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临床试验/CTRI/2023/11/060198
CTRI/2023/11/060198尚未招募1 期

Integrating physical activity program into the rehabilitation program for patients with chronic neck pain

Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月30日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
(a)pain on NPRS

研究概览

简要总结

Background And Need of Research:Chronic neck pain is a widespread medical condition that contributes significantly to disability globallyfor which the most commonly used form of treatment is based on therapeutic exercise which has had a moderate impact on people with chronic neck pain. However, there is currently little evidence to support physical activity as an effective treatment for neck pain

.

Objective: To investigate the effects of physical activity program in addition to conventional physiotherapy treatment in patients with chronic neck pain.

Methods**:** A single-blinded randomized controlled trial including 20 eligible patients will be conducted after their random allocation to either group 1 receiving conventional treatment or group 2 receiving 20 min of walking on a treadmill along with conventional treatment for 5 days per week for 4 weeks. Outcome measures will include pain, disability, muscle activity, physical activity status, muscle strength, muscle endurance, pain pressure threshold, sleep quality and quality of life at baseline (week 0) and after 4th week.

Conclusion: This study will provide a better understanding of how the addition of physical activity program in addition to neck-specific conventional physiotherapy treatment affects include pain, disability, muscle activity, physical activity status, muscle strength, muscle endurance, pain pressure threshold, sleep quality and quality of life  . Further, it will add knowledge for evidence-based practice and health promotion to physiotherapists in treating chronic neck pain.

Ethical Approval: The study is approved by the Institutional Ethical Committee, Jamia Millia Islamia, New Delhi, India. Ethical standards will be maintained during the study according to the Declaration of Helsinki, 1964.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18–45 years (both males as well as females).
  • 2.Non- radicular Chronic neck pain (> 3 months, < 7 years) (3-6 on NPRS).
  • 3.Subjects should have knowledge of English language.
  • 4.In addition, patients who had led a sedentary lifestyle and reported no leisure time physical activity Did you engage in any physical activity during your free time that caused you to have difficulty breathing for at least two days a week?

排除标准

  • 1.Neck pain associated with vertigo.
  • 3.Diagnosed with any vestibular, cardiopulmonary disorders or any medical and orthopedic condition that contraindicates physical activity program.
  • 4.Red flags (night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch) 5.Patient who underwent physiotherapy treatment in the last 3 months.

结局指标

主要结局

(a)pain on NPRS

时间窗: pre intervention at week(0) and post intervention at week (4)

(b)disability by Neck Disability

时间窗: pre intervention at week(0) and post intervention at week (4)

Index(NDI)

时间窗: pre intervention at week(0) and post intervention at week (4)

(c)Muscle activity by Electromyogram(EMG)

时间窗: pre intervention at week(0) and post intervention at week (4)

(d)Physical qctivity by International Physical Activity Questionairre(IPAQ)

时间窗: pre intervention at week(0) and post intervention at week (4)

次要结局

  • (a)Muscle strength by lafaytte dynamometer.((b)Neck muscle endurance test by Neck flexor and extensor endurance test)

研究者

申办方类型
Other [Central university]
责任方
Principal Investigator
主要研究者

Dr Zubia Veqar

Jamia Millia Islamia

研究点 (1)

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