Treatment of Calcific Tendinitis of the Rotator Cuff

NCT02419040 | Completed

• 1 other identifier: KALK-001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain; Tendonitis; Calcinosis; Shoulder Impingement Syndrome

Keywords

shoulder pain; rotator cuff; calcific tendonitis; barbotage

Outcome Measures

Primary Outcomes (1)

• Oxford Shoulder Score

  Shoulder pain and disability

  4 months

Secondary Outcomes (5)

• Oxford Shoulder Score

  after 2 and 6 weeks, and 8, 12 and 24 months

• QuickDASH Disability of shoulder, arm and hand

  after 2 and 6 weeks, and 4, 8, 12 and 24 months

• EQ 5D-5L

  4, 8, 12 and 24 months

• Cross-over of patients

  4, 8, 12 and 24 months

• Adverse-events

  2 and 6 weeks, and 4 months

Other Outcomes (2)

• Size of calcific deposits

  4 and 24 months

• Volume of removed calcific deposit

  Baseline

Study Arms (3)

Barbotage

EXPERIMENTAL

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

Corticosteroid injection

ACTIVE COMPARATOR

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

Procedure: Corticosteroid injection

Lidocain injection (sham)

SHAM COMPARATOR

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

Procedure: Lidocain injection (sham)

Interventions

Barbotage PROCEDURE

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.

Also known as: 20 mg Triamcinolon/, 9 ml Lidocain 1%

Barbotage

Corticosteroid injection PROCEDURE

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.

Also known as: 9 ml Lidocain 1%, 20 mg Triamcinolon/

Corticosteroid injection

Lidocain injection (sham) PROCEDURE

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.

Also known as: 9 ml Lidocain 1%

Lidocain injection (sham)

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Helse Fonna: collaborator
• Oslo University Hospital: collaborator
• Sykehuset i Vestfold HF: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (1)

Martina Hansen's Hospital

Sandvika, 1306, Norway

Location

Related Publications (3)

• 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.

  PMID: 28376756 BACKGROUND

• Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:2248. doi: 10.1136/bmj.p2248. No abstract available.

  PMID: 37821118 BACKGROUND

• 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.

  PMID: 37821122 RESULT

MeSH Terms

Conditions

Shoulder Pain; Tendinopathy; Calcinosis; Shoulder Impingement Syndrome

Interventions

Adrenal Cortex Hormones; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Tendon Injuries; Wounds and Injuries; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stefan Moosmayer, MD, PhD

  MHH Martine Hansens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

NO (1)