Frozen ShoulderNCT07124689
Relationship Between Central Sensitization Levels and Treatment Outcomes in Frozen Shoulder Treatment
An observational study of Frozen Shoulder and Central Sensitisation, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frozen Shoulder, Central Sensitisation, Treatment
- What is being tested?
- Treatment outcome
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Aug 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent ultrasound-guided glenohumeral intra-articular injection with a diagnosis of frozen shoulder at Edirne Sultan 1. Murat State Hospital
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Central Sensitization Levels and Treatment Outcomes in Patients Diagnosed With Frozen Shoulder and Undergoing Intra-Articular Injection
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
- Being tested
- Treatment outcome
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with central sensitization | Patients with a score of 40 or higher on theCentral Sensitization Inventory Receives: Other: Treatment outcome | |
| Patients without central sensitization | Patients with a score below 40 on the Central Sensitization Inventory Receives: Other: Treatment outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start9 Aug 2025
- Primary completion15 Nov 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan 1. Murat State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alper Mengi, Sultan 1. Murat State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124689
- Sponsor's protocol ID
- 26/06/2025-Number:37
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, the data of the study will be shared by the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Central Sensitization Levels and Treatment Outcomes in Patients Diagnosed With Frozen Shoulder and Undergoing Intra-Articular Injection
- ClinicalTrials.gov ID
- NCT07124689
- Acronym / sponsor ID
- 26/06/2025-Number:37
- Conditions
- Frozen Shoulder, Central Sensitisation, Treatment, Intra-Articular Injection, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Sultan 1. Murat State HospitalOther government
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with central sensitization | – | Other: Treatment outcomePatients with a score of 40 or higher on theCentral Sensitization Inventory |
| Patients without central sensitization | – | Other: Treatment outcomePatients with a score below 40 on the Central Sensitization Inventory |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent ultrasound-guided glenohumeral intra-articular injection with a diagnosis of frozen shoulder at Edirne Sultan 1. Murat State Hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment outcomePatients 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. | Other | Patients with central sensitization, Patients without central sensitization |
Primary outcome
Presence of Central Sensitization
Time frame: Baseline
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.
5 secondary outcomes
Post-injection pain severity of patients
Time frame: Baseline
Patients' daytime pain severity
Time frame: Baseline
Patients' nighttime pain severity
Time frame: Baseline
Pressure pain threshold around the shoulder
Time frame: Baseline
Shoulder-related disability and activities of daily living
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. If requested, the data of the study will be shared by the researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Shoulder and Central Sensitisation, run by Sultan 1. Murat State Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Central Sensitization (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.