NCT06631222

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 29, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

October 5, 2024

Last Update Submit

November 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • pressure algometer

    this device is used to describe the sensitivity of the trigger points found in cervical region

    from enrollment to nthe end of treatment at 6 weeks

Secondary Outcomes (3)

  • measurement of forward head posture

    from enrollment to nthe end of treatment at 6 weeks

  • Headache impact test

    from enrollment to nthe end of treatment at 6 weeks

  • The smartphone addiction scale short version

    from enrollment to nthe end of treatment at 6 weeks

Study Arms (2)

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)

Other: sub-occipital inhibitory pressureOther: deep friction massageOther: Spinal manipulationOther: 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.

Behavioral: cognitive behavioral therapyOther: sub-occipital inhibitory pressureOther: deep friction massageOther: Spinal manipulationOther: Exercises for forward head posture

Interventions

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.

experimental group

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.

control groupexperimental group

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

control groupexperimental group

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.

control groupexperimental group

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°

control groupexperimental group

Eligibility Criteria

Age19 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +3 more criteria

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the British University in Egypt

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Tension-Type HeadacheInternet Addiction Disorder

Interventions

Cognitive Behavioral TherapyManipulation, SpinalExercise

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTechnology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMusculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

abeer abdelrahman, professor

CONTACT

mary naseef, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer of physical therapy

Study Record Dates

First Submitted

October 5, 2024

First Posted

October 8, 2024

Study Start

January 29, 2025

Primary Completion

November 1, 2025

Study Completion

January 1, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations