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Идёт набор NCT07509021

Neuropathic Pain, Catastrophizing, and Adherence in SAIS

Наблюдательное Subacromial Impingement Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Conservative Physical Therapy.
Кому может быть актуально
Состояния в реестре: Subacromial Impingement Syndrome. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Relationship Between Neuropathic Pain, Pain Catastrophizing, and Adherence-Related Behavior in Subacromial Impingement Syndrome

Обзор

Subacromial impingement syndrome is one of the most common causes of shoulder pain and may negatively affect daily activities and quality of life. While shoulder pain is usually considered nociceptive, some patients may also have a neuropathic pain component, which can influence symptom severity and treatment outcomes. In addition, psychological factors such as pain catastrophizing and adherence-related behavior may play an important role in recovery. This prospective observational study aims to evaluate the presence of neuropathic pain in patients with subacromial impingement syndrome and to investigate its relationship with pain catastrophizing and adherence-related behavior. Patients undergoing a standard physical therapy program will be assessed at the beginning and after completion of treatment using validated clinical scales. The findings of this study may help to better understand the interaction between pain characteristics, psychological factors, and adherence-related behavior, and contribute to the development of more individualized rehabilitation strategies

Подробное описание

Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and represents a substantial proportion of rotator cuff-related shoulder disorders. Although it is traditionally associated with nociceptive and mechanical pain mechanisms, recent evidence suggests that a subset of patients may also present with a neuropathic pain component and central sensitization, which may contribute to increased pain intensity, functional impairment, and poorer treatment outcomes.

In addition to biological factors, psychosocial variables play a critical role in chronic musculoskeletal pain. Pain catastrophizing, reflecting exaggerated negative cognitive and emotional responses to pain, has been associated with increased disability and delayed recovery. Similarly, adherence-related behavior may influence clinical outcomes, particularly in the context of physical therapy and exercise-based interventions. Understanding the interaction between neuropathic pain, catastrophizing, and adherence-related behavior may help identify clinically relevant subgroups and guide individualized rehabilitation strategies.

This study is designed as a prospective observational cohort study conducted in patients diagnosed with subacromial impingement syndrome who are referred to an outpatient physical therapy and rehabilitation clinic. Participants who meet the inclusion criteria will be consecutively enrolled and will receive a standard conservative physical therapy program. No additional or experimental interventions will be applied within the scope of the study.

Clinical and patient-reported outcome measures will be used to assess pain characteristics, psychological factors, functional status, and adherence-related behavior.

The primary aim of the study is to evaluate the relationship between neuropathic pain and pain catastrophizing in patients with subacromial impingement syndrome. Secondary analyses will explore the associations between these variables and adherence-related behavior, as well as clinical outcomes such as pain intensity and functional status.

The findings of this study are expected to contribute to a better understanding of the multidimensional nature of shoulder pain and to support the development of more targeted and individualized rehabilitation approaches.

Вмешательства

  • Другое Standard Conservative Physical Therapy
    Participants receive a standard conservative physical therapy program as part of routine clinical care. No experimental or study-assigned intervention is applied within the scope of this study.

Первичные конечные точки

  • Neuropathic Pain Component (DN4) [Срок оценки: Baseline and 2 weeks]
  • Pain Catastrophizing (PCS) [Срок оценки: Baseline and 2 weeks]
Вторичные конечные точки (6)
  • Pain Intensity at Rest (VAS) [Срок оценки: Baseline and 2 weeks]
  • Pain Intensity During Activity (VAS) [Срок оценки: Baseline and 2 weeks]
  • Pain Intensity at Night (VAS) [Срок оценки: Baseline and 2 weeks]
  • Functional Status (DASH) [Срок оценки: Baseline and 2 weeks]
  • Anxiety and Depression (HADS) [Срок оценки: Baseline and 2 weeks]
  • Adherence-Related Behavior (MMAS) [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Unilateral subacromial impingement syndrome lasting at least 3 months
  • Planned to start a 10-session physical therapy program
  • Willing and able to provide informed consent

Критерии исключения

  • Upper extremity entrapment neuropathy or polyneuropathy
  • History of diabetes mellitus
  • Inflammatory rheumatic disease, infection, or malignancy
  • Frozen shoulder
  • History of shoulder fracture, dislocation, or surgery
  • Complete rotator cuff tear on magnetic resonance imaging
  • Calcific tendinitis
  • Shoulder steroid injection or physical therapy within the previous 3 months
  • Use of medication for neuropathic pain
  • Pregnancy
  • Cognitive impairment preventing completion of questionnaires

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital — Bolu

Публикации

  • Ko S, Choi C, Kim S, Chae S, Choi W, Kwon J. Prevalence and Risk Factors of Neuropathic Pain in Patients with a Rotator Cuff Tear. Pain Physician. 2018 Mar;21(2):E173-E180. PMID 29565960
  • Vogel M, Binnebose M, Wallis H, Lohmann CH, Junne F, Berth A, Riediger C. The Unhappy Shoulder: A Conceptual Review of the Psychosomatics of Shoulder Pain. J Clin Med. 2022 Sep 19;11(18):5490. doi: 10.3390/jcm11185490. PMID 36143137
  • Ucar M, Cebicci MA, Koca I, Arik HO. Frequency of neuropathic pain in patients with shoulder pain. Eur Rev Med Pharmacol Sci. 2022 Aug;26(15):5422-5425. doi: 10.26355/eurrev_202208_29410. PMID 35993637

Идентификаторы

NCT: NCT07509021 · AIBU-FTR-YE-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗