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The Effects of Connective Tissue Massage and Lifestyle Modifications in Adolescents Tension Type Headache

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2015 by Emine BARAN, Hacettepe University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02549300
First Posted: September 15, 2015
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emine BARAN, Hacettepe University
  Purpose
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.

Condition Intervention
Headache Disorders, Primary Other: Connective tissue massage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Konnektif Doku Masajı ve Yaşam Stili Modifikasyonlarının Adölesanlarda Gerilim Tipi Baş Ağrısına Etkisi

Resource links provided by NLM:


Further study details as provided by Emine BARAN, Hacettepe University:

Primary Outcome Measures:
  • Pain Severity [ Time Frame: Change from baseline in pain severity at four weeks ]
    Pain severity will be measured with McGill Short Form Pain Questionnaire


Secondary Outcome Measures:
  • Pediatric Quality of Life Inventory (Turkish version of the questionnaire) [ Time Frame: Change from baseline in questionnaire at four weeks ]
  • Range of motion [ Time Frame: Change from baseline in range of motion at four weeks ]
    Cervical range of motion will be measured with an inclinometer.

  • Pressure pain threshold [ Time Frame: Change from baseline in pressure pain threshold measurement at four weeks ]
    Pressure pain thresholds will be measured at the dorsum of the second finger (middle phalanx) and at the anterior part of the temporal muscle, where palpation had revealed it to be most prominent.


Estimated Enrollment: 30
Study Start Date: April 2015
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
15 patients will be included in control group. Control group will just receive advices about life style modifications, such as teaching good postural habits, using right glasses, not smoking, regular and quality sleep habits.
Experimental: Study Group
15 patients will be included in study group. Study group will be treated with connective tissue massage in addition to life style modifications (such as teaching good postural habits, using right glasses, not smoking, regular and quality sleep habits.). Connective tissue massage will be applied 5 times a week, totally 20 sessions in a month. Each session lasts approximately 20-30 minutes. Connective tissue massage will be applied on basic part, lower thoracic, scapular, inter scapular and neck regions.
Other: Connective tissue massage
It is a manual reflex therapy in that it is applied with the therapist's hands which are in contact with the patient's skin. The assessment of the patient and the clinical decision-making that directs treatment is based on a theoretical model that assumes a reflex effect on the autonomic nervous system which is induced by manipulating the fascial layers within and beneath the skin.
Other Name: connective tissue manipulation

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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549300


Contacts
Contact: Emine Baran, PT +903123052533 ext 173 eminekbaran@gmail.com
Contact: Emine Baran, PT +903123052525 ext 173 eminekbaran@gmail.com

Locations
Turkey
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Recruiting
Ankara, Samanpazarı, Turkey, 06100
Contact: Emine Baran, PT    +903123052533 ext 173    eminekbaran@gmail.com   
Sponsors and Collaborators
Hacettepe University
Investigators
Principal Investigator: Türkan Akbayrak, Prof.Dr. Hacettepe University
  More Information

Publications:

Responsible Party: Emine BARAN, Research Assistant Emine Baran, Hacettepe University
ClinicalTrials.gov Identifier: NCT02549300     History of Changes
Other Study ID Numbers: HU
First Submitted: March 18, 2015
First Posted: September 15, 2015
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Emine BARAN, Hacettepe University:
connective tissue massage
adolescent tension-type headache

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Headache Disorders
Headache Disorders, Primary
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases