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Completed

NCT Number: NCT01155557

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

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.

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birte Tornøe

Copenhagen, Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • post-trauma headache
  • co-morbidity

Treatment and study plan

Specific Strength Training

Device

10 weeks of progressive specific strength training for neck and shoulder muscles.

Other names: A

Lifestyle Counseling

Behavioral

10 weeks of counseling by nurse and physiotherapist in lifestyle changes.

Other names: B

Primary outcomes

  1. Headache

    Time frame: At baseline

    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  2. 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).

  3. Headache

    Time frame: After the 10 weeks intervention programme

    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  4. Headache

    Time frame: At 3 months follow up.

    Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.

  5. 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).

  6. 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 outcomes

  1. TTS

    Time frame: At baseline

    Total Tenderness Score ( palpation of percranial tenderness).

  2. Physical fitness

    Time frame: At baseline

    Submaximal ergometer bicycle test

  3. TTS

    Time frame: After the 10 weeks intervention programme

    Total Tenderness Score ( palpation of pericranial tenderness).

  4. TTS

    Time frame: At 3 months follow up.

    Total Tenderness Score ( palpation of pericranial tenderness).

  5. Physical fitness

    Time frame: After the 10 weeks intervention programme

    Submaximal ergometer bicycle test

  6. Physical fitness

    Time frame: At 3 months follow up.

    Submaximal ergometer bicycle test

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • The Beckett-Fond
  • The Fond of Jørgen Holm and Elisa F. Hansen
  • The University Hospitals Centre for Nursing and Care Research, Copenhagen

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jul 2, 2010
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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