Dry needling and aspiration treatment versus arthroscopic decompression in patients with supraspinatus tendon calcification: a randomised clinical trial.

Completed

• Conditions: Shoulder impingement; shoulder injury; 10043237

• Registration Number: NL-OMON34963
• Lead Sponsor: Sint Annaziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 99

Inclusion Criteria

1. Patients of either sex who have been clinically diagnosed with shoulder impingement. Calcification of the supraspinatus tendon has to be confirmed with both radiography and diagnostic ultrasound.
2. Integrity of the supraspinatus tendon.
3. Calcification diameter > 6 mm visible on a diagnostic radiograph less than six weeks old.
4. Patients may have calcification in one or both shoulders. For patients with bilateral calcifications, both shoulders will be included as separate cases.
5. Shoulder symptoms should be present > 6 months
6. Non-surgical treatment other than dry needling or aspiration has failed to improve symptoms in the previous six months
7. Patients over 18 years old

Exclusion Criteria

1. Patients with radiographic or diagnostic ultrasound confirmed calcification of the subacromial bursa or calcification of the subscapularis tendon.
2. Previous shoulder surgery of any kind on the affected shoulder.
3. Total or partial rotator cuff rupture
4. Shoulder instability
5. Clinically verified acromioclavicular joint osteoarthritis
6. Patients who received no non-surgical treatment for their shoulder symptoms
7. Neurological symptoms or conditions (ie MS, Parkinson, CVA etc)
8. Injections in subacromial space in the previous three months.
9. Patients with psychosomatic complaints defined as a VAS-score for pain of * 90mm.
10. Patients with very mild shoulder pain, defined as a VAS-score < 30mm
11. Patients who report spontaneous improvement of their shoulder pain in the last days or weeks when their history is taken.
12. Patients not willing to consent or to return for follow up visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoints are pain at rest, shoulder function and amount of<br /><br>calcification. Shoulder function is measured using the DASH questionnaire and<br /><br>ROM. Shoulder pain is measured using a VAS score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are quality of arm movement, safety of treatment and<br /><br>involved costs. Quality of arm movement will be measured using accelerometers.<br /><br>Safety is measured with recording of any (S)AE*s during the study. The costs<br /><br>per patient will be analysed for each study group.</p><br>