Association Between Pain Phenotype and Change in Pain Following Routine Corticosteroid Injection in Patients With Subacromial Pain Syndrome - A Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this prospective cohort study is to investigate whether pain phenotype is associated with subsequent change in pain intensity after corticosteroid injection given as part of routine care in patients diagnosed with SAPS.
The main question it aims to answer is:
Does change in shoulder pain from baseline to 4 weeks after corticosteroid injection differ between patients classified as having a nociplastic pain phenotype and those classified as having a non-nociplastic pain phenotype?
详细描述
This study is part of a larger study investigating the prevalence of nociplastic pain phenotype according to the International Association for the Study of Pain (IASP) clinical criteria (The NAP SAPS Study). This prospective cohort component includes participants with SAPS who receive a corticosteroid shoulder injection as part of routine clinical care.
Musculoskeletal pain poses a significant burden on individuals and society. The IASP describes different pain mechanisms, including nociceptive, neuropathic and nociplastic pain. Identification of different pain mechanisms may be relevant for understanding pain presentation and variation in treatment response among patients with musculoskeletal pain.
Shoulder pain ranks among the most prevalent musculoskeletal complaints, with subacromial pain syndrome (SAPS) ranking highest, and serves as a common diagnosis for non-traumatic shoulder pain.
Exercise and other conservative treatments, including corticosteroid injection, are commonly used in the management of SAPS. However, a substantial proportion of patients experience limited or transient treatment effects and may develop persistent shoulder pain. Differences in underlying pain mechanisms may contribute to variation in treatment response among patients with SAPS. Corticosteroid injection is primarily used to target local inflammatory and nociceptive processes, and differences in pain phenotype may therefore be associated with variation in response to treatment. Emerging evidence suggests that altered pain processing may also be present in patients with shoulder pain, supporting the investigation of whether pain phenotype is associated with treatment response.
Clinical criteria have been proposed to identify different pain mechanisms in musculoskeletal pain conditions. The IASP clinical criteria for nociplastic pain provide a structured approach to classifying patients based on clinical features.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 test
- •Age 18-70 years
- •Increased pain during active arm elevation
- •Pain during active elevation ≥ 3 (VAS)
- •Receving a corticosteroid injection based on routine clinical proctice
排除标准
- •Severe visual impairment
- •Severe cognitive or physical impairment
- •Language barrier (Danish)
- •Receving a corticosteroid injection at a site other than the subacromial bursa (e.g. acromioclavicular joint or intra-articular injection)
研究组 & 干预措施
Patients diagnosed with SubAcromial Pain Syndrome (SAPS)
Patients with SAPS will be classified according to the IASP criteria for nociplastic pain as having either nociplastic or non-nociplastic pain phenotype
干预措施: Clinical evaluation (Procedure)
结局指标
主要结局
Change in pain between baseline and four weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)
时间窗: 4 weeks
Pain intensity will be assessed with Visual Analog Scale. Participants will score from 0 (no pain) to 100 (the worst pain they have ever experienced)
次要结局
- Change in pain between baseline and ten minutes after corticosteroid injection as measured by the Visual Analog Scale (VAS)(10 minutes)
- Change in pain between baseline and twelve weeks after corticosteroid injection as measured by the Visual Analog Scale (VAS)(12 weeks)
- Change in Shoulder Function between baseline and four weeks after corticosteroid injection as measured by the QuickDASH(4 weeks)
- Change in Shoulder Function between baseline and twelve weeks after corticosteroid injection as measured by the QuickDASH(12 weeks)
- Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) four weeks after corticosteroid injection as measured by the PASS questionnaire.(4 weeks)
- Proportion of patients with nociplastic and non-nociplastic pain phenotype achieving a Patient Acceptable Symptom State (PASS) twelve weeks after corticosteroid injection as measured by the PASS questionnaire.(12 weeks)
- Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) four weeks after corticosteroid injection as measured by the GPE scale.(4 weeks)
- Proportion af patients with nociplastic and non-nociplastic pain phenotype reporting a clinically relevant improvement in Global Perceived Effect (GPE) twelve weeks after corticosteroid injection as measured by the GPE scale.(12 weeks)