Decompensated heart or respiratory failure
- Rheumatologic Diseases
- Psychiatric Disorders
- History of allergy to ingredients of injection solution
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Haydarpasa Numune Research and Training Hospital
Istanbul, Uskudar, 34668
About this study
Official title: Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis: A Prospective Randomised Controlled Trial
A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.
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 20 and 60 and have had elbow pain for at least three months. 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:
- Recent upper-extremity surgery,
- Recent upper extremity trauma, fracture, or dislocation,
- Upper-extremity peripheral neuropathy,
- Infectious processes of joint or soft tissues of the upper extremity
- Decompensated heart or respiratory failure
- Rheumatologic Diseases
- Psychiatric Disorders
- History of allergy to ingredients of injection solution
Demographic informations were recorded. Severity of elbow pain in resting, activity and if present night pain were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash) and Oxford Elbow Score.
Following clinical assessment, patients were divided into three treatment groups randomly. Mesotherapy, Prolotherapy and Control groups. 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, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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 dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals.
Only exercise and resting wrist splints will be administered to the third group, which is the control group.
All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
- Conditions
- Lateral Epicondylitis
- Being tested
- Mesotherapy
- Keywords
- lateral epicondylitis, mesotherapy, prolotherapy, elbow pain
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesotherapyProcedure or surgery
Also called Prolotherapy
For 1. group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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. This injection will be applied once a week for a total of 4 sessions. Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals.
| Study group | Role | What they receive |
|---|---|---|
| Mesotherapy | Active comparator | The first group received mesotherapy: For this group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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. Receives: Procedure: Mesotherapy |
| Prolotherapy | Active comparator | Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals. Receives: Procedure: Mesotherapy |
| Control | Active comparator | Only exercise and resting wrist splints will be administered to the third group, which is the control group. Receives: Procedure: Mesotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Measurement of Pain Severity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash)
Measurement of Functional Disability. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. The DASH score is one of the most established questionnaires for disorders of the upper limb.
Measured: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Oxford Elbow Score
Measurement of Functional Disability. The outcome can be interpreted based on a 48-point scale: 0-19, poor; 20-29, fair; 30-39, good; and 40-48, excellent
Measured: All measures were conducted at baseline, after treatment, at 3th and 8th 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 posted5 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel süzen Özbayrak, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538194
- Sponsor's protocol ID
- IMU-GETAT-KAEK/27.03.2024/06
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arias-Vazquez PI, Castillo-Avila RG, Tovilla-Zarate CA, Quezada-Gonzalez HR, Arcila-Novelo R, Loeza-Magana P. Efficacy of prolotherapy in pain control and function improvement in individuals with lateral epicondylitis: A Systematic Review and Meta-analysis. ARP Rheumatol. 2022 Apr-Jun;1(2):152-167.
PubMed 35810374Piraccini E, Biondi G. Prolotherapy: Regenerative Medicine for Lateral Epicondylitis. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):509-510. doi: 10.5152/TJAR.2020.82356. Epub 2020 May 18.
PubMed 33313593
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Dextrose Prolotherapy and Mesotherapy in Lateral Epicondylitis: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06538194
- Acronym / sponsor ID
- IMU-GETAT-KAEK/27.03.2024/06
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis, mesotherapy, prolotherapy, elbow pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 5 Aug 2024 (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.
A total of 84 patients with lateral epicondylitis were included in the study. The patients were randomly assigned to 3 treatment groups: mesotherapy (n = 28), prolotherapy (n = 28), and control (n = 28). Patients were evaluated before treatment and at the 3rd and 8th weeks of treatment for pain severity measured with the Visual Activity Scale (VAS) during resting, activity, and at night, and for functional status with a short version of the upper limb-specific disabilities of the arms, shoulder, and hand (Quick-Dash) and Oxford Elbow Score.
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 20 and 60 and have had elbow pain for at least three months. 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:
- Recent upper-extremity surgery,
- Recent upper extremity trauma, fracture, or dislocation,
- Upper-extremity peripheral neuropathy,
- Infectious processes of joint or soft tissues of the upper extremity
- Decompensated heart or respiratory failure
- Rheumatologic Diseases
- Psychiatric Disorders
- History of allergy to ingredients of injection solution
Demographic informations were recorded. Severity of elbow pain in resting, activity and if present night pain were recorded according to Visual analogue Scale (VAS). Functional impairment were evaluated with short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash) and Oxford Elbow Score.
Following clinical assessment, patients were divided into three treatment groups randomly. Mesotherapy, Prolotherapy and Control groups. 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, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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 dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals.
Only exercise and resting wrist splints will be administered to the third group, which is the control group.
All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesotherapy | Active comparator | Procedure: MesotherapyThe first group received mesotherapy: For this group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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. |
| Prolotherapy | Active comparator | Procedure: MesotherapyGroup 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals. |
| Control | Active comparator | Procedure: MesotherapyOnly exercise and resting wrist splints will be administered to the third group, which is the control group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elbow pain for at least three months. Pain around the lateral epicondyle during resisted extension of wrist and fingers Tenderness over the lateral epicondyle
Key exclusion criteria (8 listed)
- Recent upper-extremity surgery,
- Recent upper extremity trauma, fracture, or dislocation,
- Upper-extremity peripheral neuropathy,
- Infectious processes of joint or soft tissues of the upper extremity
- Decompensated heart or respiratory failure
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 |
|---|---|---|
| MesotherapyAlso: ProlotherapyFor 1. group, a solution containing 1 cc each of lidocaine, pentoxifylline, vitamin B complex diluted 1/10 with saline, thiocolchicoside, and meloxicam diluted 1/5 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. This injection will be applied once a week for a total of 4 sessions. Group 2 received dextrose prolotherapy: A 22 gauge syringe was used to apply a total of 5 cc of 15% dextrose solution (a combination of 3.75 ml 20% dextrose and 1.25 mg 2% lidocaine) to at least 5 most sensitive points of the lateral epicondyle. It was injected 3 times with 3 weeks intervals. | Procedure or surgery | Control, Mesotherapy, Prolotherapy |
Primary outcome
VAS
Time frame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Pain Severity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10 cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
short version of the upper limb-specific Disabilities of Arms, Shoulder and Hand (Quick-Dash)
Time frame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Functional Disability. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment. The DASH score is one of the most established questionnaires for disorders of the upper limb.
Oxford Elbow Score
Time frame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.
Measurement of Functional Disability. The outcome can be interpreted based on a 48-point scale: 0-19, poor; 20-29, fair; 30-39, good; and 40-48, excellent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 35810374Arias-Vazquez PI, Castillo-Avila RG, Tovilla-Zarate CA, Quezada-Gonzalez HR, Arcila-Novelo R, Loeza-Magana P. Efficacy of prolotherapy in pain control and function improvement in individuals with lateral epicondylitis: A Systematic Review and Meta-analysis. ARP Rheumatol. 2022 Apr-Jun;1(2):152-167.
- Background: PubMed 33313593Piraccini E, Biondi G. Prolotherapy: Regenerative Medicine for Lateral Epicondylitis. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):509-510. doi: 10.5152/TJAR.2020.82356. Epub 2020 May 18.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesotherapy in people with Lateral Epicondylitis, 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 2 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: All measures were conducted at baseline, after treatment, at 3th and 8th weeks follow-ups.). 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 NCT06538194, which also lists 2 linked publications.
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 2 Apr 2025.