Headache, CervicogenicNCT05883319
The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache
A study testing manuel therapy and exercises in people with Headache, Cervicogenic and Exercise, run by Meltem Uzun at 1 site in Turkey (Türkiye).
Trial summary
Cervicogenic headache (CH) arises from cervical region problems. Various physiotherapy methods such as manual therapy approaches and exercise training are used in the treatment of CH. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Cervicogenic, Exercise, Therapeutics
- What is being tested?
- manuel therapy and exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 3 Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Cervicogenic Headache
- aged 18-65
- did not receive medical (except analgesic) treatment or physiotherapy for bit Cervicogenic Headache in the previous few months
Who cannot join
- Individuals who have undergone Cervicogenic Headache surgery
- have had a serious cardiac history or surgery
- a history of ongoing or previous malignancy
- a diagnosis of epilepsy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SANKO University
Gaziantep, Please Select, 27060
About this study
Official title: The Effect Of Cervical Mobilization And Clinical Pilates Exercises On Pain, Muscle Hardness, Head-Neck Blood Flow in Cervicogenic Headache
Cervicogenic headache (CH) arises from cervical region problems. Various physiotherapy methods such as manual therapy approaches and exercise training are used in the treatment of CH. The aim of our study is to investigate cervical mobilization and clinical Pilates exercises on pain, muscle stiffness, head and neck blood flow in CH. Including individuals diagnosed with CH in the study. Those to be included in the study will be divided into 3 groups by a simple method. Demographic information of the individuals, age, height, weight, Body Mass Index (BMI), gender, educational status, occupation, marital status, smoking, alcohol use will be recorded. In evaluations about pain before treatment; pain intensity, pain frequency, duration and characteristics will be evaluated with Visual Analog Scale (VAS). In addition, analgesic use (frequency, amount) in headache situations will be recorded. Migraine Disability Assessment Scale (MIDAS) will be used to determine the effect of headache on quality of life. Disability Index will be used in the assessment of functional desire, and Postur Screen mobile application will be used in the assessment of posture. Range of motion(ROM) of all neck joint movements will be evaluated by CROM goniometer, deep neck flexor muscle strength by Pressure Biofeedback Unit (PBU), sternocleidomastoid(SKM), suboccipital and upper trapezius muscle stiffness myotonometer, and head-neck artery flow volume will be evaluated by Doppler ultrasound. Cervical mobilization methods will be applied to the 1st group, clinical pilates applications to the 2nd group, clinical pilates with cervical mobilization will be applied to the 3rd group for 3 days / week for 6 weeks. All evaluations were completed again after the 3rd week and after the treatment. After the obtained results are obtained, the literature will be discussed.
Read the detailed description
The scope of the study, including patients over 18 years of age who applied to the Neurology outpatient clinic of Sani Konukoğlu Application and Research Hospital and presented with cervicogenic headache by a specialist. The sometimes headache frequency variable in the reference result was 5% Power analysis calculated 9 patients per group. It was decided to recruit 15 patients for the group. Inclusion criteria: CH was diagnosed, aged 18-65, had not received medical (except analgesic) treatment or physiotherapy for CH in the previous few months. Exclusion criteria: Individuals who have undergone CH surgery, history of serious heart or surgery, history of ongoing malignancy, diagnosed with epilepsy. Individuals for whom the Voluntary Consent form will be obtained will be randomly divided into groups using the minimalization method given age, gender and duration of illness.Patients will be asked not to use analgesics as much as possible during the treatment period. In the case of analgesic use, the amount and frequency will be recorded. The change in the frequency of analgesic use will also be used to evaluate the effectiveness of the applications.
- Conditions
- Headache, Cervicogenic, Exercise, Therapeutics
- Being tested
- manuel therapy, exercises
- Keywords
- Cervicogenic Headache,, Pilates based exercises, Cervical mobilization, Blood flow, posture, muscle stifness
- Medical subject headings
- Post-Traumatic Headache, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuel therapyOther
Also called cervical mobilization
approaches will be applied for 3 days / week for 6 weeks.
exercisesOther
Also called clinical pilates exercises
approaches will be applied for 3 days / week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| cervical mobilization | Active comparator | Cervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks. Receives: Other: manuel therapy |
| clinical pilates exercises | Active comparator | clinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks. Receives: Other: exercises |
| cervical mobilization and clinical pilates exercises | Active comparator | cervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks. Receives: Other: manuel therapy; Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of headache
headache intensity by Visual Analogue Scale , headache frequency and analgesic intake
Measured: 6 week
Change of muscle stiffness degree
SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro
Measured: 6 week
Change of blood flow degree
head-neck artery flow Doppler Ultrasound (US)
Measured: 6 week
change of posture
The PostureScreen Mobile® application
Measured: 6 week
Secondary outcomes (4)
neck range of motion
range of motion by Cervical Range of Motion device
Measured: 6 week
deep neck flexor muscle endurance
muscle endurance by Pressure Biofeedback Unit
Measured: 6 week
headache life quality
Migraine Disability Assessment Scale for headache on quality of life.
Measured: 6 week
neck functional status
Neck Disability Index for functional status
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Apr 2022
- Primary completion15 Apr 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, CervicogenicStudies 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
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meltem Uzun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Uzun, Sanko University
- Investigators
- Meltem Uzun, PhD(c), Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883319
- Sponsor's protocol ID
- SankoMU
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2022
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Cervical Mobilization And Clinical Pilates Exercises On Pain, Muscle Hardness, Head-Neck Blood Flow in Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05883319
- Acronym / sponsor ID
- SankoMU
- Conditions
- Headache, Cervicogenic, Exercise, Therapeutics
- Keywords
- Cervicogenic Headache,, Pilates based exercises, Cervical mobilization, Blood flow, posture, muscle stifness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Meltem UzunUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 31 May 2023 (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 (CH) arises from cervical region problems. Various physiotherapy methods such as manual therapy approaches and exercise training are used in the treatment of CH. The aim of our study is to investigate cervical mobilization and clinical Pilates exercises on pain, muscle stiffness, head and neck blood flow in CH. Including individuals diagnosed with CH in the study. Those to be included in the study will be divided into 3 groups by a simple method. Demographic information of the individuals, age, height, weight, Body Mass Index (BMI), gender, educational status, occupation, marital status, smoking, alcohol use will be recorded. In evaluations about pain before treatment; pain intensity, pain frequency, duration and characteristics will be evaluated with Visual Analog Scale (VAS). In addition, analgesic use (frequency, amount) in headache situations will be recorded. Migraine Disability Assessment Scale (MIDAS) will be used to determine the effect of headache on quality of life. Disability Index will be used in the assessment of functional desire, and Postur Screen mobile application will be used in the assessment of posture. Range of motion(ROM) of all neck joint movements will be evaluated by CROM goniometer, deep neck flexor muscle strength by Pressure Biofeedback Unit (PBU), sternocleidomastoid(SKM), suboccipital and upper trapezius muscle stiffness myotonometer, and head-neck artery flow volume will be evaluated by Doppler ultrasound. Cervical mobilization methods will be applied to the 1st group, clinical pilates applications to the 2nd group, clinical pilates with cervical mobilization will be applied to the 3rd group for 3 days / week for 6 weeks. All evaluations were completed again after the 3rd week and after the treatment. After the obtained results are obtained, the literature will be discussed.
Detailed description
The scope of the study, including patients over 18 years of age who applied to the Neurology outpatient clinic of Sani Konukoğlu Application and Research Hospital and presented with cervicogenic headache by a specialist. The sometimes headache frequency variable in the reference result was 5% Power analysis calculated 9 patients per group. It was decided to recruit 15 patients for the group. Inclusion criteria: CH was diagnosed, aged 18-65, had not received medical (except analgesic) treatment or physiotherapy for CH in the previous few months. Exclusion criteria: Individuals who have undergone CH surgery, history of serious heart or surgery, history of ongoing malignancy, diagnosed with epilepsy. Individuals for whom the Voluntary Consent form will be obtained will be randomly divided into groups using the minimalization method given age, gender and duration of illness.Patients will be asked not to use analgesics as much as possible during the treatment period. In the case of analgesic use, the amount and frequency will be recorded. The change in the frequency of analgesic use will also be used to evaluate the effectiveness of the applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cervical mobilization | Active comparator | Other: manuel therapyCervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks. |
| clinical pilates exercises | Active comparator | Other: exercisesclinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks. |
| cervical mobilization and clinical pilates exercises | Active comparator | Other: manuel therapy, Other: exercisescervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Cervicogenic Headache
- aged 18-65
- did not receive medical (except analgesic) treatment or physiotherapy for bit Cervicogenic Headache in the previous few months
Key exclusion criteria (4 listed)
- Individuals who have undergone Cervicogenic Headache surgery
- have had a serious cardiac history or surgery
- a history of ongoing or previous malignancy
- a diagnosis of epilepsy.
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 |
|---|---|---|
| manuel therapyAlso: cervical mobilizationapproaches will be applied for 3 days / week for 6 weeks. | Other | cervical mobilization, cervical mobilization and clinical pilates exercises |
| exercisesAlso: clinical pilates exercisesapproaches will be applied for 3 days / week for 6 weeks. | Other | cervical mobilization and clinical pilates exercises, clinical pilates exercises |
Primary outcome
Change of headache
Time frame: 6 week
headache intensity by Visual Analogue Scale , headache frequency and analgesic intake
Change of muscle stiffness degree
Time frame: 6 week
SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro
Change of blood flow degree
Time frame: 6 week
head-neck artery flow Doppler Ultrasound (US)
change of posture
Time frame: 6 week
The PostureScreen Mobile® application
4 secondary outcomes
neck range of motion
Time frame: 6 week
deep neck flexor muscle endurance
Time frame: 6 week
headache life quality
Time frame: 6 week
neck functional status
Time frame: 6 week
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 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Meltem Uzun, PhD(c) study director
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manuel therapy and exercises in people with Headache, Cervicogenic and Exercise, run by Meltem Uzun at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 Mar 2024. 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 Turkey (Türkiye). 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?
Change of headache (time frame: 6 week). The study lists 4 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 Mar 2024.