Comparison of Focused Shock Waves or Ultrasound-Guided Needling and Lavage in Patients With Calcifying Tendinopathy of the Shoulder

Extracorporeal Shockwave Therapy Clinical Trial

Official title:

Long-term Treatment of Calcifying Tendinopathy of the Shoulder With Focused Shock Waves or Ultrasound-Guided Needling and Lavage: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700500
• Other study ID #: EC123-19_FJD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: January 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: ALMUDENA FERNANDEZ BRAVO
• Phone: 636287543
• Email: afernandezb[@]fjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, the only study comparing the long-term results of these procedures (two years) is that of Kim.(24) This study is the first randomized, blinded clinical trial comparing ultrasound-guided percutaneous lavage ( UPL) for rotator cuff calcific tendinopathy with subacromial injection vs. Shock (1000 impulses/0.36mJ/mm2), obtaining clinical improvement and reabsorption of calcification in both groups. In this study, greater effectiveness was observed in terms of pain improvement and functional recovery in these patients in the short term than in those undergoing UPL: The results of this study were obtained through radiographic evaluation (AP X-ray of the shoulder) before and after intervention and clinical evaluation in both groups using the scales of the American Society of Shoulder and Elbow Surgeons (ASES), the Simple Shoulder Test (SST) and the Visual Analogue Scale (VAS). Our future work may add many interesting data to the comparative study of these two techniques, since it would provide new results, overcoming the limitations of the only similar study in the literature today. On the one hand, the radiological selection of patients will be carried out with shoulder X-rays and a shoulder ultrasound performed by two expert musculoskeletal radiologists from this center and validated by interobserver correlation. This will allow a detailed selection of patients according to the characteristics and phases of the calcification that they present. Sonographically, calcifications are classified into three types (according to Garner's 1993 classification): type I, II and III. As we have previously mentioned, calcific tendinopathy is a self-limited disease and we know that calcifications in phase III or in the resorption phase tend to resolve spontaneously. The control ultrasound that will be performed on the patients will also be performed by the same expert musculoskeletal radiologists who have performed the interobserver correlation study. Secondly , we are going to define a maximum number as well as the exact protocol for carrying out the Eco - guided Puncture Lavage technique . Another contribution of our work is that we will carry out an evaluation of the differences between both techniques up to two years post-treatment, which will allow us to know the long-term evolution of the results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: January 2025
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria.

• Patients over 18 years of age
• Patients who agree to participate in the study and provide written Informed Consent
• Complete shoulder mobility.
• No associated cervicobrachialgia or associated shoulder injuries.
• No previous shoulder interventions.
• Calcification stage I-II according to the Gartner scale (diagnosed by AP X-ray of the shoulder and ultrasound that will be performed by two radiologists who are experts in musculoskeletal)
• Calcium greater than 0.5 cm
• Pain clinic (VAS > 5) of more than three months of evolution
• Exclusion criteria
• Pacemakers
• Coagulation disorders
• Pregnancy
• Active neoplastic process.
• Infiltration with corticosteroids less than 6 weeks ago.
• Contraindication to corticosteroid treatment
• Previous treatment with shock waves and / or puncture-aspiration
• Cuff pathology (tear)
• No tolerance to SW
• Previous surgeries on the same shoulder.
• Absolute contraindications for focal shock waves

Related Conditions & MeSH terms

• Extracorporeal Shockwave Therapy
• Tendinopathy

Intervention

Procedure:
• shockwave therapy, barbotage and infiltration
ultrasound guided interventions

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Díaz Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of shoulder function		3months , 6 months , 1 year
Secondary	Change in Eva scale to assess the pain	0-10	3months , 6 months , 1 year
Secondary	change in worc scale to assess shoulder function	0-210	3months , 6 months , 1 year
Secondary	changes in Constant scale to assess shoulder function	0-100	3months , 6 months , 1 year
Secondary	rate of complications of the rotator cuff assessed by MRI	bursitis , intraosseous migration , intramuscular migration	3months , 6 months , 1 year
Secondary	changes in EuroQol5d scale to assess the subjective satisfaction of the patient	0-100	3months , 6 months , 1 year