Exercise Treatment in Tension Type Headache

Sponsor

Munzur University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05431335

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Tension-type headache (TTH) is a common type of headache. Its incidence in women has been reported as 18%. It is thought to be associated with stress, contractions in peripheral muscles, and changes in pain transmission and inhibition mechanisms in the central nervous system. As a chronic pain, it can cause a decrease in the quality of life and work capacity, and significant disabilities in daily living activities and functions of the person.

Exercise treatments are one of the non-pharmacological methods in the management of TTH. Exercise reduces pain by activating descending inhibitory pathways, reducing stress response, increasing relaxation and oxygenation, and thus provides healing. By this mechanism, the effects of aerobic exercise programs on pain severity, depression, and quality of life in migraine and TTH have been demonstrated. One of the underlying causes of TTH is head-forward posture, causing ischemia, increased muscle tone, and abnormal loads in the upper cervical region. Therefore, cervical region strengthening and deep cervical flexor stabilization exercises also have an effect on TTH. Although it has been shown in the literature that different types of isolated exercise are superior to control groups in TTH, there is a need for higher quality studies showing the effect of exercise. There is a lack of evidence on the feasibility and effectiveness of combined exercise programs. It is thought that additional benefits can be obtained by using exercise types in combination in order to focus on the central and peripheral mechanisms of TTH. The effects of a structured exercise program in which aerobic, strengthening, and stretching exercises are used together are intriguing. The aim of our study is to determine the effects of the structured exercise program and whether it is superior to isolated aerobic exercises. Our study will also provide evidence to the literature on the effects of aerobic exercise programs.

64 volunteer patients who were diagnosed with chronic TTH in the neurology outpatient clinic and met the inclusion criteria will be included. Participants will be included in one of the structured exercise programs and aerobic exercise programs. Both exercise programs are planned for 8 weeks, 2 days a week for 45 minutes. Participants will be evaluated with outcome scales before and after exercise programs.

Condition or Disease	Intervention/Treatment	Phase
Tension-Type Headache	Other: Structured exercise program Other: Aerobic exercise program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel design randomized clinical trialParallel design randomized clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Investigation of the Efficacy of Structured Exercise Program in Tension-Type Headache

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Structured exercise program The structured exercise program will be applied for 8 weeks, 2 days a week, for 45 minutes by a physiotherapist.	Other: Structured exercise program It consists of aerobic exercise combined with breathing, strengthening exercises, and stretching exercises. Aerobic exercise will be performed similarly to the other group, only consisting of a five-minute warm-up period and a 15-minute aerobic load period. Strengthening exercises consist of deep cervical flexor muscles and shoulder region resistive exercises. Each exercise will be repeated as 15 repetitions, 2 sets. Stretching exercises are neck region stretching exercises. Each exercise will be performed with 10 seconds of stretching and 5 repetitions.
Other: Aerobic exercise program The aerobic exercise program will be applied for 8 weeks, 2 days a week, for 45 minutes by a physiotherapist.	Other: Aerobic exercise program Aerobic exercise intensity will be determined by the Perceived Fatigue Scale (Borg scale). It consists of a ten-minute warm-up period (Borg 11), a 15-minute aerobic load (Borg 13-14), and a five-minute cool-down period(Borg 11). The warm-up and cool-down periods include brisk walking combined with breathing, and calisthenic exercises involving the upper and lower extremities; the loading period consists of exercises using a step-dance board accompanied by music. The number of repetitions will be increased progressively to keep the exercise intensity constant.

Arm

Intervention/Treatment

Experimental: Structured exercise program

The structured exercise program will be applied for 8 weeks, 2 days a week, for 45 minutes by a physiotherapist.

Other: Structured exercise program

It consists of aerobic exercise combined with breathing, strengthening exercises, and stretching exercises. Aerobic exercise will be performed similarly to the other group, only consisting of a five-minute warm-up period and a 15-minute aerobic load period. Strengthening exercises consist of deep cervical flexor muscles and shoulder region resistive exercises. Each exercise will be repeated as 15 repetitions, 2 sets. Stretching exercises are neck region stretching exercises. Each exercise will be performed with 10 seconds of stretching and 5 repetitions.

Other: Aerobic exercise program

The aerobic exercise program will be applied for 8 weeks, 2 days a week, for 45 minutes by a physiotherapist.

Other: Aerobic exercise program

Aerobic exercise intensity will be determined by the Perceived Fatigue Scale (Borg scale). It consists of a ten-minute warm-up period (Borg 11), a 15-minute aerobic load (Borg 13-14), and a five-minute cool-down period(Borg 11). The warm-up and cool-down periods include brisk walking combined with breathing, and calisthenic exercises involving the upper and lower extremities; the loading period consists of exercises using a step-dance board accompanied by music. The number of repetitions will be increased progressively to keep the exercise intensity constant.

Outcome Measures

Primary Outcome Measures

Change in pain-related quality of life [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be measured by the headache impact test (HIT-6). It provides quantitative information about migraine and headache, based on the patient's self-report. The scale consists of six items and questions pain severity, loss of work and leisure activity, fatigue, and cognitive characteristics. The score range of the scale is 36-78. As a result, ≤49 points are considered as no effect, 50-55 as moderately affected, 56-59 as markedly affected, and ≥60 as severely affected. Its validity and reliability study was maden.

Secondary Outcome Measures

Change in pain severity [1- a day before the exercise program 2- 2nd week of exercise, 3- 3rd week of exercise, 4-4th week of exercise, 5- 5th week of exercise, 6- 6th week of exercise, 7- 7th week of exercise, 8-at the time of discharge (end of the 8 weeks exercise program)]
The pain severity will be evaluated using a 0-10 point visual analog scale (VAS). It will be evaluated with a pain diary every weeks.
Change in pain frequency [1- a day before the exercise program 2- 2nd week of exercise, 3- 3rd week of exercise, 4-4th week of exercise, 5- 5th week of exercise, 6- 6th week of exercise, 7- 7th week of exercise, 8-at the time of discharge (end of the 8 weeks exercise program)]
Pain frequency will be followed up with a pain diary during the 8-week treatment period.
Change in Pain duration, [1- a day before the exercise program 2- 2nd week of exercise, 3- 3rd week of exercise, 4-4th week of exercise, 5- 5th week of exercise, 6- 6th week of exercise, 7- 7th week of exercise, 8-at the time of discharge (end of the 8 weeks exercise program)]
Pain duration will be followed up with a pain diary during the 8-week treatment period.
Change in Amount of painkiller use [1- a day before the exercise program 2- 2nd week of exercise, 3- 3rd week of exercise, 4-4th week of exercise, 5- 5th week of exercise, 6- 6th week of exercise, 7- 7th week of exercise, 8-at the time of discharge (end of the 8 weeks exercise program)]
Use of painkillers will be followed up with a pain diary during the 8-week treatment period.
Change in Pressure pain threshold [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
Trapezius, levator scapula, suboccipital, pectorals, and deltoid muscles will be evaluated with palpation, trigger point pressure pain threshold will be measured with an dolorimeter.
Change in Pain-related disability [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be evaluated with the Pain Disability Index. The scale is a simple and fast tool used to measure the limitation of daily functions due to pain in patients with chronic pain. It consists of a total of 7 parameters: family and home responsibilities, entertainment, social activity, profession, sexual life, self-care and daily life activities. The lowest score that can be obtained from the scale is 0, and the highest score is 70. A high score indicates a high disability level.
Change in cervical flexor muscle activation score [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
Cranio-cervical Flexion Test will be used to evaluate cervical flexor muscle strength. It will be evaluated with the Cranio-cervical Flexion Test. The test evaluates the activation and isometric endurance of the deep cervical flexor muscles. The test will be evaluated with the stabilizer pressure biofeedback device developed by Physiotherapist Gwendolen Jull. It is the minimal pressure score measured.
Change in cervical flexor muscle performance index [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
Cranio-cervical Flexion Test will be used to evaluate cervical flexor muscle strength. It will be evaluated with the Cranio-cervical Flexion Test. The test evaluates the activation and isometric endurance of the deep cervical flexor muscles. The test will be evaluated with the stabilizer pressure biofeedback device developed by Physiotherapist Gwendolen Jull. It is obtained by calculating all the contractions the participant was able to achieve.
Change in Thoracic mobility [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be evaluated with the thoracic schober test. The 7th cervical spinous process and below 30 cm are marked, the distance is measured while the patient is standing and then in the forward-bent position. The difference between these two measurements is recorded.
Change in Proprioception [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
The sense of cervical proprioception will be measured. "Head repositioning" targeting the neutral position of the head and "target angle tests" targeting 20˚ extension, 30˚ flexion, 30˚ lateral flexion and 30˚ rotation angles of the neck will be measured.
Change in Craniovertebral angle [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be used to measure cervical posture. For the craniovertebral angle measurement, the angle between the horizontal plane and the line drawn over the tragus and cervical 7th spine is measured.
Change in cervical region posture [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
PostureScreen Mobile® app (PostureCo; http://postureanalysis.com/mobile/) will be used to measure head, neck and shoulder posture.The application has been shown to be valid and reliable for posture assessment. With the application, the angular values of the patient's posture are automatically created by taking the image of the patient from the front and both lateral sides.
Change in Exercise capacity [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be evaluated with the Six Minute Walk Test, which is a submaximal exercise test. After walking for 6 minutes on a 20 or 30 meter track in a straight corridor, the total distance walked is recorded in meters.
Change in Anxiety and depression [1- a day before the exercise program 2- at the time of discharge (end of the 8 weeks exercise program)]
It will be evaluated with The Hospital Anxiety and Depression Scale. The scale consists of 7 anxiety and 7 depression questions answered with a four-point Likert scale. As a result of the validity and reliability study, cut-off scores were found to be 10/11 for the anxiety subscale and 7/8 for the depression subscale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Having a diagnosis of chronic TTH according to the criteria of the International Headache Society (ICHD-III beta version, 2013)
Pain intensity values are between 4 and 7 according to the visual analog scale
If using antidepressant medication, to start using medication 2 months before participating in the study.
not having a communication difficulty or problem,

Exclusion Criteria:

Having heart disease, cardiac arrhythmia, cardiovascular disease
Receiving chemotherapy, radiotherapy with malignancy and causing malignancy
Having any neurological or orthopedic disorder that will disrupt the balance
being pregnant
Being addicted to alcohol and drugs
Having a history of Disc herniation, Radiculopathy, and Surgery in the cervical region
Increase in pain severity during treatment sessions
Not attending more than three treatment sessions