Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

NCT ID: NCT01832376

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2018-05-31

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

Conditions

Calcific Tendinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound guided needle lavage

Ultrasound guided needle lavage

Group Type: EXPERIMENTAL

Ultrasound guided needle lavage

Intervention Type: 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. 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.

Interventions

Ultrasound guided needle lavage

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.

Intervention Type: PROCEDURE

Other Intervention Names

Barbotage

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martina Hansen's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stefan Moosmayer

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Moosmayer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Martina Hansens Hospital, Sandvika, Norway

Locations

Martina Hansens Hospital

Sandvika, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

Related Links

http://www.mathewsopenaccess.com/PDF/orthopedics/M_J_Orth_3_1_020.pdf

Study publication, open access

Other Identifiers

2012/773

Identifier Type: -

Identifier Source: org_study_id