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Exercise Treatment in Tension Type Headache

Primary Purpose

Tension-Type Headache

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Structured exercise program
Aerobic exercise program
Sponsored by
Munzur University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Exercise, Aerobic exercise, Structured exercise, Tension-type headache, Quality of life

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Munzur ÜniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Structured exercise program

Aerobic exercise program

Arm Description

The structured exercise program will be applied for 12 weeks, 2 days a week, for 45 minutes by a physiotherapist.

The aerobic exercise program will be applied for 12 weeks, 2 days a week, for 45 minutes by a physiotherapist.

Outcomes

Primary Outcome Measures

Change in pain-related quality of life
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
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
Pain frequency will be followed up with a pain diary during the 8-week treatment period.
Change in Pain duration,
Pain duration will be followed up with a pain diary during the 8-week treatment period.
Change in Amount of painkiller use
Use of painkillers will be followed up with a pain diary during the 8-week treatment period.
Change in Pressure pain threshold
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
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
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
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 Proprioception
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
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
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
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
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.

Full Information

First Posted
June 14, 2022
Last Updated
August 21, 2023
Sponsor
Munzur University
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1. Study Identification

Unique Protocol Identification Number
NCT05431335
Brief Title
Exercise Treatment in Tension Type Headache
Official Title
Investigation of the Efficacy of Structured Exercise Program in Tension-Type Headache
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Munzur University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 12 weeks, 2 days a week for 45 minutes. Participants will be evaluated with outcome scales before and after exercise programs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Exercise, Aerobic exercise, Structured exercise, Tension-type headache, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel design randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Structured exercise program
Arm Type
Experimental
Arm Description
The structured exercise program will be applied for 12 weeks, 2 days a week, for 45 minutes by a physiotherapist.
Arm Title
Aerobic exercise program
Arm Type
Other
Arm Description
The aerobic exercise program will be applied for 12 weeks, 2 days a week, for 45 minutes by a physiotherapist.
Intervention Type
Other
Intervention Name(s)
Structured exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain-related quality of life
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Secondary Outcome Measure Information:
Title
Change in pain severity
Description
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.
Time Frame
1- a day before the exercise program 2- and of the 4 weeks of exercise, 3- and of the 8 weeks of exercise, 4-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in pain frequency
Description
Pain frequency will be followed up with a pain diary during the 8-week treatment period.
Time Frame
1- a day before the exercise program 2- and of the 4 weeks of exercise, 3- and of the 8 weeks of exercise, 4-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Pain duration,
Description
Pain duration will be followed up with a pain diary during the 8-week treatment period.
Time Frame
1- a day before the exercise program 2- and of the 4 weeks of exercise, 3- and of the 8 weeks of exercise, 4-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Amount of painkiller use
Description
Use of painkillers will be followed up with a pain diary during the 8-week treatment period.
Time Frame
1- a day before the exercise program 2- and of the 4 weeks of exercise, 3- and of the 8 weeks of exercise, 4-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Pressure pain threshold
Description
Trapezius, levator scapula, suboccipital, pectorals, and deltoid muscles will be evaluated with palpation, trigger point pressure pain threshold will be measured with an dolorimeter.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Pain-related disability
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in cervical flexor muscle activation score
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in cervical flexor muscle performance index
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Proprioception
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Craniovertebral angle
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in cervical region posture
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Exercise capacity
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)
Title
Change in Anxiety and depression
Description
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.
Time Frame
1- a day before the exercise program 2-at the midst of treatment (and of the 8 weeks exercise) 3-at the time of discharge (end of the 12 weeks exercise program)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having a diagnosis of chronic TTH according to the criteria of the International Headache Society (ICHD-III beta version, 2013) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra Sağır, PhD student
Phone
+905300309205
Email
kbrsgr46@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kübra Sağır, PhD student
Organizational Affiliation
Munzur University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Munzur Üniversity
City
Tunceli
ZIP/Postal Code
62000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sedat Ayden
Phone
428 213 23 48
Ext
+90
Email
genelsekreter@munzur.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://europepmc.org/article/med/24785463
Description
Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial.
URL
http://www.mdpi.com/1660-4601/18/7/3410
Description
Effect of 4 Weeks of Cervical Deep Muscle Flexion Exercise on Headache and Sleep Disorder in Patients with Tension Headache and Forward Head Posture
URL
http://www.ajol.info/index.php/ajtcam/article/view/152064
Description
The effect of body awareness therapy and aerobic exercises on pain and quality of life in the patients with tension type headache

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Exercise Treatment in Tension Type Headache

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