Relationship Between Central Sensitization Levels and Treatment Outcomes in Frozen Shoulder Treatment

NCT07124689 | Completed

• 1 other identifier: 26/06/2025-Number:37
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the relationship between treatment outcomes and central sensitization levels in patients who received intra-articular injections for frozen shoulder.

Conditions

Frozen Shoulder; Central Sensitisation; Treatment; Intra-Articular Injection; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Presence of Central Sensitization

  Patients' levels of central sensitization will be assessed using the Central Sensitization Inventory (CSI). The CSI consists of 25 items, each scored from 0 to 1. A score of 40 or higher indicates the presence of central sensitization.

  Baseline

Secondary Outcomes (5)

• Post-injection pain severity of patients

  Baseline

• Patients' daytime pain severity

  Baseline

• Patients' nighttime pain severity

  Baseline

• Pressure pain threshold around the shoulder

  Baseline

• Shoulder-related disability and activities of daily living

  Baseline

Study Arms (2)

Patients with central sensitization

Patients with a score of 40 or higher on theCentral Sensitization Inventory

Other: Treatment outcome

Patients without central sensitization

Patients with a score below 40 on the Central Sensitization Inventory

Other: Treatment outcome

Interventions

Treatment outcome OTHER

Patients will be evaluated for their central sensitization scores before the injection, the pain they experienced during the injection 1 hour after the injection, their daytime and nighttime pain intensity before and 1 month after the injection, their pain thresholds for tactile sensation around the shoulder, and their pain and disability levels.

Patients with central sensitization; Patients without central sensitization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent ultrasound-guided glenohumeral intra-articular injection with a diagnosis of frozen shoulder at Edirne Sultan 1. Murat State Hospital

You may qualify if:

• Being between 18 and 75 years of age
• More than one-third of the active and passive movement of the painful shoulder is limited in two or more planes
• Having pain and limited movement in the shoulder for 3-12 months

You may not qualify if:

• Having bilateral shoulder pain
• Patients with incomplete study data
• Having cervical radiculopathy
• Having a predominant central sensitization syndrome (such as fibromyalgia, chronic fatigue syndrome)
• Patients taking antidepressants or anticonvulsants that may affect central sensitization
• Having a history of rheumatological disease
• Having a history of active malignancy
• Patients receiving treatment for active psychiatric disorders
• Having a history of trauma and/or surgery in the same shoulder region
• Patients who received local shoulder injections and/or physical therapy within the last 3 months
• Patients with calcific tendonitis, glenohumeral osteoarthritis, or acromioclavicular joint osteoarthritis on plain radiographs
• Having a full-thickness rotator cuff tear on shoulder ultrasound

Sponsors & Collaborators

• Sultan 1. Murat State Hospital: lead

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Treatment Outcome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: August 9, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)