Comparison of Peloidotherapy and Extracorporeal Shock Wave Therapy Efficiency in Patients With Lateral Epicondylitis
NCT ID: NCT04748406
Last Updated: 2021-02-10
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.
UNKNOWN
NA
70 participants
INTERVENTIONAL
2020-12-01
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Shockwave Therapy Plus Exercise for Lateral Epicondylitis
NCT07282431
Effect of Scapular Stabilization Exercises and ESWT in Patients With Lateral Epicondylitis
NCT07238413
ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation
NCT06342518
Comparison of the Efficacy of Mesotherapy and Extracorporeal Shock Wave Therapy in Patients With Lateral Epicondylitis
NCT07043335
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
NCT03834090
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Peloids (medicinal mud) are organic or inorganic substances formed as a result of geological and / or biological events. They can be found in nature as fine particles, or they are made into small, fine particles by some pre-preparation processes. (10). Peloidotherapy is a special balneotherapy method made with natural muds (11). It is especially used in the treatment of diseases such as degenerative joint diseases, soft tissue rheumatism, lumbar discopathy, cervical discopathy, chronic back and neck pain, joint pain. Scientific studies on peloid treatment both in Turkey and abroad have shown that patients have reduced pain (12), improved physical functions, increased quality of life, and decreased pain medication use (12-15). A recent study demonstrated the effectiveness of peloidotherapy in LE. (16). Ökmen et al. In this study, the effectiveness of peloidotherapy and elbow bandage in the treatment of LE was compared. (16). This study remains the only one investigating the effectiveness of peloidotherapy in the treatment of LE.
Shock wave therapy (extracorporeal shock wave therapy, Extracorporeal Shock Wave Therapy-ESWT) is a new orthopedic treatment method based on focusing high amplitude sound waves on the desired area of the body and providing treatment there. (17). ESWT creates a cavitation effect in deep tissue by creating capillary microrupture, chemical mediator leakage, and neovascularization in damaged tissue with low or high energy options (18). Successful results have been reported with ESWT treatment in 48-73% of cases with recurrent LE with non-surgical methods (19). Due to its non-invasive nature and low complication rates, the use of ESWT in LE treatment is gradually increasing (20). Some authors state that ESWT has lateral LE effect (20). Some authors reported that ESWT is not in the treatment of LE (21).
Investigator did not find a study comparing ESWT and Peloidotherapy methods in the treatment of LE in the literature. In this thesis, our aim is to compare the effectiveness of peloidotherapy and ESWT methods used in the treatment of LE with a prospective clinical study.
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.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Peloid Therapy
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week(16).
Peloid therapy
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week
Home Workout Program
Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.
Cold application
At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.
ESWT(Extracorporeal Shock Wave Therapy)
Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied(4).
Extracorporeal Shock Wave Therapy(ESWT)
Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied.
Home Workout Program
Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.
Cold application
At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extracorporeal Shock Wave Therapy(ESWT)
Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied.
Peloid therapy
Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week
Home Workout Program
Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.
Cold application
At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* A history of cervical and shoulder problems
* History of injection, surgery, physical therapy in the elbow area in the last 6 months
* Having had ESWT treatment in the elbow area before
* History of elbow problems other than LE
* Elbow osteoarthritis, previous elbow fracture history
* A history of polyneuropathy,
* Those with a history of uncontrolled systemic disease (cardiovascular, pulmonary, hepatic, renal, hematologic ..),
* Those with a history of systemic endocrine disease (DM, hyperthyroidism ..),
* Major psychiatric illness
* History of rheumatic diseases such as fibromyalgia, polymyalgiaromatica, ankylosing spondylitis, rheumatoid arthritis
* Those who use bleeding disorders and anticoagulants
* Neurological deficit
* Malignancy
* Those with a history of pacemakers were not included in the study.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Konya Meram State Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hasan Koru
assistant doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
hasan koru
Role: PRINCIPAL_INVESTIGATOR
assistant doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Konya Beyhekim Training and Research Hospital Physical Medicine and Rehabilitation Clinic
Selçuklu, Konya, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
1.Barrington J, Hage W. Lateral epicondylitis (tenis elbow): nonoperative, open, or arthroscopic treatment?. Curr Opin Orthop 2003; 14: 291-295.
2.Chard MD. The Elbow. In Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, editors. Rheumatology. 3rd ed. Mosby, London; 2003. p. 631-9.
Shiri R, Viikari-Juntura E, Varonen H, Heliovaara M. Prevalence and determinants of lateral and medial epicondylitis: a population study. Am J Epidemiol. 2006 Dec 1;164(11):1065-74. doi: 10.1093/aje/kwj325. Epub 2006 Sep 12.
4.Soner Akkurt, Ahmet Yılmaz, Tolga Saka. Lateral epikondilit tedavisinde ekstrakorporeal şok dalga tedavisi, fizyoterapi ve lokal steroid enjeksiyonunun karşılaştırılması Turk J Phys Med Rehab 2016;1(62):37-44.
Derebery VJ, Devenport JN, Giang GM, Fogarty WT. The effects of splinting on outcomes for epicondylitis. Arch Phys Med Rehabil. 2005 Jun;86(6):1081-8. doi: 10.1016/j.apmr.2004.11.029.
6. Ölmez N, Memiş A. Lateral Epikondilit Tedavisinde Kanıta Dayalı Veriler. Rewiev . Turkiye Klinikleri J Med Sci 2010;30(1)
Foley AE. Tennis elbow. Am Fam Physician. 1993 Aug;48(2):281-8.
Wilson JJ, Best TM. Common overuse tendon problems: A review and recommendations for treatment. Am Fam Physician. 2005 Sep 1;72(5):811-8.
9. Aydin A, Celepkolu T, Atiç R, Alemdar C, Aydin ZS, Cevik R. Effects of Extracorporeal Shock Wave Therapy On The Quality of Life And Pain in Patients With Lateral Epicondylitis. Euras J Fam Med 2018;7(1):29-36
10. Karagülle MZ. Balneoloji ve Kaplıca Tıbbı. İstanbul: Nobel Tıp Kitabevleri; 2002. s. 15-36.
11. Özer UN. Kaplıca Tedavisi. In: Tuna N, Eds. Romatizmal Hastalıklar. Ankara: Hacettepe Taş Kitapçılık; 1994. s. 229-42.
Fioravanti A, Bacaro G, Giannitti C, Tenti S, Cheleschi S, Gui Delli GM, Pascarelli NA, Galeazzi M. One-year follow-up of mud-bath therapy in patients with bilateral knee osteoarthritis: a randomized, single-blind controlled trial. Int J Biometeorol. 2015 Sep;59(9):1333-43. doi: 10.1007/s00484-014-0943-0. Epub 2014 Dec 17.
Liu H, Zeng C, Gao SG, Yang T, Luo W, Li YS, Xiong YL, Sun JP, Lei GH. The effect of mud therapy on pain relief in patients with knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2013 Oct;41(5):1418-25. doi: 10.1177/0300060513488509. Epub 2013 Sep 5.
Espejo-Antunez L, Cardero-Duran MA, Garrido-Ardila EM, Torres-Piles S, Caro-Puertolas B. Clinical effectiveness of mud pack therapy in knee osteoarthritis. Rheumatology (Oxford). 2013 Apr;52(4):659-68. doi: 10.1093/rheumatology/kes322. Epub 2012 Dec 11.
Tefner IK, Gaal R, Koroknai A, Rathonyi A, Gati T, Monduk P, Kiss E, Kovacs C, Balint G, Bender T. The effect of Neydharting mud-pack therapy on knee osteoarthritis: a randomized, controlled, double-blind follow-up pilot study. Rheumatol Int. 2013 Oct;33(10):2569-76. doi: 10.1007/s00296-013-2776-2. Epub 2013 May 21.
Okmen BM, Eroksuz R, Altan L, Aksoy MK. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study. Int J Biometeorol. 2017 Nov;61(11):1965-1972. doi: 10.1007/s00484-017-1386-1. Epub 2017 Jun 15.
17.İsmail Baloğlu, M. Hakan Özsoy, Hilmi Aydınok, Veli Lök. Ortopedi ve Travmatolojide Şok Dalga Tedavisi. TOTBİD (Türk Ortopedi ve Travmatoloji Birliği Derneği) Dergisi. 2005 • Cilt: 4 Sayı: 1-2.
18. Hossain M, Makwana N. "Not Plantar Fasciitis": the differential diagnosis and management of heel pain syndrome. Orthop Trauma. 2011;25:198-206
Ogden JA, Alvarez RG, Levitt R, Marlow M. Shock wave therapy (Orthotripsy) in musculoskeletal disorders. Clin Orthop Relat Res. 2001 Jun;(387):22-40. doi: 10.1097/00003086-200106000-00005.
Bayram K, Yesil H, Dogan E. Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis. North Clin Istanb. 2014 Aug 3;1(1):33-38. doi: 10.14744/nci.2014.77487. eCollection 2014.
Melikyan EY, Shahin E, Miles J, Bainbridge LC. Extracorporeal shock-wave treatment for tennis elbow. A randomised double-blind study. J Bone Joint Surg Br. 2003 Aug;85(6):852-5.
Schmidt RT, Toews JV. Grip strength as measured by the Jamar dynamometer. Arch Phys Med Rehabil. 1970 Jun;51(6):321-7. No abstract available.
23. Düger T, Yakut E, Öksüz Ç, Yörükan S, Bilgütay BS, Ayhan Ç, Leblebicioğlu G, Kayıhan H, Kırdı N, Yakut Y, Güler Ç. Kol, Omuz ve El Sorunları (Disabilities of the Arm, Shoulder and Hand - DASH) Anketi Türkçe uyarlamasının güvenirliği ve geçerliği. Fizyoterapi Rehabilitasyon. 2006; 17(3):99-107.
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.
25. Koçyiğit H. Aydemir Ö, Fişek G. Kısa form-36(KF-36)'nın Türkçe versiyonunun güvenirliliği ve geçerliliği. İlaç ve Tedavi Dergisi.1999;12:102-106.
Balogun JA, Akomolafe CT, Amusa LO. Grip strength: effects of testing posture and elbow position. Arch Phys Med Rehabil. 1991 Apr;72(5):280-3.
27. Üncel NA, Ceceli E, Durukan BP, Öken Ö, Erdem HR. El kavrama gücüne cinsiyet ve el dominansının etkisinin değerlendirilmesi. Romatizma, Cilt: 17, Sayı: 1, 2002.
Trampisch US, Franke J, Jedamzik N, Hinrichs T, Platen P. Optimal Jamar dynamometer handle position to assess maximal isometric hand grip strength in epidemiological studies. J Hand Surg Am. 2012 Nov;37(11):2368-73. doi: 10.1016/j.jhsa.2012.08.014.
Amaral JF, Mancini M, Novo Junior JM. Comparison of three hand dynamometers in relation to the accuracy and precision of the measurements. Rev Bras Fisioter. 2012 Jun;16(3):216-24. doi: 10.1590/s1413-35552012000300007.
30. Feneis H. Sistematik Resimli Anatomi Sözlüğü (Çev. Ed: Yıldırım M) s. 90-92, Nobel Yüce, İstanbul, 1997.
Pienimaki TT, Siira PT, Vanharanta H. Chronic medial and lateral epicondylitis: a comparison of pain, disability, and function. Arch Phys Med Rehabil. 2002 Mar;83(3):317-21. doi: 10.1053/apmr.2002.29620.
Roles NC, Maudsley RH. Radial tunnel syndrome: resistant tennis elbow as a nerve entrapment. J Bone Joint Surg Br. 1972 Aug;54(3):499-508. No abstract available.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
Koru H, Yilmaz H, Yilmaz R, Karpuz S. Comparison of the efficiency of peloidotherapy and extracorporeal shock wave therapies in patients diagnosed with lateral epicondylitis: a prospective, randomized, controlled study. Int J Biometeorol. 2024 Jan;68(1):101-108. doi: 10.1007/s00484-023-02574-5. Epub 2023 Nov 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KonyaTRH1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.