Tension Type HeadacheNCT06631222
to Stuidy the Effect of Cognitive Behavior Threapy CBT on Problematic Smartphone Use Patients With Tension Type Headache
A study testing cognitive behavioral therapy, sub-occipital inhibitory pressure and deep friction massage in people with Tension Type Headache and Smartphone Addiction, run by Hatem Mostafa at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 34 years
- Conditions the study is for
- Tension Type Headache, Smartphone Addiction
- What is being tested?
- cognitive behavioral therapy, sub-occipital inhibitory pressure and deep friction massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2025to 1 Jan 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 19 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 18Show fewer
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cognitive Behaviour Approach on Subjects With Problematic Smartphone Use
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.
Read more
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.
- Conditions
- Tension Type Headache, Smartphone Addiction
- Being tested
- cognitive behavioral therapy, sub-occipital inhibitory pressure, deep friction massage, Spinal manipulation, Exercises for forward head posture
- Medical subject headings
- Tension-Type Headache, Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
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 pressureOther
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 massageOther
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 manipulationOther
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 postureOther
Scapular stabilization exercises:
- In quadruped position, the patient lift¬ up his arms alternatively with shoulder abduction and 120 ° flexion.
- 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.
- 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°
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | the participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises) Receives: Other: sub-occipital inhibitory pressure; Other: deep friction massage; Other: Spinal manipulation; Other: Exercises for forward head posture |
| experimental group | Experimental | the participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache. Receives: Behavioral: cognitive behavioral therapy; Other: sub-occipital inhibitory pressure; Other: deep friction massage; Other: Spinal manipulation; Other: Exercises for forward head posture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The smartphone addiction scale short version
This scale is a short version that contains only 10 questions for easy smartphone addiction screening of adolescents who are considered vulnerable to addiction. This scale also provides a cut-off value to evaluate the level of addiction, to evaluate the treatment effect and to provide evidence of interventions different from those in the conventional scales. This scale has a high value as a screening tool because gender differences can be reflected in the results by providing a cut-off value for both genders, and the screening process that includes the evaluation by clinical psychologists is not merely the simple percentage calculation method but reflects the characteristics of the participants. The cut-off value for boys is 31, Meanwhile, the cut-off value, for girls is 33
Measured: from enrollment to nthe end of treatment at 6 weeks
Secondary outcomes (3)
measurement of forward head posture
participants will be imaged at a distance of 1.5m from their sitting position, and the participant's shoulder and the camera height were placed at the same level. The CVA will be measured using a horizontal line passing through the C7 spinous process and a line connecting C7 to the tragus of the ear.
Measured: from enrollment to nthe end of treatment at 6 weeks
pressure algometer
this device is used to describe the sensitivity of the trigger points found in cervical region
Measured: from enrollment to nthe end of treatment at 6 weeks
Headache impact test
A popular patient-reported outcome measure for evaluating the detrimental effects of headaches on a patient's normal activity is the shortform Headache Impact Test. It was created before the FDA's now-accepted patient-reported guidance was established, utilizing the general headache population. HIT-6 was created for usage in a broad headache population and comprises of 6 elements. It gauges the frequency of recent headaches that were unbearably painful, interfered with everyday activities, made you want to lie down, or left you grouchy, exhausted, or unable to concentrate. higher values mean worse outcome while, lowered values menas better outcome
Measured: from enrollment to nthe end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start29 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension Type 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatem Mostafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem Mostafa, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631222
- Sponsor's protocol ID
- P.T.REC/120/005099
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Behaviour Approach on Subjects With Problematic Smartphone Use
- ClinicalTrials.gov ID
- NCT06631222
- Acronym / sponsor ID
- P.T.REC/120/005099
- Conditions
- Tension Type Headache, Smartphone Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hatem MostafaUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 8 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: sub-occipital inhibitory pressure, Other: deep friction massage, Other: Spinal manipulation, Other: Exercises for forward head posturethe participants will receive a conventional standard physical therapy program (sub-occipital inhibitory pressure, Spinal manipulation, deep friction massage and corrective exercises) |
| experimental group | Experimental | Behavioral: cognitive behavioral therapy, Other: sub-occipital inhibitory pressure, Other: deep friction massage, Other: Spinal manipulation, Other: Exercises for forward head posturethe participants will be treated with behavior change model in addition to a conventional standard physical therapy program for tension-type headache. |
Who may qualify
- Ages
- 19 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| cognitive behavioral therapyThe 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. | Behavioural | experimental group |
| sub-occipital inhibitory pressureThe 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. | Other | control group, experimental group |
| deep friction massageFriction 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 | Other | control group, experimental group |
| Spinal manipulationThis 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. | Other | control group, experimental group |
| Exercises for forward head postureScapular 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° | Other | control group, experimental group |
Primary outcome
The smartphone addiction scale short version
Time frame: from enrollment to nthe end of treatment at 6 weeks
This scale is a short version that contains only 10 questions for easy smartphone addiction screening of adolescents who are considered vulnerable to addiction. This scale also provides a cut-off value to evaluate the level of addiction, to evaluate the treatment effect and to provide evidence of interventions different from those in the conventional scales. This scale has a high value as a screening tool because gender differences can be reflected in the results by providing a cut-off value for both genders, and the screening process that includes the evaluation by clinical psychologists is not merely the simple percentage calculation method but reflects the characteristics of the participants. The cut-off value for boys is 31, Meanwhile, the cut-off value, for girls is 33
3 secondary outcomes
measurement of forward head posture
Time frame: from enrollment to nthe end of treatment at 6 weeks
pressure algometer
Time frame: from enrollment to nthe end of treatment at 6 weeks
Headache impact test
Time frame: from enrollment to nthe end of treatment at 6 weeks
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 16 Sep 2026.
Related trials for Tension Type Headache
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 4
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Frequent Episodic Tension-Type Headache
Not yet recruitingObservational study
Prevalence of Primary Headache in Multiple Sclerosis Patients
Multiple Sclerosis, Primary Headache Disorders
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
Recruiting
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
Acute Headache, Migraine
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy, sub-occipital inhibitory pressure and deep friction massage in people with Tension Type Headache and Smartphone Addiction, run by Hatem Mostafa at 1 site in Egypt.
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 18 inclusion and 23 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 16 Sep 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 Egypt. 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?
The smartphone addiction scale short version (time frame: from enrollment to nthe end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.