Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome

NCT06655714 | Completed

• 1 other identifier: BeylikduzuStateH7
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the impact of central sensitization in patients with shoulder impingement syndrome who have shown an inadequate response to ultrasound-guided subacromial corticosteroid injection. Additionally, the patients' pain perception and emotional state will be evaluated, and the relationships between these factors and the treatment response will be analyzed.

Conditions

Impingement Syndrome

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale (VAS)

  The Visual Analog Scale is a tool used to measure the intensity of pain. It consists of a 10 cm line, where one end represents "no pain" (0) and the other end represents "worst imaginable pain" (10). Patients mark the point on the line that reflects their current pain level. In this study, a reduction of less than 50% on the VAS after 4 weeks is considered an inadequate response to the treatment.

  0 day, 4th week

• Central Sensitization Inventory (CSI)

  The CSI is a self-reported questionnaire used to identify the presence of central sensitization, which is a condition where the central nervous system becomes hypersensitive to stimuli. It consists of 25 items that measure symptoms related to central sensitization syndromes. Higher scores indicate a greater likelihood of central sensitization, which can contribute to persistent pain in conditions like shoulder impingement syndrome.

  0 day, 4th week

• Pressure-Pain Threshold (PPT) Using Algometer

  The Pressure-Pain Threshold is the minimum force applied to the skin that induces pain. In this study, an algometer is used to measure PPT at various points on the body. Lower PPT values indicate increased sensitivity to pressure, which is a sign of hyperalgesia, often associated with central sensitization.

  0 day, 4th week

• Pain Catastrophizing Scale (PCS):

  The PCS is a psychological tool used to assess the extent to which individuals experience catastrophic thoughts related to their pain. It includes 13 items that measure rumination, magnification, and helplessness in response to pain. Higher scores on the PCS suggest that the patient tends to catastrophize pain, which can negatively affect their pain experience and recovery.

  0 day, 4th week

• Hospital Anxiety and Depression Scale (HADS):

  The HADS is a questionnaire used to assess the emotional state of patients, focusing on anxiety and depression. It consists of 14 items, divided into two subscales: one for anxiety (HADS-A) and one for depression (HADS-D). Higher scores indicate greater levels of anxiety or depression, which can influence how patients perceive and cope with their pain.

  0 day, 4th week

Study Arms (2)

Patients with adequate response

In this study, patients whose Visual Analog Scale (VAS) score decreases by 50% or more after 4 weeks of receiving the ultrasound-guided corticosteroid injection will be considered to have had an adequate response.

Other: No intervention

Patients with inadequate response

In this study, an inadequate response is defined as less than a 50% reduction in pain, as measured by the Visual Analog Scale (VAS), four weeks after the ultrasound-guided corticosteroid injection.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with adequate response; Patients with inadequate response

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include 72 patients aged 18-65 who have been diagnosed with shoulder impingement syndrome and have undergone ultrasound-guided subacromial corticosteroid injection.

You may qualify if:

• Patients aged 18-65.
• Diagnosed with shoulder impingement syndrome.
• Received ultrasound-guided subacromial corticosteroid injection.
• Experienced shoulder pain for at least 6 months.

You may not qualify if:

• History of surgery or fracture in the shoulder or related areas.
• Presence of an active infection.
• Received shoulder injection within the last 6 months.
• Underwent physical therapy for the shoulder in the last 6 months.
• Presence of other musculoskeletal or neurological conditions that could cause shoulder pain (e.g., cervical disc herniation, stenosis, moderate to severe osteoarthritis, adhesive capsulitis, rheumatologic pathologies, infectious joint diseases).

Sponsors & Collaborators

• Beylikduzu State Hospital: lead

Study Sites (1)

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (1)

• Sirin Ahisha B, Paker N, Kesiktas N, Bugdayci ND, Ahisha YC. Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization? Arch Phys Med Rehabil. 2025 Aug;106(8):1227-1237. doi: 10.1016/j.apmr.2025.01.469. Epub 2025 Feb 1.

  PMID: 39900325 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)