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

Primary Purpose

Headache Disorders, Primary

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective tissue massage
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders, Primary focused on measuring connective tissue massage, adolescent tension-type headache

Eligibility Criteria

10 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Study Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Severity
Pain severity will be measured with McGill Short Form Pain Questionnaire

Secondary Outcome Measures

Pediatric Quality of Life Inventory (Turkish version of the questionnaire)
Range of motion
Cervical range of motion will be measured with an inclinometer.
Pressure pain threshold
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.

Full Information

First Posted
March 18, 2015
Last Updated
September 11, 2015
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT02549300
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders, Primary
Keywords
connective tissue massage, adolescent tension-type headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Connective tissue massage
Other Intervention Name(s)
connective tissue manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Severity
Description
Pain severity will be measured with McGill Short Form Pain Questionnaire
Time Frame
Change from baseline in pain severity at four weeks
Secondary Outcome Measure Information:
Title
Pediatric Quality of Life Inventory (Turkish version of the questionnaire)
Time Frame
Change from baseline in questionnaire at four weeks
Title
Range of motion
Description
Cervical range of motion will be measured with an inclinometer.
Time Frame
Change from baseline in range of motion at four weeks
Title
Pressure pain threshold
Description
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.
Time Frame
Change from baseline in pressure pain threshold measurement at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Baran, PT
Phone
+903123052533
Ext
173
Email
eminekbaran@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Baran, PT
Phone
+903123052525
Ext
173
Email
eminekbaran@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Türkan Akbayrak, Prof.Dr.
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
State/Province
Samanpazarı
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine Baran, PT
Phone
+903123052533
Ext
173
Email
eminekbaran@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16776700
Citation
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Citation
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PubMed Identifier
15012658
Citation
Breuner CC, Smith MS, Womack WM. Factors related to school absenteeism in adolescents with recurrent headache. Headache. 2004 Mar;44(3):217-22. doi: 10.1111/j.1526-4610.2004.04050.x.
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PubMed Identifier
16920676
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Citation
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Results Reference
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The Effects of Connective Tissue Massage and Lifestyle Modifications in Adolescents Tension Type Headache

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