Clinical trial NCT05926895: Investigation of the Effect of Central Sensitization (CS) on Steroid Injection Response in Rotator Cuff Lesion
Official title: Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Sensitisation
Subacromial Impingement Syndrome
Keywords: central sensitisation
central sensitization inventory
subacromial impingement
shoulder pain
steroid injection
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be followed up in two groups according to the presence of central sensitization before treatment.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale
timeFrame: 1 week
measure: Visual analog scale
timeFrame: 1 months
measure: Visual analog scale
timeFrame: 3 months
measure: Shoulder range of motion
timeFrame: 1 weeks
measure: Shoulder range of motion
timeFrame: 1 months
measure: Shoulder range of motion
timeFrame: 3 months
Secondary outcomes:
measure: QuickDASH
timeFrame: 1 weeks
measure: QuickDASH
timeFrame: 1 months
measure: QuickDASH
timeFrame: 3 months
measure: SF-36 (Short form-36)
timeFrame: 1 week
measure: SF-36 (Short form-36)
timeFrame: 1 months
measure: SF-36 (Short form-36)
timeFrame: 3 months
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 1 week
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 1 month
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 3 month
measure: hand grip strength
timeFrame: 1 week
measure: hand grip strength
timeFrame: 1 months
measure: hand grip strength
timeFrame: 3 months
measure: Pressure pain threshold (PPT)
timeFrame: 1 week
measure: Pressure pain threshold (PPT)
timeFrame: 1 months
measure: Pressure pain threshold (PPT)
timeFrame: 3 months
Other outcomes:
measure: Central sensitization inventory (CSI)
timeFrame: 1week
measure: Central sensitization inventory (CSI)
timeFrame: 1 months
measure: Central sensitization inventory (CSI)
timeFrame: 3 months
Locations:
city: Istanbul
country: Turkey
facility: Sultan Abdülhamid Han Research and Training Hospital
Study officials:
affiliation: Sultan Abdülhamid Han Research and Training Hospital
name: Emre Ata, Asst.Prof
role: STUDY_CHAIR
References:
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.
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.
citation: 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.
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.
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.