Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2025-12-27 @ 2:24 PM
Study NCT ID:
NCT05926895
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2023-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion
Sponsor:
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Organization:
Study Overview
Official Title:
Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion
Status:
COMPLETED
Status Verified Date:
2025-09
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:
CS
Brief Summary:
The goal of this clinical trial is to learn whether pretreatment central sensitization presence affect shoulder steroid injection resuls in patients with rotator cuff pathology.
The main questions it aims to answer are:
1. Is central sensitization associated with decreased treatment response?
2. Do the clinical features of patients with central sensitization differ from those of those without? Participants will be applied a shoulder injection and the treatment response will be monitored.
The main questions it aims to answer are:
1. Is central sensitization associated with decreased treatment response?
2. Do the clinical features of patients with central sensitization differ from those of those without? Participants will be applied a shoulder injection and the treatment response will be monitored.
Detailed Description:
Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26%. One of the most common sources of pain in these patients is subacromial impingement syndrome leading to rotator cuff pathology. In patients with shoulder pain, one of the factors associated with the persistence of pain in different etiologies, especially subacromial impingement syndrome, is reported as central sensitization (CS). CS can be summarized as an increase in the response of neurons located in the central nervous system to sub-threshold stimuli. In a meta-analysis of patients with shoulder pain, a decrease in pressure pain threshold was found in 29-77% of patients, and CS in 11-24%. There is increasing data showing that CS negatively affects response to different treatments, including surgery and injections. One of the most frequently used treatments in subacromial impingement syndrome is subacromial/intra-articular shoulder injection. Although various factors have been identified in the prediction of shoulder injection results, the effect of pain sensitization on these procedures is unknown. In this study, it is planned to investigate the effect of the presence and severity of pretreatment central sensitization on the results of the shoulder injection in patients with a rotator cuff lesion or subacromial impingement.
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?: