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NCT Number: NCT06655714

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

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.

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Key information

Conditions

Impingement Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, 34147, Turkey (Türkiye)

About this study

Seventy-two patients aged 18-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital, diagnosed with shoulder impingement syndrome based on magnetic resonance imaging (MRI), and who received ultrasound-guided corticosteroid injection, will be included in the study. No additional interventions or procedures will be performed for the research. These patients, who were previously assessed and treated in the outpatient clinic, will be invited for a follow-up examination at the 4th week after the injection. During the follow-up, their response to the treatment will be evaluated using the Visual Analog Scale (VAS). A reduction of less than 50% on the VAS by the end of the 4th week will be considered an inadequate response. Patients with inadequate and good responses will be divided into two groups and assessed for central sensitization, pain perception, and emotional state. Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), and hyperalgesia will be assessed using an algometer to measure pressure-pain threshold. Additionally, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale will be used to determine the patients' emotional state and pain perception.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 0 day, 4th week

    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.

  2. Central Sensitization Inventory (CSI)

    Time frame: 0 day, 4th week

    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.

  3. Pressure-Pain Threshold (PPT) Using Algometer

    Time frame: 0 day, 4th week

    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.

  4. Pain Catastrophizing Scale (PCS):

    Time frame: 0 day, 4th week

    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.

  5. Hospital Anxiety and Depression Scale (HADS):

    Time frame: 0 day, 4th week

    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.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Evaluation of Inadequate Response to Ultrasound-Guided Subacromial Corticosteroid Injection in Shoulder Impingement Syndrome: Treatment Failure or Central Sensitization?

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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