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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Herlev Hospital.
Recruitment status was  Recruiting
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

June 28, 2010
August 8, 2012
August 2009
December 2013   (final data collection date for primary outcome measure)
  • 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).

Same as current
Complete list of historical versions of study NCT01155557 on ClinicalTrials.gov Archive Site
  • 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
  • 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 week intervention programme ] [ Designated as safety issue: No ]
    Total Tenderness Score ( palpation of percranial tenderness).
  • TTS [ Time Frame: At 3 month follow up. ] [ Designated as safety issue: No ]
    Total Tenderness Score ( palpation of percranial tenderness).
  • Physical fitness [ Time Frame: After the 10 week intervention programme ] [ Designated as safety issue: No ]
    Submaximal ergometer bicycle test
  • Physical fitness [ Time Frame: At 3 month follow up. ] [ Designated as safety issue: No ]
    Submaximal ergometer bicycle test
Not Provided
Not Provided
 
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tension-Type Headache
  • Device: Specific Strength Training
    10 weeks of progressive specific strength training for neck and shoulder muscles.
    Other Name: A
  • Behavioral: Lifestyle Counseling
    10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
    Other Name: B
  • Active Comparator: Specific Strength Training
    10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.
    Intervention: Device: Specific Strength Training
  • Active Comparator: Lifestyle Counseling
    10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
    Intervention: Behavioral: Lifestyle Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • post-trauma headache
  • co-morbidity
Both
9 Years to 18 Years
Yes
Contact: Birte Tornøe, Pt,MSc,Ex.A +4527595059 birte.tornoee@regionh.dk
Contact: Liselotte Skov, MD,DMSc +4538681051 liselotte.skov@regionh.dk
Denmark
 
NCT01155557
H-3-2009-081, 2009-41-3697
No
Birte Tornoe, Herlev Hospital
Herlev Hospital
  • The University Hospitals Centre for Nursing and Care Research, Copenhagen
  • The Beckett-Fond
  • The Fond of Jørgen Holm and Elisa F. Hansen
Principal Investigator: Birte Tornøe, PT,MSc,Ex.A.doctoral student Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
Herlev Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP