Clinical trial NCT05431335: Exercise Treatment in Tension Type Headache
Official title: Investigation of the Efficacy of Structured Exercise Program in Tension-Type Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tension-Type Headache
Keywords: Exercise
Aerobic exercise
Structured exercise
Tension-type headache
Quality of life
Lead sponsor: Munzur University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design randomized clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in pain-related quality of life
timeFrame: 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 outcomes:
measure: Change in pain severity
timeFrame: 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)
measure: Change in pain frequency
timeFrame: 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)
measure: Change in Pain duration,
timeFrame: 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)
measure: Change in Amount of painkiller use
timeFrame: 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)
measure: Change in Pressure pain threshold
timeFrame: 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)
measure: Change in Pain-related disability
timeFrame: 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)
measure: Change in cervical flexor muscle activation score
timeFrame: 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)
measure: Change in cervical flexor muscle performance index
timeFrame: 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)
measure: Change in Proprioception
timeFrame: 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)
measure: Change in Craniovertebral angle
timeFrame: 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)
measure: Change in cervical region posture
timeFrame: 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)
measure: Change in Exercise capacity
timeFrame: 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)
measure: Change in Anxiety and depression
timeFrame: 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)
Other outcomes:
Locations:
city: Tunceli
country: Turkey
facility: Munzur Üniversity
Study officials:
affiliation: Munzur University
name: Kübra Sağır, PhD student
role: PRINCIPAL_INVESTIGATOR
References: