Cervicogenic HeadacheNCT05397977
Comparison of the Effects of Mechanical Traction and Manual Traction on Cervicogenic Headache
A study testing mechanical traction group and manuel traction group in people with Cervicogenic Headache, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- mechanical traction group and manuel traction group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 26 Jun 2022
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-45
- having neck or headache for at least 3 months meets the diagnostic criteria for cervicogenic headache.
- Unilateral pain
- Decreased neck range of motion
- Ipsilateral shoulder discomfort
- Ipsilateral arm discomfort
- Pain increase with different neck movements and pain with palpation eligible persons will be included.
Who cannot join
- migraine
- cluster headache
- cervical radiculopathy,
- entrapment neuropathy,
- myelopathy,
- rheumatoid arthritis,
Show all 11Show fewer
- undergo cervical spinal surgery,
- to be pregnant,
- have a whiplash injury
- those who received physical therapy within 6 months will not be included in the study.
- In cases where mechanical traction is contraindicated (inflammatory joint diseases, osteoporosis, acute inflammatory conditions, acute strain and injury, vertebrobasilar artery failure of the circulation, such as stroke or transient ischemic attack. abnormal upper motor neuron lesions, cardiovascular diseases, malignant tumoral conditions) will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa VM Medical Park Hospital
Bursa, Osmangazi, 16220
About this study
Official title: Comparison of the Effects of Mechanical Traction and Manual Traction on Pain, Muscle Tone and Functionality in Persons With Cervicogenic Headache
52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).
After obtaining the demographic information of the individuals to be included in the study, the cases will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.
Read more
The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.
Intermittent traction with chattanooga tru trac traction device will be applied to CTG, and manual traction, one of Cyriax's neck mobilization techniques, will be applied to MTG.transcutaneous electrical nerve stimulation (TENS), hotpack and ultrasound will be applied to both groups, and an exercise program will be given in the form of a home program.
Read the detailed description
Cervicogenic headache (CGH) is a unilateral chronic pain that begins in the neck and neck and radiates to the back of the head. Pain in the CGH originates from structures in the cervical region innervated by the C1-C3 spinal nerves. Therefore, possible causes of CGH: Art. atlantooccipital, art. atlantoaxialis, C2-C3 art. It is related to dysfunctions arising from zygapophysial , C2-C3 discus intervertebral, upper cervical spinal nerves and their roots, skeletal muscles, connective tissue and neurovascular structures in the region.
The aim of this study was to compare the effects of mechanical traction and manual traction on pain, muscle tone and functionality in cervicogenic headache.
52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).
After obtaining the sociodemographic information of the individuals to be included in the study, the patients will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.
The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.
Intermittent traction will be applied to CTG with the chattanooga tru trac traction device. They will be placed on the treatment bed on their back with their necks on the neck collar of the device. After the patients are fixed from the head, the device will be adjusted so that the pulling force of the device starts with 10% of the patients' body weight. The device will be set as 60 seconds of pulling force and 20 seconds of relaxation. Patients will be told that they should feel moderately strong or strong so that the pulling force does not increase symptoms. In the following sessions, the pulling force will be adjusted gradually according to the patient's previous traction treatment, tolerance and symptom response. Each session will last 15 minutes.
Manual traction, one of Cyriax's neck mobilization techniques, will be applied to the MTG. Vertebrobasilar artery test will be applied to the patients before starting the treatment, and manual traction will be applied to the patients in case the vertebrobasilar artery test is negative. Manual traction technique will be applied to the cervical region for 15 minutes. While applying manual traction, the patient will be placed on his back with his head hanging off the bed. Grasp the occiput with one hand and under the chin with the other. Manual traction will be applied by keeping the neck neutral and the occiput slightly extended. After applying traction for a few seconds, it will be slowly released and returned to the starting position, and the application will be made for 15 minutes.
Both groups will be given conventional treatment. In conventional treatment, TENS, hotpack and ultrasound will be performed on patients. TENS treatment will be applied using 4 adhesive electrodes measuring 5 x 5 cm. Cervical paravertebral region, 80 Hz frequency and 180 ms current were used and will be applied for 20 minutes. The current intensity that the patient can feel intensely will be adjusted. Hotpack hot application will be applied for 20-30 minutes. Ultrasound will be applied bilaterally to the cervical paravertebral region with the help of ultrasound gel at 1 megahertz (MHz) and 1.5 W/cm² for 4 minutes, with the ultrasound head in contact with the skin.
Craniocervical flexion exercises, chin tuck, scapular depression and retraction exercises will be given to both groups as a home program.
- Conditions
- Cervicogenic Headache
- Being tested
- mechanical traction group, manuel traction group
- Keywords
- Traction, Muscle Tone, Headache, Cervicogenic Pain
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical traction groupDevice
Also called TENS, ultrasound, hotpack, home exercise programme
In the mechanical traction group, 26 people with cervicogenic headache will be traction with the Chattanooga Tru Trac traction device, 6 days a week for 2 weeks.
Persons to be mechanically traction will be placed on their backs on the treatment bed with their necks on the neck collar of the device. After the patients are fixed to the head, the pulling force of the device will start with 10% of the patient's body weight, the device will be set as 60 seconds of pulling force and 20 seconds of relaxation. In subsequent sessions, the pulling force will be gradually adjusted based on the patient's previous traction therapy, tolerance, and symptom response. Each session will take 15 minutes.
Participants will be given 20 minutes of TENS, 20 minutes of hotpack and 4 minutes of ultrasound, and the exercise will be given as a home program.
manuel traction groupOther
Also called TENS, ultrasound, hotpack, home exercise programme
Manual traction, one of Cyriax's neck mobilization techniques, will be applied to the MTG. Vertebrobasilar artery test will be applied to the patients before starting the treatment, and manual traction will be applied to the patients in case the vertebrobasilar artery test is negative. Manual traction technique will be applied to the cervical region for 15 minutes. While applying manual traction, the patient will be placed on his back with his head hanging off the bed. Grasp the occiput with one hand and under the chin with the other. Manual traction will be applied by keeping the neck neutral and the occiput slightly extended. After applying traction for a few seconds, it will be slowly released and returned to the starting position, and the application will be made for 15 minutes.
20 minutes of TENS, 20 minutes of hotpack and 4 minutes of ultrasound will be applied to the participants, and the exercise will be given as a home program.
| Study group | Role | What they receive |
|---|---|---|
| mechanical traction group | Experimental | use of device chattanooga tru trac Receives: Device: mechanical traction group |
| manual traction group | Active comparator | use of manual traction with physiotherapist hands Receives: Other: manuel traction group |
What is being measured
The primary outcome is the main question the study is designed to answer.
sociodemographic information change
The sociodemographic information, education level, existence of problems of the individuals participating in the study will be questioned and recorded.
Measured: At baseline
visual analogue scale (VAS) change
In the evaluation made with VAS, patients will be asked to mark their pain intensity on a 10 cm horizontal line. Ranges for pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain
Measured: change from baseline the visual analogue scale at 2 weeks
Mc-Gill Melzack Pain Questionnaire change
With the McGill Melzack Pain Questionnaire, the location of the pain, the emotion it creates in the individual, its relationship with time, its severity and the level of livable pain for the individual will be determined.
Measured: change from baseline Mc-Gill Melzack Pain Questionnaire at 2 weeks
electrogoniometer change
The range of motion of the cervical region of the individuals participating in the study will be evaluated with an electrogoniometer. This device consists of six axes rotating potentiometers and seven connections. The end joints, which are considered fixed by the strapping system, are fixed at the level of the first thoracic vertebra. The other link is placed on the head with an adjustable helmet. This whole system is very light. It enables the monitoring of three-dimensional continuous and unrestricted neck movements relative to the thorax. The system measures flexion, extension, lateral flexion and rotation.
Measured: change from baseline electrogoniometer change at 2 weeks
MyotonPRO device change
The muscle tone of the individuals participating in the study will be evaluated with MyotonPRO. MyotonPRO is a portable device that measures muscle tone. It measures the mechanical impulses of the soft tissue with mechanical oscillations. A brief mechanical stimulus is applied to the skin over the muscle, followed by rapid relaxation. It measures the reflective resistance of the muscle to deformation of the applied force in Newtons/meter (N/m). The stiffness value is calculated as the ossification or maximum displacement of the tissue and the maximum acceleration. Larger values indicate a harder muscle. The muscle tone of the upper trapezius, sternocleidomastoid, and suboccipital muscles will be measured.
Measured: change from baseline MyotonPRO device change at 2 weeks
Flexion endurance test change
The endurance of the cervical flexor muscles of the individuals participating in the study will be measured with the craniocervical flexion test using a stabilizer device. People lie on their back in a hooked position. Individuals will then be asked to bring their necks into the chin tuck position and feel the neck position. Subjects will be set to 20 mmHg in the stabilizer device and will be asked to increase these pressures by 2 mmHg until they reach 30 mmHg, stay at each pressure for 30 seconds, and complete the test by giving a 30-second rest period after each pressure. The test will be stopped when the individual is unable to complete the test, is in position, and feels excruciating pain.
Measured: change from baseline Flexion endurance test change at 2 weeks
Extension endurance test change
In the endurance evaluation of neck extensors, subjects will lie face down on the examination bed with their hands at their sides and their heads will be suspended from the bed until they are at chest level. The two-pound weight will hang just above ear level. With this weight, they will be asked to lift their heads back and not change this position until they get tired. The time they can hold the position will be recorded in seconds.
Measured: change from baseline extension endurance test change at 2 weeks
Secondary outcomes (3)
Headache Impact Scale (HIT-6) change
Headache Impact Scale (HIT-6) will be applied to the individuals participating in the research. This scale consists of 6 items. This scale is used to evaluate how much a headache at work affects school, home and social life. It includes pain, social life, role task, energy, cognitive status, and psychological problems. The Turkish validity and reliability study of the scale was conducted. A score between 36 and 78 can be obtained from this scale. Grade 1: No effect if scale score ≤49, Grade 2: 50-55 moderately affected, Grade 3: 56-59 significantly affected, and Grade 4: ≥60 severely affected.
Measured: change from baseline Headache Impact Scale (HIT-6) at 2 weeks
Corbin Posture Index change
Posture analysis will be performed to determine the changes in the posture of the individuals included in the study. These changes will be scored using a form prepared by Corbin et al. that includes lateral and posterior observations. This form does not detect postural disorders by observation made from the two planes mentioned, but is based on scoring according to their severity. Head anterior tilt, rounded back, shoulder protraction, kyphosis, lordosis, abdominal prolapse, genu recurvatum, head lateral tilt, scapula protrusion, and scoliosis will be evaluated. Points will be summed last and postural status will be classified according to the total score. 0-2 points as excellent, 3-4 points as very good, 5-7 points as good, 8-11 points as moderate, >12 points as bad.
Measured: change from baseline Corbin Posture Index at 2 weeks
The Pittsburgh Sleep Quality Index (PSQI) change
The Pittsburgh Sleep Quality Index will be made to the participants in the study. PSQI is a scale that provides information about sleep quality and the type and severity of sleep disturbance in the last month. In this scale, the sleep quality of the person; sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleeping pill use, and daytime dysfunction. The Turkish validity and reliability study of the scale was conducted. Each of the questionnaire questions is scored between 0-3, with high scores reflecting poor sleep quality. If the total score obtained from the scale is below 5, it is defined as 'Good sleep quality', and if it is 5 and above, it is defined as 'Poor sleep quality'.
Measured: change from baseline The Pittsburgh Sleep Quality Index (PSQI) at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Feb 2022
- Primary completion10 Jun 2022 (estimated)
- Study completion26 Jun 2022 (estimated)
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.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berrak Varhan, Study director, İstinyeU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397977
- Sponsor's protocol ID
- 2/2021.K-85
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 31 May 2022
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Mechanical Traction and Manual Traction on Pain, Muscle Tone and Functionality in Persons With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05397977
- Acronym / sponsor ID
- 2/2021.K-85
- Conditions
- Cervicogenic Headache
- Keywords
- Traction, Muscle Tone, Headache, Cervicogenic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 26 Jun 2022 (estimated)
- First posted
- 31 May 2022 (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.
52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).
After obtaining the demographic information of the individuals to be included in the study, the cases will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.
The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.
Intermittent traction with chattanooga tru trac traction device will be applied to CTG, and manual traction, one of Cyriax's neck mobilization techniques, will be applied to MTG.transcutaneous electrical nerve stimulation (TENS), hotpack and ultrasound will be applied to both groups, and an exercise program will be given in the form of a home program.
Detailed description
Cervicogenic headache (CGH) is a unilateral chronic pain that begins in the neck and neck and radiates to the back of the head. Pain in the CGH originates from structures in the cervical region innervated by the C1-C3 spinal nerves. Therefore, possible causes of CGH: Art. atlantooccipital, art. atlantoaxialis, C2-C3 art. It is related to dysfunctions arising from zygapophysial , C2-C3 discus intervertebral, upper cervical spinal nerves and their roots, skeletal muscles, connective tissue and neurovascular structures in the region.
The aim of this study was to compare the effects of mechanical traction and manual traction on pain, muscle tone and functionality in cervicogenic headache.
52 people between the ages of 18-45 who were diagnosed with cervicogenic headache by the physician who applied to the Physical Medicine and Rehabilitation Department of Bursa VM Medical Park Hospital will be included in the research. 52 people will be randomized. They will be divided into two groups, 26 people in the study group and 26 people in the control group. The study group will be called the mechanical traction group (CTG), and the control group will be called the manual traction group (MTG).
After obtaining the sociodemographic information of the individuals to be included in the study, the patients will be evaluated with the visual analogue scale (VAS) and Mc-Gill Melzack Pain Questionnaire for head and neck pain before and after treatment. Cervical joint range of motion will be measured with an electrogoniometer, and muscle tone will be measured with myotonometer (MyotonPRO). Flexion and extension endurance tests will be performed on the cervical region muscles. Headache Impact Scale (HIT-6) will be performed to evaluate the functional status of the patients. Posture of patients will be evaluated with Corbin Posture Analysis. Pittsburgh Sleep Quality Index will be used to evaluate the sleep quality of the patients. All patients will be informed about the study. An informed consent form will be obtained from each.
The mechanical traction group (CTG) and the manual traction group (MTG) will be treated for 6 days and 2 weeks.
Intermittent traction will be applied to CTG with the chattanooga tru trac traction device. They will be placed on the treatment bed on their back with their necks on the neck collar of the device. After the patients are fixed from the head, the device will be adjusted so that the pulling force of the device starts with 10% of the patients' body weight. The device will be set as 60 seconds of pulling force and 20 seconds of relaxation. Patients will be told that they should feel moderately strong or strong so that the pulling force does not increase symptoms. In the following sessions, the pulling force will be adjusted gradually according to the patient's previous traction treatment, tolerance and symptom response. Each session will last 15 minutes.
Manual traction, one of Cyriax's neck mobilization techniques, will be applied to the MTG. Vertebrobasilar artery test will be applied to the patients before starting the treatment, and manual traction will be applied to the patients in case the vertebrobasilar artery test is negative. Manual traction technique will be applied to the cervical region for 15 minutes. While applying manual traction, the patient will be placed on his back with his head hanging off the bed. Grasp the occiput with one hand and under the chin with the other. Manual traction will be applied by keeping the neck neutral and the occiput slightly extended. After applying traction for a few seconds, it will be slowly released and returned to the starting position, and the application will be made for 15 minutes.
Both groups will be given conventional treatment. In conventional treatment, TENS, hotpack and ultrasound will be performed on patients. TENS treatment will be applied using 4 adhesive electrodes measuring 5 x 5 cm. Cervical paravertebral region, 80 Hz frequency and 180 ms current were used and will be applied for 20 minutes. The current intensity that the patient can feel intensely will be adjusted. Hotpack hot application will be applied for 20-30 minutes. Ultrasound will be applied bilaterally to the cervical paravertebral region with the help of ultrasound gel at 1 megahertz (MHz) and 1.5 W/cm² for 4 minutes, with the ultrasound head in contact with the skin.
Craniocervical flexion exercises, chin tuck, scapular depression and retraction exercises will be given to both groups as a home program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mechanical traction group | Experimental | Device: mechanical traction groupuse of device chattanooga tru trac |
| manual traction group | Active comparator | Other: manuel traction groupuse of manual traction with physiotherapist hands |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18-45
- having neck or headache for at least 3 months meets the diagnostic criteria for cervicogenic headache.
Key exclusion criteria (11 listed)
- migraine
- cluster headache
- cervical radiculopathy,
- entrapment neuropathy,
- myelopathy,
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 |
|---|---|---|
| mechanical traction groupAlso: TENS, ultrasound, hotpack, home exercise programmeIn the mechanical traction group, 26 people with cervicogenic headache will be traction with the Chattanooga Tru Trac traction device, 6 days a week for 2 weeks. Persons to be mechanically traction will be placed on their backs on the treatment bed with their necks on the neck collar of the device. After the patients are fixed to the head, the pulling force of the device will start with 10% of the patient's body weight, the device will be set as 60 seconds of pulling force and 20 seconds of relaxation. In subsequent sessions, the pulling force will be gradually adjusted based on the patient's previous traction therapy, tolerance, and symptom response. Each session will take 15 minutes. Participants will be given 20 minutes of TENS, 20 minutes of hotpack and 4 minutes of ultrasound, and the exercise will be given as a home program. | Device | mechanical traction group |
| manuel traction groupAlso: TENS, ultrasound, hotpack, home exercise programmeManual traction, one of Cyriax's neck mobilization techniques, will be applied to the MTG. Vertebrobasilar artery test will be applied to the patients before starting the treatment, and manual traction will be applied to the patients in case the vertebrobasilar artery test is negative. Manual traction technique will be applied to the cervical region for 15 minutes. While applying manual traction, the patient will be placed on his back with his head hanging off the bed. Grasp the occiput with one hand and under the chin with the other. Manual traction will be applied by keeping the neck neutral and the occiput slightly extended. After applying traction for a few seconds, it will be slowly released and returned to the starting position, and the application will be made for 15 minutes. 20 minutes of TENS, 20 minutes of hotpack and 4 minutes of ultrasound will be applied to the participants, and the exercise will be given as a home program. | Other | manual traction group |
Primary outcome
sociodemographic information change
Time frame: At baseline
The sociodemographic information, education level, existence of problems of the individuals participating in the study will be questioned and recorded.
visual analogue scale (VAS) change
Time frame: change from baseline the visual analogue scale at 2 weeks
In the evaluation made with VAS, patients will be asked to mark their pain intensity on a 10 cm horizontal line. Ranges for pain intensity; <3 mild pain, 3-6 moderate pain, >6 severe pain
Mc-Gill Melzack Pain Questionnaire change
Time frame: change from baseline Mc-Gill Melzack Pain Questionnaire at 2 weeks
With the McGill Melzack Pain Questionnaire, the location of the pain, the emotion it creates in the individual, its relationship with time, its severity and the level of livable pain for the individual will be determined.
electrogoniometer change
Time frame: change from baseline electrogoniometer change at 2 weeks
The range of motion of the cervical region of the individuals participating in the study will be evaluated with an electrogoniometer. This device consists of six axes rotating potentiometers and seven connections. The end joints, which are considered fixed by the strapping system, are fixed at the level of the first thoracic vertebra. The other link is placed on the head with an adjustable helmet. This whole system is very light. It enables the monitoring of three-dimensional continuous and unrestricted neck movements relative to the thorax. The system measures flexion, extension, lateral flexion and rotation.
MyotonPRO device change
Time frame: change from baseline MyotonPRO device change at 2 weeks
The muscle tone of the individuals participating in the study will be evaluated with MyotonPRO. MyotonPRO is a portable device that measures muscle tone. It measures the mechanical impulses of the soft tissue with mechanical oscillations. A brief mechanical stimulus is applied to the skin over the muscle, followed by rapid relaxation. It measures the reflective resistance of the muscle to deformation of the applied force in Newtons/meter (N/m). The stiffness value is calculated as the ossification or maximum displacement of the tissue and the maximum acceleration. Larger values indicate a harder muscle. The muscle tone of the upper trapezius, sternocleidomastoid, and suboccipital muscles will be measured.
Flexion endurance test change
Time frame: change from baseline Flexion endurance test change at 2 weeks
The endurance of the cervical flexor muscles of the individuals participating in the study will be measured with the craniocervical flexion test using a stabilizer device. People lie on their back in a hooked position. Individuals will then be asked to bring their necks into the chin tuck position and feel the neck position. Subjects will be set to 20 mmHg in the stabilizer device and will be asked to increase these pressures by 2 mmHg until they reach 30 mmHg, stay at each pressure for 30 seconds, and complete the test by giving a 30-second rest period after each pressure. The test will be stopped when the individual is unable to complete the test, is in position, and feels excruciating pain.
Extension endurance test change
Time frame: change from baseline extension endurance test change at 2 weeks
In the endurance evaluation of neck extensors, subjects will lie face down on the examination bed with their hands at their sides and their heads will be suspended from the bed until they are at chest level. The two-pound weight will hang just above ear level. With this weight, they will be asked to lift their heads back and not change this position until they get tired. The time they can hold the position will be recorded in seconds.
3 secondary outcomes
Headache Impact Scale (HIT-6) change
Time frame: change from baseline Headache Impact Scale (HIT-6) at 2 weeks
Corbin Posture Index change
Time frame: change from baseline Corbin Posture Index at 2 weeks
The Pittsburgh Sleep Quality Index (PSQI) change
Time frame: change from baseline The Pittsburgh Sleep Quality Index (PSQI) at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- 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.
Berrak Varhan study director
İstinyeU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical traction group and manuel traction group in people with Cervicogenic Headache, run by Istinye University 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 May 2022. 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?
Results are not available in the source record.
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?
sociodemographic information change (time frame: At baseline). The study lists 7 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 31 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.