search
Back to results

Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache (CGH)

Primary Purpose

Cervicogenic Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lumbar motor control exercises
Cervical stabilization exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring lumbar motor control, cervicogenic hedache, cervical stabilization exercises

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The age of the subjects ranged from 20-40 years old, both genders. Patients with chronic mechanical neck pain with frequent cervicogenic headaches persisting for more than 3 months. Positive flexion rotation test. Unilateral head pain without side shift or bilateral head pain with dominant side headache associated with neck pain and aggravated by neck movement and/or sustained awkward head positioning Joint tenderness in at least one of the upper three cervical joints or the occipital region as detected by manual palpation. Intensity of headache is moderate to severe. Abnormal performance in CCFT < = 26 mmHg Body mass index range from 18 to 25 km/m2 Exclusion Criteria: Fracture or previous surgery on the vertebral column. Spinal stenosis. Disc prolapsed. TMJ dysfunction. Headache with autonomic involvement, dizziness, or visual disturbance. Congenital condition of the cervical spine. Neck pain of less than three months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    lumbar motor control exercises

    cervical stabilization exercises

    Arm Description

    patients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks

    the patients will receive cervical stabilization exercises three times a week for four weeks

    Outcomes

    Primary Outcome Measures

    Headache frequency:
    Headache frequency will measure as the number of days with headache in the last week, ranging from 0 to 7 days
    Headache duration
    Headache duration will measure in total hours and average number of hours headaches lasted in the past week
    Headache intensity
    The Visual Analog Scale will use to quantify the patient's pain level or intensity. these scale consists of line, usually 10 cm long, ranging from no pain at one end and worst pain at the other end

    Secondary Outcome Measures

    neck disability
    Arabic version of neck disability index will be used to measure neck disability. The NDI consists of 10 sections: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each section is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating highest disability. The total score ranges from 0 to 50.0-4= No disability,5-14= Mild disability,15-24=Moderate disability, 25-34=Sever disability,35 or more=Complete disability.

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05952115
    Brief Title
    Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache
    Acronym
    CGH
    Official Title
    Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 16, 2023 (Anticipated)
    Primary Completion Date
    October 16, 2023 (Anticipated)
    Study Completion Date
    October 16, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    this study will be conducted to investigate the effect of lumbar motor control training exercise on headache frequency, duration, intensity and neck functional disability in cervicogenic headache patients
    Detailed Description
    Cervicogenic Headache is a referred pain spreading from cervical structures supplied by the upper cervical spinal nerve roots (C1-C3), this referred pain that starts from the posterior aspect of the head and neck is usually found to be unilateral, and it also can spread to the frontal, temporal and orbital aspects of the head.The patient frequently reports having a terrible headache, having less neck range of motion, performing less well at work, and having trouble focusing, that may linger for hours. The convergence of primary sensory afferents from cervical nerve roots C1 to C3 with the afferents from the occiput and trigeminal nerve causes the underlying pathology. Because of this, the Suboccipital muscles particularly, which cervical roots C1 innervates to C3, are potential risk structures. Treatment options include posture correction, cervical and upper thoracic strengthening exercises, facet joint manipulation, ultrasound therapy, laser therapy, trigger release therapy, and cervical joint mobilization.famous exercise known as "Motor control exercise" attempts to improve the coordination and effectiveness of the muscles that support and govern the spine. It can also improve coordination between the deep neck flexors and superficial neck flexors and between core muscles of the lumbar region. fifty two patients will be randomly assigned to two equal groups; experimental group will receive lumbar motor control and cervical stabilization exercises and control group will receive cervical stabilization exercises only.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervicogenic Headache
    Keywords
    lumbar motor control, cervicogenic hedache, cervical stabilization exercises

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    lumbar motor control and cervical stabilization exercises
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    opaque sealed envelop
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    lumbar motor control exercises
    Arm Type
    Experimental
    Arm Description
    patients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks
    Arm Title
    cervical stabilization exercises
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive cervical stabilization exercises three times a week for four weeks
    Intervention Type
    Other
    Intervention Name(s)
    lumbar motor control exercises
    Intervention Description
    the patients will receive lumbar motor control exercises in the form of three exercises (Abdominal draw in maneuver, side-bridge, and quadruped) and the level of difficulty increased each week. For all exercises, the number of repetitions stayed the same, but the difficulty increased each week, and we progressed to the advanced level of each of the three exercises. This training achieves co-contraction of the local/deep stabilizing muscles (Transversus abdominis and multifidus) and strengthening the global/large spinal stabilizers (erector spinae and obliques).
    Intervention Type
    Other
    Intervention Name(s)
    Cervical stabilization exercises
    Intervention Description
    The exercise program consisted of an axial elongation exercise, cranio-cervical flexion exercise, cervical extension exercise, and cervical-scapulothoracic strengthening exercise. The exercise program progressed based on the exercise tolerance of the patients by increasing the repetition of the exercise (10 reps to 15 reps to 20 reps). And for the resistive exercise, the participants change to an elastic band with greater resistance (progress to the next color resistance band). Exercises were performed for 20 min/session, and an exercise log recording the date and repetition of the exercises was maintained by the therapist for each participant.
    Primary Outcome Measure Information:
    Title
    Headache frequency:
    Description
    Headache frequency will measure as the number of days with headache in the last week, ranging from 0 to 7 days
    Time Frame
    up to four weeks
    Title
    Headache duration
    Description
    Headache duration will measure in total hours and average number of hours headaches lasted in the past week
    Time Frame
    up to four weeks
    Title
    Headache intensity
    Description
    The Visual Analog Scale will use to quantify the patient's pain level or intensity. these scale consists of line, usually 10 cm long, ranging from no pain at one end and worst pain at the other end
    Time Frame
    up to four weeks
    Secondary Outcome Measure Information:
    Title
    neck disability
    Description
    Arabic version of neck disability index will be used to measure neck disability. The NDI consists of 10 sections: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and recreation. Each section is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating highest disability. The total score ranges from 0 to 50.0-4= No disability,5-14= Mild disability,15-24=Moderate disability, 25-34=Sever disability,35 or more=Complete disability.
    Time Frame
    up to four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The age of the subjects ranged from 20-40 years old, both genders. Patients with chronic mechanical neck pain with frequent cervicogenic headaches persisting for more than 3 months. Positive flexion rotation test. Unilateral head pain without side shift or bilateral head pain with dominant side headache associated with neck pain and aggravated by neck movement and/or sustained awkward head positioning Joint tenderness in at least one of the upper three cervical joints or the occipital region as detected by manual palpation. Intensity of headache is moderate to severe. Abnormal performance in CCFT < = 26 mmHg Body mass index range from 18 to 25 km/m2 Exclusion Criteria: Fracture or previous surgery on the vertebral column. Spinal stenosis. Disc prolapsed. TMJ dysfunction. Headache with autonomic involvement, dizziness, or visual disturbance. Congenital condition of the cervical spine. Neck pain of less than three months

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache

    We'll reach out to this number within 24 hrs