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

Primary Purpose

Calcific Tendinopathy of Shoulders, Extracorporeal Shockwave Therapy, Ultrasound Guided Barbotage Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
shockwave therapy, barbotage and infiltration
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinopathy of Shoulders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundacion Jimenez Díaz HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

shockwave therapy

Ultrasound-Guided Barbotage

us guided subacromial injections

Arm Description

The calcification will be located by ultrasound and the energy will be applied in the precise place. 3 sessions will be carried out as follows: 1, 2, 3 weeks This procedure will be carried out by a single experienced Physical and Rehabilitation medical doctor

The calcification will be located by ultrasound. By injecting serum at high pressure, it is intended to wash away the calcification. A subacromial inyection will be associated with this procedure. A maximum of 3 Ultrasound-Guided Barbotage will be performed with an interval of 6 weeks between each puncture. This procedure will be performed by two experienced radiologists

An US guided subacromial injection (1 cc of corticostheroid ) and anesthetic (2 cc of mepivacaine) will be performed. The periodicity will be one infiltration every 8-10 weeks, being able to carry out a maximum of 3 per year.

Outcomes

Primary Outcome Measures

Results of shoulder function

Secondary Outcome Measures

Change in Eva scale to assess the pain
0-10
change in worc scale to assess shoulder function
0-210
changes in Constant scale to assess shoulder function
0-100
rate of complications of the rotator cuff assessed by MRI
bursitis , intraosseous migration , intramuscular migration
changes in EuroQol5d scale to assess the subjective satisfaction of the patient
0-100

Full Information

First Posted
October 10, 2022
Last Updated
January 17, 2023
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT05700500
Brief Title
Comparison of Focused Shock Waves or Ultrasound-Guided Needling and Lavage in Patients With Calcifying Tendinopathy of the Shoulder
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinopathy of Shoulders, Extracorporeal Shockwave Therapy, Ultrasound Guided Barbotage Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
shockwave therapy
Arm Type
Experimental
Arm Description
The calcification will be located by ultrasound and the energy will be applied in the precise place. 3 sessions will be carried out as follows: 1, 2, 3 weeks This procedure will be carried out by a single experienced Physical and Rehabilitation medical doctor
Arm Title
Ultrasound-Guided Barbotage
Arm Type
Experimental
Arm Description
The calcification will be located by ultrasound. By injecting serum at high pressure, it is intended to wash away the calcification. A subacromial inyection will be associated with this procedure. A maximum of 3 Ultrasound-Guided Barbotage will be performed with an interval of 6 weeks between each puncture. This procedure will be performed by two experienced radiologists
Arm Title
us guided subacromial injections
Arm Type
Experimental
Arm Description
An US guided subacromial injection (1 cc of corticostheroid ) and anesthetic (2 cc of mepivacaine) will be performed. The periodicity will be one infiltration every 8-10 weeks, being able to carry out a maximum of 3 per year.
Intervention Type
Procedure
Intervention Name(s)
shockwave therapy, barbotage and infiltration
Intervention Description
ultrasound guided interventions
Primary Outcome Measure Information:
Title
Results of shoulder function
Time Frame
3months , 6 months , 1 year
Secondary Outcome Measure Information:
Title
Change in Eva scale to assess the pain
Description
0-10
Time Frame
3months , 6 months , 1 year
Title
change in worc scale to assess shoulder function
Description
0-210
Time Frame
3months , 6 months , 1 year
Title
changes in Constant scale to assess shoulder function
Description
0-100
Time Frame
3months , 6 months , 1 year
Title
rate of complications of the rotator cuff assessed by MRI
Description
bursitis , intraosseous migration , intramuscular migration
Time Frame
3months , 6 months , 1 year
Title
changes in EuroQol5d scale to assess the subjective satisfaction of the patient
Description
0-100
Time Frame
3months , 6 months , 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALMUDENA FERNANDEZ BRAVO
Phone
636287543
Email
afernandezb@fjd.es
First Name & Middle Initial & Last Name or Official Title & Degree
ALMUDENA FERNANDEZ BRAVO
Email
afernandezb@fjd.es
Facility Information:
Facility Name
Fundacion Jimenez Díaz Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALMUDENA FERNANDEZ BRAVO
Phone
636287543
Email
afernandezb@fjd.es

12. IPD Sharing Statement

Learn more about this trial

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

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