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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05999201
Collaborator
(none)
30
2
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: craniocervical neural mobilization
  • Other: selected physiotherapy program
N/A

Detailed Description

The World Health Organization estimates that the three most prevalent neurologic disorders worldwide are tension-type headache (1.5 billion), migraine (958.8 million), and medication overuse headache (58.5 million). Collectively, these three disorders contribute approximately 17% to the global burden of neurologic diseases, with migraine the second most disabling disease overall. TTH (Tension Type of Headache) is defined as mild to moderate band-like pressure headache with few associated symptoms. It varies considerably in frequency and duration, from rare, short-lasting episodes of discomfort to frequent, long-lasting, or even continuous disabling headaches.Physiotherapy treatment based on manual therapy achieved positive outcomes in pain intensity and frequency, disability, impact of headache, quality of life, and craniocervical range of motion in adults with TTH. Although pervious findings showed a clinical improvement, there is no clear evidence that one technique is superior to another.Neurodynamic techniques can improve mechanical functions in nerve structures, such as tension and sliding functions. When the nerve structure experiences clamping and disrupts mobility, pain occurs along the nerve. Neurodynamic sliding techniques play a major role in improving blood circulation and axonal transport, as well as increasing nerve integrity and reducing the pressure caused by intraneural and extraneural fibrosis. thirty patients with tension headache will be allocated randomly into two equal groups. the first one will receive craniocervical mobilization and a selected physiotherapy program and the control group will receive selected physiotherapy program for one month.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Craniocervical Neural Mobilization and selected physiotherapy programCraniocervical Neural Mobilization and selected physiotherapy program
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
opaque sealed envelope
Primary Purpose:
Treatment
Official Title:
Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache
Anticipated Study Start Date :
Aug 20, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: craniocervical neural mobilization

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

Other: craniocervical neural mobilization
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

Other: selected physiotherapy program
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

Active Comparator: selected physiotherapy program

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

Other: selected physiotherapy program
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

Outcome Measures

Primary Outcome Measures

  1. life disability [up to four weeks]

    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).

  2. frequency and severity of headache [up to four weeks]

    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

  3. pain intensity [up to four weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Mohammed Abdul Hamid Elgendy, principle investigator amira mohamed abdul hamid, Cairo University
ClinicalTrials.gov Identifier:
NCT05999201
Other Study ID Numbers:
  • p.t.REC/012/003179
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amira Mohammed Abdul Hamid Elgendy, principle investigator amira mohamed abdul hamid, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023