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

Subacromial Impingement Syndrome Clinical Trial

— CS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926895
• Other study ID #: 23-20
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: Feyza Nur Yücel, Specialist
• Phone: +905385577059
• Email: dr.fny28[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Drug:
• Injection of 1 CC Betamethasone Dipropionate + Betamethasone Sodium Phosphate (Diprospan) and 4 cc 2% Prilocaine (Priloc)mixture into the subacromial space
Treatment method used in the treatment of subacromial impingement syndrome

Locations

Country	Name	City	State
Turkey	Sultan Abdülhamid Han Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Coronado RA, Simon CB, Valencia C, George SZ. Experimental pain responses support peripheral and central sensitization in patients with unilateral shoulder pain. Clin J Pain. 2014 Feb;30(2):143-51. doi: 10.1097/AJP.0b013e318287a2a4. — View Citation

Previtali D, Bordoni V, Filardo G, Marchettini P, Guerra E, Candrian C. High Rate of Pain Sensitization in Musculoskeletal Shoulder Diseases: A Systematic Review and Meta-analysis. Clin J Pain. 2021 Mar 1;37(3):237-248. doi: 10.1097/AJP.0000000000000914. — View Citation

Sanchis MN, Lluch E, Nijs J, Struyf F, Kangasperko M. The role of central sensitization in shoulder pain: A systematic literature review. Semin Arthritis Rheum. 2015 Jun;44(6):710-6. doi: 10.1016/j.semarthrit.2014.11.002. Epub 2014 Nov 13. — View Citation

Walankar PP, Panhale VP, Patil MM. Psychosocial factors, disability and quality of life in chronic shoulder pain patients with central sensitization. Health Psychol Res. 2020 Oct 1;8(2):8874. doi: 10.4081/hpr.2020.8874. eCollection 2020 Oct 5. — View Citation

Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Central sensitization inventory (CSI)	Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.	1week
Other	Central sensitization inventory (CSI)	Clinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.	1 months
Other	Central sensitization inventory (CSI)	Clinical scale used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.	3 months
Primary	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
Primary	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
Primary	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
Primary	Shoulder range of motion	Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex	1 weeks
Primary	Shoulder range of motion	Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex	1 months
Primary	Shoulder range of motion	Goniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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