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

This study is currently recruiting participants.
Verified August 2012 by Herlev Hospital
Sponsor:
Collaborators:
The University Hospitals Centre for Nursing and Care Research, Copenhagen
The Beckett-Fond
The Fond of Jørgen Holm and Elisa F. Hansen
Information provided by (Responsible Party):
Birte Tornoe, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01155557
First received: June 28, 2010
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Tension-Type Headache
 Device: Specific Strength Training
Behavioral: Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Headache [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • Muscle Capacity [ Time Frame: At baseline ] [ Designated as safety issue: No ]

    Neck and shoulder muscle function variables:

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


  • Headache [ Time Frame: After the 10 weeks intervention programme ] [ Designated as safety issue: No ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • Headache [ Time Frame: At 3 months follow up. ] [ Designated as safety issue: No ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • Muscle Capacity [ Time Frame: After the 10 weeks intervention programme ] [ Designated as safety issue: No ]

    Neck and shoulder muscle function variables:

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


  • Muscle Capacity [ Time Frame: At 3 months follow up. ] [ Designated as safety issue: No ]

    Neck and shoulder muscle function variables:

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



Secondary Outcome Measures:
  • TTS [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Total Tenderness Score ( palpation of percranial tenderness).

  • Physical fitness [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Submaximal ergometer bicycle test

  • TTS [ Time Frame: After the 10 weeks intervention programme ] [ Designated as safety issue: No ]
    Total Tenderness Score ( palpation of pericranial tenderness).

  • TTS [ Time Frame: At 3 months follow up. ] [ Designated as safety issue: No ]
    Total Tenderness Score ( palpation of pericranial tenderness).

  • Physical fitness [ Time Frame: After the 10 weeks intervention programme ] [ Designated as safety issue: No ]
    Submaximal ergometer bicycle test

  • Physical fitness [ Time Frame: At 3 months follow up. ] [ Designated as safety issue: No ]
    Submaximal ergometer bicycle test


Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Specific Strength Training
10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.
 Device: Specific Strength Training
10 weeks of progressive specific strength training for neck and shoulder muscles.
Other Name: A
Active Comparator: Lifestyle Counseling
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
 Behavioral: Lifestyle Counseling
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Other Name: B

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • post-trauma headache
  • co-morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155557

Contacts
Contact: Birte Tornøe, Pt,MSc,Ex.A +4527595059 birte.tornoee@regionh.dk
Contact: Liselotte Skov, MD,DMSc +4538681051 liselotte.skov@regionh.dk

Locations
Denmark
Birte Tornøe Recruiting
Copenhagen, Herlev, Denmark, 2730
Contact: Birte Tornøe, PT,MSc,Ex.A.     +4527595059     Birte.tornoee@regionh.dk    
Contact: Liselotte Skov, MD,DMSc     +4540378137     liselotte.skov@regionh.dk    
Principal Investigator: Birte Tornøe, PT,MSc,Ex.A.            
Sponsors and Collaborators
Herlev Hospital
The University Hospitals Centre for Nursing and Care Research, Copenhagen
The Beckett-Fond
The Fond of Jørgen Holm and Elisa F. Hansen
Investigators
Principal Investigator: Birte Tornøe, PT,MSc,Ex.A.doctoral student Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
  More Information

No publications provided

Responsible Party: Birte Tornoe, Pt MSc, doctoral student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01155557     History of Changes
Other Study ID Numbers: H-3-2009-081, 2009-41-3697
Study First Received: June 28, 2010
Last Updated: August 8, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Herlev Hospital:
Tension-Type Headache
Strength Capacity
Neck and Shoulder

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013