NCT01155557

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

4.1 years

First QC Date

June 28, 2010

Last Update Submit

March 18, 2015

Conditions

Tension-Type Headache

Keywords

Tension-Type HeadacheStrength CapacityNeck and Shoulder

Outcome Measures

Primary Outcomes (6)

  • Headache

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

    At baseline

  • Muscle Capacity

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

    At baseline

  • Headache

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

    After the 10 weeks intervention programme

  • Headache

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

    At 3 months follow up.

  • Muscle Capacity

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

    After the 10 weeks intervention programme

  • Muscle Capacity

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

    At 3 months follow up.

Secondary Outcomes (6)

  • TTS

    At baseline

  • Physical fitness

    At baseline

  • TTS

    After the 10 weeks intervention programme

  • TTS

    At 3 months follow up.

  • Physical fitness

    After the 10 weeks intervention programme

  • +1 more secondary outcomes

Study Arms (2)

Specific Strength Training

ACTIVE COMPARATOR

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

Device: Specific Strength Training

Lifestyle Counseling

ACTIVE COMPARATOR

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

Behavioral: Lifestyle Counseling

Interventions

Specific Strength TrainingDEVICE

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

Also known as: A
Specific Strength Training
Lifestyle CounselingBEHAVIORAL

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

Also known as: B
Lifestyle Counseling

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • post-trauma headache
  • co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birte Tornøe

Copenhagen, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Birte Tornøe, PhD,MSc,PT

    Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, PT

Study Record Dates

First Submitted

June 28, 2010

First Posted

July 2, 2010

Study Start

August 1, 2009

Primary Completion

September 1, 2013

Study Completion

August 1, 2014

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

DK(1)