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

NCT ID: NCT02549300

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache Disorders, Primary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Connective tissue massage

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

connective tissue manipulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emine BARAN

Research Assistant Emine Baran

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Türkan Akbayrak, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Ankara, Samanpazarı, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emine Baran, PT

Role: CONTACT

+903123052533 ext. 173

Emine Baran, PT

Role: CONTACT

+903123052525 ext. 173

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emine Baran, PT

Role: primary

+903123052533 ext. 173

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16776700 (View on PubMed)

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.

Reference Type RESULT
PMID: 23299655 (View on PubMed)

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.

Reference Type RESULT
PMID: 15012658 (View on PubMed)

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.

Reference Type RESULT
PMID: 16920676 (View on PubMed)

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.

Reference Type RESULT
PMID: 19845788 (View on PubMed)

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.

Reference Type RESULT
PMID: 25365048 (View on PubMed)

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.

Reference Type RESULT
PMID: 24411158 (View on PubMed)

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.

Reference Type RESULT
PMID: 20647241 (View on PubMed)

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.

Reference Type RESULT
PMID: 10024117 (View on PubMed)

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.

Reference Type RESULT
PMID: 17106618 (View on PubMed)

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

Reference Type RESULT
PMID: 23771275 (View on PubMed)

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.

Reference Type RESULT
PMID: 16630694 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.