Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34963
Enrollment
99
Registered
2010-04-29
Start date
2010-10-07
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Shoulder impingement shoulder injury

Interventions

The study intervention group will receive dry needling and aspiration-treatment of the calcification in the supraspinatus tendon. The first control group will be treated with ASD surgery of the shou

Sponsors

Sint Annaziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main study endpoints are pain at rest, shoulder function and amount of calcification. Shoulder function is measured using the DASH questionnaire and ROM. Shoulder pain is measured using a VAS score.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)