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ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

Primary Purpose

Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

MODULITH® SLK, STORZ MEDICAL AG, Switzerland

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

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Elbow pain, lateral epicondylitis, conservative treatment, shock wave treatment, therapeutic ultrasound

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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:

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

Sites / Locations

Sant'Andrea Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ESWT Group

Cryo-US Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patients satisfaction based on the Roles and Maudsley score

the number of patients who achieved at least 50% satisfactory results at 3, 6 and 12 months after the treatment. Satisfactory results were described as the sum of the excellent and good scores based on the Roles and Maudsley score.

Full Information

NCT ID

NCT02371902

First Posted

February 12, 2015

Last Updated

February 19, 2015

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT02371902

Brief Title

ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

Official Title

Extracorporeal Shock Wave Therapy vs Cryoultrasound Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at 48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session- (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12 months post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendinopathy

Keywords

Elbow pain, lateral epicondylitis, conservative treatment, shock wave treatment, therapeutic ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESWT Group

Arm Type

Active Comparator

Arm Description

Arm Title

Cryo-US Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

MODULITH® SLK, STORZ MEDICAL AG, Switzerland

Other Intervention Name(s)

Focused Extracorporeal Shock Wave Therapy, ESWT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Therapeutic Ultrasound, Cryo-US therapy

Intervention Description

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).

Primary Outcome Measure Information:

Title

Difference of two points in pain recorded on the VAS

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Patients satisfaction based on the Roles and Maudsley score

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria C Vulpiani, MD

Organizational Affiliation

La Sapienza University of Rome

Official's Role

Study Chair

Facility Information:

Facility Name

Sant'Andrea Hospital

City

Rome

ZIP/Postal Code

00144

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

16968862

Citation

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.

Results Reference

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PubMed Identifier

10073590

Citation

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.

Results Reference

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PubMed Identifier

24005204

Citation

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.

Results Reference

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PubMed Identifier

12810936

Citation

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.

Results Reference

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PubMed Identifier

23335238

Citation

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.

Results Reference

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PubMed Identifier

21617986

Citation

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.

Results Reference

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PubMed Identifier

23189160

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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Citation

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16116824

Citation

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Citation

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Citation

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Citation

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Citation

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ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study

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