Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT05478902
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)
Sponsor:
University of Valencia
Organization:
Study Overview
Official Title:
Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy: a Randomised Clinical Trial (THE EFFECT TRIAL)
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFFECT
Brief Summary:
The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.
Detailed Description:
Rotator cuff calcific tendinopathy (RCCT) is a common musculoskeletal disorder caused by the presence of calcific deposits in the rotator cuff with an important impact in the quality of life of those who are suffering it. Conservative interventions such as extracorporeal shockwave therapy (ESWT) or ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) have been commonly recommended as part of the early management for this clinical condition. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been tested in people with RCCT yet. A randomised, single-blinded four parallel group clinical trial will be conducted. Participants (n=116) will be randomised in four groups: (1) ET; (2) ESWT; (3) US-PICT or (4) control.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: