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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05926895
Acronym
CS
Enrollment
44
Registered
2023-07-03
Start date
2023-06-02
Completion date
2024-12-30
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitisation, Subacromial Impingement Syndrome

Keywords

central sensitisation, central sensitization inventory, subacromial impingement, shoulder pain, steroid injection

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.

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.

Interventions

DRUGInjection 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

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Patients will be followed up in two groups according to the presence of central sensitization before treatment.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder range of motion1 weeksGoniometric measurement of flexion, extension, abduction, adduction and internal and external rotation angles of the shoulder complex
Visual analog scale1 weekThe visual analog scale (VAS) is a validated subjective measure for pain, scored in the 0-10 range (0:no pain; 10: worst pain).

Secondary

MeasureTime frameDescription
SF-36 (Short form-36)1 weekThe 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.
Hospital anxiety and depression scale (HADS)1 weekSelf-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.
Pressure pain threshold (PPT)1 weekPain 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.
hand grip strength1 weekGrip 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.
QuickDASH1 weeksQuickDASH is a shortened version of the original DASH outcome measure used in upper extremity musculoskeletal disorders. Higher scores are associated with increased disability.

Other

MeasureTime frameDescription
Central sensitization inventory (CSI)1weekClinical instrument used in the diagnosis of central sensitization. A CSI part-A score of 40 and above is significant in the diagnosis.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026