Clinical trial NCT02371902: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: Elbow pain
lateral epicondylitis
conservative treatment
shock wave treatment
therapeutic ultrasound
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference of two points in pain recorded on the VAS
timeFrame: 3, 6, or 12 months after the end of treatments
Secondary outcomes:
measure: Patients satisfaction based on the Roles and Maudsley score
timeFrame: 3, 6, or 12 months after the end of treatments
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sant'Andrea Hospital
Study officials:
affiliation: La Sapienza University of Rome
name: Maria C Vulpiani, MD
role: STUDY_CHAIR
References:
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