to Stuidy the Effect of Cognitive Behavior Threapy CBT on Smartphone Addiction Patients With Tension Type Headache

NCT ID: NCT06631222

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-29

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn if cognitive behavioral approach works to treat tension type headache in smartphone addiction in adults. The main questions it aims to answer are:

Is there an effect of adding cognitive behavior approach to physical therapy (manual therapy, corrective exercise therapy) on pain pressure threshold, forward head posture and headache intensity in smartphone addiction patients with tension-type headache? Researchers will compare adding cognitive behavior approach to physical therapy (manual therapy, corrective exercise therapy) to see if cognitive behavior approach works to treat tension type headache in smartphone addiction than physical therapy alone.

Participants will:

All participants will receive twelve treatment sessions (twice per week) in a 6 weeks period with a rest period of 48 to 72 hour between them.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tension Type Headache Smartphone Addiction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises)

Group Type ACTIVE_COMPARATOR

sub-occipital inhibitory pressure

Intervention Type OTHER

The suboccipital musculature will be palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure was applied, pushing the atlas anteriorly. The occiput will be rested on the hands of the therapist while the atlas is supported by the fingertips. Finger pressure will be maintained for 10 minutes to produce the proposed therapeutic effect of inhibiting the suboccipital soft tissues.

deep friction massage

Intervention Type OTHER

Friction massage is performed with the fingertips placed on the trigger points. Pressure was applied and the fingertips move in a circular manner, while the pressure is gradually increased. This massage will be applied until the patient report a reduction in pain at the trigger point

Spinal manipulation

Intervention Type OTHER

This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateral flexion will be used. Application will be bilateral. First, cephalic decompression will be performed lightly, followed by small circumductions. Selective tension will be applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique will be applied with the aim of increasing occiput, atlas, and axis joint mobility.

Exercises for forward head posture

Intervention Type OTHER

Scapular stabilization exercises:

1. In quadruped position, the patient lift¬ up his arms alternatively with shoulder abduction and 120 ° flexion.
2. In sitting position, with 90° knee flexion on a stool or bed without backrest, patient hold a pair of dumb¬bells (2 kg) in each hand and lift them up laterally while maintaining scapulae's height below 80°. The patient was instructed to hold each stage for 10 seconds and then re-turn to the starting position and three sets of 10 repetitions with 30-second pause in between were completed.
3. As for the progression of scapular stability exercise, T to Y the patient was instructed to lie in prone lying position on Swiss ball with arms abducted to 90° (the letter T); then she asked to flex elbows to 90°, retract scapulae and externally ro¬tate arms while keeping arm in 90° abductions. While maintaining the retraction of scapula, the patient is asked to raise his arms above head and extend the elbow while his arm flexed and abducted to 120°

experimental group

the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache.

Group Type EXPERIMENTAL

cognitive behavioral therapy

Intervention Type BEHAVIORAL

The therapeutic patient education (TPE) program was based on a biobehavioral approach and was divided into the following three parts: cognitive, operant, and respondent. The purpose of the TPE program was to modify erroneous beliefs about pain and disability, as well as to provide coping strategies and improve patient self-efficacy through a graded activity.

sub-occipital inhibitory pressure

Intervention Type OTHER

The suboccipital musculature will be palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure was applied, pushing the atlas anteriorly. The occiput will be rested on the hands of the therapist while the atlas is supported by the fingertips. Finger pressure will be maintained for 10 minutes to produce the proposed therapeutic effect of inhibiting the suboccipital soft tissues.

deep friction massage

Intervention Type OTHER

Friction massage is performed with the fingertips placed on the trigger points. Pressure was applied and the fingertips move in a circular manner, while the pressure is gradually increased. This massage will be applied until the patient report a reduction in pain at the trigger point

Spinal manipulation

Intervention Type OTHER

This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateral flexion will be used. Application will be bilateral. First, cephalic decompression will be performed lightly, followed by small circumductions. Selective tension will be applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique will be applied with the aim of increasing occiput, atlas, and axis joint mobility.

Exercises for forward head posture

Intervention Type OTHER

Scapular stabilization exercises:

1. In quadruped position, the patient lift¬ up his arms alternatively with shoulder abduction and 120 ° flexion.
2. In sitting position, with 90° knee flexion on a stool or bed without backrest, patient hold a pair of dumb¬bells (2 kg) in each hand and lift them up laterally while maintaining scapulae's height below 80°. The patient was instructed to hold each stage for 10 seconds and then re-turn to the starting position and three sets of 10 repetitions with 30-second pause in between were completed.
3. As for the progression of scapular stability exercise, T to Y the patient was instructed to lie in prone lying position on Swiss ball with arms abducted to 90° (the letter T); then she asked to flex elbows to 90°, retract scapulae and externally ro¬tate arms while keeping arm in 90° abductions. While maintaining the retraction of scapula, the patient is asked to raise his arms above head and extend the elbow while his arm flexed and abducted to 120°

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive behavioral therapy

The therapeutic patient education (TPE) program was based on a biobehavioral approach and was divided into the following three parts: cognitive, operant, and respondent. The purpose of the TPE program was to modify erroneous beliefs about pain and disability, as well as to provide coping strategies and improve patient self-efficacy through a graded activity.

Intervention Type BEHAVIORAL

sub-occipital inhibitory pressure

The suboccipital musculature will be palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure was applied, pushing the atlas anteriorly. The occiput will be rested on the hands of the therapist while the atlas is supported by the fingertips. Finger pressure will be maintained for 10 minutes to produce the proposed therapeutic effect of inhibiting the suboccipital soft tissues.

Intervention Type OTHER

deep friction massage

Friction massage is performed with the fingertips placed on the trigger points. Pressure was applied and the fingertips move in a circular manner, while the pressure is gradually increased. This massage will be applied until the patient report a reduction in pain at the trigger point

Intervention Type OTHER

Spinal manipulation

This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateral flexion will be used. Application will be bilateral. First, cephalic decompression will be performed lightly, followed by small circumductions. Selective tension will be applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique will be applied with the aim of increasing occiput, atlas, and axis joint mobility.

Intervention Type OTHER

Exercises for forward head posture

Scapular stabilization exercises:

1. In quadruped position, the patient lift¬ up his arms alternatively with shoulder abduction and 120 ° flexion.
2. In sitting position, with 90° knee flexion on a stool or bed without backrest, patient hold a pair of dumb¬bells (2 kg) in each hand and lift them up laterally while maintaining scapulae's height below 80°. The patient was instructed to hold each stage for 10 seconds and then re-turn to the starting position and three sets of 10 repetitions with 30-second pause in between were completed.
3. As for the progression of scapular stability exercise, T to Y the patient was instructed to lie in prone lying position on Swiss ball with arms abducted to 90° (the letter T); then she asked to flex elbows to 90°, retract scapulae and externally ro¬tate arms while keeping arm in 90° abductions. While maintaining the retraction of scapula, the patient is asked to raise his arms above head and extend the elbow while his arm flexed and abducted to 120°

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects were those diagnosed with tension type headache by neurologists based on the criteria of the International Headache Society.
* age between 19-34.
* International Headache Society diagnostic criteria of tension type headaches:
* Frequent ETTH or CTTH diagnosed, in both cases more than three months.
* Episodes of pain from 30 minutes to 7 days Fulfil 2 or more of the following characteristics:
* Bilateral location of pain.
* Non-pulsatile pain pressure.
* Pain mild to moderate.
* The headache does not increase with physical activity.
* The headache may be associated with pericranial tenderness.
* Controlled pharmacologically.
* Myofascial TrPs were bilaterally explored in upper trapezius, splenius capitis, sternocleidomastoid, masseter, superior oblique, levator scapulae and suboccipital muscles, TrP diagnosis was conducted following the diagnostic criteria:
* presence of a palpable taut band within a skeletal muscle.
* presence of a hypersensitive tender spot in the taut band.
* local twitch response elicited by snapping palpation of the taut band reproduction of the typical referred pain pattern of the TrP in response to compression.
* TrPs were considered active if both the local and the referred pain evoked by manual palpation reproduced total or partial pattern of the headache.
* Patients with FHP who have craniovertebral angle less than 49 degrees were included. Forward head posture is measured by calculating the angle between the horizontal line passing through C7 and a line extending from the tragus of the ear to C7.
* patients with smartphone addiction who will score 31 for males and 33 for females on smartphone addiction scale - short version.

Exclusion Criteria

* rheumatoid arthritis.
* suspected malignancy.
* pregnancy.
* if they had received manual therapy treatment in the 2 months before enrolment into the study.
* Patients with infrequent episodic tension type headache, or with probable frequent and infrequent forms of tension type headache or other concomitant headache.
* They can never have vomiting or headache episodes during the treatment.
* Episodic tension type headache patients may experience very occasionally photophobia or phonophobia during their episodes of headache.
* Chronic tension type headache patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes.
* Pain aggravated by movement of the head.
* Metabolic or musculoskeletal problems with similar headache symptoms.
* Previous trauma to the cervical spine.
* Active vertigo history.
* Poorly controlled hypertension.
* Atherosclerosis.
* Advanced osteoarthritis.
* Patients undergoing pharmacological adaptation or changes in the prophylactic medication.
* Excessive emotional stress.
* Patients with heart devices.
* Joint instability.
* Neurological disorders.
* Laxity of cervical soft tissues.
* Radiographic abnormalities.
* Generalized hyperlaxity or hypermobility.
Minimum Eligible Age

19 Years

Maximum Eligible Age

34 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hatem Mostafa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hatem Mostafa

assistant lecturer of physical therapy

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the British University in Egypt

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

abeer abdelrahman, professor

Role: CONTACT

002001006899872

mary naseef, assistant professor

Role: CONTACT

002001222817512

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hatem Mostafa, lecturer assistant

Role: primary

00248810965 ext. 3018

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P.T.REC/120/005099

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.