Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion

Study Overview
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Brief Summary
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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: Is central sensitization associated with decreased treatment response? 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
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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.

Official Title
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Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion

Conditions
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Central Sensitisation, Subacromial Impingement Syndrome

Intervention / Treatment
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* Drug: Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rotator cuff pathology confirmed clinically and radiologically (USG/MRI) Failure to respond to medical/physical treatment Agree to participate in the study Exclusion Criteria: Shoulder trauma and history of previous shoulder surgery History of injection to the painful shoulder in the last 3 months Use of centrally acting drugs (antidepressants, pregabalin, gabapentin and myorelaxant etc.) History of active cancer, systemic inflammatory disease, and infection Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be followed up in two groups according to the presence of central sensitization before treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with subacromial impingement syndrome (central sensitization positive)<br>Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa. | Drug: Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space<br>* Treatment method used in the treatment of subacromial impingement syndrome<br>|
| Experimental: Patients with subacromial impingement syndrome (central sensitization negative)<br>Subacromial steroid injection While the patient is in a sitting position the subacromial space and the rotator cuff will be evaluated with the sonosite-m turbo ultrasonography device linear probe. The area where the rotator cuff and subacromial bursa are most prominent will be determined under the deltoid muscle. The injection site is first covered with povidone iodine and then with 80% alcohol solution will be wiped to provide antisepsis. The subacromial bursa between the deltoid muscle and the rotator cuff will be advanced from lateral to medial with an inplane approach with a 21 g 38 mm needle under the guidance of ultrasonography. Bleeding after making sure that the needle tip is in the bursa by checking, 1 cc betamethasone dipropionate + betamethasone sodium phosphate and 4 cc 2% prilocaine mixture will be injected, showing that it is evenly distributed in the bursa. | Drug: Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space<br>* Treatment method used in the treatment of subacromial impingement syndrome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain). | 1 week | 
| Visual analog scale | The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain). | 1 months | 
| Visual analog scale | The visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain). | 3 months | 
| Shoulder range of motion | Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex | 1 weeks | 
| Shoulder range of motion | Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex | 1 months | 
| Shoulder range of motion | Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QuickDASH | QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability. | 1 weeks | 
| QuickDASH | QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability. | 1 months | 
| QuickDASH | QuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability. | 3 months | 
| SF-36 (Short form-36) | The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life. | 1 week | 
| SF-36 (Short form-36) | The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life. | 1 months | 
| SF-36 (Short form-36) | The 36-item Short Form Questionnaire (SF-36) is used for objective measurement of quality of life. It consists of 8 dimensions scored between 0-100, and low scores are associated with poor in quality of life. | 3 months | 
| Hospital anxiety and depression scale (HADS) | Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression. | 1 week | 
| Hospital anxiety and depression scale (HADS) | Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression. | 1 month | 
| Hospital anxiety and depression scale (HADS) | Self-test questionnaire for anxiety and depression. The score between 0 and 21 for either anxiety or depression. A score of 8 and above is significant for the diagnosis of anxiety or depression. | 3 month | 
| hand grip strength | Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer. | 1 week | 
| hand grip strength | Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer. | 1 months | 
| hand grip strength | Grip strength is a measure of muscle strength or the maximum force/tension produced by one's forearm muscles and is measured with a hand dynamometer. | 3 months | 
| Pressure pain threshold (PPT) | Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity. | 1 week | 
| Pressure pain threshold (PPT) | Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity. | 1 months | 
| Pressure pain threshold (PPT) | Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. Algometer is used in the measurement and low values are interpreted in favor of increased sensitivity. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central sensitisation, central sensitization inventory, subacromial impingement, shoulder pain, steroid injection