A randomized clinical trial of ultrasound-guided double percutaneous needling versus high-energy extracorporeal shockwave therapy in the treatment of calcific tendinopathy of the rotator cuff.

A randomized clinical trial of ultrasound-guided double percutaneous needling versus high-energy extracorporeal shockwave therapy in the treatment of calcific tendinopathy of the rotator cuff. - nvt

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40188

Enrollment

100

Registered

2013-06-25

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

calcific tendinopathy shoulder pain

Interventions

Group 1. High-intensity extra corporeal shockwave therapy (2000 pulses, 4Hz, 0.35 mJ/mm2). Four sessions with 1 week in between. Group 2. Ultrasound guided double percutaneous needling. Both grou

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 years Clinical signs of subacromial impingement of the shoulder Symptoms persisting for more than four months Unsuccessful conservative therapy within the previous four months. (Physiotherapy, radiotherapy, infiltration with local anaesthetics and/or steroids, anti-inflammatory drugs) Standardised radiographs showing calcific deposits with a diameter of at least 5 mm. (Morphological type-I and type-II deposits corresponding to the classification of Gartner and Simons on radiographs: Type I, sharply outlined and densely structured. Type II, sharply outlined and inhomogenous or homogenous with no defined border)

Exclusion criteria

Exclusion criteria: Evidence of full-thickness tears of the rotator cuff on physical examination, ultrasound images or MRI. Radiological signs of spontaneous resorption of the deposit and type-III deposits according to the classification of Gartner and Simons: Type III, cloudy and transparent in structure. Calcific deposits in multiple tendons of the rotator cuff. Acute subacromial/subdeltoid bursitis. Osteoarthritis of the glenohumeral or acromioclavicular joint. Previous surgery to the shoulder. Adhesive capsulitis Instability of the shoulder. ESWT / barbotage within the last year. Reumatoid arthritis. Neurological disorders or dysfunction of the upper limb. Heart pacemaker, pregnancy, infection, tumour, hypocoagulability. Unability to give informed consent.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the Constant Murley Scale score	—

Secondary

Measure	Time frame
Other outcome parameters are a VAS (pain score), VAS (satisfaction score), SF-12 score, work-ablity questionnaire, DASH score and changes in radiologic appearance of the calcific deposits.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)