Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff
Sodium Thiosulfate, Calcific Tendinitis, Shoulder Pain
About this trial
This is an interventional treatment trial for Sodium Thiosulfate
Eligibility 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.
Sites / Locations
- Unidade Local de Saúde do Alto Minho - Hospital Conde de BertiandosRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ultrasound guided percutaneous lavage with STS
Ultrasound guided percutaneous lavage without STS
Ultrasound guided percutaneous lavage with a single needle technic. A total of 10 mL of lidocaine 1% will be injected in the subcutaneous tissues, the subacromial bursa and over the surface of the calcific deposit. A 21 G pediatric spinal needle will be used for the procedure to prevent needle clogging by calcific debris. When backflow of calcific material could be identified in the syringe, lavage of the deposit will be performed using sodium thiosulfate 25 %: a volume of 1 mL of sodium thiosulfate will be prepared in a syringe and successive propulsion and aspiration will be performed. The procedure will be repeated until the backflow becomes clear. At the end of the procedure 1 mL (250 mg) of thiosulfate will be injected inside the calcific deposit. Finally, 1.5 mL of methylprednisolone will be injected in the SAB. Only a single procedure will be performed and the outcomes measured after 1 week, 1 month and 3 months.
Ultrasound guided percutaneous lavage with a single needle technic. A total of 10 mL of lidocaine 1% will be injected in the subcutaneous tissues, the subacromial bursa and over the surface of the calcific deposit. A 21 G pediatric spinal needle will be used for the procedure to prevent needle clogging by calcific debris. When backflow of calcific material could be identified in the syringe, lavage of the deposit will be performed using of saline solution and successive propulsion and aspiration will be performed. The procedure will be repeated until the backflow becomes clear. Finally, 1.5 mL of methylprednisolone will be injected in the SAB. Only a single procedure will be performed and the outcomes measured after 1week, 1month and 3months