Measuring Pain Experience in Individuals With Lateral Elbow Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Central Sensitization Inventory
研究概览
简要总结
The study will address the gaps in the pain experience measurement in those with lateral elbow tendinopathy (LET) by building on the current body of literature, as well as applying modern pain science measures. The comprehensive measurement of various biomedical, psychological, and psychosocial constructs will provide pain profiles that will allow for the subclassification of LET to better inform loading prescriptions based on the systemic effects from LET.
详细描述
Methods: Subjects complete the eight patient reported questionnaires as well as go through 4 clinical examination procedures. Through this cross-sectional design and single session of testing, the investigator seeks to identify associations amongst constructs and variables in order to sub classify patients with LET based on their pain experience.
Study aim 1: The goal of this study is to determine the associations among the various measurements of the pain experience, psychological, psychosocial, and biomedical domains in those with LET.
Research Questions
- How is the pain experience in individuals with LET associated with chance locus of control (LOC)?
- What is the impact of fear avoidance on the pain experience in those with LET?
- How does central sensitization alter the pain experience in those with LET?
- Which pain experience measures are associated with functional ability in LET?
Hypotheses
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking and reading
- •Aged 18-75
- •Diagnosis of lateral elbow tendinopathy provoked by 2 clinical tests: painful resisted 2nd or 3rd finger extension, painful wrist extension, painful stretching of forearm extensor muscles, or painful gripping.
排除标准
- •Receiving any medical intervention for LET from a physician within 90 days. Medical intervention operationally defined as any intervention requiring a medical state license to administer (injection or surgery) or prescribe (medication applied to or ingested that is not available without a physician script) with the exception of patient education.
- •Positive mechanical sensitivity of the median nerve (Upper Limb Tension Test a (ULTTa)).
- •Positive pain provocation of passive elbow flexion.
结局指标
主要结局
Central Sensitization Inventory
时间窗: Baseline
1. The subject will be asked to assess for the presence of a central sensitization state on 25 questions scored in ordinal fashion 0 (never) - 4 (always). 2. Data from this instrument will be obtained by recording the total score on a scale of 0-100. 3. Higher score is worse.
Short Form-McGill Pain Questionnaire-2
时间窗: Baseline
1. The subject will be asked to rate their pain on a 0-10 scale for 22 different pain descriptors. 2. Continuous (1, 5, 6, 8, 9, 10), Intermittent (2, 3, 4, 11, 16, 18), Neuropathic (7, 17, 19, 20, 21, 22), and Affective (12, 13, 14, 15) subscales will be calculated by taking the mean of these items scores in addition to total score. 3. The subject will also mark their pain on a numeric pain rating score. 4. Scale is 0-10. 5. Higher score is worse.
Patient Specific Functional Scale
时间窗: Baseline
1. The subject will identify 3 activities that are most limited and meaningful to them. 2. The subject will rate these activities on an 11-point scale ranging from 0 "unable to perform" to 10 "Able to perform the activity at the same level as before the injury or problem." 3. Scale is 0-30. 4. Higher score is better.
Multidimensional health locus of control scale form C
时间窗: Baseline
1. The subject rates their opinion or sense that his/her outcomes are determined by luck, fate, or a random occurrence that controls experiences. 2. The 6-point Likert scale is rated from strongly agree to strongly disagree, with 18 questions with 3 subscales including different types of loci of control (LOC; internal, chance, and doctors). 3. Chance LOC scores range from 6-36 in an ordinal measurement. 4. Data from this instrument will be obtained by recording the total score on a scale of 6-36. 5. Higher score is worse.
Fear Avoidance Belief Questionnaire
时间窗: Baseline
1. The subject will be asked to assess for the presence of fear avoidance behavior. 2. Items are scored on a 6-point Likert scale with questions 2-5 a subscale for work and 6, 7, 9, 10, 11, 12, and 15 for physical activity. 3. Scale is 0-66. 4. Higher score is worse.
Hospital Anxiety and Depression Scale
时间窗: Baseline
1. The subject will be asked to assess for the presence of anxiety or depression on 14 questions scored in 4-point Likert scale. 2. Data from this instrument will be obtained by recording the total score and subscores for anxiety and depression. 3. Scale is 0-56 4. Higher score is worse.
Pain Catastrophizing Scale
时间窗: Baseline
1. The subject will be asked to assess for the presence of a pain catastrophizing on 13 questions scored in ordinal fashion 0 (not at all) - 4 (all the time). 2. Data from this instrument will be obtained by recording the total score on a scale of 0-52. 3. Higher score is worse.
次要结局
- Laterality(Baseline)
- Pressure Pain Threshold(Baseline)
- Two Point Discrimination(Baseline)
- Pain-Free Grip Strength(Baseline)