NCT02371902

Brief Summary

Chronic lateral epicondylitis is usually managed conservatively. The purpose of this single-blinded, randomized, controlled study is to compare the clinical therapeutic effects of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US) therapy in chronic lateral epicondylitis (LE) during a period of 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

1.6 years

First QC Date

February 12, 2015

Last Update Submit

February 19, 2015

Conditions

Tendinopathy

Keywords

Elbow painlateral epicondylitisconservative treatmentshock wave treatmenttherapeutic ultrasound

Outcome Measures

Primary Outcomes (1)

  • Difference of two points in pain recorded on the VAS

    a difference of two points in pain recorded on the VAS during a maximum voluntary resisted isometric wrist extension with the elbow in extension (Cozen test), between the ESWT Group and the Cryo-US Group, in at least one of the periods taken into account.

    3, 6, or 12 months after the end of treatments

Secondary Outcomes (1)

  • Patients satisfaction based on the Roles and Maudsley score

    3, 6, or 12 months after the end of treatments

Study Arms (2)

ESWT Group

ACTIVE COMPARATOR

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

Device: MODULITH® SLK, STORZ MEDICAL AG, Switzerland

Cryo-US Group

ACTIVE COMPARATOR

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.

Device: Cryoultrasound™, Medisport S.r.l., Italy

Interventions

MODULITH® SLK, STORZ MEDICAL AG, SwitzerlandDEVICE

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.

Also known as: Focused Extracorporeal Shock Wave Therapy, ESWT
ESWT Group
Cryoultrasound™, Medisport S.r.l., ItalyDEVICE

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).

Also known as: Therapeutic Ultrasound, Cryo-US therapy
Cryo-US Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • an age range from 18 to 75 years
  • 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
  • capability of filling in the questionnaires and signing the consent form

You may not qualify if:

  • Previous treatment with Cryo-US, ultrasound therapy, ESWT
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Andrea Hospital

Rome, Italy, 00144, Italy

Location

Related Publications (16)

  • 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.

    PMID: 16968862RESULT

  • 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.

    PMID: 10073590RESULT

  • 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.

    PMID: 24005204RESULT

  • 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.

    PMID: 12810936RESULT

  • 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.

    PMID: 23335238RESULT

  • 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.

    PMID: 21617986RESULT

  • 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.

    PMID: 23189160RESULT

  • Speed CA. Therapeutic ultrasound in soft tissue lesions. Rheumatology (Oxford). 2001 Dec;40(12):1331-6. doi: 10.1093/rheumatology/40.12.1331.

    PMID: 11752501RESULT

  • 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.

    PMID: 16705693RESULT

  • 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.

    PMID: 16116824RESULT

  • 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.

    PMID: 24172641RESULT

  • 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.

    PMID: 16162988RESULT

  • 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.

    PMID: 17551726RESULT

  • 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.

    PMID: 15090392RESULT

  • 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.

    PMID: 12919888RESULT

  • 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.

    PMID: 17254903RESULT

MeSH Terms

Conditions

TendinopathyTennis Elbow

Interventions

Extracorporeal Shockwave TherapyUltrasonic Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesElbow TendinopathyElbow InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Maria C Vulpiani, MD

    La Sapienza University of Rome

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 26, 2015

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 26, 2015

Record last verified: 2015-02

Locations

IT(1)