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临床试验/NCT04355104
NCT04355104已完成不适用

Effects of Low Back Pain Knowledge-Related Education on Attitudes and Knowledge in Patients With Low Back Pain

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年8月1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
52
试验地点
2
主要终点
Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months

研究概览

简要总结

Low back pain (LBP) is the leading musculoskeletal condition in burden of disease and years lived with disability. This high ranking is in large part due to the high prevalence of LBP. LBP is not only mechanically related to spinal pathophysiology (i.e., postural alterations, articular stiffness, or muscle weakness), but may also be influenced by psychosocial factors such as attitudes and beliefs. Multidisciplinary rehabilitation programs, which include biopsychosocial management, resulted in a better outcome. The aim of this project is to determine if the change in LBP-related knowledge and attitudes toward LBP are correlated with the change in LBP-related pain, disability, fear avoidance, and emotional states of depression, anxiety, and stress after three months. The second aim is to investigate the effect of adding LBP knowledge related education sessions to standard physical therapy treatment on patients' LBP knowledge, attitudes toward LBP, LBP-related pain, disability, fear avoidance, and emotional symptoms in comparison to standard physical therapy alone.

详细描述

Low back pain (LBP) is the leading musculoskeletal condition in burden of disease and years lived with disability. This high ranking is in large part due to the high prevalence of LBP. LBP is not only mechanically related to spinal pathophysiology (i.e., postural alterations, articular stiffness, or muscle weakness), but may also be influenced by psychosocial factors such as attitudes and beliefs. Multidisciplinary rehabilitation programs, which include biopsychosocial management, resulted in a better outcome. The aim of this project is to determine if the change in LBP-related knowledge and attitudes toward LBP are correlated with the change in LBP-related pain, disability, fear avoidance, and emotional states of depression, anxiety, and stress after three months. Secondly, the investigators will investigate the effect of adding LBP knowledge related education sessions to standard physical therapy treatment on patients' LBP knowledge, attitudes toward LBP, LBP-related pain, disability, fear avoidance, and emotional symptoms in comparison to standard physical therapy alone. 74 patients with LBP receiving standard physical therapy service for the first time will be interviewed and their knowledge and attitude about LBP will be collected at the baseline. After 3 months, the LBP related pain, emotional symptoms, and LBP disability will be collected. The patients will be allocated to "Experimental group" consist of 37 patients will take education sessions in addition to standard physical therapy for 12 sessions or "control group" consist of 37 patients take just standard physical therapy for the same number of sessions without education. Participants will be assessed at baseline and at 3 months follow up. Outcome measures include Arabic version of the Back Pain Attitudes (Back-PAQ), Low Back Pain Knowledge (LKQ) Questionnaires, Arabic version of Oswestry Disability Index (ODI) to assess the function, Visual Analogue Scale for pain intensity, Depression Anxiety Stress Scales (DASS-21) for emotional states, and Fear-Avoidance Beliefs Questionnaire (FABQ) for fear avoidance beliefs. Spearman correlation coefficient r will be used to investigate the correlation between change in LBP knowledge and attitude, and change in pain, disability, fear avoidance and emotional symptoms after three months. Independent sample t-test will be used to compare the knowledge, attitude, VAS, ODI, FABQ, and DASS- between the experimental group and control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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

入选标准

  • Patients reported persistent LBP of more than 3/10 in the last 12 weeks.

排除标准

  • Subjects with acute low back pain, "red flags" indicating signs of serious pathology, previous back surgery, pregnancy, specific rheumatological diseases, spodylolysis or spondylolisthesis, spinal tumor or spinal fracture, mental disorders, or neurological diseases will be excluded.

结局指标

主要结局

Change in Low Back Pain Knowledge questionnaire from baseline to 4 weeks and 3 months

时间窗: Change from baseline to 4 weeks and 3 months

Low Back Pain Knowledge questionnaire evaluates a person's knowledge of low back pain. It is a valid, reliable and sensitive to change instrument consists of 16 multiple-choice questions divided into three topics: general aspects (Questions 1, 6, 7, 8, 15), with a maximum score of nine, concepts (Questions 2, 3, 4, 5), with a maximum score of four, and treatment (Question 9, 10, 11, 12, 13, 14, 16), with a maximum score of 11. The overall maximum score of the questionnaire was 24.13 The higher score reflects a higher knowledge.

Change in Oswestry Disability Index from baseline to 4 weeks and 3 months

时间窗: Change from baseline to 4 weeks and 3 months

It measures the patient's permanent functional disability due to low back pain. It is a valid, reliable assessment tool with acceptable internal consistency (Cronbach α ranges from .71 to .87) and test-retest reliability ((r=0.83-0.99) vary according to the time interval between measurement), diagnosed to collect information about the effect of low back pain on an individual's ability to manage everyday life. Intraclass correlation coefficient values from (0.84-0.94). It includes 9 sections with a total possible score of 5 for each one. The total score which ranges from 0%-20% represents a minimal disability and from 81%-100% is represent the highest disability .

Change in Visual analogue scale from baseline to 4 weeks and 3 months

时间窗: Change from baseline to 4 weeks and 3 months

It measures the level of pain intensity. It is a valid, reliable, acceptable and sensitive to change unidimensional assessment scale of pain intensity, with acceptable (test-retest reliability (r=0.71-0.94,p\<0.001)) and construct validity. The scale consists of an 11 point likert rating scale (with response options from "no pain" "0 score" to "worst pain ever" "10 score").

Change in Back Pain Attitude Questionnaire from baseline to 4 weeks and 3 months

时间窗: Change from baseline to 4 weeks and 3 months

Back Pain Attitude Questionnaire is a valid, reliable instrument with acceptable internal consistency (α=0.70; 95% CI 0.66 to 0.73) used to assess beliefs about back pain among the general public, people with back pain and health professionals. It contains 34 items, divided into 6 sections with a five-point Likert scale, and response options ranging from 'False' to 'True' for each one.14 The score range from 0-34 with higher scores indicate a negative attitude toward LBP.

次要结局

  • Change in Fear-Avoidance Beliefs Questionnaire (FABQ) from baseline to 4 weeks and 3 months.(Change from baseline to 4 weeks and 3 months)
  • Change in Depression Anxiety Stress Scales (DASS-21) from baseline to 4 weeks and 3 months(Change from baseline to 4 weeks and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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