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

NCT04251832 | Unknown Phase 2

• 1 other identifier: STShoulderPain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sodium Thiosulfate; Calcific Tendinitis; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Evolution of the calcific deposit

  Evaluated using a semi-quantitative score as followed: 0: no change or minimal changes; 1: decrease size of the calcification less than 50%; 2: decrease of the calcification between 50 and 90%; 3: more than 90% decrease size or disappearance of the calcification

  1 week, 1 month and 3 months

Secondary Outcomes (5)

• Visual Analogue Scale pain at rest

  1 week, 1 month and 3 months

• Visual Analogue Scale pain at during activities

  1 week, 1 month and 3 months

• Shoulder range of motion

  1 week, 1 month and 3 months

• Disabilities of the Arm, Shoulder and Hand score

  1 week, 1 month and 3 months

• EuroQol-5D quality of life score

  1 week, 1 month and 3 months

Study Arms (2)

Ultrasound guided percutaneous lavage with STS

EXPERIMENTAL

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.

Drug: Sodium Thiosulfate

Ultrasound guided percutaneous lavage without STS

ACTIVE COMPARATOR

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

Drug: Sodium Thiosulfate

Interventions

Sodium Thiosulfate DRUG

Ultrasound guided percutaneous lavage with and without Sodium Thiosulfate

Ultrasound guided percutaneous lavage with STS; Ultrasound guided percutaneous lavage without STS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soraia Azevedo: lead

Study Sites (1)

Unidade Local de Saúde do Alto Minho - Hospital Conde de Bertiandos

Ponte de Lima, 4900-041, Portugal

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 5, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

PT (1)