Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 6:41 PM
Study NCT ID:
NCT07057128
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropathic Characteristics of Subacromial Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-28', 'studyFirstSubmitDate': '2025-06-28', 'studyFirstSubmitQcDate': '2025-06-28', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperalgesia', 'timeFrame': 'At baseline (single assessment)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': 'Neuropathic Pain', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': 'Central Sensitization', 'timeFrame': 'At baseline', 'description': '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).'}, {'measure': 'Function', 'timeFrame': 'At baseline', 'description': '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.'}, {'measure': 'Range of Motion Measurement', 'timeFrame': 'At baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuropathic Pain', 'Central Sensitization', 'Subacromial Pain Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of subacromial pain syndrome (SAPS)\n2. Age ≥ 19 years\n3. Shoulder pain lasting for at least 3 months\n4. Shoulder pain intensity rated as 3 or higher on the Visual Analog Scale (VAS) in the past week\n5. Positive findings on the following clinical tests:\n\nHawkins-Kennedy test Painful arc test Infraspinatus muscle strength test\n\nExclusion Criteria:\n\n1. History of inflammatory disease involving the shoulder joint\n2. History of neurological disorders\n3. History of prior shoulder surgery\n4. Positive drop arm test\n5. Loss of passive range of motion in the shoulder joint\n6. Presence of muscle strength loss\n7. Structurally confirmed shoulder pathology based on imaging studies\n8. Full-thickness tear of the rotator cuff muscles\n9. Presence of neurodeficit in the upper extremity\n10. Diagnosis of cancer or active infection\n11. Use of medications for neuropathic pain within the past 3 months for any reason'}, 'identificationModule': {'nctId': 'NCT07057128', 'briefTitle': 'Neuropathic Characteristics of Subacromial Pain Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Izmir City Hospital'}, 'officialTitle': 'Descriptors of Neuropathic Pain and Its Association With Central Sensitization in Subacromial Pain Syndrome', 'orgStudyIdInfo': {'id': 'SAPS-NP'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Doctor, Department of Physical Medicine and Rehabilitation, Izmir City Hospital', 'investigatorFullName': 'Aslı Gökgöz Azak', 'investigatorAffiliation': 'Izmir City Hospital'}}}}