- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05952115
Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache (CGH)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: lumbar motor control exercises
patients will receive lumbar motor control and cervical stabilization exercises three times a week for four weeks
|
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).
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.
|
|
Active Comparator: cervical stabilization exercises
the patients will receive cervical stabilization exercises three times a week for four weeks
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
up to four weeks
|
|
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
|
up to four weeks
|
|
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
|
up to four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck disability
Time Frame: up to four weeks
|
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.
|
up to four weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003835
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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