Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis
NCT ID: NCT06236178
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
119 participants
INTERVENTIONAL
2023-01-01
2023-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Corticosteroid Injection for Common Upper Extremity Problems
NCT00438672
Radial Tunnel Syndrome in Resistant Lateral Epicondylitis
NCT04856228
Effect of Eccentric Stretching in Patients With Lateral Epicondylitis
NCT05823233
Comparison of Initial Treatment for Carpal Tunnel Syndrome Related to Rheumatic Diseases: Corticosteroid Injection Versus Nighttime Splinting
NCT07042282
Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome
NCT02652390
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Autologous Blood Injection Mixed With Local Anesthetic
Autologous Blood Injection group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously.
Autologous Blood
1 ml of autologous venous blood
Local Anesthetic
1 ml of 2% prilocaine HCl
Corticosteroid Injection Mixed With Local Anesthetic
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.
Corticosteroid
1 ml of 40 mg methylprednisolone acetate
Local Anesthetic
1 ml of 2% prilocaine HCl
Combined Injection Mixed With Local Anesthetic
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.
Corticosteroid
1 ml of 40 mg methylprednisolone acetate
Autologous Blood
1 ml of autologous venous blood
Local Anesthetic
1 ml of 2% prilocaine HCl
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Corticosteroid
1 ml of 40 mg methylprednisolone acetate
Autologous Blood
1 ml of autologous venous blood
Local Anesthetic
1 ml of 2% prilocaine HCl
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Congenital or neuromuscular disease or abnormality of the upper limb
3. Previous upper limb surgery,
4. History of rheumatic disease,
5. History of cervical disc pathology or carpal tunnel syndrome
6. Systemic corticosteroid treatment
7. Any previous local injection treatment
8. Patients with a history of previous allergic reaction towards local anesthetics and corticosteroids
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul Training and Research Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Albert ÇAKAR
MD, Orthopedic and Traumatology Surgeon
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Albert ÇAKAR, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Training and Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Istanbul Training and Research Hospital, Department of Orthopedics and Traumatology,
Istanbul, , Turkey (Türkiye)
Istanbul Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Nirschl RP. Elbow tendinosis/tennis elbow. Clin Sports Med. 1992 Oct;11(4):851-70.
Krogh 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.
Kivrak 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.
Goorens 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.
Tang 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.
Arirachakaran 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.
Kinney 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.
Edwards 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.
Kazemi 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.
Ozturan 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.
MacDermid 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.
Altan 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.
Poltawski 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.
BAILY RA, BROCK BH. Hydrocortisone in tennis elbow; a controlled series. Proc R Soc Med. 1957 Jun;50(6):389-90. doi: 10.1177/003591575705000605. No abstract available.
Judson CH, Wolf JM. Lateral epicondylitis: review of injection therapies. Orthop Clin North Am. 2013 Oct;44(4):615-23. doi: 10.1016/j.ocl.2013.06.013. Epub 2013 Aug 21.
Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.
Dojode CM. A randomised control trial to evaluate the efficacy of autologous blood injection versus local corticosteroid injection for treatment of lateral epicondylitis. Bone Joint Res. 2012 Aug 1;1(8):192-7. doi: 10.1302/2046-3758.18.2000095. Print 2012 Aug.
Jindal N, Gaury Y, Banshiwal RC, Lamoria R, Bachhal V. Comparison of short term results of single injection of autologous blood and steroid injection in tennis elbow: a prospective study. J Orthop Surg Res. 2013 Apr 27;8:10. doi: 10.1186/1749-799X-8-10.
Arik HO, Kose O, Guler F, Deniz G, Egerci OF, Ucar M. Injection of autologous blood versus corticosteroid for lateral epicondylitis: a randomised controlled study. J Orthop Surg (Hong Kong). 2014 Dec;22(3):333-7. doi: 10.1177/230949901402200313.
Branson R, Naidu K, du Toit C, Rotstein AH, Kiss R, McMillan D, Fooks L, Coombes BK, Vicenzino B. Comparison of corticosteroid, autologous blood or sclerosant injections for chronic tennis elbow. J Sci Med Sport. 2017 Jun;20(6):528-533. doi: 10.1016/j.jsams.2016.10.010. Epub 2016 Oct 29.
Kaya SS, Yardimci G, Goksu H, Genc H. Effects of splinting and three injection therapies (corticosteroid, autologous blood and prolotherapy) on pain, grip strength, and functionality in patients with lateral epicondylitis. Turk J Phys Med Rehabil. 2022 Jun 1;68(2):205-213. doi: 10.5606/tftrd.2022.8007. eCollection 2022 Jun.
Lee SH, Choi HH, Chang MC. The effects of inclusion of minimal-dose corticosteroid in autologous whole blood and dextrose injection for the treatment of lateral epicondylitis. J Back Musculoskelet Rehabil. 2022;35(1):129-134. doi: 10.3233/BMR-200261.
Cakar A, Gozlu OD. Comparing autologous blood, corticosteroid, and a combined injection of both for treating lateral epicondylitis: a randomized clinical trial. J Orthop Traumatol. 2024 Jul 4;25(1):34. doi: 10.1186/s10195-024-00772-4.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TR13734
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.