Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management
详细描述
This study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb Orthopaedic Surgeon at the Department of Hand & Upper Limb Microsurgery of the 'KAT General Hospital' in Athens, Greece. Participants that will be diagnosed with RCRSP by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. Written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. The main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65
- •Pain: >3 months, non-traumatic, unilateral or bilateral of anterolateral location
- •ROM: >50% all planes, AROM painful in forward flexion and/or abduction
- •Provocation testing: Hawkins-Kennedy, Neer, Painful Arc, Resisted ER, Empty Can (3 or more out of the 5 +ve)
排除标准
- •Pain < 3months
- •History of neck or shoulder trauma
- •Radicular signs, shoulder pain reproduced with neck movements
- •Frozen Shoulder
- •Tears >C3 according to Snyder Classification
- •Fibromyalgia
- •Neurological, systemic local or autoimmune inflammatory conditions
- •Clinical depression
- •No injected corticosteroids or physiotherapy the last 3/12
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Once - Baseline
Obtain a measurement of pain Score: 0-10 Higher scores indicate more pain
Western Ontario Rotator Cuff Index (WORC)
时间窗: Once - Baseline
Assess the self-reported functional ability of participants Score: 0-100 % Higher scores indicate higher functional status
Pain Drawings (PD)
时间窗: Once - Baseline
Capture painful body locations for participants with the spectrum of pathologies
Quantitative Sensory Testing (QST)
时间窗: Once - Baseline
Assessment of Pressure Pain Threshold, Conditioned Pain Modulation \& Temporal Summation
Range of Motion (ROM)
时间窗: Once - Baseline
Assess Range of motion of the movements of interest
Posterior Shoulder Endurance Test (PSET)
时间窗: Once - Baseline
Assess the endurance of the Rotator Cuff myotendinous unit
Hospital Anxiety & Depression Scale (HADS)
时间窗: Once - Baseline
Obtain a score of Anxiety \& Depression among participants Score: 0-42 (Two scales between 0 \& 21 each - one for anxiety and 1 for depression) Higher Scores indicate higher anxiety \& depression
Pittsburgh Sleep Quality Index (PSQI)
时间窗: Once - Baseline
Assess sleep quality of participants Score: 0-21 Higher scores indicate worse sleep quality
Modified Baecke Physical Activity Questionnaire (MBPAQ)
时间窗: Once - Baseline
Evaluate Physical Activity levels of participants Score: low - moderate - high Higher scores indicate higher activity levels
The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS)
时间窗: Once - Baseline
Identify possible participants with neuropathic type of pain Score: 0-24 Score \>12 indicates neuropathic pain
Pain Catastrophising Scale (PCS)
时间窗: Once - Baseline
Explore how the pain experience is perceived by the individual Scale: 0-52 Higher scores indicate higher levels of catastrophising
EuroQol-5Dimension (EQ-5D)
时间窗: Once - Baseline
Investigate quality of life levels of participants Score: 5-likert with no problem, slight, moderate, severe and extreme in each of the dimensions plus the 0-100 VAS as a global rating of self-perceived health with higher scores indcating better health
Dynamometry
时间窗: Once - Baseline
Assess strength and explore pain provocation in participants
Pain Self-Efficacy Questionnaire (PSEQ)
时间窗: Once - Baseline
Assess the ability of the participant to cope with a spectrum of activities Score: 0-60 Lower scores indicate less self-efficacy
Allostatic Index-5 (ALI-5)
时间窗: Once - Baseline
Investigate psychosocial stressors reflective of chronc adaptive states for 'wear \& tear' of the human body Score: 0-5 Higher score indicating higher allostatic load
Central Sensitisation Inventory (CSI)
时间窗: Once - Baseline
Identify participants suspicious of central sensitisation symptoms Score: 0-100 Score\>40 indicates central sensitisation
Nociplastic Pain Flow Chart by IASP
时间窗: Once - Baseline
Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain
Tampa Scale of Kinesiophobia (TSK)
时间窗: Once - Baseline
Explore fear of movement and avoidance of participants Score: 17-68 Higher scores indicate higher levels of Kinesiophobia, cut-off point: scores \>37 are indicative of kinesiophobia
次要结局
未报告次要终点
研究者
Achilleas Paliouras
Principal Investigator, Physiotherapist, MSc, PhD candidate
University of Thessaly