- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02549300
The Effects of Connective Tissue Massage and Lifestyle Modifications in Adolescents Tension Type Headache
September 11, 2015 updated by: Emine BARAN, Hacettepe University
Konnektif Doku Masajı ve Yaşam Stili Modifikasyonlarının Adölesanlarda Gerilim Tipi Baş Ağrısına Etkisi
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.
Study Overview
Status
Unknown
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emine Baran, PT
- Phone Number: 173 +903123052533
- Email: eminekbaran@gmail.com
Study Contact Backup
- Name: Emine Baran, PT
- Phone Number: 173 +903123052525
- Email: eminekbaran@gmail.com
Study Locations
-
-
Samanpazarı
-
Ankara, Samanpazarı, Turkey, 06100
- Recruiting
- Hacettepe University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
-
Contact:
- Emine Baran, PT
- Phone Number: 173 +903123052533
- Email: eminekbaran@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity
Time Frame: Change from baseline in pain severity at four weeks
|
Pain severity will be measured with McGill Short Form Pain Questionnaire
|
Change from baseline in pain severity at four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Quality of Life Inventory (Turkish version of the questionnaire)
Time Frame: Change from baseline in questionnaire at four weeks
|
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.
|
Change from baseline in range of motion at four weeks
|
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.
|
Change from baseline in pressure pain threshold measurement at four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Türkan Akbayrak, Prof.Dr., Hacettepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Olesen J. ICHD-3 beta is published. Use it immediately. Cephalalgia. 2013 Jul;33(9):627-8. doi: 10.1177/0333102413487610. No abstract available.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
March 18, 2015
First Submitted That Met QC Criteria
September 11, 2015
First Posted (Estimate)
September 15, 2015
Study Record Updates
Last Update Posted (Estimate)
September 15, 2015
Last Update Submitted That Met QC Criteria
September 11, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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