Back to resultsEffects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
Primary Purpose
Cervicogenic Headache, Headache
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy and Exercises
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Cervicogenic headache, exercise, manual therapy, upper cervical spine
Eligibility Criteria
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.
Sites / Locations
- Universidad de Zaragoza
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual Therapy + Exercise Group
Exercise Group
Arm Description
Combination of manual therapy and exercises for cervicogenic headache
Only exercises for cervicogenic headache
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Upper cervical flexion range of motion
Active flexion of the upper cervical spine will be measured in standing position using a CROM device
Headache Intensity
Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.
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.
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.
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).
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".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04401501
Brief Title
Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache, Headache
Keywords
Cervicogenic headache, exercise, manual therapy, upper cervical spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual Therapy + Exercise Group
Arm Type
Experimental
Arm Description
Combination of manual therapy and exercises for cervicogenic headache
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Only exercises for cervicogenic headache
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Exercises
Intervention Description
Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercises for cervicogenic headache
Primary Outcome Measure Information:
Title
Headache Intensity (HIT-6)
Description
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
Title
Flexion-rotation test
Description
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
Secondary Outcome Measure Information:
Title
Upper cervical flexion range of motion
Description
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
Title
Headache Intensity
Description
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
Title
Craniocervical flexion test
Description
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
Title
Pain Pressure Thresholds
Description
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
Title
Global Raiting of Scale (GROC-Scale)
Description
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
Title
Adherence to self-treatment scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad de Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
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Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
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