Condition category
Musculoskeletal Diseases
Date applied
07/11/2010
Date assigned
20/12/2010
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Olimpio Galasso

ORCID ID

Contact details

Viale Europa
Catanzaro
88100
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Non-calcifying tendinopathy of supraspinatus tendon

Intervention

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

Other

Phase

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

07/10/2002

Overall trial end date

05/05/2003

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

20

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

07/10/2002

Recruitment end date

05/05/2003

Locations

Countries of recruitment

Italy

Trial participating centre

Viale Europa
Catanzaro
88100
Italy

Sponsor information

Organisation

Storz Medical AG (Switzerland)

Sponsor details

Lohstampfestrasse 8
Tägerwilen
8274
Switzerland

Sponsor type

Industry

Website

http://www.storzmedical.com/

Funders

Funder type

University/education

Funder name

Storz Medical AG, Tägerwilen (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 http://www.ncbi.nlm.nih.gov/pubmed/22672772

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