Supraspinatus Calcifying TendonitisNCT01602653
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
A study testing Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK in people with Supraspinatus Calcifying Tendonitis, run by University of Roma La Sapienza.
Trial summary
The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Supraspinatus Calcifying Tendonitis
- What is being tested?
- Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no visible clinical benefits by previous conservative treatment
- medium and large calcific deposits, according to Bosworth classification
- type I and II Gartner deposits
Who cannot join
- presence of tiny calcific deposits, according to Bosworth classification
- type III, according to the Gartner classification
- age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases
About this study
The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.
- Conditions
- Supraspinatus Calcifying Tendonitis
- Being tested
- Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKDevice
an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKDevice
an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks. Receives: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK |
| 2 | Active comparator | The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks. Receives: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Scale
Constant-Murley scale is the scoring system used to assess shoulder function in four of the studies being reviewed. It combines physical examination tests with subjective evaluations by the patients and consists of 35 points and 65 points respectively. Its strength is the method of its application, which is quite clearly described, and its being an improvement on pre-existing scales
Measured: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.
Secondary outcomes (1)
Visual Analogic Scale
It is a horizontal line, 10 cm in length with 0 cm labeled "no pain" and 10 cm labeled "worst pain I have ever had". The patient marks on the line the point that they feel represents their perception of their current state
Measured: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startNov 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus Calcifying TendonitisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Ioppolo, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602653
- Sponsor's protocol ID
- PTJ-2011-0252.R1
- Status last verified
- May 2012
- First submitted
- 14 May 2012
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
PubMed 22745199
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
- ClinicalTrials.gov ID
- NCT01602653
- Acronym / sponsor ID
- PTJ-2011-0252.R1
- Conditions
- Supraspinatus Calcifying Tendonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKthe first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks. |
| 2 | Active comparator | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKThe second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no visible clinical benefits by previous conservative treatment
- medium and large calcific deposits, according to Bosworth classification
- type I and II Gartner deposits
Key exclusion criteria (3 listed)
- presence of tiny calcific deposits, according to Bosworth classification
- type III, according to the Gartner classification
- age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKan energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks. | Device | 1 |
| Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLKan energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks. | Device | 2 |
Primary outcome
Constant Murley Scale
Time frame: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.
Constant-Murley scale is the scoring system used to assess shoulder function in four of the studies being reviewed. It combines physical examination tests with subjective evaluations by the patients and consists of 35 points and 65 points respectively. Its strength is the method of its application, which is quite clearly described, and its being an improvement on pre-existing scales
1 secondary outcome
Visual Analogic Scale
Time frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Derived from this study: PubMed 22745199Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK in people with Supraspinatus Calcifying Tendonitis, run by University of Roma La Sapienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Murley Scale (time frame: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012.