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CompletedNCT01155557Updated Mar 19, 2015

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

An interventional study of Specific Strength Training and Lifestyle Counseling in Tension-Type Headache, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 9 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-19.

Sponsored by Herlev Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
9 Years to 18 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Tension-Type Headache

Keywords

  • Tension-Type Headache
  • Strength Capacity
  • Neck and Shoulder
03

In context

Tension-Type Headache

144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.

This study's enrollment of 58 is close to the median of 60 across 109 interventional studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • post-trauma headache
  • co-morbidity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    Specific Strength Training

    10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.

    Device: Specific Strength Training

  • Active comparator
    Lifestyle Counseling

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

    Behavioral: Lifestyle Counseling

Interventions

  • DeviceSpecific Strength Training

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

    Also known as: A

  • BehavioralLifestyle Counseling

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

    Also known as: B

06

What researchers measure

Primary outcomes

  1. Headache

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

    Time frame: At baseline

  2. Muscle Capacity

    Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).

    Time frame: At baseline

  3. Headache

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

    Time frame: After the 10 weeks intervention programme

  4. Headache

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

    Time frame: At 3 months follow up.

  5. Muscle Capacity

    Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).

    Time frame: After the 10 weeks intervention programme

  6. Muscle Capacity

    Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).

    Time frame: At 3 months follow up.

Secondary outcomes

  1. TTS

    Total Tenderness Score ( palpation of percranial tenderness).

    Time frame: At baseline

  2. Physical fitness

    Submaximal ergometer bicycle test

    Time frame: At baseline

  3. TTS

    Total Tenderness Score ( palpation of pericranial tenderness).

    Time frame: After the 10 weeks intervention programme

  4. TTS

    Total Tenderness Score ( palpation of pericranial tenderness).

    Time frame: At 3 months follow up.

  5. Physical fitness

    Submaximal ergometer bicycle test

    Time frame: After the 10 weeks intervention programme

  6. Physical fitness

    Submaximal ergometer bicycle test

    Time frame: At 3 months follow up.

07

Study locations

1 site
  • Birte Tornøe
    Copenhagen, Herlev 2730, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01155557
Lead sponsor
Herlev Hospital
Collaborators
The University Hospitals Centre for Nursing and Care Research, Copenhagen, The Beckett-Fond, The Fond of Jørgen Holm and Elisa F. Hansen
Responsible party
Birte Tornoe (PhD, MSc, PT, Herlev Hospital) — Principal investigator
First posted
Jul 2, 2010
Start date
Aug 2009
Primary completion
Sep 2013
Completion
Aug 2014
Last update
Mar 19, 2015

Study contacts

Birte Tornøe, PhD,MSc,PT
principal investigator · Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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