Telerehabilitation, Face-to-Face Exercises, and a Mixed Model in Chronic Non-Specific Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Functional Disability
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of different physical therapy delivery models in treating chronic non-specific neck pain in adults aged 20-40 years with a history of neck pain for three months or longer.
The main questions it aims to answer are:
- Which approach (tele-rehabilitation, face-to-face exercises, or a mixed model) is most effective at reducing neck pain intensity and functional disability?
- Are there significant differences between the three models in improving cervical range of motion, kinesiophobia (fear of movement), patient satisfaction, and adherence to the exercise program?
Researchers will compare three groups to see if the delivery model affects outcomes:
- A tele-rehabilitation group receiving real-time, video-guided exercise sessions.
- A face-to-face group receiving traditional, in-person supervised exercise sessions.
- A mixed-model group receiving a combination of both tele-rehabilitation and face-to-face sessions.
Participants will:
- Be randomly assigned to one of the three groups.
- Engage in a structured exercise program for 45-60 minutes per session, three times a week for six weeks.
- Follow a phased exercise protocol that begins with mobility and pain reduction, progresses to strengthening, and finishes with endurance and functional training.
- Complete assessments for pain, disability, range of motion, and other outcomes at the beginning and end of the 6-week intervention, with a final follow-up at 3 months.
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
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the study if they fulfil the following criteria:
- •Adults (20-40 years) with chronic non-specific neck pain (≥3 months' duration).
- •Participants with stable internet, and experienced in using either computer, laptop, tablet, or smartphone.
排除标准
- •Patients will be excluded if they had:
- •Neck pain due to specific pathologies (e.g., fractures, infections, or malignancies) and severe neurological deficits.
- •History of neck surgery.
- •Participants with cognitive impairments or language barriers that would prevent them from following the interventions.
研究组 & 干预措施
Real-time Video-Guided Neck Exercises (Tele-rehabilitation)
Participants in this arm receive real-time, synchronous tele-rehabilitation sessions delivered via Microsoft Teams video conferencing platform. A licensed physiotherapist provides live supervision, real-time feedback, and technique correction throughout each session. This arm tests the effectiveness of remote delivery of structured neck exercises with synchronous clinician guidance.
干预措施: Real-Time Video-Guided Neck Exercises (Tele-Rehabilitation) (Other)
In-Person Supervised Neck Exercises (Face-to-Face)
Participants in this arm receive traditional, in-person supervised exercise sessions at a clinical facility. A licensed physiotherapist provides hands-on guidance, manual corrections, and real-time feedback during each session. This arm serves as the standard care comparison and tests the effectiveness of conventional face-to-face delivery.
干预措施: In-Person Supervised Neck Exercises (Face-to-Face) (Other)
Hybrid Tele-rehabilitation and In-Person Exercises (Mixed Model)
Participants in this arm receive a novel 50/50 hybrid intervention combining equal proportions of tele-rehabilitation and face-to-face sessions delivered in alternating weekly blocks. Weeks with odd numbers (1, 3, 5) consist of three in-person face-to-face sessions, while weeks with even numbers (2, 4, 6) consist of three tele-rehabilitation sessions. This arm tests whether a hybrid approach optimizes accessibility, adherence, and clinical outcomes by combining the convenience of remote delivery with the benefits of in-person supervision.
干预措施: Hybrid Tele-Rehabilitation and In-Person Exercises (Mixed Model) (Other)
结局指标
主要结局
Functional Disability
时间窗: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention)
The Neck Disability Index is the most widely used and validated instrument for assessing the impact of neck pain on patients' functional activities and disability. The NDI-AR consists of 10 items covering functional domains: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (complete disability), with a maximum total score of 50.
Neck Pain Intensity
时间窗: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention
The Visual Analogue scale is a self-reported, unidimensional measure of pain intensity. Participants mark their current pain level on a 10-centimeter line, where 0 represents "no pain" and 10 represents "worst pain imaginable.
Range of motion
时间窗: • Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention.
The CROM device is a non-invasive, objective measurement tool designed specifically for assessing cervical spine mobility. The device measures cervical motion in six planes: flexion, extension, right lateral flexion, left lateral flexion, right rotation, and left rotation. Measurements are recorded in degrees.
次要结局
- Kinesiophobia(• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session) • 3 months post-treatment (Month 3, 12 weeks after completion of intervention))
- Patient Satisfaction(• Baseline (Week 0, before intervention begins) • Within 1 week post-treatment (Week 6, immediately after final intervention session))
- Adherence to Treatment(• Throughout the 6-week intervention period (Weeks 1-6, continuous tracking at each session) • Final adherence rate calculated within 1 week post-treatment (Week 6, at completion of intervention))
研究者
Amr Ahmad Fallatah
Dr. Amr
Cairo University