Triamcinolone acetonide for Chronic shoulder pain

Inclusion criteria

• {"criterion_text":"- Men and women scheduled for suprascapular nerve block due to shoulder pain (omalgia).\n- Age >18 years.\n- Shoulder pain (omalgia) lasting >3 months.\n- Signed informed consent form."}

Exclusion criteria

• {"criterion_text":"- Allergy to corticosteroids.\n- Systemic infections.\n- Women of childbearing potential not using highly effective contraceptive methods (as defined in the ICH M3 guidance, Note 3).\n- Patient refusal.\n- Blood dyscrasias.\n- Inability to perform the infiltration due to technical difficulties.\n- Lack of understanding of the informed consent document.\n- Pregnancy or breastfeeding.\n- External causes of shoulder pain (omalgia), such as secondary to stroke, post-surgical conditions (shoulder surgery, laparoscopic surgery, or thoracic surgery), or cervicobrachial syndrome.\n- Severe pain in other locations, specifically in cases of polymyalgic syndromes (fibromyalgia), other conditions with poor response to treatments (chronic fatigue syndrome), or at the physician's discretion.\n- Participation in other studies that may affect the results."}

Primary endpoints

• {"endpoint_text":"- The SPADI (Shoulder Pain and Disability Index) is a quality-of-life questionnaire designed to evaluate pain and disability related to shoulder pathology.","definition_or_measurement_approach":"Assessment using the SPADI questionnaire to evaluate shoulder pain and disability (Shoulder Pain and Disability Index)."}

Secondary endpoints

• {"endpoint_text":"- Demographics","definition_or_measurement_approach":"Collection of participant demographic data (age, sex, etc.)."}
• {"endpoint_text":"- Comorbidity","definition_or_measurement_approach":"Recording of participant comorbid conditions."}
• {"endpoint_text":"- Visual Analog Scale (VAS)","definition_or_measurement_approach":"Pain assessment using the Visual Analog Scale (VAS)."}
• {"endpoint_text":"- Numerical Verbal Scale (NVS)","definition_or_measurement_approach":"Pain assessment using the Numerical Verbal Scale (NVS)."}
• {"endpoint_text":"- Range of Motion","definition_or_measurement_approach":"Assessment of active and passive shoulder mobility (range of motion: elevation, abduction, external rotation)."}
• {"endpoint_text":"- Amount of Analgesics Administered","definition_or_measurement_approach":"Measurement of analgesic use (amount/frequency) during follow-up."}
• {"endpoint_text":"- Hospital Anxiety and Depression Scale (HAD)","definition_or_measurement_approach":"Assessment of anxiety and depression using the HAD scale."}
• {"endpoint_text":"- EuroQol 5D (EQ-5D)","definition_or_measurement_approach":"Quality of life assessment using the EQ-5D instrument."}
• {"endpoint_text":"- Medical Outcomes Study Sleep Scale (MOS)","definition_or_measurement_approach":"Assessment of sleep quality using the MOS Sleep Scale."}
• {"endpoint_text":"- Satisfaction Assessment","definition_or_measurement_approach":"Assessment of patient satisfaction with the treatment received (questionnaire/scale as per protocol)."}

Spain

Earliest CTIS Part Ii Submission Date

23-12-2024

Latest Decision Or Authorization Date

15-01-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

76

Primary sponsor

Full Name

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain