Extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus
| ISRCTN | ISRCTN41236511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41236511 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Viale Europa
Catanzaro
88100
Italy
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 objectives | 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(s) | Local Ethics Committee (Comitato Etico Azienda Ospedaliera Universitaria Integrata) approved |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 07/10/2002 |
| Completion date | 05/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/10/2002 |
| Date of final enrolment | 05/05/2003 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Europa
Catanzaro
88100
Italy
88100
Italy
Sponsor information
Storz Medical AG (Switzerland)
Industry
Industry
Lohstampfestrasse 8
Tägerwilen
8274
Switzerland
| Website | http://www.storzmedical.com/ |
|---|---|
"ROR" |
https://ror.org/049vzz986 |
Funders
Funder type
University/education
Storz Medical AG, Tägerwilen (Switzerland)
No information available
University Magna Graecia, Catanzaro (Italy) - School of Medicine University
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
