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

Headache Disorders, Primary Clinical Trial

Official title:

Konnektif Doku Masajı ve Yaşam Stili Modifikasyonlarının Adölesanlarda Gerilim Tipi Baş Ağrısına Etkisi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02549300
• Other study ID #: HU
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2015
• Last updated: September 11, 2015
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Hacettepe University
• Contact: Emine Baran, PT
• Phone: +903123052533
• Email: eminekbaran[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Tension-Type Headache

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Ankara	Samanpazari

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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- — View Citation

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):224-3 — View Citation

Breuner CC, Smith MS, Womack WM. Factors related to school absenteeism in adolescents with recurrent headache. Headache. 2004 Mar;44(3):217-22. — View Citation

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. Epub 2006 Apr 13. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Oksanen A, Metsähonkala L, Viander S, Jäppilä E, Aromaa M, Anttila P, Salminen J, Sillanpää M. Strength and mobility of the neck-shoulder region in adolescent headache. Physiother Theory Pract. 2006 Sep;22(4):163-74. — View Citation

Olesen J. ICHD-3 beta is published. Use it immediately. Cephalalgia. 2013 Jul;33(9):627-8. doi: 10.1177/0333102413487610. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Nov 15. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	Pain severity will be measured with McGill Short Form Pain Questionnaire	Change from baseline in pain severity at four weeks	No
Secondary	Pediatric Quality of Life Inventory (Turkish version of the questionnaire)		Change from baseline in questionnaire at four weeks	No
Secondary	Range of motion	Cervical range of motion will be measured with an inclinometer.	Change from baseline in range of motion at four weeks	No
Secondary	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.	Change from baseline in pressure pain threshold measurement at four weeks	No