Clinical trial NCT05397977: Comparison of the Effects of Mechanical Traction and Manual Traction on Cervicogenic Headache
Official title: Comparison of the Effects of Mechanical Traction and Manual Traction on Pain, Muscle Tone and Functionality in Persons With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Traction, Muscle Tone, Headache, Cervicogenic Pain
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-45
* having neck or headache for at least 3 months meets the diagnostic criteria for cervicogenic headache.

  1. Unilateral pain
  2. Decreased neck range of motion
  3. Ipsilateral shoulder discomfort
  4. Ipsilateral arm discomfort
  5. Pain increase with different neck movements and pain with palpation eligible persons will be included.

Exclusion Criteria:

* migraine
* cluster headache
* cervical radiculopathy,
* entrapment neuropathy,
* myelopathy,
* rheumatoid arthritis,
* 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.

Primary outcomes:
measure: sociodemographic information change
timeFrame: At baseline
measure: visual analogue scale (VAS) change
timeFrame: change from baseline the visual analogue scale at 2 weeks
measure: Mc-Gill Melzack Pain Questionnaire change
timeFrame: change from baseline Mc-Gill Melzack Pain Questionnaire at 2 weeks
measure: electrogoniometer change
timeFrame: change from baseline electrogoniometer change at 2 weeks
measure: MyotonPRO device change
timeFrame: change from baseline MyotonPRO device change at 2 weeks
measure: Flexion endurance test change
timeFrame: change from baseline Flexion endurance test change at 2 weeks
measure: Extension endurance test change
timeFrame: change from baseline extension endurance test change at 2 weeks
Secondary outcomes:
measure: Headache Impact Scale (HIT-6) change
timeFrame: change from baseline Headache Impact Scale (HIT-6) at 2 weeks
measure: Corbin Posture Index change
timeFrame: change from baseline Corbin Posture Index at 2 weeks
measure: The Pittsburgh Sleep Quality Index (PSQI) change
timeFrame: change from baseline The Pittsburgh Sleep Quality Index (PSQI) at 2 weeks
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa VM Medical Park Hospital
state: Osmangazi
Study officials:
affiliation: İstinyeU
name: Berrak Varhan
role: STUDY_DIRECTOR
References: