Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Primary Purpose
Calcific Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ultrasound guided needle lavage
Sponsored by
About this trial
This is an interventional treatment trial for Calcific Tendinitis focused on measuring Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Martina Hansens Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound guided needle lavage
Arm Description
Ultrasound guided needle lavage
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of patients who need operative treatment during follow-up
Full Information
NCT ID
NCT01832376
First Posted
April 8, 2013
Last Updated
October 29, 2018
Sponsor
Martina Hansen's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01832376
Brief Title
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Official Title
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martina Hansen's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis
Keywords
Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound guided needle lavage
Arm Type
Experimental
Arm Description
Ultrasound guided needle lavage
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided needle lavage
Other Intervention Name(s)
Barbotage
Intervention Description
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.
Primary Outcome Measure Information:
Title
The self-report section of the American Shoulder and Elbow Surgeons score (ASES)
Description
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.
Time Frame
Baseline and 24 months
Secondary Outcome Measure Information:
Title
Number of patients who need operative treatment during follow-up
Time Frame
Baseline to 24 months
Other Pre-specified Outcome Measures:
Title
Size of the calcific deposit as determined on X-rays of the affected shoulder
Description
Standardized X-rays of the shoulder are taken at baseline, 3 and 24 month follow-up and the size of the calcific deposits will be measured and compared between examinations
Time Frame
Baseline to 3 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Moosmayer, MD, PhD
Organizational Affiliation
Martina Hansens Hospital, Sandvika, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martina Hansens Hospital
City
Sandvika
ZIP/Postal Code
1306
Country
Norway
12. IPD Sharing Statement
Citations:
Citation
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.
Results Reference
result
Links:
URL
http://www.mathewsopenaccess.com/PDF/orthopedics/M_J_Orth_3_1_020.pdf
Description
Study publication, open access
Learn more about this trial
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage
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