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临床试验/NCT07354776
NCT07354776已完成不适用

A Randomized Controlled Trial Evaluating the Effects of Isometric Neck Exercises and Postural Advice on Cervicogenic Headache Symptoms , Serum Cortisol, and Brain-Derived Neurotrophic Factor Levels in Adolescents With Smartphone Addiction

Khyber Medical University Peshawar1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Change in Neck Disability Index (NDI) Score

研究概览

简要总结

Cervicogenic headache (CGH) is a secondary headache type caused due to refereed pain arising from the cervical spine in the forehead, sometimes in temporal region. Which may have great impact on our daily life activities; decreased range of motion at cervical spine, decreased sleep quality, increased stress, disturbed mood and altered physiologic chemicals. It is found to be more prevalent in females and is experimentally diagnosed by the Cervical Flexion-Rotation Test (CFRT) which is performed by a therapist. Also, the upper trapezius midpoint (2 cm lateral to C2) mostly acts as a pressure point. Other pressure points in cervical region may also develop. The pain is mostly on one side and remains on one side. It can be dull aching or pressure like pain. No photophobia, phonophobia, nausea, or tearing of eyes is associated with it.

In the modern age, smartphone addiction (SPA) contributes significantly to CGH by promoting forward head posture, rounded shoulders, and impaired proprioception. (4)Despite this, there is a clear gap in the literature regarding body awareness, ergonomics, and targeted prevention strategies for smartphone-related postural problems. There is an urgent need for structured training programs and therapeutic interventions to address these concerns, combined with long-term follow-up studies.

In this study, investigators focus on brain-derived neurotrophic factor (BDNF) as a key biomarker of pain sensitization. Chronic stress and pain reduce neuronal BDNF uptake, decreasing the serum BDNF levels, while effective interventions are expected to elevate BDNF levels, improving motor performance and reducing nociceptive signaling. Literature shows that there is a significant increase in BDNF levels in moderate intensity aerobic exercise groups as compared to the control group. This study aims to improve BDNF levels through isometric targeted exercise and ultimately improve the synaptic plasticity, mitochondrial activity, increased beta-endorphins. An increase in body temperature through exercise will also reduce pain sensitization and improve function.

In this study, we also target stress levels by focusing on cortisol as a biomarker. As the physiological and psychological stress is increased due to prolonged flexion and increased screen tim,e sleep quality is also disturbed. We aim to evaluate whether targeted isometric neck exercises can enhance BDNF levels, regulate cortisol as a stress marker, and ultimately improve CGH symptoms. As we know that high stress elevates cortisol and disrupts the HPA axis, This study was having hypothesis that exercise-induced adaptations will downregulate the HPA axis, decrease cortisol, restore neuronal health, and enhance cognitive and motor functions and we also address how poor sleep, exacerbated by excessive screen time, contributes to cognitive, memory, and metabolic issues. By investigating the effects of exercise on sleep quality, our study fills a crucial research gap linking SPA, stress, BDNF, cortisol, and CGH offering a novel therapeutic approach that combines patient education, circadian rhythm alignment, and structured isometric exercise to improve health outcomes in adolescents.

详细描述

Smartphone addiction (SPA) increasingly contributes to cervicogenic headaches (CGH) and alters stress biomarkers (cortisol, BDNF) in adolescents. This study aims to evaluate isometric neck exercises' impact on CGH symptoms, cortisol, and BDNF levels in SPA-affected adolescents. It will be a single-blind randomized controlled trial (RCT). This study had a sample size of 44, based on a medium effect size of 0.9 with 80% power. Which include adolescents (13 to 24 years) with SPA and CGH.

Intervention: One month of supervised/home-based isometric neck exercises (n=24) versus control (n=24).

Outcomes: Primary: Changes in NDI, HIT-6. Secondary: Changes in cortisol, BDNF, PSQI from baseline to 1-month.

This RCT will assess if isometric exercises reduce CGH symptoms and modulate key biomarkers such as BDNF informing interventions for SPA-related health issues.

The primary outcome for this study was the reduction in Cervicogenic Headache (CGH) symptom burden and associated pain sensitization processes involved in causing CGH. This outcome will be quantified by measuring the change from baseline to 1-month post-intervention using three distinct measures:

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 (Participant)

盲法说明

The coin flip for randomization is done by a researcher after a participant meets eligibility criteria and gives consent, ensuring group assignment happens at randomization. This method, though not using a pre-determined concealed sequence, reduces bias by preventing prediction of group assignment before eligibility is confirmed. Participants will be masked to group allocation. They will not be informed whether they are receiving only posture advice or posture advice combined with isometric neck exercises.

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 1 to 24 years.
  • Smartphone addiction, defined as using a smartphone for ≥4 hours per day.
  • A confirmed diagnosis of Cervicogenic Headache (CGH), as determined by a positive Cervical Flexion-Rotation Test (CFRT) performed by a physical therapist.

排除标准

  • Diagnosis of other primary headache disorders (e.g., migraine, tension-type headache, cluster headache) or sinusitis.
  • Presence of fever, cranial tumors, meningitis, or subarachnoid hemorrhage.
  • Known carotid or vertebral artery dysfunction.
  • Significant use of other screened devices (e.g., tablets, laptops) that would confound the primary exposure.
  • History of prior neck injuries or cervical fractures.
  • Any medical condition that renders the individual unfit to participate in a moderate exercise program.
  • Presence of photophobia or phonophobia.
  • Current drug addiction.
  • Extreme, uncorrectable vision issues (Snellen chart score worse than 20/200 in either eye).

研究组 & 干预措施

Intervention Arm

Experimental

Participants receive a one-month supervised and home-based isometric neck exercise program combined with posture advice.

干预措施: Isometric Neck Exercise Program (Behavioral)

Control Arm

Active Comparator

Participants receive posture advice only, with no exercise intervention.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Change in Neck Disability Index (NDI) Score

时间窗: Change from Baseline to 1-month post-intervention

The Neck Disability Index (NDI) is a 10-item questionnaire assessing perceived functional disability related to neck issues. The change in total score will be used to measure the impact of the intervention on neck-related function in adolescents with cervicogenic headache.

Change in Headache Impact Test (HIT-6) Score

时间窗: Change from Baseline to 1-month post-intervention.

The Headache Impact Test (HIT-6) is a 6-item questionnaire evaluating the impact of headaches on daily function and quality of life. The change in total score will be used to measure the reduction in headache burden.

Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Level

时间窗: Change from Baseline to 1-month post-intervention.

Serum BDNF levels, determined via ELISA analysis, will be used as a biomarker potentially reflecting changes in neuronal plasticity associated with pain sensitization in cervicogenic headache.

次要结局

  • Change in Serum Cortisol Level(Change from Baseline to 1-month post-intervention.)
  • Change in Pittsburgh Sleep Quality Index (PSQI) Score(Change from Baseline to 1-month post-intervention.)

研究者

发起方
Khyber Medical University Peshawar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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