Lateral Epicondylitis (Tennis Elbow)NCT07620678
Comparison of ESWT and Single-Session 5% Dextrose Prolotherapy in Lateral Epicondylitis
A study testing Conventional Treatment group, Extracorporeal Shock Wave Therapy (ESWT) and Dextrose prolotherapy (DPT) in people with Lateral Epicondylitis (Tennis Elbow) and Lateral Epicondylitis, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is a common musculoskeletal disorder associated with pain and impaired upper extremity function. The aim of this study was to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow), Lateral Epicondylitis
- What is being tested?
- Conventional Treatment group, Extracorporeal Shock Wave Therapy (ESWT) and Dextrose prolotherapy (DPT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 29 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years
- Clinical and ultrasonographic diagnosis of lateral epicondylitis
- Symptoms persisting for at least 3 months
- Visual Analog Scale (VAS) score ≥4
- Resistance to previous medical treatment
- Ability to comply with study procedures and complete questionnaires
Who cannot join
- Injection treatment for lateral epicondylitis within the previous 3 months
- History of trauma within the previous 3 months
- Cervical disc herniation
- Median or ulnar tunnel neuropathy
- Medial epicondylitis
- Anticoagulant therapy use
Show all 12Show fewer
- Pregnancy or breastfeeding
- Psychiatric disorders or cognitive impairment interfering with questionnaire -completion
- Allergy to the treatment solution
- History of upper extremity surgery or fracture
- Rheumatoid arthritis
- Connective tissue diseases such as dermatomyositis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Ankara Physical Medicine and Rehabilitation Training and Research Hospital Ankara, Turkey
Ankara, Cankaya
About this study
Official title: Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and 5% Dextrose Prolotherapy in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial
Lateral epicondylitis is a common musculoskeletal disorder associated with pain and impaired upper extremity function. The aim of this study was to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate the relative superiority of these treatment approaches during short- and mid-to-long-term follow-up. Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Pain, functional status, grip strength, and common extensor tendon thickness were evaluated during follow-up.
Read the detailed description
Lateral epicondylitis is a common musculoskeletal disorder associated with pain, reduced grip strength, and impaired upper extremity function. This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate their relative effectiveness during short- and mid-to-long-term follow-up.
Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Conventional treatment consisted of home exercise and splinting. ESWT was applied in 3 sessions (2000 pulses, 0.15 mJ/mm²), while the DPT group received a single ultrasound-guided 5% dextrose injection.
Primary outcomes included Visual Analog Scale pain scores for rest, night pain, resisted wrist extension, and grip pain. Secondary outcomes included QuickDASH, PRTEE, grip strength measured with a Jamar dynamometer, and ultrasonographic assessment of common extensor tendon thickness. Clinical assessments were performed at baseline, 1, 3, and 6 months.
- Being tested
- Conventional Treatment group, Extracorporeal Shock Wave Therapy (ESWT), Dextrose prolotherapy (DPT)
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Dextrose Prolotherapy, ESWT, Extracorporeal Shock Wave
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Treatment groupBehavioural
Splinting and home exercise program
Extracorporeal Shock Wave Therapy (ESWT)Device
3 sessions, weekly, 4Hz, 2000 pulses/session, 0.15 mJ/mm².
Dextrose prolotherapy (DPT)Procedure or surgery
Single-session ultrasound-guided 1 mL 5% dextrose injection.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment + ESWT | Active comparator | Three treatment sessions administered at weekly intervals using 2000 pulses per session at an energy flux density of 0.15 mJ/mm². Receives: Behavioral: Conventional Treatment group; Device: Extracorporeal Shock Wave Therapy (ESWT) |
| Conventional Treatment + Dextrose Prolotherapy | Active comparator | Single-session ultrasound-guided injection of 1 mL 5% dextrose. Receives: Behavioral: Conventional Treatment group; Procedure: Dextrose prolotherapy (DPT) |
| Conventional Treatment | Active comparator | Splinting and home exercise program. Receives: Behavioral: Conventional Treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Resisted Wrist Extension Pain
Pain during resisted wrist extension assessed using the Visual Analog Scale (VAS).
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
VAS Gripping Pain
Pain intensity during gripping assessed using the Visual Analog Scale (VAS).
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
VAS Resting Pain
Resting pain assessed using the Visual Analog Scale (VAS).
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
VAS Night Pain
Night pain assessed using the Visual Analog Scale (VAS).
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Secondary outcomes (4)
Quick-DASH Score
Functional disability assessed using the Quick Disabilities of the Arm, Shoulder and Hand questionnaire. The QuickDASH score ranges from 0 to 100, where 0 indicates no symptoms and normal upper extremity function, while 100 indicates the highest symptom severity and the poorest functional status.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
PRTEE Score
Functional outcome assessed using the Patient-Rated Tennis Elbow Evaluation questionnaire. The PRTEE consists of 15 items divided into two subscales: pain (5 items) and function (10 items). The total score ranges from 0 to 100, with 0 indicating no pain and normal function, and 100 indicating the highest pain severity and the poorest functional status. Higher scores reflect greater pain intensity and functional impairment.
Measured: Baseline, 1 month, 3 months, and 6 months after treatment
Grip Strength
Grip strength measured using a Jamar dynamometer.
Measured: Baseline and 6 months
Common Extensor Tendon Thickness
Ultrasonographic measurement of common extensor tendon thickness.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Oct 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies 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
- Model description
- Participants were allocated into three parallel groups: conventional treatment alone, conventional treatment plus extracorporeal shock wave therapy (ESWT), and conventional treatment plus single-session 5% dextrose prolotherapy.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Örücü Atar, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620678
- Sponsor's protocol ID
- E1-23-4037
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to institutional and ethical restrictions regarding patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Extracorporeal Shock Wave Therapy and 5% Dextrose Prolotherapy in Patients With Lateral Epicondylitis: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07620678
- Acronym / sponsor ID
- E1-23-4037
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Dextrose Prolotherapy, ESWT, Extracorporeal Shock Wave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 2 Jun 2026 (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.
Lateral epicondylitis is a common musculoskeletal disorder associated with pain and impaired upper extremity function. The aim of this study was to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate the relative superiority of these treatment approaches during short- and mid-to-long-term follow-up. Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Pain, functional status, grip strength, and common extensor tendon thickness were evaluated during follow-up.
Detailed description
Lateral epicondylitis is a common musculoskeletal disorder associated with pain, reduced grip strength, and impaired upper extremity function. This study aimed to compare the effectiveness of extracorporeal shock wave therapy (ESWT) and single-session 5% dextrose prolotherapy (DPT) in patients with lateral epicondylitis and to evaluate their relative effectiveness during short- and mid-to-long-term follow-up.
Ninety-six patients were allocated into three groups: conventional treatment alone, conventional treatment plus ESWT, and conventional treatment plus DPT. Conventional treatment consisted of home exercise and splinting. ESWT was applied in 3 sessions (2000 pulses, 0.15 mJ/mm²), while the DPT group received a single ultrasound-guided 5% dextrose injection.
Primary outcomes included Visual Analog Scale pain scores for rest, night pain, resisted wrist extension, and grip pain. Secondary outcomes included QuickDASH, PRTEE, grip strength measured with a Jamar dynamometer, and ultrasonographic assessment of common extensor tendon thickness. Clinical assessments were performed at baseline, 1, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were allocated into three parallel groups: conventional treatment alone, conventional treatment plus extracorporeal shock wave therapy (ESWT), and conventional treatment plus single-session 5% dextrose prolotherapy.
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment + ESWT | Active comparator | Behavioral: Conventional Treatment group, Device: Extracorporeal Shock Wave Therapy (ESWT)Three treatment sessions administered at weekly intervals using 2000 pulses per session at an energy flux density of 0.15 mJ/mm². |
| Conventional Treatment + Dextrose Prolotherapy | Active comparator | Behavioral: Conventional Treatment group, Procedure: Dextrose prolotherapy (DPT)Single-session ultrasound-guided injection of 1 mL 5% dextrose. |
| Conventional Treatment | Active comparator | Behavioral: Conventional Treatment groupSplinting and home exercise program. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-75 years
- Clinical and ultrasonographic diagnosis of lateral epicondylitis
- Symptoms persisting for at least 3 months
- Visual Analog Scale (VAS) score ≥4
- Resistance to previous medical treatment
Key exclusion criteria (12 listed)
- Injection treatment for lateral epicondylitis within the previous 3 months
- History of trauma within the previous 3 months
- Cervical disc herniation
- Median or ulnar tunnel neuropathy
- Medial epicondylitis
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 |
|---|---|---|
| Conventional Treatment groupSplinting and home exercise program | Behavioural | Conventional Treatment, Conventional Treatment + Dextrose Prolotherapy, Conventional Treatment + ESWT |
| Extracorporeal Shock Wave Therapy (ESWT)3 sessions, weekly, 4Hz, 2000 pulses/session, 0.15 mJ/mm². | Device | Conventional Treatment + ESWT |
| Dextrose prolotherapy (DPT)Single-session ultrasound-guided 1 mL 5% dextrose injection. | Procedure or surgery | Conventional Treatment + Dextrose Prolotherapy |
Primary outcome
VAS Resisted Wrist Extension Pain
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Pain during resisted wrist extension assessed using the Visual Analog Scale (VAS).
VAS Gripping Pain
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Pain intensity during gripping assessed using the Visual Analog Scale (VAS).
VAS Resting Pain
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Resting pain assessed using the Visual Analog Scale (VAS).
VAS Night Pain
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Night pain assessed using the Visual Analog Scale (VAS).
4 secondary outcomes
Quick-DASH Score
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
PRTEE Score
Time frame: Baseline, 1 month, 3 months, and 6 months after treatment
Grip Strength
Time frame: Baseline and 6 months
Common Extensor Tendon Thickness
Time frame: Baseline and 6 months
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 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to institutional and ethical restrictions regarding patient confidentiality.
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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 Conventional Treatment group, Extracorporeal Shock Wave Therapy (ESWT) and Dextrose prolotherapy (DPT) in people with Lateral Epicondylitis (Tennis Elbow) and Lateral Epicondylitis, run by Gaziler Physical Medicine and Rehabilitation Education 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 6 inclusion and 12 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 Jun 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?
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 Resisted Wrist Extension Pain (time frame: Baseline, 1 month, 3 months, and 6 months after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.