NCT02549300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

March 18, 2015

Last Update Submit

September 11, 2015

Conditions

Headache Disorders, Primary

Keywords

connective tissue massageadolescent tension-type headache

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    Pain severity will be measured with McGill Short Form Pain Questionnaire

    Change from baseline in pain severity at four weeks

Secondary Outcomes (3)

  • Pediatric Quality of Life Inventory (Turkish version of the questionnaire)

    Change from baseline in questionnaire at four weeks

  • Range of motion

    Change from baseline in range of motion at four weeks

  • Pressure pain threshold

    Change from baseline in pressure pain threshold measurement at four weeks

Study Arms (2)

Control Group

NO INTERVENTION

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.

Study Group

EXPERIMENTAL

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

Interventions

Connective tissue massageOTHER

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.

Also known as: connective tissue manipulation
Study Group

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Samanpazarı, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (12)

  • Grimmer K, Nyland L, Milanese S. Repeated measures of recent headache, neck and upper back pain in Australian adolescents. Cephalalgia. 2006 Jul;26(7):843-51. doi: 10.1111/j.1468-2982.2006.01120.x.

    PMID: 16776700RESULT

  • Albers L, Milde-Busch A, Bayer O, Lehmann S, Riedel C, Bonfert M, Heinen F, Straube A, von Kries R. Prevention of headache in adolescents: population-attributable risk fraction for risk factors amenable to intervention. Neuropediatrics. 2013 Feb;44(1):40-5. doi: 10.1055/s-0032-1332742. Epub 2013 Jan 8.

    PMID: 23299655RESULT

  • 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.

    PMID: 15012658RESULT

  • Oksanen A, Metsahonkala L, Viander S, Jappila E, Aromaa M, Anttila P, Salminen J, Sillanpaa M. Strength and mobility of the neck-shoulder region in adolescent headache. Physiother Theory Pract. 2006 Sep;22(4):163-74. doi: 10.1080/09593980600822800.

    PMID: 16920676RESULT

  • Borusiak P, Biedermann H, Bosserhoff S, Opp J. Lack of efficacy of manual therapy in children and adolescents with suspected cervicogenic headache: results of a prospective, randomized, placebo-controlled, and blinded trial. Headache. 2010 Feb;50(2):224-30. doi: 10.1111/j.1526-4610.2009.01550.x. Epub 2009 Oct 21.

    PMID: 19845788RESULT

  • Walter S. Lifestyle behaviors and illness-related factors as predictors of recurrent headache in U.S. adolescents. J Neurosci Nurs. 2014 Dec;46(6):337-50. doi: 10.1097/JNN.0000000000000095.

    PMID: 25365048RESULT

  • Holey LA, Dixon J. Connective tissue manipulation: a review of theory and clinical evidence. J Bodyw Mov Ther. 2014 Jan;18(1):112-8. doi: 10.1016/j.jbmt.2013.08.003. Epub 2013 Sep 8.

    PMID: 24411158RESULT

  • Castien RF, van der Windt DA, Grooten A, Dekker J. Effectiveness of manual therapy for chronic tension-type headache: a pragmatic, randomised, clinical trial. Cephalalgia. 2011 Jan;31(2):133-43. doi: 10.1177/0333102410377362. Epub 2010 Jul 20.

    PMID: 20647241RESULT

  • Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.

    PMID: 10024117RESULT

  • Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.

    PMID: 17106618RESULT

  • Olesen J. ICHD-3 beta is published. Use it immediately. Cephalalgia. 2013 Jul;33(9):627-8. doi: 10.1177/0333102413487610. No abstract available.

    PMID: 23771275RESULT

  • Buchgreitz L, Lyngberg AC, Bendtsen L, Jensen R. Frequency of headache is related to sensitization: a population study. Pain. 2006 Jul;123(1-2):19-27. doi: 10.1016/j.pain.2006.01.040. Epub 2006 Apr 13.

    PMID: 16630694RESULT

MeSH Terms

Conditions

Headache Disorders, Primary

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Türkan Akbayrak, Prof.Dr.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Baran, PT

CONTACT

+903123052533eminekbaran@gmail.com

Emine Baran, PT

CONTACT

+903123052525eminekbaran@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 Emine Baran

Study Record Dates

First Submitted

March 18, 2015

First Posted

September 15, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

TU(1)