Calcific TendinitisNCT01832376
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
A study testing Ultrasound guided needle lavage in people with Calcific Tendinitis, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- Ultrasound guided needle lavage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2011to May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain for at least 6 months, localised laterally on the upper humerus
- Painful arc
- Positive Hawkins test and/or Neers tegn for impingement
- Calcific deposit of >= 5 mm on shoulder x-ray, verified on sonography with a localisation in the supraspinatus or infraspinatus tendon
Who cannot join
- The presence of other local or systemic diseases affecting shoulder function like arthritis, inflammatory arthropathy or instability
- Symptoms from a cervical root syndrome
- Sonographic or MRI findings for a rotator cuff tear
- Earlier surgery in the study shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment
Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty.
Read more
Purpose of the study: The investigators want to find out
- if shoulder function, measured by a shoulder score, will increase during follow-up
- how much of the calcific material can be aspirated (in ml)
- to which extend the calcific deposit disappears on x-rays and sonographic images
- how many patients will need surgical treatment
- Conditions
- Calcific Tendinitis
- Being tested
- Ultrasound guided needle lavage
- Keywords
- Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided needle lavageProcedure or surgery
Also called Barbotage
A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided needle lavage | Experimental | Ultrasound guided needle lavage Receives: Procedure: Ultrasound guided needle lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
The self-report section of the American Shoulder and Elbow Surgeons score (ASES) consists of two equally weighted parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. Pain measurement is performed on a 10 cm visual analogue scale divided into 1 cm increments. Shoulder function is measured by classifying 10 activities of daily living on a four-point ordinal scale. Change in points on the ASES scale from baseline to 24 month follow-up is the primary outcome measure of our study.
Measured: Baseline and 24 months
Secondary outcomes (1)
Number of patients who need operative treatment during follow-up
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJun 2011
- Primary completionFeb 2016
- Study completionMay 2018
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 Calcific TendinitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Moosmayer, Vestre Viken Hospital Trust
- Investigators
- Stefan Moosmayer, MD, PhD, Principal investigator, Martina Hansens Hospital, Sandvika, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832376
- Sponsor's protocol ID
- 2012/773
- Status last verified
- Oct 2018
- First submitted
- 8 Apr 2013
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moosmayer S and Aasen IB. Ultrasound- Guided Percutaneous Needle Treatment and Steroid Injection for Calcific Tendinopathy of the Shoulder: Can the Orthopedic Surgeon do it?. M J Orth. 3(1): 020, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
- ClinicalTrials.gov ID
- NCT01832376
- Acronym / sponsor ID
- 2012/773
- Conditions
- Calcific Tendinitis
- Keywords
- Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 16 Apr 2013 (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.
Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment
Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty.
Purpose of the study: The investigators want to find out
- if shoulder function, measured by a shoulder score, will increase during follow-up
- how much of the calcific material can be aspirated (in ml)
- to which extend the calcific deposit disappears on x-rays and sonographic images
- how many patients will need surgical treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided needle lavage | Experimental | Procedure: Ultrasound guided needle lavageUltrasound guided needle lavage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Shoulder pain for at least 6 months, localised laterally on the upper humerus
- Painful arc
- Positive Hawkins test and/or Neers tegn for impingement
- Calcific deposit of >= 5 mm on shoulder x-ray, verified on sonography with a localisation in the supraspinatus or infraspinatus tendon
Key exclusion criteria (4 listed)
- The presence of other local or systemic diseases affecting shoulder function like arthritis, inflammatory arthropathy or instability
- Symptoms from a cervical root syndrome
- Sonographic or MRI findings for a rotator cuff tear
- Earlier surgery in the study shoulder
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 |
|---|---|---|
| Ultrasound guided needle lavageAlso: BarbotageA 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption. | Procedure or surgery | Ultrasound guided needle lavage |
Primary outcome
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
Time frame: Baseline and 24 months
The self-report section of the American Shoulder and Elbow Surgeons score (ASES) consists of two equally weighted parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. Pain measurement is performed on a 10 cm visual analogue scale divided into 1 cm increments. Shoulder function is measured by classifying 10 activities of daily living on a four-point ordinal scale. Change in points on the ASES scale from baseline to 24 month follow-up is the primary outcome measure of our study.
1 secondary outcome
Number of patients who need operative treatment during follow-up
Time frame: Baseline to 24 months
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 31 Oct 2018.
- Results publicationMoosmayer S and Aasen IB. Ultrasound- Guided Percutaneous Needle Treatment and Steroid Injection for Calcific Tendinopathy of the Shoulder: Can the Orthopedic Surgeon do it?. M J Orth. 3(1): 020, 2018.
- Study publication, open accessLink provided by the sponsor.
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Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
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RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
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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.
Stefan Moosmayer, MD, PhD principal investigator
Martina Hansens Hospital, Sandvika, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided needle lavage in people with Calcific Tendinitis, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 4 inclusion and 4 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 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The self-report section of the American Shoulder and Elbow Surgeons score (ASES) (time frame: Baseline and 24 months). 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 NCT01832376, 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 31 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.