Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Olimpio Galasso


Contact details

Viale Europa

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomised, placebo-controlled trial


Study hypothesis

To investigate the efficacy and safety of low energy shock waves as compared to placebo in the treatment of uncalcifying tendinopathy of the rotator cuff.

Ethics approval

Local Ethics Committee (Comitato Etico Azienda Ospedaliera Universitaria Integrata) approved

Study design

Double-blind randomised placebo-controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Non-calcifying tendinopathy of supraspinatus tendon


The treatment regimen requires administration of two treatment sessions with 3000 impulses separated by 7 days. The sham treatment will entail use of the Modulith SLK in which the shockwave generator has been disconnected although all other aspects of the device will appear to be normal, including the audible sound characteristic of the generator.
All patients will be required to have two follow-up visits to complete the study. The initial follow-up visit will occur 6 weeks after the last treatment. The final follow-up visit will occur 3 months after the final treatment.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Efficacy: Constant-Murley Score (CMS), measured at baseline, 6 weeks and three months follow up
2. Safety (adverse effects), measured immediately after treatment, at the beginning of the second session of shock waves and at 6 weeks and three months follow up

Secondary outcome measures

Roentgenographic and magnetic resonance images (MRI) changes, measured at baseline and three months follow up

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Male and non-pregnant female patients 18 years of age or older (women of child-bearing potential must have a negative serum pregnancy test performed within 1 - 14 days prior to the treatment procedure) suffering from chronic non-calcific supraspinatus tendinopathy as diagnosed by X-ray, magnetic resonance imaging (MRI) and physical examination
2. Patient has not responded to a standard course of non-pharmacological and non-surgical conservative treatment for a minimum of 4 months. Non-surgical conservative treatment may consist of: therapeutic exercise, ultrasound, iontophoresis, cryotherapy, and immobilisation or activity modification.
3. Patient has not responded to non-surgical, pharmacological conservative treatment and has had at least one sub-acromial steroid injection and at least one course of the standard dose of prescribed non-steroidal anti-inflammatory drugs (NSAIDs) or other pharmacological therapy a minimum of thirty days prior to SV
4. Diagnosis of supraspinatus tendinopathy is only in one shoulder
5. Patient has free passive range of movement and at least 90 degrees active abduction in the affected shoulder
6. Patient is willing to participate in the study and return for all scheduled follow-up visits
7. Patient is capable of giving, and has given, written informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patient has a history of uncontrolled severe hypertension (systolic pressure greater than 180 mmHg, diastolic pressure greater than 110 mmHg)
2. Patient has unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
3. Patient has a white blood cell count less than 2,000 or greater than 15,000, and/or platelet count less than 50,000
4. Patient has a known bleeding disorder or is currently being treated with anticoagulant therapy
5. Patient is currently being treated with a narcotic or NSAIDs and/or has used analgesics or NSAIDs within the 72 hours prior to the SV
6. Patient has participated in any other shoulder pain treatment research study within 30 days prior to the SV
7. Patient has had prior shoulder surgery
8. Patient is complaining of pain in both shoulders
9. Patient has malignant tumours, irrespective of location
10. Patient has a cardiac pacemaker implant
11. Patient has anatomy that prevents the focusing of the device into the shoulder in the area of the supraspinatus tendon (e.g., extensive scarring, misalignment of side fractures, non-unions or delayed fracture healing, congenital malformation, etc.)
12. Patient has any upper extremity neurological disorder as diagnosed from focused neurological exam (e.g. thoracic outlet syndrome, reflex sympathetic dystrophy, etc.)
13. Patient has a full-thickness rotator cuff tear of any of four tendons as seen on MRI
14. Patient has an acromiohumeral interval less than 7 mm as measured on a standard AP X-ray or severe symptomatic degenerative changes in the glenohumeral or acromioclavicular joint
15. Patient has acute subacromial bursitis as diagnosed by physical examination findings and MRI
16. Patient has generalised polyarthritis, rheumatoid arthritis
17. Patient is allergic to local anaesthetic

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Viale Europa

Sponsor information


Storz Medical AG (Switzerland)

Sponsor details

Lohstampfestrasse 8

Sponsor type




Funder type


Funder name

Storz Medical AG, Tägerwilen (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

University Magna Graecia, Catanzaro (Italy) - School of Medicine University

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in

Publication citations

  1. Results

    Galasso O, Amelio E, Riccelli DA, Gasparini G, Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial., BMC Musculoskelet Disord, 2012, 13, 86, doi: 10.1186/1471-2474-13-86.

Additional files

Editorial Notes