Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404125
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Brief Title:
Investigation of the Effect of Central Sensitization Symptom Severity on Steroid Injection Results in Shoulder Pain
Sponsor:
Sultan Abdulhamid Han Training and Research Hospital Istanbul Turkey
Organization:
Sultan Abdulhamid Han Training and Research Hospital Istanbul Turkey
Study Overview
Official Title:
Investigation of the Effect of Pre-treatment Central Sensitization Severity on Steroid Injection Results in Rotator Cuff-induced Shoulder Pain
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The aim of this study was to investigate the effect of the presence and severity of pre-treatment central sensitization on the results of subacromial intra-articular shoulder injection in patients with rotator cuff lesionsubacromial impingement The hypothesis of the study is that the treatment response will decrease in patients with pre-injection central sensitization
There are many studies investigating the frequency of central sensitization in various shoulder pathologies However the effect of this condition which is likely to be associated with chronic pain in these patients on treatment response is unknown The effect on the results of shoulder injection one of the most common procedures in physical therapy practice will be investigated
There are many studies investigating the frequency of central sensitization in various shoulder pathologies However the effect of this condition which is likely to be associated with chronic pain in these patients on treatment response is unknown The effect on the results of shoulder injection one of the most common procedures in physical therapy practice will be investigated
Detailed Description:
Shoulder pain is one of the most common musculoskeletal complaints and its prevalence varies between 7-26 Although some of the patients with shoulder pain show complete recovery pain persists in some of them One of the most common sources of pain in these patients is subacromial impingement syndrome SIS leading to rotator cuff pathology The multifactorial nature of pain in these patients makes the treatment of SIS difficult
Central sensitization CS has been reported as one of the factors associated with persistence of pain in patients with shoulder pain in different etiologies especially in the SIS CS can be summarized as an increase in the response of neurons located in the central nervous system to subthreshold stimuli and is the source of chronic pain in many diseases A decrease in the pressure pain threshold was observed in the painful shoulder of 58 patients with experimental pain response in the shoulder
In a meta-analysis of patients with shoulder pain a decrease in pressure pain threshold was found in 29-77 of patients while SS was found in 11-24 of patients The authors emphasized the significant correlation of CS with poor treatment response There is increasing evidence that CS negatively affects various pain treatment responses including surgery Considering the frequency of CS in patients with shoulder pain it is likely to have a negative impact on treatment response in these patients as well One of the most common treatments for SIS is subacromial intra-articular shoulder injection Although several factors have been identified in the prediction of shoulder injection outcomes the effect of pain sensitization on these procedures is not yet known
This study was designed as a prospective single-center study Patients aged 18-65 years with rotator cuff lesions lasting more than three months and presenting to our physical medicine and rehabilitation outpatient clinic will be included Patients who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection Injection preference will be determined according to the patient primary complaint and lesion and will be administered into the subacromial space or into the shoulder joint There is no additional interventional procedure due to the study Patients will be divided into 2 groups with and without central sensitization A total of 18 patients were planned for each group The study will be conducted between March 2023 and June 2024
Within the scope of the study age gender body mass index marital status education level and occupation of the participants will be recorded as demographic data Clinical evaluation includes pain duration treatments received pain intensity numeric pain scale 0-10 disease-related MRIUSG findings and the following evaluations
All patients will be evaluated before injection 1 week 1 and 3 months after injection Within the scope of evaluation Central Sensitization Scale Quick DASH SF-36 and Hospital Anxiety and Depression questionnaire pressure pain threshold goniometric shoulder range of motion measurement hand grip strength with Jamar hydraulic hand dynamometer numeric pain scale no pain 0- unbearable pain 10 and pain intensity will be recorded at each visit
Data analysis will be performed by using the Statistical Package for the Social Sciences SPSS version 230 IBM Corp Armonk NY USA
Central sensitization CS has been reported as one of the factors associated with persistence of pain in patients with shoulder pain in different etiologies especially in the SIS CS can be summarized as an increase in the response of neurons located in the central nervous system to subthreshold stimuli and is the source of chronic pain in many diseases A decrease in the pressure pain threshold was observed in the painful shoulder of 58 patients with experimental pain response in the shoulder
In a meta-analysis of patients with shoulder pain a decrease in pressure pain threshold was found in 29-77 of patients while SS was found in 11-24 of patients The authors emphasized the significant correlation of CS with poor treatment response There is increasing evidence that CS negatively affects various pain treatment responses including surgery Considering the frequency of CS in patients with shoulder pain it is likely to have a negative impact on treatment response in these patients as well One of the most common treatments for SIS is subacromial intra-articular shoulder injection Although several factors have been identified in the prediction of shoulder injection outcomes the effect of pain sensitization on these procedures is not yet known
This study was designed as a prospective single-center study Patients aged 18-65 years with rotator cuff lesions lasting more than three months and presenting to our physical medicine and rehabilitation outpatient clinic will be included Patients who have received medical treatment as part of routine practice and have not had an adequate response will be evaluated before and after injection Injection preference will be determined according to the patient primary complaint and lesion and will be administered into the subacromial space or into the shoulder joint There is no additional interventional procedure due to the study Patients will be divided into 2 groups with and without central sensitization A total of 18 patients were planned for each group The study will be conducted between March 2023 and June 2024
Within the scope of the study age gender body mass index marital status education level and occupation of the participants will be recorded as demographic data Clinical evaluation includes pain duration treatments received pain intensity numeric pain scale 0-10 disease-related MRIUSG findings and the following evaluations
All patients will be evaluated before injection 1 week 1 and 3 months after injection Within the scope of evaluation Central Sensitization Scale Quick DASH SF-36 and Hospital Anxiety and Depression questionnaire pressure pain threshold goniometric shoulder range of motion measurement hand grip strength with Jamar hydraulic hand dynamometer numeric pain scale no pain 0- unbearable pain 10 and pain intensity will be recorded at each visit
Data analysis will be performed by using the Statistical Package for the Social Sciences SPSS version 230 IBM Corp Armonk NY USA
Study Oversight
Has Oversight DMC:
None
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?:
None