- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401501
Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
Short- and Mid-Term Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache. A Randomized Controlled Trial.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Zaragoza, Spain, 50009
- Universidad de Zaragoza
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
- Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.
- A positive result in the flexion-rotation test.
- A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.
- Be at least 18 years old.
- Have signed the informed consent.
Exclusion Criteria:
- Contraindications for manual therapy or exercise.
- Participation in exercise or manual therapy programs in the last three months.
- Inability to maintain supine position.
- The use of pacemakers (the magnets in the CROM device could alter their signal).
- Inability to perform the flexion-rotation test.
- Language difficulties.
- Pending litigation or lawsuits.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual Therapy + Exercise Group
Combination of manual therapy and exercises for cervicogenic headache
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Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
|
Active Comparator: Exercise Group
Only exercises for cervicogenic headache
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Exercises for cervicogenic headache
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Intensity (HIT-6)
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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.
|
Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Flexion-rotation test
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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
|
Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper cervical flexion range of motion
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Active flexion of the upper cervical spine will be measured in standing position using a CROM device
|
Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Headache Intensity
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.
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Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Craniocervical flexion test
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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.
|
Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Pain Pressure Thresholds
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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.
|
Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Global Raiting of Scale (GROC-Scale)
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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).
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Change between baseline and post intervention (1 month), after 3 months and after 6 months
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Adherence to self-treatment scale
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
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".
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Change between baseline and post intervention (1 month), after 3 months and after 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- N14/2020
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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