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CompletedNCT07124689Updated Dec 31, 2025

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

An observational study in Frozen Shoulder, Central Sensitisation and Treatment, sponsored by Sultan 1. Murat State Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Sultan 1. Murat State Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
87
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Frozen Shoulder
  • Central Sensitisation
  • Treatment
  • Intra-Articular Injection
  • Shoulder Pain
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

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

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherTreatment outcome

    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.

05

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

    Time frame: Baseline

  5. Shoulder-related disability and activities of daily living

    Shoulder-related disability and activities of daily living will be assessed using the The Shoulder Pain and Disability Index (SPADI). The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.

    Time frame: Baseline

06

Study locations

1 site
  • Sultan 1. Murat State Hospital
    Edirne, 22030, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: Yes — If requested, the data of the study will be shared by the researchers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07124689
Lead sponsor
Sultan 1. Murat State Hospital
Responsible party
Alper Mengi (Associate Professor, Sultan 1. Murat State Hospital) — Principal investigator
First posted
Aug 15, 2025
Start date
Aug 9, 2025
Primary completion
Nov 15, 2025
Completion
Dec 15, 2025
Last update
Dec 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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