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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155557
First Posted: July 2, 2010
Last Update Posted: March 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by Birte Tornoe, Herlev Hospital:

Primary Outcome Measures:
  • Headache [ Time Frame: At baseline ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • 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).


  • Headache [ Time Frame: After the 10 weeks intervention programme ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • Headache [ Time Frame: At 3 months follow up. ]
    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  • 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).


  • 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).



Secondary Outcome Measures:
  • TTS [ Time Frame: At baseline ]
    Total Tenderness Score ( palpation of percranial tenderness).

  • Physical fitness [ Time Frame: At baseline ]
    Submaximal ergometer bicycle test

  • TTS [ Time Frame: After the 10 weeks intervention programme ]
    Total Tenderness Score ( palpation of pericranial tenderness).

  • TTS [ Time Frame: At 3 months follow up. ]
    Total Tenderness Score ( palpation of pericranial tenderness).

  • Physical fitness [ Time Frame: After the 10 weeks intervention programme ]
    Submaximal ergometer bicycle test

  • Physical fitness [ Time Frame: At 3 months follow up. ]
    Submaximal ergometer bicycle test


Enrollment: 58
Study Start Date: August 2009
Study Completion Date: August 2014
Primary Completion Date: September 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

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155557


Locations
Denmark
Birte Tornøe
Copenhagen, Herlev, Denmark, 2730
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, PhD,MSc,PT Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
  More Information

Responsible Party: Birte Tornoe, PhD, MSc, PT, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01155557     History of Changes
Other Study ID Numbers: H-3-2009-081
2009-41-3697 ( Other Identifier: The Danish Data Council, Datatilsynet )
First Submitted: June 28, 2010
First Posted: July 2, 2010
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Birte Tornoe, 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