NCT07025187

Brief 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 . Patients in both groups will receive a traditional medical treatment, but group (B) will receive additional integrated neuromuscular inhibition technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

June 9, 2025

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • headache pain intensity

    headache pain intensity measured by 11-Numerical rating scale. Primary outcome updated to headache intensity to better reflect the study objective.

    Baseline, 4 weeks and 8 weeks .

Secondary Outcomes (7)

  • kinesiophobia

    Baseline, 4 weeks and 8 weeks .

  • Isometric endurance capacity of sternocledomastoid and anterior scalene

    Baseline, 4 weeks and 8 weeks .

  • the impact of headaches on patients' lives

    Baseline, 4 weeks and 8 weeks .

  • neck disability

    Baseline, 4 weeks and 8 weeks .

  • headache frequency

    Baseline, 4 weeks and 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Muscle relaxants tizanidineOther: integrated neuromuscular inhibition technique

Interventions

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 .

Control groupexperimental group

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 .

Also known as: INIT
experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • In addition, patients should exhibit active trigger points within the suboccipital, and upper trapezius muscles, ipsilaterally over the symptomatic side reproducing their headache symptoms .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khalid enb elwaleed polyclinic

Tanta, Algharbia, 6620010, Egypt

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the department

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 17, 2025

Study Start

June 16, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations