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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tendinopathy

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESWT Group<br>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<br>* 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.<br>* Other names: ESWT;|
| Active Comparator: Cryo-US Group<br>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<br>* 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).<br>* Other names: Cryo-US therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3, 6, or 12 months after the end of treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elbow pain, lateral epicondylitis, conservative treatment, shock wave treatment, therapeutic ultrasound