Clinical trial NCT02549300: The Effects of Connective Tissue Massage and Lifestyle Modifications in Adolescents Tension Type Headache
Official title: Konnektif Doku Masajı ve Yaşam Stili Modifikasyonlarının Adölesanlarda Gerilim Tipi Baş Ağrısına Etkisi
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache Disorders, Primary
Keywords: connective tissue massage
adolescent tension-type headache
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of connective tissue massage and lifestyle modifications in adolescents tension type headache, pain severity, pain duration, pain frequency and quality of life and pressure pain threshold rates. The patients will be accepted to study according to 'The International Classification of Headache Disorders-III' criteria. Including criteria are; being between 10-19 ages adolescents, suffering from tension type headache at least for 6 months, pain severity between 4-7 on visual analog scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic accident, head trauma and any kind of neurological disorder. Patients will be divided into two groups randomly. The investigators plan to receive 30 patients to the study. 15 of them will be in control group, 15 in study group. Control group will just receive some advices including life style modifications, like using right glasses, not smoking, true posture habits and regular and quality sleep habits. In addition to life style modifications, the other group will be treated with connective tissue massage. Connective tissue massage will be applied on basic part, lower thoracic, scapular, inter scapular and neck regions, 5 times a week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes. Patients detailed medical history and demographic data will be recorded. Pain severity, duration, frequency, analgesic usage, connective tissue evaluation of back, range of motion of neck, pressure pain threshold for pain sensitization measurements and quality of life will be evaluated before treatment and after 4 weeks of treatment.

Detailed description: The patients will be accepted to study according to 'The International Classification of Headache Disorders-III'. Including criteria are; being between 10-19 aged adolescents, suffering from tension type headache at least for 6 months, pain severity between 4-7 on visual analog scale. Excluding criteria are; current pregnancy, having any history of cancer, traffic accident, head trauma and any kind of neurological disorder. Patients will be divided into two groups randomly. Control group will be taught some advices about life style modifications, like using right glasses, teaching true posture, regular and quality sleep habits. In addition to life style modifications, the other group will be treated with connective tissue massage. Connective tissue massage will be applied 5 times a week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes.

Eligibility criteria: Inclusion Criteria:

* Adolescents between 10-19 ages
* Prognosed with tension type headache according to 'The International Classification of Headache Disorders-III' criteria
* Suffering from tension type headache for at least 6 months
* Pain severity must be between 4-7 on visual analog scale

Exclusion Criteria:

* Current pregnancy
* Any kind of cancer history
* History of head trauma
* Any kind of neurological disorder
* Receiving physiotherapy in last 6 months
* Unwillingness to participate in the study

Primary outcomes:
measure: Pain Severity
timeFrame: Change from baseline in pain severity at four weeks
Secondary outcomes:
measure: Pediatric Quality of Life Inventory (Turkish version of the questionnaire)
timeFrame: Change from baseline in questionnaire at four weeks
measure: Range of motion
timeFrame: Change from baseline in range of motion at four weeks
measure: Pressure pain threshold
timeFrame: Change from baseline in pressure pain threshold measurement at four weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Samanpazarı
Study officials:
affiliation: Hacettepe University
name: Türkan Akbayrak, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
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