Lateral EpicondylitisNCT06236178
Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis
A study testing Corticosteroid, Autologous Blood and Local Anesthetic in people with Lateral Epicondylitis and Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare autologous blood, corticosteroid, and their combined injection for treating lateral epicondylitis. The main question it aims to answer are: Which of these highly used drugs in treatment of lateral epicondylitis is more effective? Participants were randomly allocated into… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Epicondylitis, Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis
- What is being tested?
- Corticosteroid, Autologous Blood and Local Anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Nov 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-Patients with LE whose complaints persisted for more than 3 months
Who cannot join
- Patients with a history of recent trauma,
- Congenital or neuromuscular disease or abnormality of the upper limb
- Previous upper limb surgery,
- History of rheumatic disease,
- History of cervical disc pathology or carpal tunnel syndrome
- Systemic corticosteroid treatment
- Any previous local injection treatment
- Patients with a history of previous allergic reaction towards local anesthetics and corticosteroids
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Training and Research Hospital, Department of Orthopedics and Traumatology,
Istanbul, 34098
Istanbul Training and Research Hospital
Istanbul, 34098
About this study
Official title: Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis: A Randomized Clinical Trial
The goal of this clinical trial is to compare autologous blood, corticosteroid, and their combined injection for treating lateral epicondylitis. The main question it aims to answer are:
- Which of these highly used drugs in treatment of lateral epicondylitis is more effective? Participants were randomly allocated into three equal treatment groups (AB versus CS versus their combination) with sealed envelopes prepared by a computer-based random number generator. Patients in the AB Group received 1 ml of autologous venous blood mixed with 2 ml of 2% prilocaine HCl, patients in the CS Group received 1 ml of 40 mg methylprednisolone acetate mixed with 2 ml of 2% prilocaine HCl, and patients in the Combined Group (AB+CS) received 1 ml of autologous venous blood, 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2% prilocaine HCl. Each group received an equal amount of (3 ml) injected material. PRTEE and HGS measurements were assessed before the injection (baseline values), on Day 15, Day 30, and Day 90, in the same manner by the senior author.
Read the detailed description
This study aimed to compare the efficacy of autologous blood (AB) and corticosteroid (CS) injections and their combination in treating lateral epicondylitis (LE), hypothesizing that the combined approach might offer immediate symptom resolution and lower recurrence. Methods: A total of 120 patients diagnosed with lateral epicondylitis were systematically distributed among three distinct therapeutic injection groups. Those in the AB group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl. Participants in the CS category were given 1ml of 40 mg methylprednisolone acetate mixed with 2ml of 2% prilocaine HCl. Meanwhile, patients in the combined group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate, along with 1ml of 2% prilocaine HCl. Prior to receiving their respective injections, a comprehensive assessment of all participants was carried out. Follow-up assessments were subsequently conducted on days 15, 30, and 90, utilizing metrics of patient-rated tennis elbow evaluation (PRTEE) and measurements of hand grip strength (HGS).
- Conditions
- Lateral Epicondylitis, Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis
- Being tested
- Corticosteroid, Autologous Blood, Local Anesthetic
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
1 ml of 40 mg methylprednisolone acetate
Autologous BloodDrug
1 ml of autologous venous blood
Local AnestheticDrug
1 ml of 2% prilocaine HCl
| Study group | Role | What they receive |
|---|---|---|
| Autologous Blood Injection Mixed With Local Anesthetic | Active comparator | Autologous Blood Injection group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. Receives: Drug: Autologous Blood; Drug: Local Anesthetic |
| Corticosteroid Injection Mixed With Local Anesthetic | Active comparator | Corticosteroid Injection category were given 1ml of 40 mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey) mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. Receives: Drug: Corticosteroid; Drug: Local Anesthetic |
| Combined Injection Mixed With Local Anesthetic | Active comparator | Combined Injection group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey), along with 1ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. Receives: Drug: Corticosteroid; Drug: Autologous Blood; Drug: Local Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores
Patient-rated tennis elbow evaluation questionnaire (PRTEE) is consist of 2 steps, pain and function score.
Pain Score is measured by sum of the 5 pain items (out of 50) (Best Score = 0, Worst Score = 50) Function Score is measured by sum of the of the 10 function items, divided by 2 (out of 50) (Best Score = 0, Worst Score = 50) Total Score is measured by sum of pain and function scores(Best Score = 0, Worst Score = 100)
Measured: Before the injection (baseline values), on Day 15, Day 30, and Day 90
Secondary outcomes (1)
Hand Grip Strength (HGS) measurements
Hand grip strength (HGS) was measured with a digital hand dynamometer before and on Day 15, Day 30, and Day 90 after injection in all patients.
Measured: Before the injection (baseline values), on Day 15, Day 30, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Clinical Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Albert ÇAKAR, Istanbul Training and Research Hospital
- Investigators
- Albert ÇAKAR, MD, Principal investigator, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236178
- Sponsor's protocol ID
- TR13734
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Defoort S, De Smet L, Brys P, Peers K, Degreef I. Lateral elbow tendinopathy: surgery versus extracorporeal shock wave therapy. Hand Surg Rehabil. 2021 Jun;40(3):263-267. doi: 10.1016/j.hansur.2020.12.008. Epub 2021 Feb 23.
PubMed 33636381Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70.
PubMed 1423702Krogh TP, Bartels EM, Ellingsen T, Stengaard-Pedersen K, Buchbinder R, Fredberg U, Bliddal H, Christensen R. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med. 2013 Jun;41(6):1435-46. doi: 10.1177/0363546512458237. Epub 2012 Sep 12.
PubMed 22972856Kivrak A, Ulusoy I. Comparison of the Clinical Results of Platelet-Rich Plasma, Steroid and Autologous Blood Injections in the Treatment of Chronic Lateral Epicondylitis. Healthcare (Basel). 2023 Mar 6;11(5):767. doi: 10.3390/healthcare11050767.
PubMed 36900772Goorens CK, Wernaers P, Dewaele J. Standardized Tendon Fenestration with Injection of Autologous Blood for Treatment of Lateral Epicondylitis. J Hand Microsurg. 2020 Sep 17;14(3):240-244. doi: 10.1055/s-0040-1716991. eCollection 2022 Jul.
PubMed 36016641Tang S, Wang X, Wu P, Wu P, Yang J, Du Z, Liu S, Wei F. Platelet-Rich Plasma Vs Autologous Blood Vs Corticosteroid Injections in the Treatment of Lateral Epicondylitis: A Systematic Review, Pairwise and Network Meta-Analysis of Randomized Controlled Trials. PM R. 2020 Apr;12(4):397-409. doi: 10.1002/pmrj.12287. Epub 2020 Jan 13.
PubMed 31736257Arirachakaran A, Sukthuayat A, Sisayanarane T, Laoratanavoraphong S, Kanchanatawan W, Kongtharvonskul J. Platelet-rich plasma versus autologous blood versus steroid injection in lateral epicondylitis: systematic review and network meta-analysis. J Orthop Traumatol. 2016 Jun;17(2):101-12. doi: 10.1007/s10195-015-0376-5. Epub 2015 Sep 11.
PubMed 26362783Kinney WR, Anderson BR. Nonoperative Management of Lateral Epicondyle Tendinopathy: An Umbrella Review. J Chiropr Med. 2023 Sep;22(3):204-211. doi: 10.1016/j.jcm.2023.04.004. Epub 2023 Jul 10.
PubMed 37644995Edwards SG, Calandruccio JH. Autologous blood injections for refractory lateral epicondylitis. J Hand Surg Am. 2003 Mar;28(2):272-8. doi: 10.1053/jhsu.2003.50041.
PubMed 12671860Kazemi M, Azma K, Tavana B, Rezaiee Moghaddam F, Panahi A. Autologous blood versus corticosteroid local injection in the short-term treatment of lateral elbow tendinopathy: a randomized clinical trial of efficacy. Am J Phys Med Rehabil. 2010 Aug;89(8):660-7. doi: 10.1097/PHM.0b013e3181ddcb31.
PubMed 20463564Ozturan KE, Yucel I, Cakici H, Guven M, Sungur I. Autologous blood and corticosteroid injection and extracoporeal shock wave therapy in the treatment of lateral epicondylitis. Orthopedics. 2010 Feb;33(2):84-91. doi: 10.3928/01477447-20100104-09.
PubMed 20192142MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.
PubMed 9840793Altan L, Ercan I, Konur S. Reliability and validity of Turkish version of the patient rated tennis elbow evaluation. Rheumatol Int. 2010 Jun;30(8):1049-54. doi: 10.1007/s00296-009-1101-6. Epub 2009 Aug 26.
PubMed 19707766Poltawski L, Watson T. Measuring clinically important change with the Patient-rated Tennis Elbow Evaluation. Hand Therapy. 2011;16(3):52-57. https://doi.org/ 10.1258/ht.2011.011013
Fess EE. Grip strength. In: Casanova JS, editor. Clinical assessment recommendations, Chicago: American Society of Hand Therapists;1992; p. 41-5.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06236178
- Acronym / sponsor ID
- TR13734
- Conditions
- Lateral Epicondylitis, Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 1 Feb 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.
The goal of this clinical trial is to compare autologous blood, corticosteroid, and their combined injection for treating lateral epicondylitis. The main question it aims to answer are:
- Which of these highly used drugs in treatment of lateral epicondylitis is more effective? Participants were randomly allocated into three equal treatment groups (AB versus CS versus their combination) with sealed envelopes prepared by a computer-based random number generator. Patients in the AB Group received 1 ml of autologous venous blood mixed with 2 ml of 2% prilocaine HCl, patients in the CS Group received 1 ml of 40 mg methylprednisolone acetate mixed with 2 ml of 2% prilocaine HCl, and patients in the Combined Group (AB+CS) received 1 ml of autologous venous blood, 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2% prilocaine HCl. Each group received an equal amount of (3 ml) injected material. PRTEE and HGS measurements were assessed before the injection (baseline values), on Day 15, Day 30, and Day 90, in the same manner by the senior author.
Detailed description
This study aimed to compare the efficacy of autologous blood (AB) and corticosteroid (CS) injections and their combination in treating lateral epicondylitis (LE), hypothesizing that the combined approach might offer immediate symptom resolution and lower recurrence. Methods: A total of 120 patients diagnosed with lateral epicondylitis were systematically distributed among three distinct therapeutic injection groups. Those in the AB group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl. Participants in the CS category were given 1ml of 40 mg methylprednisolone acetate mixed with 2ml of 2% prilocaine HCl. Meanwhile, patients in the combined group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate, along with 1ml of 2% prilocaine HCl. Prior to receiving their respective injections, a comprehensive assessment of all participants was carried out. Follow-up assessments were subsequently conducted on days 15, 30, and 90, utilizing metrics of patient-rated tennis elbow evaluation (PRTEE) and measurements of hand grip strength (HGS).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Autologous Blood Injection Mixed With Local Anesthetic | Active comparator | Drug: Autologous Blood, Drug: Local AnestheticAutologous Blood Injection group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. |
| Corticosteroid Injection Mixed With Local Anesthetic | Active comparator | Drug: Corticosteroid, Drug: Local AnestheticCorticosteroid Injection category were given 1ml of 40 mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey) mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. |
| Combined Injection Mixed With Local Anesthetic | Active comparator | Drug: Corticosteroid, Drug: Autologous Blood, Drug: Local AnestheticCombined Injection group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey), along with 1ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1-Patients with LE whose complaints persisted for more than 3 months
Key exclusion criteria (8 listed)
- Patients with a history of recent trauma,
- Congenital or neuromuscular disease or abnormality of the upper limb
- Previous upper limb surgery,
- History of rheumatic disease,
- History of cervical disc pathology or carpal tunnel syndrome
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 |
|---|---|---|
| Corticosteroid1 ml of 40 mg methylprednisolone acetate | Drug | Combined Injection Mixed With Local Anesthetic, Corticosteroid Injection Mixed With Local Anesthetic |
| Autologous Blood1 ml of autologous venous blood | Drug | Autologous Blood Injection Mixed With Local Anesthetic, Combined Injection Mixed With Local Anesthetic |
| Local Anesthetic1 ml of 2% prilocaine HCl | Drug | Autologous Blood Injection Mixed With Local Anesthetic, Combined Injection Mixed With Local Anesthetic, Corticosteroid Injection Mixed With Local Anesthetic |
Primary outcome
Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores
Time frame: Before the injection (baseline values), on Day 15, Day 30, and Day 90
Patient-rated tennis elbow evaluation questionnaire (PRTEE) is consist of 2 steps, pain and function score. Pain Score is measured by sum of the 5 pain items (out of 50) (Best Score = 0, Worst Score = 50) Function Score is measured by sum of the of the 10 function items, divided by 2 (out of 50) (Best Score = 0, Worst Score = 50) Total Score is measured by sum of pain and function scores(Best Score = 0, Worst Score = 100)
1 secondary outcome
Hand Grip Strength (HGS) measurements
Time frame: Before the injection (baseline values), on Day 15, Day 30, and Day 90
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 1 Feb 2024.
- Background: PubMed 33636381Defoort S, De Smet L, Brys P, Peers K, Degreef I. Lateral elbow tendinopathy: surgery versus extracorporeal shock wave therapy. Hand Surg Rehabil. 2021 Jun;40(3):263-267. doi: 10.1016/j.hansur.2020.12.008. Epub 2021 Feb 23.
- Background: PubMed 1423702Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70.
- Background: PubMed 22972856Krogh TP, Bartels EM, Ellingsen T, Stengaard-Pedersen K, Buchbinder R, Fredberg U, Bliddal H, Christensen R. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med. 2013 Jun;41(6):1435-46. doi: 10.1177/0363546512458237. Epub 2012 Sep 12.
- Background: PubMed 36900772Kivrak A, Ulusoy I. Comparison of the Clinical Results of Platelet-Rich Plasma, Steroid and Autologous Blood Injections in the Treatment of Chronic Lateral Epicondylitis. Healthcare (Basel). 2023 Mar 6;11(5):767. doi: 10.3390/healthcare11050767.
- Background: PubMed 36016641Goorens CK, Wernaers P, Dewaele J. Standardized Tendon Fenestration with Injection of Autologous Blood for Treatment of Lateral Epicondylitis. J Hand Microsurg. 2020 Sep 17;14(3):240-244. doi: 10.1055/s-0040-1716991. eCollection 2022 Jul.
- Background: PubMed 31736257Tang S, Wang X, Wu P, Wu P, Yang J, Du Z, Liu S, Wei F. Platelet-Rich Plasma Vs Autologous Blood Vs Corticosteroid Injections in the Treatment of Lateral Epicondylitis: A Systematic Review, Pairwise and Network Meta-Analysis of Randomized Controlled Trials. PM R. 2020 Apr;12(4):397-409. doi: 10.1002/pmrj.12287. Epub 2020 Jan 13.
- Background: PubMed 26362783Arirachakaran A, Sukthuayat A, Sisayanarane T, Laoratanavoraphong S, Kanchanatawan W, Kongtharvonskul J. Platelet-rich plasma versus autologous blood versus steroid injection in lateral epicondylitis: systematic review and network meta-analysis. J Orthop Traumatol. 2016 Jun;17(2):101-12. doi: 10.1007/s10195-015-0376-5. Epub 2015 Sep 11.
- Background: PubMed 37644995Kinney WR, Anderson BR. Nonoperative Management of Lateral Epicondyle Tendinopathy: An Umbrella Review. J Chiropr Med. 2023 Sep;22(3):204-211. doi: 10.1016/j.jcm.2023.04.004. Epub 2023 Jul 10.
- Background: PubMed 12671860Edwards SG, Calandruccio JH. Autologous blood injections for refractory lateral epicondylitis. J Hand Surg Am. 2003 Mar;28(2):272-8. doi: 10.1053/jhsu.2003.50041.
- Background: PubMed 20463564Kazemi M, Azma K, Tavana B, Rezaiee Moghaddam F, Panahi A. Autologous blood versus corticosteroid local injection in the short-term treatment of lateral elbow tendinopathy: a randomized clinical trial of efficacy. Am J Phys Med Rehabil. 2010 Aug;89(8):660-7. doi: 10.1097/PHM.0b013e3181ddcb31.
- Background: PubMed 20192142Ozturan KE, Yucel I, Cakici H, Guven M, Sungur I. Autologous blood and corticosteroid injection and extracoporeal shock wave therapy in the treatment of lateral epicondylitis. Orthopedics. 2010 Feb;33(2):84-91. doi: 10.3928/01477447-20100104-09.
- Background: PubMed 9840793MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998 Nov-Dec;12(8):577-86. doi: 10.1097/00005131-199811000-00009.
- Individual participant dataSharing planned: Yes
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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.
Albert ÇAKAR, MD principal investigator
Istanbul Training and Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid, Autologous Blood and Local Anesthetic in people with Lateral Epicondylitis and Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis, run by Istanbul Training and Research Hospital at 2 sites 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores (time frame: Before the injection (baseline values), on Day 15, Day 30, and Day 90). 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 NCT06236178, which also lists 25 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 1 Feb 2024.