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临床试验/NCT05244876
NCT05244876已完成不适用

Effect of Back School-based Intervention on Non-specific Neck Pain in Adults.

University of Vigo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Short-Form Health Survey-36

研究概览

简要总结

The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education). In addition, they had an initial session and a session at the end of the of the intervention in which measurements of the different variables were taken (The Visual Analogue Scale; Neck Disability Index; Tampa Scale Of kinesiophobia).These variables will be measured on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region. Therefore, the aim of this study is to investigate the effects of a BS-based intervention on neck pain and functionality as well as kinesiophobia and quality of life in adults. The hypothesis previously hypothesised that this BS-based intervention would have positive effects on pain, functionality, kinesiophobia and quality of life.

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)

盲法说明

The person analysing the data does not know which group he or she belongs to.

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

  • 18-65 years of age.
  • With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).

排除标准

  • Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder.
  • Missing more than two Back School sessions.
  • Not being able to attend the measurement sessions.

结局指标

主要结局

Short-Form Health Survey-36

时间窗: Through study completion, an average of 2 months.

Short-Form Health Survey (SF-36) was used to measure quality of life.The SF-36 explores people's physical and mental health. It consists of 36 items that assessed eight dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores ranged from 0 (worst health status) to 100 (best health status).

Visual Analogue Scale

时间窗: Through study completion, an average of 2 months.

The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score).

Neck Disability Index

时间窗: Through study completion, an average of 2 months.

The NDI can be scored as a raw scorer doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score. The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.

Tampa Scale Of Kinesiophobia.

时间窗: Through study completion, an average of 2 months.

This scale measures kinesiophobia. The total scale score ranges from 11 to 44, where 11 means no kinesiophobia and 44 means severe kinesiophobia.

次要结局

未报告次要终点

研究者

发起方
University of Vigo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo Hernandez-Lucas

Associate professor in health sciences

University of Vigo

研究点 (2)

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