ClinicalTrials.gg
Status unknownNCT02549300Updated Sep 15, 2015

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

An interventional study of Connective tissue massage in Headache Disorders, Primary, sponsored by Hacettepe University. Status unknown at 1 site in Turkey. Open to participants aged 10 Years to 19 Years. Per ClinicalTrials.gov, last updated 2015-09-15.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
10 Years to 19 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Headache Disorders, Primary

Keywords

  • connective tissue massage
  • adolescent tension-type headache
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In context

Headache Disorders, Primary

42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 19 interventional studies indexed under Headache Disorders, Primary.

Browse Headache Disorders, Primary studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • OtherConnective 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.

    Also known as: connective tissue manipulation

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What researchers measure

Primary outcomes

  1. Pain Severity

    Pain severity will be measured with McGill Short Form Pain Questionnaire

    Time frame: Change from baseline in pain severity at four weeks

Secondary outcomes

  1. Pediatric Quality of Life Inventory (Turkish version of the questionnaire)

    Time frame: Change from baseline in questionnaire at four weeks

  2. Range of motion

    Cervical range of motion will be measured with an inclinometer.

    Time frame: Change from baseline in range of motion at four weeks

  3. 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.

    Time frame: Change from baseline in pressure pain threshold measurement at four weeks

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Study locations

1 of 1 sites recruiting
  • Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
    Ankara, Samanpazarı 06100, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 16776700 ↗
  • 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. PubMed 23299655 ↗
  • 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. PubMed 15012658 ↗
  • 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. PubMed 16920676 ↗
  • 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. PubMed 19845788 ↗
  • 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. PubMed 25365048 ↗
  • 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. PubMed 24411158 ↗
  • 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. PubMed 20647241 ↗
  • 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. PubMed 10024117 ↗
  • 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. PubMed 17106618 ↗
  • Olesen J. ICHD-3 beta is published. Use it immediately. Cephalalgia. 2013 Jul;33(9):627-8. doi: 10.1177/0333102413487610. No abstract available. PubMed 23771275 ↗
  • 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. PubMed 16630694 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02549300
Responsible party
Emine BARAN (Research Assistant Emine Baran, Hacettepe University) — Principal investigator
First posted
Sep 15, 2015
Start date
Apr 2015
Primary completion
Apr 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Sep 15, 2015

Study contacts

Emine Baran, PT
Contact
eminekbaran@gmail.com
+903123052533 ext. 173
Emine Baran, PT
Contact
eminekbaran@gmail.com
+903123052525 ext. 173
Türkan Akbayrak, Prof.Dr.
principal investigator · Hacettepe University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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