Lateral EpicondylitisNCT07002879
Ultrasound-Guided Dry Needling vs PRP for Refractory Lateral Epicondylitis
A study testing dry needle and Platelet Rich Plasma in people with Lateral Epicondylitis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- dry needle and Platelet Rich Plasma
- Type of treatment
- 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 Jan 2022to 1 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 18 and 65 years of age, having a clinical diagnosis of lateral epicondylitis based on localized lateral elbow pain exacerbated by resisted wrist or middle finger extension and tenderness over the lateral epicondyle on physical examination, and failure to respond to at least six weeks of conservative treatment.
-
Exclusion Criteria:the presence of cervical discopathy or upper extremity nerve entrapment, radiocapitellar arthrosis, uncontrolled metabolic diseases (hypothyroidism, diabetes), bleeding diathesis, a history of previous elbow injection or surgery, pregnancy or lactation, cognitive impairment, and skin compromise at the injection site
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Ultrasound-guided Dry Needling and Platelet-rich Plasma Administration in the Treatment of Refractory Lateral Epicondylitis
This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not responded to at least six weeks of conservative treatment were included. Exclusion criteria included cervical disc disease, nerve entrapment, arthrosis, uncontrolled metabolic disorders, bleeding disorders, prior elbow surgery or injection, pregnancy, cognitive impairment, or compromised skin at the injection site. A G*Power sample size calculation determined that at least 50 patients were needed.
Participants were randomly assigned to two groups: 25 received ultrasound-guided dry needling and 25 received platelet-rich plasma (PRP) injections. All participants gave informed consent, and the study adhered to the Declaration of Helsinki. Baseline demographic and clinical data were collected, and the diagnosis was confirmed using Mills, Maudsley, and Thomsen tests, along with grip-strength assessment. Pain and function were evaluated using the PRTEE, Visual Analog Scale (VAS), and QuickDASH questionnaires at baseline, and at 1, 3, and 6 months post-treatment.
Read more
Ultrasound imaging was used to identify tendinopathic changes. Local anesthesia was administered with 2 mL of prilocaine.
In the dry needling group, an 18-gauge needle was used to fenestrate the tendon with 40-50 passes in a "peppering" motion under continuous ultrasound guidance.
In the PRP group, 15 mL of blood was drawn, centrifuged, and approximately 2 mL of PRP was injected into the lesion under ultrasound guidance.
After the procedure, patients were advised to apply ice, perform passive stretching, avoid lifting heavy objects, and refrain from NSAID use for two weeks. Gradual return to normal activities was encouraged thereafter to restore full elbow function.
- Conditions
- Lateral Epicondylitis
- Being tested
- dry needle, Platelet Rich Plasma
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needleProcedure or surgery
An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes
Platelet Rich PlasmaProcedure or surgery
A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| dry needle | Active comparator | An 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes. Receives: Procedure: dry needle |
| platelet rich plasma injection | Active comparator | A 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance. Receives: Procedure: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Measured: 1-3-6 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire
Measured: 1-3-6 months
Patient-Rated Tennis Elbow Evaluation
Measured: 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jan 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Kıratlıoğlu, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002879
- Sponsor's protocol ID
- İ07-436-22
- Status last verified
- Jan 2022
- First submitted
- 25 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound-guided Dry Needling and Platelet-rich Plasma Administration in the Treatment of Refractory Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07002879
- Acronym / sponsor ID
- İ07-436-22
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 4 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.
This single-center, randomized, prospective study was conducted between January 2022 and September 2023 with ethics committee approval. Adults aged 18-65 with a clinical diagnosis of lateral epicondylitis-characterized by lateral elbow pain exacerbated by resisted wrist or middle finger extension-and who had not responded to at least six weeks of conservative treatment were included. Exclusion criteria included cervical disc disease, nerve entrapment, arthrosis, uncontrolled metabolic disorders, bleeding disorders, prior elbow surgery or injection, pregnancy, cognitive impairment, or compromised skin at the injection site. A G*Power sample size calculation determined that at least 50 patients were needed.
Participants were randomly assigned to two groups: 25 received ultrasound-guided dry needling and 25 received platelet-rich plasma (PRP) injections. All participants gave informed consent, and the study adhered to the Declaration of Helsinki. Baseline demographic and clinical data were collected, and the diagnosis was confirmed using Mills, Maudsley, and Thomsen tests, along with grip-strength assessment. Pain and function were evaluated using the PRTEE, Visual Analog Scale (VAS), and QuickDASH questionnaires at baseline, and at 1, 3, and 6 months post-treatment.
Ultrasound imaging was used to identify tendinopathic changes. Local anesthesia was administered with 2 mL of prilocaine.
In the dry needling group, an 18-gauge needle was used to fenestrate the tendon with 40-50 passes in a "peppering" motion under continuous ultrasound guidance.
In the PRP group, 15 mL of blood was drawn, centrifuged, and approximately 2 mL of PRP was injected into the lesion under ultrasound guidance.
After the procedure, patients were advised to apply ice, perform passive stretching, avoid lifting heavy objects, and refrain from NSAID use for two weeks. Gradual return to normal activities was encouraged thereafter to restore full elbow function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needle | Active comparator | Procedure: dry needleAn 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes. |
| platelet rich plasma injection | Active comparator | Procedure: Platelet Rich PlasmaA 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| dry needleAn 18-gauge needle was first used to fenestrate the common extensor tendon and lateral periosteum. Once adequate anesthesia was confirmed, an 18-gauge needle was inserted along the tendon's longitudinal axis (without exiting the skin) and advanced in a "peppering" motion 40 to 50 passes from superficial to deep layers over approximately two minutes | Procedure or surgery | dry needle |
| Platelet Rich PlasmaA 15 mL peripheral blood sample was drawn and centrifuged at 3 000 rpm for 3 minutes. Approximately 2 mL of PRP was aspirated directly from the buffy coat and injected into the epicondylar region under ultrasound guidance. | Procedure or surgery | platelet rich plasma injection |
Primary outcome
visual analog scale
Time frame: 1-3-6 months
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire
Time frame: 1-3-6 months
Patient-Rated Tennis Elbow Evaluation
Time frame: 1-3-6 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 4 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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 dry needle and Platelet Rich Plasma in people with Lateral Epicondylitis, run by Ankara University 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?
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 4 Jun 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?
visual analog scale (time frame: 1-3-6 months). 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?
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 4 Jun 2025.