Extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus

ISRCTN ISRCTN41236511
DOI https://doi.org/10.1186/ISRCTN41236511
Protocol serial number N/A
Sponsor Storz Medical AG (Switzerland)
Funders Storz Medical AG, Tägerwilen (Switzerland), University Magna Graecia, Catanzaro (Italy) - School of Medicine University
Submission date
07/11/2010
Registration date
20/12/2010
Last edited
05/11/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Olimpio Galasso
Scientific

Viale Europa
Catanzaro
88100
Italy

Study information

Primary study designInterventional
Study designDouble-blind randomised placebo-controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleExtracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomised, placebo-controlled trial
Study objectivesTo 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(s)Local Ethics Committee (Comitato Etico Azienda Ospedaliera Universitaria Integrata) approved
Health condition(s) or problem(s) studiedNon-calcifying tendinopathy of supraspinatus tendon
InterventionThe 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date05/05/2003

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration20
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment07/10/2002
Date of final enrolment05/05/2003

Locations

Countries of recruitment

  • Italy

Study participating centre

Viale Europa
Catanzaro
88100
Italy

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/06/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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