Investigation of the Profile of Patients With Chronic Shoulder Pain: A Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.
详细描述
The main part of the study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT. The measurements will be performed in one session. Once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. They will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale),
- •aged 18-65 years
- •mentally able to follow instructions or
- •healthy volunteers
- •aged 18-65
- •who do not experience pain and have not received analgesic medication in the last trimester.
排除标准
- •referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke),
- •pain manifested by movements in the neck,
- •shoulder arthroplasty or fractures or dislocation of the shoulder, -
- •diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases,
- •use of medication for neurological/psychiatric disorders,
- •the presence of gastrointestinal or renal disease
- •taking medication that may affect the assessment results, such as calcium channel blockers that could alter HRV,
- •pregnancy or childbirth before 1 year will be excluded from the study.
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: Only one time (baseline)
PPT will be used to assess the pain sensitivity
Conditioned Pain Modulation (CPM)
时间窗: Only one time (baseline)
CPM will be used to examine the descending inhibition of nociceptive signals
Nociplastic Pain Criteria
时间窗: Only one time (baseline)
The grading system for recognition of nociplastic pain will be used (Kosek et al. 2021).
次要结局
- Central Sensitization Inventory (CSI)(Only one time (baseline))
- Numeric Pain Rating Scale(Only one time (baseline))
- Pain Distribution(Only one time (baseline))
- Heart Rate Variability (HRV)(Only one time (baseline))
- Range of motion(Only one time (baseline))
- Hospital Anxiety and Depression Scale (HADS)(Only one time (baseline))
- Brief Illness Perception Questionnaire (BIPQ)(Only one time (baseline))
- Pain Sensitivity Questionnaire (PSQ)(Only one time (baseline))
- Pittsburgh Sleep Quality Index (PSQI)(Only one time (baseline))
- Tampa Scale Kinesiophobia (TSK)(Only one time (baseline))
- EuroQol-5 Dimension (EQ-5D)(Only one time (baseline))
- 3-Minute Step Test (3MST)(Only one time (baseline))
- Hand Grip(Only one time (baseline))
- Pain Catastrophizing Scale (PCS)(Only one time (baseline))
- Work Ability Index (WAI)(Only one time (baseline))
- Pain Self-Efficacy Questionnaire (PSEQ)(Only one time (baseline))
- Shoulder Pain and Disability Index (SPADI)(Only one time (baseline))
研究者
Paraskevi Bilika
Study Director
University of Thessaly