Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. Ultrasound guided percutaneous lavage (UGPL or barbotage or irrigation) of calcific tendinopathy is indicated when conservative treatments (physiotherapy, nonsteroidal anti-inflammatory drugs) have failed. Our hypothesis is that lavage followed by intra-calcic injection of STS could fasten the dissolution of the calcific deposit. In view of the short half-life of this molecule the investigators hypothesize that this would happen within the first month after the procedure. Therefore, the investigatorschose to assess our primary objective at 1 month. Few studies have evaluated the short-term radiographic evolution after lavage.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Soraia Azevedo
• Treatments: Sodium thiosulfate

Criteria

Inclusion Criteria:

• Age over 18 years old;

• Pain for more than 3 months;

• Worsening of symptoms with activities above shoulder level;

• Minimum one the 3 following impingement positive clinical tests: Yocum, Hawkins or Neer;

• Calcification > 5 mm in size on the standard anteroposterior radiographs;

• Type A calcification according the Molé Classification .

Exclusion Criteria:

• Allergy to sodium metabisulfite;

• Asthma;

• Chronic renal disease (creatinine clearance <30 ml/min);

• Type B or C calcification according the Molé Classification;

• Other shoulder disease (glenohumeral or acromioclavicular osteoarthritis, rotator cuff tear, rheumatoid arthritis);

• Previous percutaneous irrigation of the same calcification.