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

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Device: MODULITH® SLK, STORZ MEDICAL AG, Switzerland; Device: Cryoultrasound™, Medisport S.r.l., Italy

• Registration Number: NCT02371902
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2015-02
• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-19
• Last Update Submitted: 2015-02-19
• Study First Posted: 2015-02-26
• Last Update Posted: 2015-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESWT Group	MODULITH® SLK, STORZ MEDICAL AG, Switzerland	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
Cryo-US Group	Cryoultrasound™, Medisport S.r.l., Italy	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.

Primary Outcome Measures

Name	Time	Method
Difference of two points in pain recorded on the VAS	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 Outcome Measures

Name	Time	Method
Patients satisfaction based on the Roles and Maudsley score	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.

Trial Locations

Locations (1)

Sant'Andrea Hospital; 🇮🇹 Rome, Italy