An interventional study of Manual Therapy and Exercises and Exercise in Cervicogenic Headache and Headache, sponsored by Universidad de Zaragoza. Completed at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Universidad de Zaragoza · Not applicable, Interventional, and Treatment
Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of manual translatoric therapy of the upper cervical spine associated with cervical exercises in these patients is currently unknown. Our aim was to determine if adding manual therapy to an exercise and home-exercise program improved effects on symptoms and function in short- and mid-term in patients with cervicogenic headache.
A randomized controlled study will be conducted with 40 subjects with cervicogenic headache. Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity, craniocervical flexion test, pain pressure thresholds and Global Rating of Change (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.
188 studies on the registry are indexed under Post-Traumatic Headache; 51 are open to participants now.
This study's enrollment of 40 is close to the median of 44 across 166 interventional studies indexed under Post-Traumatic Headache.
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Exclusion Criteria:
Combination of manual therapy and exercises for cervicogenic headache
Other: Manual Therapy and Exercises
Only exercises for cervicogenic headache
Other: Exercise
Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
Exercises for cervicogenic headache
Headache Intensity (HIT-6)
Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Flexion-rotation test
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Upper cervical flexion range of motion
Active flexion of the upper cervical spine will be measured in standing position using a CROM device
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Headache Intensity
Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Craniocervical flexion test
This test will be used to measure the strength of the deep flexor muscles. The activation and resistance of the deep flexor muscles will be evaluated in five progressive pressure increases of 2 mmHg up to a maximum of 30 mmHg. The patient will pass to the next level after reaching one certain level three times.
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Pain Pressure Thresholds
Pain pressure thresholds will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2. Pressure will be applied at a rate of 1 kg/cm2/s, perpendicular to the skin. Pressure pain thresholds will be assessed over six points bilaterally with the subject in supine position: suboccipital region, C2-3, C5-6, elevator of scapula, trapezius and first metacarpal joint.
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Global Raiting of Scale (GROC-Scale)
GROC-Scale will be used to measure the personal evolution that the patient had experienced. This scale is considered to be an efficient way to score patients' perceived clinical change and test-reliability has shown to be excellent (ICC=0.90).
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Adherence to self-treatment scale
This scale will be used in order to measure the adherence to self-treatment at home. Patients will be asked to choose between the following answers: "I have done the exercises every day"; "I have performed the exercises 4-6 days a week"; "I have performed the exercises 1-3 days a week"; "I have performed the exercises less than 1 day a week"; or "I have not performed them".
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Universidad de Zaragoza