Tension-Type HeadacheTTHNCT05999201
Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache
A study testing craniocervical neural mobilization and selected physiotherapy program in people with Tension-Type Headache, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of craniocervical neural mobilization on quality of life in patients with primary tension headache. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- craniocervical neural mobilization and selected physiotherapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 30 Oct 2023
- 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 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
this study will be conducted to investigate the effect of craniocervical neural mobilization on quality of life in patients with primary tension headache.
Read the 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.
- Conditions
- Tension-Type Headache
- Being tested
- craniocervical neural mobilization, selected physiotherapy program
- Keywords
- craniocervical neural mobilization, quality of life, primary tension headache
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
craniocervical neural mobilizationOther
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
selected physiotherapy programOther
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
| Study group | Role | What they receive |
|---|---|---|
| craniocervical neural mobilization | Experimental | the patients will receive craniocervical neural mobilization and a selected physiotherapy program twice a week for four weeks Receives: 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 Receives: Other: selected physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start20 Aug 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Craniocervical Neural Mobilization and selected physiotherapy program
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdul Hamid Elgendy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999201
- Sponsor's protocol ID
- p.t.REC/012/003179
- Acronym
- TTH
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Craniocervical Neural Mobilization on Quality of Life in Patients With Primary Tension Headache
- ClinicalTrials.gov ID
- NCT05999201
- Acronym / sponsor ID
- TTH / p.t.REC/012/003179
- Conditions
- Tension-Type Headache
- Keywords
- craniocervical neural mobilization, quality of life, primary tension headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 21 Aug 2023 (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.
this study will be conducted to investigate the effect of craniocervical neural mobilization on quality of life in patients with primary tension headache.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Craniocervical Neural Mobilization and selected physiotherapy program
| Arm | Type | Receives |
|---|---|---|
| craniocervical neural mobilization | Experimental | Other: craniocervical neural mobilization, Other: selected physiotherapy programthe patients will receive craniocervical neural mobilization and a selected physiotherapy program twice a week for four weeks |
| selected physiotherapy program | Active comparator | Other: selected physiotherapy programthe patients will receive a selected physiotherapy program twice a week for four weeks |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| craniocervical neural mobilizationthe 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 | craniocervical neural mobilization |
| selected physiotherapy programthe 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 | Other | craniocervical neural mobilization, selected physiotherapy program |
Primary outcome
life disability
Time frame: 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).
frequency and severity of headache
Time frame: 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
pain intensity
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing craniocervical neural mobilization and selected physiotherapy program in people with Tension-Type Headache, run by Cairo University.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
life disability (time frame: up to four weeks). The study lists 3 primary outcomes in all. 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 21 Aug 2023.