The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years

March 18, 2015 updated by: Birte Tornoe, Herlev Hospital

Strength Capacity of Neck and Shoulder Muscles in Children and Adolescents 9-17 Years With Tension Type Headache and the Effect of Specific Strength-Training on Tension-Type Headache

This study aims at examining muscle strength capacity in neck and shoulder muscles in children and adolescents with and without tension-type headache, and furthermore examining the effect of a 10 week specific strength training programme for neck and shoulder muscles compared to a multi-disciplinary approach in 10 weeks.

Study Overview

Detailed Description

Frequent and chronic tension type headache are the most frequent pain illnesses in children with a prevalence of 0.5-7,6%. Frequent or daily headache leads to constraints in the child's life in relation to school and social activities.

The underlying pathophysiological mechanisms are not yet fully examined. In several studies in adults and in children it is found that the shoulder muscles are tense and tender, but it is not known whether this phenomenon is primary or secondary to tension-type headache. A decrease in muscle capacity is furthermore found in studies. We therefore aim at examining parameters for muscle function in order to compare the differences between children with and without headache, and at examining the effect of a 10 week progressive specific strength training programme on headache compared to an in time comparable multidisciplinary intervention based on lifestyle counseling.

Study Type

Interventional

Enrollment (Actual)

58

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 Locations

    • Herlev
      • Copenhagen, Herlev, Denmark, 2730
        • Birte Tornøe

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

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary tension-type headache with no more than one episode of migraine pr. month

Exclusion Criteria:

  • post-trauma headache
  • co-morbidity

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Specific Strength Training
10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.
10 weeks of progressive specific strength training for neck and shoulder muscles.
Other Names:
  • A
Active Comparator: Lifestyle Counseling
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Other Names:
  • B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache
Time Frame: At baseline
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
At baseline
Muscle Capacity
Time Frame: At baseline

Neck and shoulder muscle function variables:

MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).

At baseline
Headache
Time Frame: After the 10 weeks intervention programme
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
After the 10 weeks intervention programme
Headache
Time Frame: At 3 months follow up.
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
At 3 months follow up.
Muscle Capacity
Time Frame: After the 10 weeks intervention programme

Neck and shoulder muscle function variables:

MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).

After the 10 weeks intervention programme
Muscle Capacity
Time Frame: At 3 months follow up.

Neck and shoulder muscle function variables:

MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).

At 3 months follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTS
Time Frame: At baseline
Total Tenderness Score ( palpation of percranial tenderness).
At baseline
Physical fitness
Time Frame: At baseline
Submaximal ergometer bicycle test
At baseline
TTS
Time Frame: After the 10 weeks intervention programme
Total Tenderness Score ( palpation of pericranial tenderness).
After the 10 weeks intervention programme
TTS
Time Frame: At 3 months follow up.
Total Tenderness Score ( palpation of pericranial tenderness).
At 3 months follow up.
Physical fitness
Time Frame: After the 10 weeks intervention programme
Submaximal ergometer bicycle test
After the 10 weeks intervention programme
Physical fitness
Time Frame: At 3 months follow up.
Submaximal ergometer bicycle test
At 3 months follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Birte Tornøe, PhD,MSc,PT, Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK

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

August 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 28, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • H-3-2009-081
  • 2009-41-3697 (Other Identifier: The Danish Data Council, Datatilsynet)

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.

Clinical Trials on Tension-Type Headache

Clinical Trials on Specific Strength Training

3
Subscribe