Clinical trial NCT06631222: This Study Will Be Conducted to Stuidy the Effect of Cognitive Behavior Threapy CBT on Smartphone Addiction Patients with Tension Type Headache
Official title: EFFECT of COGNITIVE BEHAVIOR APPROACH on SUBJECTS with SMARTPHONE ADDICTION
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tension Type Headache
Smartphone Addiction
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

- 1- Subjects were those diagnosed with tension type headache by neurologists based on the criteria of the International Headache Society (2013).

2- age between 19-34 (Csibi, S., et al, 2021). 3- International Headache Society diagnostic criteria of tension type headaches: (Espí-López et al, 2016).

* 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:

  1. Bilateral location of pain.
  2. Non-pulsatile pain pressure.
  3. Pain mild to moderate.
  4. The headache does not increase with physical activity.
  5. The headache may be associated with pericranial tenderness.
  6. Controlled pharmacologically. 4- 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: (Shah, J. P., et al 2015).

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  1. presence of a palpable taut band within a skeletal muscle.
  2. presence of a hypersensitive tender spot in the taut band.
  3. 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 (Shah, J. P., et al 2015).

     5- Patients with FHP who have craniovertebral angle less than 49 degrees were included (Abhilash, P., et al, 2021). 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.

     6- patients with smartphone addiction who will score 31 for males and 33 for females on smartphone addiction scale - short version (Kwon, M., et al, 2013).

     Exclusion Criteria:
     * 1. rheumatoid arthritis. 2. suspected malignancy. 3. pregnancy. 4. if they had received manual therapy treatment in the 2 months before enrolment into the study.

       5. Patients with infrequent episodic tension type headache, or with probable frequent and infrequent forms of tension type headache or other concomitant headache.

       6. They can never have vomiting or headache episodes during the treatment. 7. Episodic tension type headache patients may experience very occasionally photophobia or phonophobia during their episodes of headache.

       8. Chronic tension type headache patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes.

       9. Pain aggravated by movement of the head. 10. Metabolic or musculoskeletal problems with similar headache symptoms. 11. Previous trauma to the cervical spine. 12. Active vertigo history. 13. Poorly controlled hypertension. 14. Atherosclerosis. 15. Advanced osteoarthritis. 16. Patients undergoing pharmacological adaptation or changes in the prophylactic medication.

       17. Excessive emotional stress. 18. Patients with heart devices. 19. Joint instability. 20. Neurological disorders. 21. Laxity of cervical soft tissues. 22. Radiographic abnormalities. 23. Generalized hyperlaxity or hypermobility.

Primary outcomes:
measure: pressure algometer
timeFrame: from enrollment to nthe end of treatment at 6 weeks
Secondary outcomes:
measure: measurement of forward head posture
timeFrame: from enrollment to nthe end of treatment at 6 weeks
measure: Headache impact test (HIT-6):
timeFrame: from enrollment to nthe end of treatment at 6 weeks
measure: The smartphone addiction scale short version (SAS- SV):
timeFrame: from enrollment to nthe end of treatment at 6 weeks
Other outcomes:
Locations:
Study officials:
References: