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临床试验/NCT03756740
NCT03756740已完成不适用

The Effectiveness of Telerehabilitation Modalities in Physical Therapy in the Management of Chronic Low Back Pain

University of Haifa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11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
30
试验地点
1
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

Low back pain (LBP), a common disorder, causes disability, functional decline and high health care costs. Patient care programs include specific exercises for promoting function and improving health. Self-practice and adherence to treatment are important for treatment success and better outcomes. Telerehabilitation (TR) might improve patient symptoms, compliance to treatment and reduce patient symptoms, however, its effectiveness in treating LBP, still needs further investigation.

The overall aim of this study will be to examine the effectiveness of combining telerehabilitation within physical therapy treatments for patients with LBP

详细描述

The study will include 60 patients complaining of chronic nonspecific LBP over a 6 month period of time and referred for physical therapy treatment. They will undergo a routine physical examination and be assigned a personal treatment (manual therapy and electrotherapy) and exercise program in accordance with their condition. Participants will receive a total of 8 treatments over a 4-week period (twice a week).

The sample will be randomly divided into 2 groups: a. research group A will receive a video of the exercises via e-mails or to their cellphones; b. a control group will receive the exercises printed on paper.

The exercises will be recorded and be supplemented by a verbal explanation and instructions as to how to correctly perform the exercises. In total, there will be ten videos, found to be important and effective for LBP patients. From these videos, a physical therapist will choose the most suitable exercises for the patients after each treatment meeting (face to face). The patients will be assessed at baseline, at the end of treatment and at a 3 month follow-up telephone assessment.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know the intervention in other groups or the research aim in details. they will only know that it is a research for low back pain treatment.

The physical therapists performing the examination pre and post intervention will be blinded to the participants group.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Main complaint of nonspecific LBP over a 3 month period
  • Possess a smartphone, e-mail and the understanding of using these tools for viewing videos.

排除标准

  • Signs or symptoms of possible malignancy are present, such as unexplained weight loss, slight or no reduction of pain while in a recumbent position or subjects were not screened prior to referral to physical therapy.
  • two or more of the following signs are present on physical examination: lower extremity weakness in a myotome distribution, decreased sensation in a dermatomal distribution, altered lower extremity deep tendon reflexes, pathological reflexes, a positive straight leg raise (SLR) test, crossed SLR or femoral nerve stretch test.
  • Symptoms began immediately after a significant trauma (motor vehicle accident, fall from a height) and subjects were not been screened for possible fractures.
  • Physical therapy or chiropractic treatment for LBP was provided during the 6 months prior to participation in the study or are currently being treated.

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: 3 months

level of pain on an 11-point numeric pain rating scale

Modified Oswestry Disability Index

时间窗: 3 months

questionnaire to assess the disability level associated with LBP and includes 10 questions regarding activities likely to be affected by LBP

Fear-Avoidance Beliefs Questionnaire

时间窗: 3 months

questionnaire to assess the subject's beliefs as to the potential harm of several physical and work-related activities

Survey Health Form Short

时间窗: 3 months

questionnaire to assess the subject's belief as to his/her health-related quality of life

次要结局

  • Global rating of change(3 months)
  • A questionnaire regarding treatment satisfaction(3 months)

研究者

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

Gali Dar

principal investigator

University of Haifa

研究点 (1)

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