NCT07057128

Brief Summary

This single-center observational study aims to investigate neuropathic pain descriptors and their relationship with central sensitization in patients diagnosed with subacromial pain syndrome (SAPS) who have had shoulder pain for at least 3 months. A total of 82 participants aged 19 years or older will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Izmir City Hospital. After obtaining informed consent, participants will complete validated questionnaires assessing pain severity (VAS), neuropathic pain characteristics (painDETECT), central sensitization (Central Sensitization Inventory), and shoulder function (SPADI). Range of motion will be measured using a goniometer. No imaging or invasive procedures will be performed. Using the central sensitization scale and pain detect, the presence or absence of the 7 pain descriptors will be investigated in patients with subacromial pain syndrome with or without central sensitization and neuropathic pain pattern and it will be investigated whether the contribution of hyperalgesia, one of these pain descriptors, to neuropathic pain and central sensitization in patients with subacromial pain syndrome is greater than the contribution of other pain descriptors.The results of this study are expected to provide insight into pain mechanisms and guide clinical management in patients with SAPS.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Sep 2025Jun 2026

First Submitted

Initial submission to the registry

June 28, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

June 28, 2025

Last Update Submit

April 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hyperalgesia

    Hyperalgesia is defined as an exaggerated pain response to a painful stimulus that is disproportionate to the intensity of the stimulus. It is one of the pain descriptors assessed in the painDETECT questionnaire, which evaluates neuropathic pain features.It is one of the 7 questions in the painDETECT scale that evaluates neuropathic pain and is scored on a 6-point Likert scale and receives a score between 0-5.

    At baseline (single assessment)

Secondary Outcomes (5)

  • Pain Intensity

    At baseline

  • Neuropathic Pain

    At baseline

  • Central Sensitization

    At baseline

  • Function

    At baseline

  • Range of Motion Measurement

    At baseline

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted with 82 patients aged 19 years and older who have been admitted to the PTR outpatient clinic of Izmir City Hospital with shoulder pain and diagnosed with subacromial pain syndrome and who have had shoulder pain for at least 3 months.

You may qualify if:

  • Clinical diagnosis of subacromial pain syndrome (SAPS)
  • Age ≥ 19 years
  • Shoulder pain lasting for at least 3 months
  • Shoulder pain intensity rated as 3 or higher on the Visual Analog Scale (VAS) in the past week
  • Positive findings on the following clinical tests:
  • Hawkins-Kennedy test Painful arc test Infraspinatus muscle strength test

You may not qualify if:

  • History of inflammatory disease involving the shoulder joint
  • History of neurological disorders
  • History of prior shoulder surgery
  • Positive drop arm test
  • Loss of passive range of motion in the shoulder joint
  • Presence of muscle strength loss
  • Structurally confirmed shoulder pathology based on imaging studies
  • Full-thickness tear of the rotator cuff muscles
  • Presence of neurodeficit in the upper extremity
  • Diagnosis of cancer or active infection
  • Use of medications for neuropathic pain within the past 3 months for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir City Hospital

Izmir, İzmir, 35300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Doctor, Department of Physical Medicine and Rehabilitation, Izmir City Hospital

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 9, 2025

Study Start

September 15, 2025

Primary Completion

March 26, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations