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Completed

NCT Number: NCT02371902

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sant'Andrea Hospital

Rome, Italy, 00144

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MODULITH® SLK, STORZ MEDICAL AG, Switzerland

Device

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.

Other names: Focused Extracorporeal Shock Wave Therapy, ESWT

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

Device

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 names: Therapeutic Ultrasound, Cryo-US therapy

Primary outcomes

  1. Difference of two points in pain recorded on the VAS

    Time frame: 3, 6, or 12 months after the end of treatments

    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 outcomes

  1. Patients satisfaction based on the Roles and Maudsley score

    Time frame: 3, 6, or 12 months after the end of treatments

    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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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