Prevalence of Nociplastic Pain Phenotype in Patients Diagnosed With Subacromial Pain Syndrome (SAPS) - a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of patients with chronic Subacromial Pain Syndrome (SAPS) classified as having a nociplastic pain phenotype according to the IASP classification of nociplastic pain.
研究概览
简要总结
The goal of this cross-sectional study is to estimate the prevalence of the nociplastic pain phenotype, according to the IASP clinical criteria, among patients diagnosed with SubAcromial Pain Syndrome (SAPS).
The main question it aims to answer is: What is the prevalence of the nociplastic pain phenotype in patients diagnosed with SAPS in an outpatient clinic?
Primary outcome: Proportion of patients with SAPS meeting the IASP criteria for nociplastic pain.
详细描述
Musculoskeletal pain poses a significant burden on both individuals and society. The International Association for the Study of Pain (IASP) describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and treatment response in patients with musculoskeletal pain.
Shoulder pain ranks among the most prevalent musculoskeletal complaints with subacromial pain syndrome (SAPS) being the most prevalent diagnosis and a common diagnosis for non-traumatic shoulder pain. Exercise and other conservative treatments are considered first line treatment modalities in SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop chronic shoulder pain. This modest effect may be explained by a potential mismatch between the pain phenotype and the mechanistic assumptions underlying the treatment.
There are emerging clinical consensus statements for identifying primary pain phenotypes in musculoskeletal pain conditions. The IASP criteria for nociplastic pain offer a structured approach for classifying patients based on clinical features. However, the IASP criteria for identifying nociplastic pain have not, to our knowledge, been sufficiently investigated among patients with SAPS to elucidate the distribution of pain phenotypes in this population of patients with shoulder pain.
Movement-evoked pain is a key feature in many patients with SAPS. Virtual Reality (VR) may provide a controlled enviroment in which visual feedback and percevied movement can be manipulated. Such manipulation may influence movement-evoked pain and could potentially provide additional information about pain responses associated with different pain phenotype. In this study, VR is therefore included as an exploratory assessment.
The primary aim of this cross-sectional study is to investigate the proportion and characteristics of patients diagnosed with SAPS who meet the IASP clinical criteria for nociplastic pain in an outpatient hospital setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with SAPS (dm751, dm753, dm754, dm755
- •Shoulder pain ≥ 3 months
- •≥ 3 out of 5 specific shoulder tests
- •Age 18-70 years
- •Increased pain during active arm elevation
- •Pain during active elevation ≥ 3 (VAS)
排除标准
- •Severe visual impairment
- •Severe cognitive or physical impairment
- •Language barrier (Danish)
研究组 & 干预措施
Patients diagnosed with SubAcromial Pain Syndrome (SAPS)
干预措施: Clinical evaluation (Procedure)
结局指标
主要结局
Proportion of patients with chronic Subacromial Pain Syndrome (SAPS) classified as having a nociplastic pain phenotype according to the IASP classification of nociplastic pain.
时间窗: One time (baseline)
Grading system for nociplastic pain according to the International Association for the Study of Pain (IASP) classification of nociplastic pain (Kosek et al. 2021)
次要结局
- Difference in shoulder function between nociplastic and non-nociplastic pain phenotypes as assessed by the QuickDASH questionnaire(One time (baseline))
- Difference in Kinesiophobia between nociplastic and non-nociplastic pain phenotypes as assessed by the Tampa Scale of Kinesiophobia (TSK) questionnaire.(one time (baseline))
- Difference in Self-efficacy between nociplastic and non-nociplastic pain phenotypes according to the Pain Self-Efficacy Questionnaire (PSEQ4)(one time (baseline))
- Difference in Overall health between nociplastic and non-nociplastic pain phenotype as assessed by the Health (WHO-5) questionnaire(One time (baseline))
- Difference in Quality of life between nociplastic and non-nociplastic pain phenotype as assessed by the EQ-5D-5L questionnaire(One time (baseline))