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Treatment of Calcific Tendinitis of the Rotator Cuff

Primary Purpose

Shoulder Pain, Tendonitis, Calcinosis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Barbotage
Corticosteroid injection
Lidocain injection (sham)
Sponsored by
Martina Hansen's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring shoulder pain, rotator cuff, calcific tendonitis, barbotage

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 30 years or older
  2. 3 months or more of shoulder pain
  3. Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
  4. Painful arc
  5. Positive Hawkin's test and/or Neer's sign for impingement
  6. Finding of one or more calcifications ≥5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle, together with a sonographic finding of one or more calcifications ≥5 mm in size on the short or long axis view, localized in the supraspinatus or infraspinatus tendon
  7. Morphological radiographic appearance of Molé type A, B or C12 (appendix 2) A: Dense, homogeneous with well-defined limits B: Dense, fragmented with well-defined limits C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance
  8. Ability to understand written and spoken Norwegian (Swedish/English)
  9. Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up

Exclusion criteria:

  1. Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain
  2. Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
  3. Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon
  4. A history of surgical treatment of the relevant shoulder
  5. A subacromial injection with a corticosteroid during the last 3 months before inclusion
  6. Medical contraindications for any of the invasive procedures
  7. One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys.
  8. One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex.
  9. Concomitant medication with one of the following medicinal products: Anti-arrythmics such as mexiletine or class III antiarrythmics (e.g. amiodarone), muscle relaxants (e.g. suxamethonium) or antipsychotics (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine, tropisetrone, dolasetron), antibiotics such as quinopristin/dalfopristin.
  10. Any history of prior allergic/hypersensitivity reactions related to the study medication
  11. Knowledge of an ongoing pregnancy (Fertile women not using contraception and who are uncertain whether they are pregnant or not will have to perform a pregnancy test)
  12. Nursing women

Sites / Locations

  • Martina Hansen's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Barbotage

Corticosteroid injection

Lidocain injection (sham)

Arm Description

Ultrasound guided needling, lavage and steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises

Ultrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises

Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises

Outcomes

Primary Outcome Measures

Oxford Shoulder Score
Shoulder pain and disability

Secondary Outcome Measures

Oxford Shoulder Score
Shoulder pain and disability
QuickDASH Disability of shoulder, arm and hand
Shoulder pain and disability
EQ 5D-5L
Health related quality of life
Cross-over of patients
number of patients crossing over to other group or other treatment
Adverse-events
Patient reported adverse events

Full Information

First Posted
April 10, 2015
Last Updated
March 13, 2023
Sponsor
Martina Hansen's Hospital
Collaborators
Helse Fonna, Oslo University Hospital, Sykehuset i Vestfold HF, Haraldsplass Deaconess Hospital, University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02419040
Brief Title
Treatment of Calcific Tendinitis of the Rotator Cuff
Official Title
Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
April 2022 (Actual)
Study Completion Date
April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martina Hansen's Hospital
Collaborators
Helse Fonna, Oslo University Hospital, Sykehuset i Vestfold HF, Haraldsplass Deaconess Hospital, University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.
Detailed Description
Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis is considered to be a consequence of increased tendon volume or changed tendon texture in the area of the calcification which leads to secondary impingement and inflammation. Consequently, removal of the deposit should be a causal treatment measure. Scientific evidence for the efficacy of the barbotage procedure in patients with persistent symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of the disease, and an anticipated placebo effect, questions about the method's efficacy can only be answered by high-quality randomized studies. In this trial the investigators want to randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound guided lidocain injection (sham). The investigators want to follow the patients over two years with repeated testing with a set of validated outcome measures together with radiologic re-examinations. The investigators want to find out whether the active treatments (1, 2) are more effective than the sham treatment and whether there are differences in outcome between the two active treatments. To increase the generalizability of the investigators' results, the investigators want to perform the study as a multi-centre study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Tendonitis, Calcinosis, Shoulder Impingement Syndrome
Keywords
shoulder pain, rotator cuff, calcific tendonitis, barbotage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Barbotage
Arm Type
Experimental
Arm Description
Ultrasound guided needling, lavage and steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises
Arm Title
Corticosteroid injection
Arm Type
Active Comparator
Arm Description
Ultrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises
Arm Title
Lidocain injection (sham)
Arm Type
Sham Comparator
Arm Description
Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises
Intervention Type
Procedure
Intervention Name(s)
Barbotage
Other Intervention Name(s)
20 mg Triamcinolon/, 9 ml Lidocain 1%
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. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injection
Other Intervention Name(s)
9 ml Lidocain 1%, 20 mg Triamcinolon/
Intervention Description
The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
Intervention Type
Procedure
Intervention Name(s)
Lidocain injection (sham)
Other Intervention Name(s)
9 ml Lidocain 1%
Intervention Description
The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
Primary Outcome Measure Information:
Title
Oxford Shoulder Score
Description
Shoulder pain and disability
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Oxford Shoulder Score
Description
Shoulder pain and disability
Time Frame
after 2 and 6 weeks, and 8, 12 and 24 months
Title
QuickDASH Disability of shoulder, arm and hand
Description
Shoulder pain and disability
Time Frame
after 2 and 6 weeks, and 4, 8, 12 and 24 months
Title
EQ 5D-5L
Description
Health related quality of life
Time Frame
4, 8, 12 and 24 months
Title
Cross-over of patients
Description
number of patients crossing over to other group or other treatment
Time Frame
4, 8, 12 and 24 months
Title
Adverse-events
Description
Patient reported adverse events
Time Frame
2 and 6 weeks, and 4 months
Other Pre-specified Outcome Measures:
Title
Size of calcific deposits
Description
Measured in millimeter AP radiographs
Time Frame
4 and 24 months
Title
Volume of removed calcific deposit
Description
Volume of removed calcific deposit in milliliter
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 30 years or older 3 months or more of shoulder pain Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level Painful arc Positive Hawkin's test and/or Neer's sign for impingement Finding of one or more calcifications ≥5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle, together with a sonographic finding of one or more calcifications ≥5 mm in size on the short or long axis view, localized in the supraspinatus or infraspinatus tendon Morphological radiographic appearance of Molé type A, B or C12 (appendix 2) A: Dense, homogeneous with well-defined limits B: Dense, fragmented with well-defined limits C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance Ability to understand written and spoken Norwegian (Swedish/English) Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up Exclusion criteria: Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon A history of surgical treatment of the relevant shoulder A subacromial injection with a corticosteroid during the last 3 months before inclusion Medical contraindications for any of the invasive procedures One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys. One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex. Concomitant medication with one of the following medicinal products: Anti-arrythmics such as mexiletine or class III antiarrythmics (e.g. amiodarone), muscle relaxants (e.g. suxamethonium) or antipsychotics (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine, tropisetrone, dolasetron), antibiotics such as quinopristin/dalfopristin. Any history of prior allergic/hypersensitivity reactions related to the study medication Knowledge of an ongoing pregnancy (Fertile women not using contraception and who are uncertain whether they are pregnant or not will have to perform a pregnancy test) Nursing women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Moosmayer, MD, PhD
Organizational Affiliation
MHH Martine Hansens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martina Hansen's Hospital
City
Sandvika
ZIP/Postal Code
1306
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28376756
Citation
Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Blomquist J, Pripp AH, Juel NG, Kjellevold SH, Brox JI; KALK study group. KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study. BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9.
Results Reference
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Treatment of Calcific Tendinitis of the Rotator Cuff

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