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临床试验/NCT04251832
NCT04251832Unknown2 期

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

Soraia Azevedo1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
80
试验地点
1
主要终点
Evolution of the calcific deposit

研究概览

简要总结

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.

详细描述

Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. It is characterized by calcium phosphate crystal deposition in the rotator cuff. Its pathogenesis and etiology remains unclear and the mechanisms leading to this pathological mineralization are still largely unknown. This disorder can lead to a chronic pain during daily or professional activities and to a restriction of range of motion. During the disease, spontaneous resorption can occur with migration of apatite crystals into the subacromial bursa causing severe pain and restriction of movement. Factors associated with the development of symptoms are still unclear although the size and presence of a bursitis on imaging have been shown to be associated with 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. At this stage, extracorporeal shock wave therapy (ESWT) or subacromial corticosteroid injection can also be discussed. However, a recent network meta-analysis has shown that UGPL could be the treatment of choice compared to the other nonsurgical options such as ESWT or SAI. Arthroscopic removal of the calcific deposit is considered as a second line therapy after failure of UGPL or EWST.

Efficacy of UGPL depends on the type of calcification. Calcific deposits can be differentiated in hard calcifications, usually dense on X-Ray with an acoustic shadow on US, and soft calcifications, with more heterogeneous or faint contours without acoustic shadowing. Some studies observed failure only in patients presenting with a dense and homogeneous calcification type A according to the Molé Classification and also showed that outcome after needling and/or ESWT will be worse in case of dense calcifications, with only 30% of success compared to 61% in patients with soft calcification. These failures are most of the time explained by the persistence of the calcific deposit. In line with this, was found a positive correlation between the decrease of the size of the calcification and the pain score over time; as the calcification became smaller, the pain became less intense.

Several approaches are currently used to facilitate the extraction of the calcification. It has been shown that lavage with warm saline heated at 42°C reduced the procedure duration and improved calcification dissolution. Another randomized controlled study recently reported that lavage with a 2 needle approach also shortened the procedure in hard calcification. However, none of these studies showed an impact on the rate of calcification elimination. Other strategies are therefore needed to treat hard calcification of the rotator cuff.

Sodium thiosulfate (STS) (Na2S2O3) is primarily used to prevent and treat cyanide poisoning. Intravenous STS is also used off-label to treat calciphylaxis leading to a significant decrease of soft-tissue and vascular calcifications. However, its systemic use may be limited by adverse effects, such as gastrointestinal upset, metabolic acidosis, and sodium overload. Thus, alternative local approaches have been developed. Recent reports have shown the interest of topical STS in the treatment of calciphylaxis, tumoral calcinosis associated with connective tissue disease, pseudohypoparathyroidism or hyperphosphatemic familial tumoral calcinosis. For instance, a daily application of topical STS on the calcific lesions of patients with hyperphosphatemic familial tumoral calcinosis led to their decrease after 5 months of treatment. Topical application of STS has also showed an anti-inflammatory effect in patients with calcinosis cutis secondary to connective tissue disease and radiodermatitis. Because deeper calcific deposits are unlikely to be reached by topical therapeutic agents, some authors performed intralesional STS injections in patients with localized cutaneous calciphylaxis. They observed a complete healing of ulcers and remission of disease with only transient localized discomfort during injection. Despite these promising results, the exact mechanisms by which STS is able to dissolve ectopic calcifications remain still unclear.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 .

排除标准

  • Allergy to sodium metabisulfite;
  • 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.

研究组 & 干预措施

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.

干预措施: Sodium Thiosulfate (Drug)

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

干预措施: Sodium Thiosulfate (Drug)

结局指标

主要结局

Evolution of the calcific deposit

时间窗: 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

次要结局

  • Visual Analogue Scale pain at rest(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)
  • 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)

研究者

发起方
Soraia Azevedo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Soraia Azevedo

Principal Investigator

Unidade Local de Saúde do Alto Minho

研究点 (1)

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