ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
NCT ID: NCT02371902
Last Updated: 2015-02-26
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
80 participants
INTERVENTIONAL
2011-06-30
2013-01-31
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.
Comparison of Two Different Treatment Effects on Individuals With Chronic Lateral Epicondylitis
NCT04187287
Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
NCT03834090
ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation
NCT06342518
Shockwave Therapy Plus Exercise for Lateral Epicondylitis
NCT07282431
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
NCT01602653
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
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ESWT Group
Focused Extracorporeal Shock Wave Therapy: 3 sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2
MODULITH® SLK, STORZ MEDICAL AG, Switzerland
Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.
Cryo-US Group
Therapeutic cryoultrasound: 12 sessions was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each.
Cryoultrasound™, Medisport S.r.l., Italy
Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MODULITH® SLK, STORZ MEDICAL AG, Switzerland
Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.
Cryoultrasound™, Medisport S.r.l., Italy
Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* clinical or instrumental diagnosis of chronic lateral epicondylitis, present for at least three months
* intensity of pain of more than 5 on the Visual Analogue Scale (VAS) performing a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test)
* the failure of conservative treatments previously made
* a wash-out period of at least 12 weeks since the last conservative therapy carried out before inclusion in the study
* capability of filling in the questionnaires and signing the consent form
Exclusion Criteria
* The conjoint presence of bilateral or lateral and medial epicondylitis
* Acute infection of the soft tissues or the bones adjacent to the area of treatment
* Local bleedings or skin lesions, pathologies of the blood coagulation, or use of anticoagulant drugs
* Pacemaker, pregnancy
* Neoplastic disease
* Raynaud's disease, altered thermal and pain sensitivity, or cold intolerance
* Evidence of elbow bursitis, or articular or synovial pathologies; signs of elbow laxity or instability
* Cervicobrachialgia; syndrome of ulnar, radial, or posterior interosseous nerve entrapment
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Roma La Sapienza
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mario Vetrano, MD
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria C Vulpiani, MD
Role: STUDY_CHAIR
La Sapienza University of Rome
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sant'Andrea Hospital
Rome, Italy, Italy
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.
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.
Kraushaar BS, Nirschl RP. Tendinosis of the elbow (tennis elbow). Clinical features and findings of histological, immunohistochemical, and electron microscopy studies. J Bone Joint Surg Am. 1999 Feb;81(2):259-78. No abstract available.
Galloway MT, Lalley AL, Shearn JT. The role of mechanical loading in tendon development, maintenance, injury, and repair. J Bone Joint Surg Am. 2013 Sep 4;95(17):1620-8. doi: 10.2106/JBJS.L.01004.
Haahr JP, Andersen JH. Prognostic factors in lateral epicondylitis: a randomized trial with one-year follow-up in 266 new cases treated with minimal occupational intervention or the usual approach in general practice. Rheumatology (Oxford). 2003 Oct;42(10):1216-25. doi: 10.1093/rheumatology/keg360. Epub 2003 Jun 16.
Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
Vetrano M, d'Alessandro F, Torrisi MR, Ferretti A, Vulpiani MC, Visco V. Extracorporeal shock wave therapy promotes cell proliferation and collagen synthesis of primary cultured human tenocytes. Knee Surg Sports Traumatol Arthrosc. 2011 Dec;19(12):2159-68. doi: 10.1007/s00167-011-1534-9. Epub 2011 May 27.
Leone L, Vetrano M, Ranieri D, Raffa S, Vulpiani MC, Ferretti A, Torrisi MR, Visco V. Extracorporeal Shock Wave Treatment (ESWT) improves in vitro functional activities of ruptured human tendon-derived tenocytes. PLoS One. 2012;7(11):e49759. doi: 10.1371/journal.pone.0049759. Epub 2012 Nov 26.
Speed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology (Oxford). 2001 Dec;40(12):1331-6. doi: 10.1093/rheumatology/40.12.1331.
Tsai WC, Pang JH, Hsu CC, Chu NK, Lin MS, Hu CF. Ultrasound stimulation of types I and III collagen expression of tendon cell and upregulation of transforming growth factor beta. J Orthop Res. 2006 Jun;24(6):1310-6. doi: 10.1002/jor.20130.
Costantino C, Pogliacomi F, Vaienti E. Cryoultrasound therapy and tendonitis in athletes: a comparative evaluation versus laser CO2 and t.e.ca.r. therapy. Acta Biomed. 2005 Apr;76(1):37-41.
Costantino C, Vulpiani MC, Romiti D, Vetrano M, Saraceni VM. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med. 2014 Feb;50(1):39-47. Epub 2013 Oct 30.
Chung B, Wiley JP, Rose MS. Long-term effectiveness of extracorporeal shockwave therapy in the treatment of previously untreated lateral epicondylitis. Clin J Sport Med. 2005 Sep;15(5):305-12. doi: 10.1097/01.jsm.0000179137.69598.7e.
Radwan YA, ElSobhi G, Badawy WS, Reda A, Khalid S. Resistant tennis elbow: shock-wave therapy versus percutaneous tenotomy. Int Orthop. 2008 Oct;32(5):671-7. doi: 10.1007/s00264-007-0379-9. Epub 2007 Jun 6.
Rompe JD, Decking J, Schoellner C, Theis C. Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J Sports Med. 2004 Apr-May;32(3):734-43. doi: 10.1177/0363546503261697.
Day B. 'Extracorporeal shock wave therapy for lateral epicondylitis--a double blind randomised controlled trial', by Speed CA, Nichols D, Richards C, Humphreys H, Wies JT, Burnet S, Hazleman BL [Journal of Orthopaedic Research 29 (2002) 895-898]. J Orthop Res. 2003 Sep;21(5):960; author reply 961. doi: 10.1016/S0736-0266(03)00045-7. No abstract available.
Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.