Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache

NCT05999201 | Unknown

• 1 other identifier: p.t.REC/012/003179
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study will be conducted to investigate the effect of craniocervical neural mobilization on quality of life in patients with primary tension headache.

Conditions

Tension-Type Headache

Keywords

craniocervical neural mobilization; quality of life; primary tension headache

Outcome Measures

Primary Outcomes (3)

• life disability

  Headache Impact Test-6 scale will be used to assess life disability.It is a six-item, self-report, retrospective questionnaire. The six items in the HIT-6 address such aspects of quality of life as pain, social functioning, cognitive functioning, and psychological distress.The HIT-6 is scored by giving these responses a value of 6, 8, 10, 11, and 13, respectively. The four headache impact severity categories are little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).

  up to four weeks

• frequency and severity of headache

  headache disability index will be used to assess the frequency and severity of headache. The questionnaire begins with two items that assess pain severity (mild, moderate, and severe) and frequency (once month, from 1 to 4 times a month, and more than once a week). It also includes 25 question on functional sub-scale (12 items) and emotional subscale (13 items) with three possible response option (No=0 points; Sometimes=2 points; Yes=4 points). The maximum score is 100 points, ranging from 0=no disability to 100=severe disability. A total score of 10-28 is considered o indicate mild disability; 30-48 is moderate disability; 50-68 is sever disability; 72 or more is complete disability

  up to four weeks

• pain intensity

  visaul analogue scale will be used to assess pain intensity. Patients will be informed about visual analog scale that has two ends ; 0: no pain; 10: maximum pain.

  up to four weeks

Study Arms (2)

craniocervical neural mobilization

EXPERIMENTAL

the patients will receive craniocervical neural mobilization and a selected physiotherapy program twice a week for four weeks

Other: craniocervical neural mobilization; Other: selected physiotherapy program

selected physiotherapy program

ACTIVE COMPARATOR

the patients will receive a selected physiotherapy program twice a week for four weeks

Other: selected physiotherapy program

Interventions

craniocervical neural mobilization OTHER

the patients will receive The craniocervical neural mobilization in the form of passive craniocervical flexion in which An anterior rotation of the head will be done which stimulates the meninges.To increase mechanical stress in the nervous system, patients will be asked to do a descent and retropulsion of the shoulders while gradually extending both elbows. in addition to Passive lateral cervical sliding and Craniocervical flexion with mouth opening.The neural mobilization should be mild, progressive, and slow. The protocol lasted 15 minutes and also the patients will receive selected physiotherapy program

craniocervical neural mobilization

selected physiotherapy program OTHER

the patients will receive selected physiotherapy program in the form of Suboccibital muscles inhibition suboccipital inhibition technique (SIT), from supine lying position, the therapist will sit at the patient's head head with the elbows rested on the surface of the table. Then, the therapist will place both hands behind the head of the patient with the palms facing upwards, the fingers flexed, and the finger pads positioned on the posterior arch of the atlas to allow the occiput to rest in the palm of the hands. the patients will receive also trigger point release technique in the form of An ischemic compression for sternocleidomastoid muscle, temporal muscle, upper trapezius muscle and splines muscles

craniocervical neural mobilization; selected physiotherapy program

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The type of headache will be primary tension type of headache.
• Age of subjects will range from 25-40 years.
• The duration of headaches swill be one years ago.
• Body mass index from 25 to less than 30.

You may not qualify if:

• Major neurological conditions (e.g. stroke, multiple sclerosis, epilepsy, brain tumor, meningitis, and hypertension).
• Patients with cervical spinal cord injury, recent trauma of head.
• Patients with auditory and visual impairments.
• Smoker and addicted subjects.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator amira mohamed abdul hamid

Model Details: Craniocervical Neural Mobilization and selected physiotherapy program

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: August 20, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08