Cervicogenic HeadacheNCT07025187
the Effect of Integrated Neuomuscular Inhibition Technique on Adult Females With Cervicogenic Headache
A study testing Muscle relaxants tizanidine and integrated neuromuscular inhibition technique in people with Cervicogenic Headache, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The purpose of the current study is investigating the effect of integrated neuromuscular inhibition technique on adult females with cervicogenic headache. Methods: Forty females with cervicogenic headache will be recruited. Patients will be randomly assigned into two groups, group A and group B . Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Muscle relaxants tizanidine and integrated neuromuscular inhibition technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2025to 1 Nov 2025
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1 - A diagnosis of CGH will be made by an experienced neurologist as per the International Classification of Headache Disorders 3rd edition (ICHD-3) , but not including occipital nerve blockage 2-Additional inclusion criteria will include female patients aged> 18 years and<60 years.
- 3-headache intensity ≥ 3 on eleven-point numerical rating scale at enrolment. 4-at least three-month history of headache with a mean frequency of > 1/week. 5-hypomobility of the upper cervical spine (C0 to C3) on manual examination; and reproduction of the headache on palpation of the upper cervical spine (C0 to C3).
- 6-In addition, patients should exhibit active trigger points within the suboccipital, and upper trapezius muscles, ipsilaterally over the symptomatic side reproducing their headache symptoms .
Who cannot join
- Patients will be excluded if they have any of the following:
- cervical radiculopathy,
- history of neck, shoulder trauma or surgery,
- history of intervention for head or neck pain within the previous 3 months,
- A diagnosis of other types of headaches using the criteria of ICHD-3.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the current study is investigating the effect of integrated neuromuscular inhibition technique on adult females with cervicogenic headache.
Methods: Forty females with cervicogenic headache will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional medical treatment, but group (B) will receive additional integrated neuromuscular inhibition technique.
Read the detailed description
Measurements will be taken for all participants before the start of treatment program then after the end of 4 weeks treatment program, then after another 4 weeks of follow up.all patients will be evaluated for headache pain intensity, cervicogenic headache frequency, cervicogenic headache duration, cervical range of motion in all directions, the isometric endurance capacity of sternocledomastoid and anterior scalene, kinesiophobia, neck disability, and headache impact test-6.
All patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day.
Patients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month.
- Conditions
- Cervicogenic Headache
- Being tested
- Muscle relaxants tizanidine, integrated neuromuscular inhibition technique
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle relaxants tizanidineDrug
All patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day for one month .
integrated neuromuscular inhibition techniqueOther
Also called INIT
Patients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month .
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | All patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day. Receives: Drug: Muscle relaxants tizanidine |
| experimental group | Experimental | Patients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month. Receives: Drug: Muscle relaxants tizanidine; Other: integrated neuromuscular inhibition technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache pain intensity
headache pain intensity measured by 11-Numerical rating scale. Primary outcome updated to headache intensity to better reflect the study objective.
Measured: Baseline, 4 weeks and 8 weeks .
Secondary outcomes (7)
kinesiophobia
kinesiophobia will be measured by Arabic Tampa scale
Measured: Baseline, 4 weeks and 8 weeks .
Isometric endurance capacity of sternocledomastoid and anterior scalene
The isometric endurance capacity of the sternocleidomastoid and anterior scalene will be assessed using an isometric test.
Measured: Baseline, 4 weeks and 8 weeks .
the impact of headaches on patients' lives
the impact of headaches on patients' lives measured by Arabic headache impact test-6.
Measured: Baseline, 4 weeks and 8 weeks .
neck disability
the neck disability will be measured by Arabic neck disability index
Measured: Baseline, 4 weeks and 8 weeks .
headache frequency
Cervicogenic headache frequency, which is a self-administered outcome variable, will be identified by asking patients to enter their CGH pain experience in a medical logbook every evening to find the number of painful days in the last week, ranging from 0 to 7 days.
Measured: Baseline, 4 weeks and 8 weeks
headache duration
Headache duration will be measured as the total hours of headache in the last week.
Measured: Baseline, 4 weeks and 8 weeks .
cervical ROM in all directions
Cervical right and left lateral flexion, extension, and flexion ROM will be measured using the iPhone clinometer application, whereas cervical right and left rotation ROM will be measured using the iPhone compass application.
Measured: Baseline, 4 weeks and 8 weeks .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Jun 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Karam Mohammed, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025187
- Sponsor's protocol ID
- KFSIRB200-612
- Status last verified
- Nov 2025
- First submitted
- 9 Jun 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karam M, El-Shamy FF, Elhosary EA, Mofreh A, Adel J. Efficacy of integrated neuromuscular inhibition technique in women with cervicogenic headache: a double-blind randomized controlled trial. Physiother Theory Pract. 2026 Jun 4:1-15. doi: 10.1080/09593985.2026.2683245. Online ahead of print.
PubMed 42237665
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Integrated Neuomuscular Inhibition Technique on Adult Females With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT07025187
- Acronym / sponsor ID
- KFSIRB200-612
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 17 Jun 2025 (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.
The purpose of the current study is investigating the effect of integrated neuromuscular inhibition technique on adult females with cervicogenic headache.
Methods: Forty females with cervicogenic headache will be recruited. Patients will be randomly assigned into two groups, group A and group B . Patients in both groups will receive a traditional medical treatment, but group (B) will receive additional integrated neuromuscular inhibition technique.
Detailed description
Measurements will be taken for all participants before the start of treatment program then after the end of 4 weeks treatment program, then after another 4 weeks of follow up.all patients will be evaluated for headache pain intensity, cervicogenic headache frequency, cervicogenic headache duration, cervical range of motion in all directions, the isometric endurance capacity of sternocledomastoid and anterior scalene, kinesiophobia, neck disability, and headache impact test-6.
All patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day.
Patients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Muscle relaxants tizanidineAll patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day. |
| experimental group | Experimental | Drug: Muscle relaxants tizanidine, Other: integrated neuromuscular inhibition techniquePatients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1 - A diagnosis of CGH will be made by an experienced neurologist as per the International Classification of Headache Disorders 3rd edition (ICHD-3) , but not including occipital nerve blockage 2-Additional inclusion criteria will include female patients aged> 18 years and<60 years.
- 3-headache intensity ≥ 3 on eleven-point numerical rating scale at enrolment. 4-at least three-month history of headache with a mean frequency of > 1/week. 5-hypomobility of the upper cervical spine (C0 to C3) on manual examination; and reproduction of the headache on palpation of the upper cervical spine (C0 to C3).
- 6-In addition, patients should exhibit active trigger points within the suboccipital, and upper trapezius muscles, ipsilaterally over the symptomatic side reproducing their headache symptoms .
Key exclusion criteria (5 listed)
- Patients will be excluded if they have any of the following:
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 |
|---|---|---|
| Muscle relaxants tizanidineAll patients will receive a traditional medical program by an experienced neurologist in the form of Muscle relaxants tizanidine ,4 mg to 32 mg, Three times a day for one month . | Drug | Control group, experimental group |
| integrated neuromuscular inhibition techniqueAlso: INITPatients in experimental group (B) will receive the same program as control group (A) plus the INIT for upper trapezius and suboccipital muscles. The INIT program will be administrated three times a week for one month . | Other | experimental group |
Primary outcome
headache pain intensity
Time frame: Baseline, 4 weeks and 8 weeks .
headache pain intensity measured by 11-Numerical rating scale. Primary outcome updated to headache intensity to better reflect the study objective.
7 secondary outcomes
kinesiophobia
Time frame: Baseline, 4 weeks and 8 weeks .
Isometric endurance capacity of sternocledomastoid and anterior scalene
Time frame: Baseline, 4 weeks and 8 weeks .
the impact of headaches on patients' lives
Time frame: Baseline, 4 weeks and 8 weeks .
neck disability
Time frame: Baseline, 4 weeks and 8 weeks .
headache frequency
Time frame: Baseline, 4 weeks and 8 weeks
headache duration
Time frame: Baseline, 4 weeks and 8 weeks .
cervical ROM in all directions
Time frame: Baseline, 4 weeks and 8 weeks .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 42237665Karam M, El-Shamy FF, Elhosary EA, Mofreh A, Adel J. Efficacy of integrated neuromuscular inhibition technique in women with cervicogenic headache: a double-blind randomized controlled trial. Physiother Theory Pract. 2026 Jun 4:1-15. doi: 10.1080/09593985.2026.2683245. Online ahead of print.
Related trials for Cervicogenic Headache
Not yet recruiting
Trigger Point Injection and Myofascial Release for Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Comparative Effects of Dynamic Cupping and Facilitated Positional Release in Cervicogenic Headache
Cervicogenic Headache
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Recruiting
Clinical Study of Myofascial Trigger Points(MTrPs) Injection in the Treatment of Knee Osteoarthritis(OA)
Myofascial Trigger Points, Migraine
Recruiting
Comparative Effects of Post Isometric Relaxation and Reciprocal Inhibition in Individuals With Cervicogenic Headache.
Post Traumatic Headache, Cervicogenic Headache
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle relaxants tizanidine and integrated neuromuscular inhibition technique in people with Cervicogenic Headache, run by Kafrelsheikh University at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
headache pain intensity (time frame: Baseline, 4 weeks and 8 weeks .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07025187, which also lists 1 linked publication.
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 18 Nov 2025.