跳至主要内容
临床试验/NCT05467592
NCT05467592已完成不适用

Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Pittsburg sleep scale

研究概览

简要总结

This is an observational study to examine presence of CS in patients with knee osteoarthritis (OA), chronic LBP (CLBP), and chronic neck pain (CNP) seeking outpatient physical therapy (PT) services. The study will also examine if outcomes differ between patients with CS and patients without CS symptoms with standard PT interventions.

详细描述

Central Sensitization (CS), defined as augmented pain processing, is common in subgroup of nearly all chronic pain conditions, including fibromyalgia, CLBP, OA, and chronic tension headache. However, current studies of CS are primarily limited to research settings, lacking the knowledge about prevalence of CS and rehabilitation outcomes in usual clinical care.

Practicing clinicians do not routinely assess for CS symptoms. Without proper screening for CS, and lack of knowledge of varying levels of nervous system involvement contributing to pain, clinicians are unable to fully identify the depth of the mechanisms and therefore unable to fully determine the best treatment strategies. This observational study addresses this gap in knowledge by screening patients for CS symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of knee, neck, or back pain
  • Chronic pain as defined pain > 3 months
  • Able to read and understand English

排除标准

  • Pregnancy
  • Pain less than 3 months

结局指标

主要结局

Pittsburg sleep scale

时间窗: Through study completion, up to 16 weeks

A standard questionnaire to examine sleep problems. A total of 5 scores or greater indicate poor sleep quality

Lower Extremity Functional Scale (LEFS) for patients with knee OA

时间窗: Through study completion, up to 16 weeks

LEFS is a 20-question survey about the participant's ability to perform everyday tasks.

Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms.

时间窗: Through study completion, up to 16 weeks

Percentage of patients with knee OA, CLBP, and CNP presenting with CS symptoms.

Functional Exam as part of routine primary PT

时间窗: Through study completion, up to 16 weeks

Routine PT functional assessment includes gait, sit-to-stand, stair climbing, and squats

2011 Fibromyalgia (FM) survey

时间窗: Through study completion, up to 16 weeks

A standard questionnaire for centralized pain. Scores 3-6 in widespread pain index and 9 or greater in symptom severity suggest widespread pain

Oswestry Disability Index (ODI) for patients with CLBP

时间窗: Through study completion, up to 16 weeks

ODI is a 10-question survey in which participants check a box corresponding to how their low back pain impacts their activities of daily living.

Beck Anxiety Inventory

时间窗: Through study completion, up to 16 weeks

A standard questionnaire with 21 questions. Scores 0-21=low anxiety, scores 22-35=moderate anxiety and scores 36 and above=potentially concerning level of anxiety

Fear Avoidance Questionnaire

时间窗: Through study completion, up to 16 weeks

A standard questionnaire to examine fear related to work and physical activities.

Physical Therapy examination data

时间窗: Through study completion, up to 16 weeks

Routine PT subjective and objective examination data that includes history taking, range of motion, muscle testing, and neurological exam if necessary

Neck Disability Index (NDI) for patients with CNP

时间窗: Through study completion, up to 16 weeks

NDI is a 10-question survey in which participants check a box corresponding to how their neck pain impacts their activities of daily living.

Neck flexor muscle performance

时间窗: Through study completion, up to 16 weeks

Strength and endurance. Strength will be tested manually with 0-5 MMT standard grading scale or with use of dynamometer for strength and endurance performance of individual muscles.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neena Sharma, PT, PhD, CMPT

Principal Investigator

University of Kansas Medical Center

研究点 (1)

Loading locations...

相似试验

Central Sensitization in Patients Seeking Outpatient... | 临床试验