Treatment of Calcific Tendinitis of the Rotator Cuff

Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome; Shoulder Pain; Calcinosis; Tendonitis
• Intervention / Treatment: Procedure: Barbotage; Procedure: Corticosteroid injection; Procedure: Lidocain injection (sham)

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Sandvika, Norway, 1306
    • Martina Hansen's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Barbotage; 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	Procedure: 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. 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.; Other Names: 20 mg Triamcinolon/; 9 ml Lidocain 1%
Active Comparator: Corticosteroid injection; Ultrasound guided steroid/lidocain injection (20 mg Triamcinolon/9 ml Lidocain 1%) and home exercises	Procedure: Corticosteroid injection; 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.; Other Names: 20 mg Triamcinolon/; 9 ml Lidocain 1%
Sham Comparator: Lidocain injection (sham); Ultrasound guided lidocain injection (10 ml Lidocain 1%, sham group) and home exercises	Procedure: Lidocain injection (sham); 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.; Other Names: 9 ml Lidocain 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	Shoulder pain and disability	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score	Shoulder pain and disability	after 2 and 6 weeks, and 8, 12 and 24 months
QuickDASH Disability of shoulder, arm and hand	Shoulder pain and disability	after 2 and 6 weeks, and 4, 8, 12 and 24 months
EQ 5D-5L	Health related quality of life	4, 8, 12 and 24 months
Cross-over of patients	number of patients crossing over to other group or other treatment	4, 8, 12 and 24 months
Adverse-events	Patient reported adverse events	2 and 6 weeks, and 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of calcific deposits	Measured in millimeter AP radiographs	4 and 24 months
Volume of removed calcific deposit	Volume of removed calcific deposit in milliliter	Baseline

Collaborators and Investigators

• Sponsor: Martina Hansen's Hospital
• Collaborators: Oslo University Hospital; Helse Fonna; University Hospital, Linkoeping; Haraldsplass Deaconess Hospital; Sykehuset i Vestfold HF
• Investigators: Principal Investigator: Stefan Moosmayer, MD, PhD, MHH Martine Hansens Hospital

Publications and helpful links

General Publications

• 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.
• Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:p2248. doi: 10.1136/bmj.p2248. No abstract available.
• Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Juel NG, Blomquist J, Pripp AH, Brox JI. Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study. BMJ. 2023 Oct 11;383:e076447. doi: 10.1136/bmj-2023-076447.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: April 10, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimated): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 28, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: shoulder pain; rotator cuff; calcific tendonitis; barbotage
• Additional Relevant MeSH Terms: Metabolic Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Shoulder Injuries; Tendon Injuries; Arthralgia; Calcium Metabolism Disorders; Tendinopathy; Shoulder Impingement Syndrome; Shoulder Pain; Calcinosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: KALK-001