Effect of Isometric Neck Exercises on Cervicogenic Headache, Cortisol, and BDNF in Adolescents With Smartphone Addiction

NCT07354776 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/013
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervicogenic Headache; Sleep Disturbance; Stress

Keywords

Exercise Physiology; Stress; Sleep disturbance; Isometric exercises

Outcome Measures

Primary Outcomes (3)

• Change in Neck Disability Index (NDI) Score

  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 from Baseline to 1-month post-intervention

• Change in Headache Impact Test (HIT-6) Score

  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 from Baseline to 1-month post-intervention.

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

  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.

  Change from Baseline to 1-month post-intervention.

Secondary Outcomes (2)

• 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.

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Behavioral: Isometric Neck Exercise Program

Control Arm

ACTIVE COMPARATOR

Participants receive posture advice only, with no exercise intervention.

Behavioral: Usual Care

Interventions

Isometric Neck Exercise Program BEHAVIORAL

One-month program of supervised (2x/week, 30 mins) and home-based (daily, 15 mins) exercises. Includes TENS, chin tucks, isometric neck exercises in multiple directions, head protrusion, wall push-ups, shoulder shrugs, weight-bearing shoulder flexion, and PNF for deep neck flexors. Combined with structured patient education on posture and smartphone ergonomics. Adherence supported via app reminders and weekly check-ins.

Intervention Arm

Usual Care BEHAVIORAL

Receives only basic posture advice with no structured exercises or ergonomic training.

Control Arm

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 13 to 19 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• The Institute of Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

Institute of Basic Medical Sciences (IBMS), Khyber Medical University

Peshawar, KPK, 25100, Pakistan

RECRUITING

Related Publications (5)

• Aabroo S, Shafique S, Javed A, Fatima A, Khan O, Riaz S. Frequency of Cervicogenic Headache in Students Due To Usage of Smart Devices - Cross Sectional Survey. Pakistan J Rehabil. 2022;11(2):36-41

  BACKGROUND

• Hall T, Briffa K, Hopper D. Clinical evaluation of cervicogenic headache: a clinical perspective. J Man Manip Ther. 2008;16(2):73-80. doi: 10.1179/106698108790818422.

  PMID: 19119390 BACKGROUND

• Li W, Liu Y, Deng J, Wang T. Influence of aerobic exercise on depression in young people: a meta-analysis. BMC Psychiatry. 2024 Aug 20;24(1):571. doi: 10.1186/s12888-024-06013-6.

  PMID: 39164715 BACKGROUND

• Blandini F, Rinaldi L, Tassorelli C, Sances G, Motta M, Samuele A, Fancellu R, Nappi G, Leon A. Peripheral levels of BDNF and NGF in primary headaches. Cephalalgia. 2006 Feb;26(2):136-42. doi: 10.1111/j.1468-2982.2005.01006.x.

  PMID: 16426267 BACKGROUND

• Sadeghi A, Rostami M, Ameri S, Karimi Moghaddam A, Karimi Moghaddam Z, Zeraatchi A. Effectiveness of isometric exercises on disability and pain of cervical spondylosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Jun 16;14(1):108. doi: 10.1186/s13102-022-00500-7.

  PMID: 35710510 BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache; Parasomnias

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Mental Disorders

Study Officials

• Misbah Ali Syed

  Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Mohsin Shah

  Khyber Medical University Peshawar, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Misbah Ali Syed, Mphil

CONTACT

+92 342 9620074; misbahalisyed.ibms@kmu.edu.pk

Mohsin Shah, PhD

CONTACT

+92 342 9620074; Mohsin.ibms@kmu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an intervention group (receiving isometric neck exercises plus posture advice) or a control group (receiving posture advice only). Both groups will be followed in parallel over a one-month intervention period to assess changes in headache symptoms, stress biomarkers, sleep quality, and functional outcomes.

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available starting 6 months after the publication of the primary thesis findings (expected circa mid-2026). Data will be available for a period of 5 years.
• Access Criteria: Access to data will be granted to qualified researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be directed to the corresponding author (Dr. Mohsin Shah, Mohsin.ibms@kmu.edu.pk). A signed data access agreement will be required. Requestors will bear any associated costs.

Locations

PA (1)