Comparison of the Effects of Mechanical Traction and Manual Traction on Cervicogenic Headache

NCT05397977 | Unknown

• 1 other identifier: 2/2021.K-85
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache

Keywords

Traction, Muscle Tone, Headache, Cervicogenic Pain

Outcome Measures

Primary Outcomes (7)

• sociodemographic information change

  The sociodemographic information, education level, existence of problems of the individuals participating in the study will be questioned and recorded.

  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

  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.

  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.

  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.

  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.

  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.

  change from baseline extension endurance test change at 2 weeks

Secondary Outcomes (3)

• Headache Impact Scale (HIT-6) change

  change from baseline Headache Impact Scale (HIT-6) at 2 weeks

• Corbin Posture Index change

  change from baseline Corbin Posture Index at 2 weeks

• The Pittsburgh Sleep Quality Index (PSQI) change

  change from baseline The Pittsburgh Sleep Quality Index (PSQI) at 2 weeks

Study Arms (2)

mechanical traction group

EXPERIMENTAL

use of device chattanooga tru trac

Device: mechanical traction group

manual traction group

ACTIVE COMPARATOR

use of manual traction with physiotherapist hands

Other: manuel traction group

Interventions

mechanical traction group DEVICE

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.

Also known as: TENS, ultrasound, hotpack, home exercise programme

mechanical traction group

manuel traction group OTHER

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.

Also known as: TENS, ultrasound, hotpack, home exercise programme

manual traction group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Bursa VM Medical Park Hospital

Bursa, Osmangazi, 16220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Headache

Interventions

Transcutaneous Electric Nerve Stimulation; Ultrasonography; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Berrak Varhan

  İstinyeU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 31, 2022
• Study Start: February 10, 2022
• Primary Completion: June 10, 2022
• Study Completion: June 26, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)