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临床试验/NCT04834895
NCT04834895Unknown不适用

Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain

Marmara University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change from Exercise Adherence Scale Points at 6 Weeks

研究概览

简要总结

In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:

  • Increase exercise adherence with mhealth apps.
  • To reduce pain and disability of patients with chronic neck pain.

详细描述

Neck pain is one of the most common musculoskeletal diseases after low back pain in the community. The incidence of neck pain was reported as %37,2. Neck pain can be caused by trauma, poor posture, degenerative diseases, tumors, muscle stress, wiplash injuries, cervical myelopathy, cervical ligamentous instability, fracture, vascular insufficiency or systemic diseases. Neck pain is classified as acute (less than six weeks), subacute (six to twelve weeks) or chronic (lasting more than twelve weeks). While neck pain is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment.

It is emphasized that home exercise programs for neck pain are effective, but exercise adherence is an important factor. Nowadays, with the rapid development of mobile healthcare applications, digital based exercise applications have started to be used in physiotherapy and rehabilitation. Although it has been shown to be useful in studies examining the effectiveness of mHealth applications for different musculoskeletal problems, these studies are quite limited. Several studies have identified the beneficial effects of digital-based exercises, but no clear evidence of superiority over written or oral home exercise programs. In 2019, a mobile exercise application (Neck Exercise) for neck pain patients was developed as a thesis study at Marmara University Health Sciences Institute. The availability of this mobile application is shown on healthy people. However, its efficacy has not been studied in patients with chronic neck pain. This mobile app includes for the neck spinal stabilization , posture, breathing exercises and exercises for scapula circumference. Each exercise is explained with video. In addition, this application gives reminder signals at user-defined time intervals. Participants with chronic neck pain aged between 18-65 years will be included in the study and randomly divided into two groups. One group will be given home exercises via brochure to the other group via mobile application. Participants will be asked to do home exercises 3 days a week for 6 weeks. Pain, disability and exercise adherence of the participants will be evaluated. The Nordic Musculoskeletal Questionnaire, VAS, neck disability index and exercise adherence scale will be used in the evaluation. Our thesis will be the first study examining the effect of a mobile application developed for neck pain on adherence to home exercises. As a result of study, the researchers aim to save paper by prescribing home exercise programs via mobile application and to promote a platform where users can better understand the exercises.

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
Single (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

  • Neck pain that has been going on for at least 3 months
  • Participant can use smart phone,
  • No problem affecting reading and answering survey questions

排除标准

  • Presence of visual and auditory problems that may prevent the use of the smartphone application
  • Torticollis
  • Pregnancy
  • Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
  • Inflammatory rheumatic disease
  • Psychosis and neurological disease diagnosis
  • Receiving another treatment or having surgery in 3 months
  • Exposure to any neck trauma in the past 6 months
  • A past or ongoing cancer history

结局指标

主要结局

Change from Exercise Adherence Scale Points at 6 Weeks

时间窗: Baseline and Week 6

It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence.

Change from Visual Analog Scale (VAS) score at 6 Weeks

时间窗: Baseline and Week 6

VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups.

次要结局

  • Change from Neck Pain and Disability Index Points at 6 Weeks(Baseline and Week 6)

研究者

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

Eda Tonga

Doctor of Philosopy

Marmara University

研究点 (2)

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