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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251832
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Soraia Azevedo, Unidade Local de Saúde do Alto Minho

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.

Condition or disease Intervention/treatment Phase
Sodium Thiosulfate Calcific Tendinitis Shoulder Pain Drug: Sodium Thiosulfate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ultrasound guided percutaneous lavage with 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.

Drug: Sodium Thiosulfate
Ultrasound guided percutaneous lavage with and without Sodium Thiosulfate

Active Comparator: 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 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
Ultrasound guided percutaneous lavage with and without Sodium Thiosulfate




Primary Outcome Measures :
  1. Evolution of the calcific deposit [ Time Frame: 1 week, 1 month and 3 months ]
    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


Secondary Outcome Measures :
  1. Visual Analogue Scale pain at rest [ Time Frame: 1 week, 1 month and 3 months ]
    Visual Analogue Scale minimum:"0" - "no pain maximum:"10" - extreme pain

  2. Visual Analogue Scale pain at during activities [ Time Frame: 1 week, 1 month and 3 months ]
    Visual Analogue Scale minimum:"0" - "no pain maximum:"10" - extreme pain

  3. Shoulder range of motion [ Time Frame: 1 week, 1 month and 3 months ]
    Impingement positive clinical tests (Yocum; Hawkins; Neer) Shoulder range of motion

  4. Disabilities of the Arm, Shoulder and Hand score [ Time Frame: 1 week, 1 month and 3 months ]
    Disabilities of the Arm, Shoulder and Hand score: 30 items, scored 1-5; scaled on a 0-100 scale: a higher score indicates greater disability

  5. EuroQol-5D quality of life score [ Time Frame: 1 week, 1 month and 3 months ]
    EuroQol-5D quality of life score, better outcome: 1, worse outcome: -0.4963



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251832


Locations
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Portugal
Unidade Local de Saúde do Alto Minho - Hospital Conde de Bertiandos Recruiting
Ponte de Lima, Portugal, 4900-041
Contact: Soraia Azevedo    +351258909500    soraia.azevedo@ulsam.min-saude.pt   
Sponsors and Collaborators
Soraia Azevedo
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Responsible Party: Soraia Azevedo, Principal Investigator, Unidade Local de Saúde do Alto Minho
ClinicalTrials.gov Identifier: NCT04251832    
Other Study ID Numbers: STShoulderPain
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Shoulder Pain
Tendinopathy
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Sodium thiosulfate
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents