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

U

University of Roma La Sapienza

Status

Completed

Conditions

Tendinopathy

Treatments

Device: Cryoultrasound™, Medisport S.r.l., Italy
Device: MODULITH® SLK, STORZ MEDICAL AG, Switzerland

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

ESWT Group
Active Comparator group
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
Treatment:
Device: MODULITH® SLK, STORZ MEDICAL AG, Switzerland
Cryo-US Group
Active Comparator group
Description:
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.
Treatment:
Device: Cryoultrasound™, Medisport S.r.l., Italy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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