Neuropathic PainNCT07057128
Neuropathic Characteristics of Subacromial Pain Syndrome
An observational study of Neuropathic Pain and Central Sensitization, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuropathic Pain, Central Sensitization, Subacromial Pain Syndrome
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to Jun 2026
- Phase
- Observational
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İzmir City Hospital
Izmir, İzmir, 35300
Aslı Gökgöz Azak, +902329550500, asli.gokgoz@sbu.edu.tr
About this study
Official title: Descriptors of Neuropathic Pain and Its Association With Central Sensitization in Subacromial Pain Syndrome
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.
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (single assessment)
Secondary outcomes (5)
Pain Intensity
Pain severity will be assessed using the Visual Analog Scale (VAS). VAS is a 10 cm horizontal line with endpoints labeled "no pain" (0) and "worst imaginable pain" (10). Patients will mark a point on the line that best represents their current level of shoulder pain.
Measured: At baseline
Neuropathic Pain
Neuropathic pain features will be assessed using the painDETECT questionnaire, which consists of 9 items. Two items evaluate pain pattern and radiation, and seven items assess descriptors such as burning, tingling, mechanical allodynia, paroxysmal pain, thermal hyperalgesia, numbness, and pressure-induced pain (hyperalgesia). Each descriptor is rated on a 0-5 scale. The total score helps determine the likelihood of neuropathic pain.
Measured: At baseline
Central Sensitization
Central sensitization will be evaluated using the Central Sensitization Inventory (CSI), which includes 25 items scored from 0 (never) to 4 (always). A score of 40 or more suggests a high probability of central sensitization (81% sensitivity, 75% specificity).
Measured: At baseline
Function
It will be evaluated with the shoulder pain and disability index (SPADI-Shoulder Pain and Disability Index). SPADI is a questionnaire with a total of 13 questions developed to measure disability associated with shoulder pain. In the subgroup of the questionnaire assessing pain, the patient is asked to rate the severity of pain during different activities in the past week by giving a score between zero (no pain) and 10 (most severe pain). In the sub-group assessing disability, the patient is asked to rate how much difficulty he/she has had during different activities in the last week by giving a score between zero (no difficulty at all) and 10 (receiving assistance). A score of zero indicates maximum well-being and a score of 130 indicates maximum ill health. The validity and reliability of the Turkish version of SPADI has been demonstrated.
Measured: At baseline
Range of Motion Measurement
Active and passive shoulder range of motion (ROM) will be measured using a goniometer. The movements evaluated include flexion, extension, abduction, adduction, internal and external rotation.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 Sep 2025
- Primary completion26 Mar 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aslı Gökgöz Azak, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057128
- Sponsor's protocol ID
- SAPS-NP
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided