Cervicogenic HeadacheNCT04401501
Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
A study testing Manual Therapy and Exercises and Exercise in people with Cervicogenic Headache and Headache, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cervicogenic Headache, Headache
- What is being tested?
- Manual Therapy and Exercises and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Jan 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Cervicogenic Headache, Headache
- Being tested
- Manual Therapy and Exercises, Exercise
- Keywords
- Cervicogenic headache, exercise, manual therapy, upper cervical spine
- Medical subject headings
- Post-Traumatic Headache, Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy and ExercisesOther
Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
ExerciseOther
Exercises for cervicogenic headache
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy + Exercise Group | Experimental | Combination of manual therapy and exercises for cervicogenic headache Receives: Other: Manual Therapy and Exercises |
| Exercise Group | Active comparator | Only exercises for cervicogenic headache Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Secondary outcomes (6)
Upper cervical flexion range of motion
Active flexion of the upper cervical spine will be measured in standing position using a CROM device
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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".
Measured: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez-Sanz, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401501
- Sponsor's protocol ID
- N14/2020
- Status last verified
- May 2020
- First submitted
- 20 May 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04401501
- Acronym / sponsor ID
- N14/2020
- Conditions
- Cervicogenic Headache, Headache
- Keywords
- Cervicogenic headache, exercise, manual therapy, upper cervical spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 26 May 2020 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy + Exercise Group | Experimental | Other: Manual Therapy and ExercisesCombination of manual therapy and exercises for cervicogenic headache |
| Exercise Group | Active comparator | Other: ExerciseOnly exercises for cervicogenic headache |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Manual Therapy and ExercisesCombination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache | Other | Manual Therapy + Exercise Group |
| ExerciseExercises for cervicogenic headache | Other | Exercise Group |
Primary outcome
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.
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
6 secondary outcomes
Upper cervical flexion range of motion
Time frame: 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
Craniocervical flexion test
Time frame: 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
Global Raiting of Scale (GROC-Scale)
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Adherence to self-treatment scale
Time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercises and Exercise in people with Cervicogenic Headache and Headache, run by Universidad de Zaragoza at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Intensity (HIT-6) (time frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months). The study lists 2 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 27 Apr 2021.