Cervicogenic HeadacheCGHNCT05952115
Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache
A study testing Cervical stabilization exercises in people with Cervicogenic Headache, run by Cairo University.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Cervical stabilization exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2023to 16 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- lumbar motor control exercises, Cervical stabilization exercises
- Keywords
- lumbar motor control, cervicogenic hedache, cervical stabilization exercises
- 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.
lumbar motor control exercisesOther
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).
Cervical stabilization exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| lumbar motor control exercises | Experimental | patients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks Receives: Other: lumbar motor control exercises; Other: Cervical stabilization exercises |
| cervical stabilization exercises | Active comparator | the patients will receive cervical stabilization exercises three times a week for four weeks Receives: Other: Cervical stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency:
Headache frequency will measure as the number of days with headache in the last week, ranging from 0 to 7 days
Measured: up to four weeks
Headache duration
Headache duration will measure in total hours and average number of hours headaches lasted in the past week
Measured: up to four weeks
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
Measured: up to four weeks
Secondary outcomes (1)
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.
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 posted19 Jul 2023
- Study start16 Jul 2023 (estimated)
- Primary completion16 Oct 2023 (estimated)
- Study completion16 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic 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
- lumbar motor control and cervical stabilization exercises
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Abd_El basset Ismail Marzok, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952115
- Sponsor's protocol ID
- P.T.REC/012/003835
- Acronym
- CGH
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 19 Jul 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05952115
- Acronym / sponsor ID
- CGH / P.T.REC/012/003835
- Conditions
- Cervicogenic Headache
- Keywords
- lumbar motor control, cervicogenic hedache, cervical stabilization exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jul 2023 (estimated)
- Primary completion
- 16 Oct 2023 (estimated)
- Study completion
- 16 Oct 2023 (estimated)
- First posted
- 19 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- lumbar motor control and cervical stabilization exercises
| Arm | Type | Receives |
|---|---|---|
| lumbar motor control exercises | Experimental | Other: lumbar motor control exercises, Other: Cervical stabilization exercisespatients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks |
| cervical stabilization exercises | Active comparator | Other: Cervical stabilization exercisesthe patients will receive cervical stabilization exercises three times a week for four weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- Fracture or previous surgery on the vertebral column.
- Spinal stenosis.
- Disc prolapsed.
- TMJ dysfunction.
- Headache with autonomic involvement, dizziness, or visual disturbance.
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 |
|---|---|---|
| lumbar motor control exercisesthe 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). | Other | lumbar motor control exercises |
| Cervical stabilization exercisesThe 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. | Other | cervical stabilization exercises, lumbar motor control exercises |
Primary outcome
Headache frequency:
Time frame: up to four weeks
Headache frequency will measure as the number of days with headache in the last week, ranging from 0 to 7 days
Headache duration
Time frame: up to four weeks
Headache duration will measure in total hours and average number of hours headaches lasted in the past week
Headache intensity
Time frame: up to four weeks
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
1 secondary outcome
neck disability
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 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 Cervical stabilization exercises in people with Cervicogenic 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 8 inclusion and 7 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 19 Jul 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?
Headache frequency: (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 19 Jul 2023.