NCT07006454

Brief Summary

This study is a randomised control trial and the purpose of this study is to compare ventro-cephalic to dorso-caudal translatoric glides in management of cervicogenic headache.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 18, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

June 16, 2025

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

May 28, 2025

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Headache intensity

    It will be measured on a numeric pain rating scale where participant select number ranging from 0 to 10 based on pain intensity, with 0 representing no pain and 10 denotes extreme pain.

    Variable will be evaluated at baseline and then weekly for next 2 weeks.

  • Headache disability

    It will be measured using headache disability index (HDI) which is a 25 item self-rated questionnaire in which participants rate their headache disability by selecting an option from 1 to 3 (yes= 4 points, sometimes= 2 points, and No = 0 point) then sum of responses is used to get final score. Interpretation: 10 to 28= mild disability 30 to 48= moderate disability 50 to 68= severe disability 72 or more= complete disability

    Variable will be evaluated at baseline and then weekly for next 2 weeks

  • Quality of Life of patient

    It will be measured using headache impact test (HIT-6), this tool is used to measure impact of headache on ability to function, a 6 items self-rated questionnaire in which participant select an option from 1 to 5 (Never= 6 points, rarely= 8, sometimes= 10, very often= 11, always= 13) then sum of responses is used to get final score. Interpretation: 60 or more= Very severe impact 56 to 59= Substantial impact 50 to 55= Some impact 49 or less= Little or no impact

    Variable will be evaluated at baseline and then weekly for next 2 weeks

  • Headache Frequency

    It will be measured using medical diary, which is a self-reported measure in which the patient will be asked to report the number of headache days per week through a medical logbook, which will be recorded every day and night.

    Variable will be evaluated at baseline and then weekly for next 2 weeks

  • Cervical range of motion

    It will be measured using CROM instrument a plastic frame device that is fastened to the head with help of Velcro-strap, it consist of 3 separate inclinometers that are fixed to frame (1 in sagittal plan which evaluates range of motion in flexion and extension, where 2nd in frontal plane which evaluates range of motion in side bending, and 3rd in horizontal plan which indicates range of motion in rotation)

    Variable will be evaluated at baseline and then weekly for next 2 weeks

  • Cervical flexion rotation test

    It is used to evaluate impairment of cervical function as the diagnostic criterion of internation headache society (IHS) consist of subjective feathers which includes impairments at atlanto-axial motion segments which is assessed by cervical flexion rotation test.

    Variable will be evaluated at baseline and then weekly for next 2 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Participants of group A will receive ventro-cephalic translatoric glide, total of 3 sets with 15 repetitions per set. Duration (5 treatment sessions per week for 2 weeks)

Procedure: Ventro-Cephalic Translatoric Glide

Group B

EXPERIMENTAL

Participants of group B will receive Dorso-caudal translatoric glide, total of 3 sets with 15 repetitions per set. Duration (5 treatment sessions per week for 2 weeks)

Procedure: Dorso-Caudal Translatoric Glide

Interventions

Participants of group A will receive ventro-cephalic translatoric glides, total of 3 sets with 15 repetitions per set. PROCEDURE: 1. Patient sits on low chair with back straight and therapist stand facing the patient's right side. 2. Therapist's stable hand: with the thumb and index finger of left hand fixate caudal vertebra. 3. Therapist's moving hand: therapist will place his/her right hand on left side of patient's head and cervical spine than place little finger around cranial vertebra of segment to be moved. 4. Apply glide in ventro-cranial direction in the right angle of the treatment plane of the facet joint.

Group A

Participants of group B will receive Dorso-caudal translatoric glides, total of 3 sets with 15 repetitions per set. PROCEDURE: 1. Patient sits on low chair with back straight and therapist stand facing the patient's left side. 2. Therapist's stable hand: with the thumb and index finger of right hand fixate caudal vertebra. 3. Therapist's moving hand: therapist will place his/her left hand on right side of patient's head and cervical spine than place little finger around cranial vertebra of segment to be moved. 4. Apply glide in dorso-caudal direction in the right angle of the treatment plane of the facet joint.

Group B

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 44 years old
  • Both male and female A- Any headache fulling criterion C. B- Clinical and/or imaging evidence of lesion or disorder in cervical spine or soft tissues of neck that can cause headache.
  • C- Evidence of cause of headache demonstrated by at least 2 of these:
  • headache has developed in temporal relation to the onset of the cervical disorder or lesion.
  • headache has significantly improved or resolved in parallel with improvement in cervical lesion or disorder.
  • cervical range of motion is reduced, and headache is made significantly worse by provocative maneuvers.
  • headache is abolished following diagnostic blocked of cervical structure. D- Not better accounted for by another ICHD-3 diagnosis

You may not qualify if:

  • Tension-type headaches and migraine 2- History of Vertigo or Dizziness 3- Already taking manual therapy treatment 4- Prior surgery to the head and neck 5- Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 5, 2025

Study Start

July 18, 2024

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

June 16, 2025

Record last verified: 2024-07

Locations