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

Sultan 1. Murat State Hospital87 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Frozen Shoulder Central Sensitisation Treatment Intra-Articular Injection Shoulder Pain

Interventions

Treatment outcomeOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Sultan 1. Murat State Hospital

Edirne, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

Post-injection pain severity of patients

Patients will be questioned about their post-injection pain using the Visual Analog Scale (VAS). A 10-cm-long horizontal straight line will be used for VAS assessment. 0 is considered no pain, and 10 is considered the most severe pain.

Time frame: Baseline

Patients' daytime pain severity

Patients will be questioned about their daytime pain intensity using the Visual Analog Scale (VAS). A 10-cm-long horizontal straight line will be used for the VAS assessment. 0 is considered no pain, and 10 is considered the most severe pain. Daytime pain intensity will be measured at each assessment as the average pain intensity over the past 48 hours. Daytime pain is measured as the average pain experienced while performing daily routine tasks.

Time frame: Baseline

Patients' nighttime pain severity

Patients will be questioned about their nighttime pain intensity using a visual analog scale (VAS). A 10-cm-long horizontal straight line is used for the VAS assessment. 0 is considered no pain, and 10 is considered the most severe pain. Nighttime pain intensity is measured as the average of the pain intensity experienced over the last 48 hours at each assessment. Nighttime pain is questioned as pain upon awakening from sleep or shoulder pain that awakens the patient from sleep.

Time frame: Baseline

Pressure pain threshold around the shoulder

Patients' shoulder-area pressure pain thresholds will be assessed using a manual pressure algometer (Baseline Dolorimeter®). Patients' pain perception thresholds will be measured at the midpoint of the bilateral trapezius muscle, the midpoint of the supraspinatus muscle, the midpoint of the deltoid muscle, and the midpoint of the volar aspect of both forearms. During measurement, the 1.52 cm2 flat circular probe of the algometer will be placed on the affected area, and the pressure will be increased at a rate of 1 kg/second. Patients will be asked to report the first time they experience pain. The value for each reference area will be obtained by calculating the arithmetic mean of the paired measurements.

Data from ClinicalTrials.gov

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