Skip to content

Needle aspiration of calcific deposits versus Shock Wave Therapy for conservative therapy resistant calcifying tendinitis of the shoulder. A Randomized Controlled Trial

Needle aspiration of calcific deposits versus Shock Wave Therapy for conservative therapy resistant calcifying tendinitis of the shoulder. A Randomized Controlled Trial - NACD vs ESWT for calcifying tendinitis van de schouder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49558
Enrollment
140
Registered
2018-02-16
Start date
2018-05-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcific tendinitis of the shoulder

Interventions

Patients will be randomized to receive ESWT or NACD treatment. ESWT treatment: patients will receive a focused ESWT. NACD treatment: a sonographically guided removal of the calcific deposits will be

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * age >18 years • calcifications on conventional x-rays O type I and II calcifications according to the Gärtner classification. O minimal diameter 10 mm on AP view • able and willing to comply to study protocol

Exclusion criteria

Exclusion criteria: * clinical signs of a frozen shoulder or adhesive capsulitis • operations of the affected shoulder in medical history * ESWT or NACD tretament during the last 6 months • full-thickness lesion of the rotator cuff tendon(s) on sonography • clinical and radiological signs of acute subacromial bursitis • clinical and radiological signs of acromioclavicular osteoarthritis • Rheumatic Arthritis or fibromyalgia • any contra-indications for the specific treatments (e.g. coagulopathies, malignancies in treated area) • other intra articular pathology: cartilage lesions, biceps pathology.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be the between group differences in functional outcome (measured with the Constant-Murley Score) between baseline and 12 months follow-up.

Secondary

MeasureTime frame
1. to assess the cost-effectiveness of both interventions over a period of 12 months. 2. to assess between group differences in change in pain scores, quality of life, adverse events and use of medications between baseline and 12 months follow-up.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)