Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- visual analog scale (VAS)
研究概览
简要总结
This study aimed to compare the efficacy of online exercise therapy with conventional exercise therapy on pain, function, psychological status and work efficiency of young adults with chronic neck pain. A randomized clinical trial recruiting 39 university students with self-reported chronic neck pain was conducted. Participants were randomly assigned into the experimental group receiving online exercise therapy and the active control group receiving conventional exercise therapy. Participants in both groups completed the same exercise program 3 sessions per week for 6 weeks, with either face-to-face or online mode of delivery by physiotherapists. The pain level was assessed using visual analogue scale (VAS) based on average and at maximum intensity. Neck function and work limitations were assessed by the Neck Disability Index (NDI) and Work Limitations Questionnaire (WLQ) respectively. The Hospital Anxiety and Depression Scale (HADS) and its subscales (HADS-A and HADS-D) were used to evaluate the overall symptoms, levels of anxiety and depression respectively. Participants were assessed at baseline and at 6 weeks while the changes in WLQ were assessed biweekly.
It is hypothesized that, young adults with chronic neck pain, both the online and conventional exercise interventions could improve their pain level, neck disability, anxiety state and work efficiency, and the online exercise intervention appeared feasible as an alternative treatment option for them.
详细描述
Study Title： Effects of Online Exercise Intervention on Physical and Mental Conditions in Young Adults with Chronic Neck Pain Study Population： The target participants were adults with self-reported non-specific neck pain for more than three months. They were recruited through posters and social media in the campus of the Beijing Sport University.
Study Design： The present study was an assessor blinded randomized controlled trial conducted according to the Declaration of Helsinki (World Medical Association, 2013). The Institutional Review Board of the Beijing Sport University approved the study (reference number: 2023006H). A randomized clinical trial recruiting 39 university students with self-reported chronic neck pain was conducted. Participants were randomly assigned into the experimental group receiving online exercise therapy and the active control group receiving conventional exercise therapy. Participants in both groups completed the same exercise program 3 sessions per week for 6 weeks, with either face-to-face or online mode of delivery by physiotherapists.
Sample Size Assessment： The sample size for the study was calculated to be 32 using the G*Power 3.1.9.2 (University Kiel, Germany), with an estimated effect size of group difference of 0.9 in primary outcomes and a level of significance of 0.05, statistical power of 80% with 2-tailed independent sample t test. With an anticipated dropout rate of 15%, a total of 39 participants was required.
Study Duration： Totally 8 weeks, including 1-week baseline testing, 6-week intervention and 1-week post intervention testing.
Study Intervention Description： Participants in both groups completed the same exercise program three times a week for six weeks with either face-to-face or online mode of delivery by physiotherapists.
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
This experiment was performed as a single-blind experiment. The outcomes assessors are specialized personnel who do not participate in the trial intervention process and are not clear about the grouping of participants situation and the intervention situation. Outcome statistics were also performed by dedicated data analysts.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults between 18 and 50 years of age with neck pain (from occiput to 7th cervical vertebra) for at least 3 months
- •a score of >= 4/50 on the Neck Disability Index.
排除标准
- •adults with a history of previous neck surgery, cervical radiculopathy, acute neck injury or fracture
- •persons who had more than two hours of moderate intensity exercise or more than four hours of low intensity exercise in a week
- •persons who had received any form of physiotherapy treatment in the last 6 months.
结局指标
主要结局
visual analog scale (VAS)
时间窗: measured at baseline prior to randomization and after the 6-week intervention period
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. In this study, the VAS is used to measure the average and maximum neck pain level. The outcome is measured with 100-mm visual analog scale (VAS), in which 0 indicating no pain and 10.0 indicating unbearable pain.
Neck Disability Index (NDI)
时间窗: measured at baseline prior to randomization and after the 6-week intervention period
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. The NDI consists of 10 items related to pain intensity, headache, concentration and different physical activities. The score of each item ranges from 0 to 5. The maximum total score is 50 and the final score will be standardized into 0 to 100. The higher the score of the NDI, the more severe the neck dysfunction is.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(measured at baseline prior to randomization and after the 6-week intervention period)
- Work Limitations Questionnaire (WLQ)(measured at baseline prior to randomization and after the 2-week, 4-week, 6-week intervention period)
研究者
JINGHUA QIAN
Professor, deputy dean of School of Sports Medicine and Rehabilitation
Beijing Sport University