Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528756
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Calciying Tendinopathy of the Rotator Cuff Barbotage Vs Shock Waves
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Calciying Tendinopathy of the Rotator Cuff Barbotage Vs Shock Waves
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BOTCH
Brief Summary:
The objective of this block randomized prospective experimental longitudinal analytical clinical trial is to compare the mean differences in Visual analgesic scale VAS at 1 month 3 months and 6 months depending on the treatment received ultrasound-guided barbotage US-PICT or shock waves ESWT in patients with calcifying tendinopathies according to the lesion based on the Bianchi Martinolli classification as well as to know if there are variations in functionality with the Latinen test joint balance patient global improvement impression scale PGI-I global improvement impression scale CGI - GI
For this purpose patients between 30 and 60 years old with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies who have not received these previous treatments will be selected
The main question to be answered is
Do patients with calcifying tendinopathies of the shoulder in its different degrees who have received as treatment barbottage obtain the same VAS differences at 1 month 3 month and 6 month as patients who received as treatment shock waves in the population
Patients will be sorted into two arms according to the Bianchi Martinoli classification I or II III and subsequently included in groups according to the treatment received The decision to treat with one or the other therapy will be made randomly 11 depending on the treatment assigned to the previous patient An initial consultation and 3 revisions 1 month 3 months and 6 months will be performed after the end of therapy
The following variables will be collected VAS Lattinen test joint balances ROM flexion abduction and external and internal rotation PGI-I CGI - GI
For this purpose patients between 30 and 60 years old with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies who have not received these previous treatments will be selected
The main question to be answered is
Do patients with calcifying tendinopathies of the shoulder in its different degrees who have received as treatment barbottage obtain the same VAS differences at 1 month 3 month and 6 month as patients who received as treatment shock waves in the population
Patients will be sorted into two arms according to the Bianchi Martinoli classification I or II III and subsequently included in groups according to the treatment received The decision to treat with one or the other therapy will be made randomly 11 depending on the treatment assigned to the previous patient An initial consultation and 3 revisions 1 month 3 months and 6 months will be performed after the end of therapy
The following variables will be collected VAS Lattinen test joint balances ROM flexion abduction and external and internal rotation PGI-I CGI - GI
Detailed Description:
Shoulder pain is a very common health issue among adults being 8 due to calcifying tendinopathies of the shoulder CT The evolutionary process of this lesion can be classified according to Bianchi Martinoli as I hard II semi-soft and III soft due to their ultrasound appearance
In 50 of cases with first-line treatments such as kinesitherapy and taking anti-inflammatories they resolve spontaneously However in the remaining 50 they become chronic requiring other lines of treatment such as shock waves ESWT or ultrasound-guided barbotage US-PICT
Starting hypothesis
Patients with CT in its different degrees who have received barbottage as treatment obtain the same VAS differences at 1 month 3 months and 6 months as patients who received ESWT as treatment in the population
Main objective
The main objective is to compare the mean differences in VAS at 1 month 3 months and 6 months according to the treatment received barbotage or ESWT in patients with CT according to the evolutionary stage of the lesion based on the Bianchi Martinolli classification
Secondary objectives
To know if there are variations in functionality with the Latinen test joint balance ROM PGI and CGI
To protocolize an attitude towards this type of pathology
To favor the use of hospital resources
We propose to conduct a block randomized prospective experimental longitudinal analytical block randomized clinical trial For this purpose patients aged between 30 - 60 years with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies will be selected
The protocol carried out was as follows
1 st Phase in this first phase patients will be collected according to the criteria set out above for a period of 12 months During this time the patients will be explained the two possible treatments to be received and after signing the appropriate informed consent they will be divided into groups according to treatment ESWT vs US-PICT stratifying according to the Bianchi Martinolli classification I or IIIIII The decision for each treatment will be made randomly dividing the patients in a 11 ratio according to whether they attend the initial consultation and the previous patient has received one or the other treatment
2 nd Phase Subsequently 3 revisions will be performed One at 1 month 3 months and another one at 6 months after the end of the therapy
3 rd Phase The information collected will be synthesized and entered into the SPSS V21 program to obtain results
In 50 of cases with first-line treatments such as kinesitherapy and taking anti-inflammatories they resolve spontaneously However in the remaining 50 they become chronic requiring other lines of treatment such as shock waves ESWT or ultrasound-guided barbotage US-PICT
Starting hypothesis
Patients with CT in its different degrees who have received barbottage as treatment obtain the same VAS differences at 1 month 3 months and 6 months as patients who received ESWT as treatment in the population
Main objective
The main objective is to compare the mean differences in VAS at 1 month 3 months and 6 months according to the treatment received barbotage or ESWT in patients with CT according to the evolutionary stage of the lesion based on the Bianchi Martinolli classification
Secondary objectives
To know if there are variations in functionality with the Latinen test joint balance ROM PGI and CGI
To protocolize an attitude towards this type of pathology
To favor the use of hospital resources
We propose to conduct a block randomized prospective experimental longitudinal analytical block randomized clinical trial For this purpose patients aged between 30 - 60 years with chronic shoulder pain for more than 3 months due only to calcifying tendinopathies will be selected
The protocol carried out was as follows
1 st Phase in this first phase patients will be collected according to the criteria set out above for a period of 12 months During this time the patients will be explained the two possible treatments to be received and after signing the appropriate informed consent they will be divided into groups according to treatment ESWT vs US-PICT stratifying according to the Bianchi Martinolli classification I or IIIIII The decision for each treatment will be made randomly dividing the patients in a 11 ratio according to whether they attend the initial consultation and the previous patient has received one or the other treatment
2 nd Phase Subsequently 3 revisions will be performed One at 1 month 3 months and another one at 6 months after the end of the therapy
3 rd Phase The information collected will be synthesized and entered into the SPSS V21 program to obtain results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None