Exercise Treatment in Tension Type Headache

NCT05431335 | Unknown

• 1 other identifier: KubraTTH2022
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-Type Headache

Keywords

Exercise; Aerobic exercise; Structured exercise; Tension-type headache; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (13)

• Change in pain severity

  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)

• Change in pain frequency

  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)

• Change in Pain duration,

  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)

• Change in Amount of painkiller use

  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)

• Change in Pressure pain threshold

  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)

Study Arms (2)

Structured exercise program

EXPERIMENTAL

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

Other: Structured exercise program

Aerobic exercise program

OTHER

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

Other: Aerobic exercise program

Interventions

Structured exercise program OTHER

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.

Structured exercise program

Aerobic exercise program OTHER

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.

Aerobic exercise program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Munzur University: lead

Study Sites (1)

Munzur Üniversity

Tunceli, 62000, Turkey (Türkiye)

RECRUITING

Related Links

• Effect of manual therapy techniques on headache disability in patients with tension-type headache. Randomized controlled trial.

MeSH Terms

Conditions

Tension-Type Headache; Motor Activity

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Kübra Sağır, PhD student

  Munzur University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Sağır, PhD student

CONTACT

+905300309205; kbrsgr46@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD student

Model Details: Parallel design randomized clinical trial

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 24, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)