Clinical trial
Investigation of the Effect of Central Sensitization on Steroid Injection Response in Patients With Shoulder Pain Secondary to Rotator Cuff Lesion
Name
23-20
Description
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.
Trial arms
Trial start
2023-06-02
Estimated PCD
2024-08-30
Trial end
2024-12-30
Status
Recruiting
Treatment
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
Arms:
Patients with subacromial impingement syndrome (central sensitization negative), Patients with subacromial impingement syndrome (central sensitization positive)
Size
36
Primary endpoint
Visual analog scale
1 week
Visual analog scale
1 months
Visual analog scale
3 months
Shoulder range of motion
1 weeks
Shoulder range of motion
1 months
Shoulder range of motion
3 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be followed up in two groups according to the presence of central sensitization before treatment.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}
Updated at
2023-07-03
1 organization
1 product
2 indications
Indication
Central SensitizationIndication
Subacromial Impingement Syndrome