Cervicogenic HeadacheNCT07354776
Effect of Isometric Neck Exercises on Cervicogenic Headache Symptoms, Cortisol and BDNF Levels Among Smart Phone Users
A study testing Isometric Neck Exercise Program in people with Cervicogenic Headache and Sleep Disturbance, run by Khyber Medical University Peshawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache, Sleep Disturbance, Stress
- What is being tested?
- Isometric Neck Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Presence of photophobia or phonophobia.
- Current drug addiction.
- Extreme, uncorrectable vision issues (Snellen chart score worse than 20/200 in either eye).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of Basic Medical Sciences (IBMS), Khyber Medical University
Peshawar, KPK, 25100
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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:
- The Neck Disability Index (NDI): A questionnaire assessing perceived functional disability related to neck issues.
- The Headache Impact Test (HIT-6): A questionnaire evaluating the impact of headaches on daily function.
- Serum Brain-Derived Neurotrophic Factor (BDNF) levels: Determined via ELISA analysis, utilized as a biomarker potentially reflecting changes in neuronal plasticity associated with pain sensitization.
The secondary outcome will be stress reduction, evaluated via both physiological and subjective indicators linked to stress levels. This will be quantified by measuring the change from baseline to 1-month post-intervention using:
- Serum Cortisol levels: Determined via ELISA analysis, serving as a physiological marker of hypothalamic-pituitary-adrenal (HPA) axis activity.
- The Pittsburgh Sleep Quality Index (PSQI): A questionnaire assessing subjective sleep quality, considered here as an indicator influenced by overall stress. The Intervention Group (n=22) will participate in supervised exercise sessions twice weekly at the IPMR KMU Physiotherapy Department, each lasting 30 minutes and led by a physiotherapist. These sessions will include specific exercises:
TENS (for pain relief): Intensity is typically set to a sensory level, where the patient feels a comfortable tingling or buzzing sensation without muscle contraction. Pulse duration often ranges from 50-100 microseconds, and treatment sessions usually last for 20-30 minutes, performed once or twice daily.
Chin tuck in Gently retract chin backward ("double chin") while sitting or standing tall, keeping eyes forward. Low intensity, focusing on controlled muscle activation. Aims to strengthen deep neck muscles, improve posture, and stretch sub occipital muscles. Repetitions 10 times and hold times 10 sec and then released.
Isometric exercises involve contracting neck muscles against a fixed resistance (like your hand or a wall) in various directions (flexion, extension, lateral flexion, rotation) for 10-second holds. Performed at a moderate intensity for 10 repetitions, lasting about 15 minutes, this strengthening exercise aims to build neck muscle strength and endurance.
Head protrusion in antigravity Lying down with head slightly off the edge, actively lift head to neutral or hold isometrically against gravity for 10 seconds, repeated 5 times at moderate intensity. This exercise strengthens deep neck flexors and improves postural endurance. Wall Push-Ups Standing facing a wall with hands shoulder-width apart, lean in by bending elbows, then push back. Intensity is moderate. Aims to strengthen chest, triceps, and key scapular stabilizers (serratus anterior, rhomboids, trapezius) for better shoulder posture. Reps 10 times Isometric shoulder shrugs by Standing or sitting tall, the individual actively elevates (shrugs) their shoulders straight up towards their ears, then lowers them back down by holding a weight of intensity is mild to moderate hold for 10 sec and repeat 6-10 times Weight-Bearing Shoulder Flexion: In supine position with both hands holding a stick/ weight raise arm forward and upward for 10 repetitions at moderate intensity. This functional exercise strengthens shoulder flexion and improves scapular/core stability under load, promoting integrated movement. Deep neck flexors engage to stabilize the head and neck against the shifting weight and forces during the arm movement.
PNF exercise for deep neck flexors in sitting position tuck chin towards the chest until the participant feels a mild to moderate stretch at the back of neck. The therapist will apply resistance in this position to engage participant deep neck flexors in isometric contraction against the slight resistance for 10 sec then completely relax participant neck muscles. Repeat this isometric contraction and relaxation of deep flexors 6-10 times. Participants will perform the same exercises daily at home for approximately 15 minutes. Patient education on posture and smartphone ergonomics. Adherence will be supported through app reminders and weekly phone check-ins, aiming for over 80% compliance. Where as controlled group will only receive posture advice subjective sleep quality, considered here as an indicator influenced by overall stress.
- Conditions
- Cervicogenic Headache, Sleep Disturbance, Stress
- Being tested
- Isometric Neck Exercise Program, Usual Care
- Keywords
- Exercise Physiology, Stress, Sleep disturbance, Isometric exercises
- Medical subject headings
- Post-Traumatic Headache, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric Neck Exercise ProgramBehavioural
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.
Usual CareBehavioural
Receives only basic posture advice with no structured exercises or ergonomic training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants receive a one-month supervised and home-based isometric neck exercise program combined with posture advice. Receives: Behavioral: Isometric Neck Exercise Program |
| Control Arm | Active comparator | Participants receive posture advice only, with no exercise intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 1-month post-intervention.
Secondary outcomes (2)
Change in Serum Cortisol Level
Serum cortisol levels, determined via ELISA analysis, will serve as a physiological marker of hypothalamic-pituitary-adrenal (HPA) axis activity to evaluate the intervention's effect on physiological stress.
Measured: Change from Baseline to 1-month post-intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire assessing subjective sleep quality over a one-month interval. The change in global score will be used as an indicator influenced by overall stress and pain.
Measured: Change from Baseline to 1-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jun 2025
- Primary completion30 Dec 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- The Institute of Physical Medicine and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Misbah Ali Syed, Principal investigator, Khyber Medical UniversityMohsin Shah, Principal investigator, Khyber Medical University Peshawar, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354776
- Sponsor's protocol ID
- KMU/DIR/CTU/2025/013
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication (thesis and any subsequent journal articles) may be shared with qualified researchers upon reasonable request.
Publications
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
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.
PubMed 19119390Li 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.
PubMed 39164715Blandini 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.
PubMed 16426267Sadeghi 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.
PubMed 35710510
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07354776
- Acronym / sponsor ID
- KMU/DIR/CTU/2025/013
- Conditions
- Cervicogenic Headache, Sleep Disturbance, Stress
- Keywords
- Exercise Physiology, Stress, Sleep disturbance, Isometric exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- The Institute of Physical Medicine and Rehabilitation
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- The Neck Disability Index (NDI): A questionnaire assessing perceived functional disability related to neck issues.
- The Headache Impact Test (HIT-6): A questionnaire evaluating the impact of headaches on daily function.
- Serum Brain-Derived Neurotrophic Factor (BDNF) levels: Determined via ELISA analysis, utilized as a biomarker potentially reflecting changes in neuronal plasticity associated with pain sensitization.
The secondary outcome will be stress reduction, evaluated via both physiological and subjective indicators linked to stress levels. This will be quantified by measuring the change from baseline to 1-month post-intervention using:
- Serum Cortisol levels: Determined via ELISA analysis, serving as a physiological marker of hypothalamic-pituitary-adrenal (HPA) axis activity.
- The Pittsburgh Sleep Quality Index (PSQI): A questionnaire assessing subjective sleep quality, considered here as an indicator influenced by overall stress. The Intervention Group (n=22) will participate in supervised exercise sessions twice weekly at the IPMR KMU Physiotherapy Department, each lasting 30 minutes and led by a physiotherapist. These sessions will include specific exercises:
TENS (for pain relief): Intensity is typically set to a sensory level, where the patient feels a comfortable tingling or buzzing sensation without muscle contraction. Pulse duration often ranges from 50-100 microseconds, and treatment sessions usually last for 20-30 minutes, performed once or twice daily.
Chin tuck in Gently retract chin backward ("double chin") while sitting or standing tall, keeping eyes forward. Low intensity, focusing on controlled muscle activation. Aims to strengthen deep neck muscles, improve posture, and stretch sub occipital muscles. Repetitions 10 times and hold times 10 sec and then released.
Isometric exercises involve contracting neck muscles against a fixed resistance (like your hand or a wall) in various directions (flexion, extension, lateral flexion, rotation) for 10-second holds. Performed at a moderate intensity for 10 repetitions, lasting about 15 minutes, this strengthening exercise aims to build neck muscle strength and endurance.
Head protrusion in antigravity Lying down with head slightly off the edge, actively lift head to neutral or hold isometrically against gravity for 10 seconds, repeated 5 times at moderate intensity. This exercise strengthens deep neck flexors and improves postural endurance. Wall Push-Ups Standing facing a wall with hands shoulder-width apart, lean in by bending elbows, then push back. Intensity is moderate. Aims to strengthen chest, triceps, and key scapular stabilizers (serratus anterior, rhomboids, trapezius) for better shoulder posture. Reps 10 times Isometric shoulder shrugs by Standing or sitting tall, the individual actively elevates (shrugs) their shoulders straight up towards their ears, then lowers them back down by holding a weight of intensity is mild to moderate hold for 10 sec and repeat 6-10 times Weight-Bearing Shoulder Flexion: In supine position with both hands holding a stick/ weight raise arm forward and upward for 10 repetitions at moderate intensity. This functional exercise strengthens shoulder flexion and improves scapular/core stability under load, promoting integrated movement. Deep neck flexors engage to stabilize the head and neck against the shifting weight and forces during the arm movement.
PNF exercise for deep neck flexors in sitting position tuck chin towards the chest until the participant feels a mild to moderate stretch at the back of neck. The therapist will apply resistance in this position to engage participant deep neck flexors in isometric contraction against the slight resistance for 10 sec then completely relax participant neck muscles. Repeat this isometric contraction and relaxation of deep flexors 6-10 times. Participants will perform the same exercises daily at home for approximately 15 minutes. Patient education on posture and smartphone ergonomics. Adherence will be supported through app reminders and weekly phone check-ins, aiming for over 80% compliance. Where as controlled group will only receive posture advice subjective sleep quality, considered here as an indicator influenced by overall stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Isometric Neck Exercise ProgramParticipants receive a one-month supervised and home-based isometric neck exercise program combined with posture advice. |
| Control Arm | Active comparator | Behavioral: Usual CareParticipants receive posture advice only, with no exercise intervention. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric Neck Exercise ProgramOne-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. | Behavioural | Intervention Arm |
| Usual CareReceives only basic posture advice with no structured exercises or ergonomic training. | Behavioural | Control Arm |
Primary outcome
Change in Neck Disability Index (NDI) Score
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in Serum Cortisol Level
Time frame: Change from Baseline to 1-month post-intervention.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Change from Baseline to 1-month post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- BackgroundAabroo 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: PubMed 19119390Hall 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.
- Background: PubMed 39164715Li 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.
- Background: PubMed 16426267Blandini 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.
- Background: PubMed 35710510Sadeghi 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the primary publication (thesis and any subsequent journal articles) may be shared with qualified researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ali Syed principal investigator
Khyber Medical University
Mohsin Shah principal investigator
Khyber Medical University Peshawar, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Neck Exercise Program in people with Cervicogenic Headache and Sleep Disturbance, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck Disability Index (NDI) Score (time frame: Change from Baseline to 1-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354776, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.