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

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Specific Strength Training
Lifestyle Counseling
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Tension-Type Headache, Strength Capacity, Neck and Shoulder

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • post-trauma headache
  • co-morbidity

Sites / Locations

  • Birte Tornøe

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Specific Strength Training

Lifestyle Counseling

Arm Description

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

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

Outcomes

Primary Outcome Measures

Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Muscle Capacity
Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).
Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Muscle Capacity
Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).
Muscle Capacity
Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS(Force-steadiness).

Secondary Outcome Measures

TTS
Total Tenderness Score ( palpation of percranial tenderness).
Physical fitness
Submaximal ergometer bicycle test
TTS
Total Tenderness Score ( palpation of pericranial tenderness).
TTS
Total Tenderness Score ( palpation of pericranial tenderness).
Physical fitness
Submaximal ergometer bicycle test
Physical fitness
Submaximal ergometer bicycle test

Full Information

First Posted
June 28, 2010
Last Updated
March 18, 2015
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
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1. Study Identification

Unique Protocol Identification Number
NCT01155557
Brief Title
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Tension-Type Headache, Strength Capacity, Neck and Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specific Strength Training
Arm Type
Active Comparator
Arm Description
10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.
Arm Title
Lifestyle Counseling
Arm Type
Active Comparator
Arm Description
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Intervention Type
Device
Intervention Name(s)
Specific Strength Training
Other Intervention Name(s)
A
Intervention Description
10 weeks of progressive specific strength training for neck and shoulder muscles.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Other Intervention Name(s)
B
Intervention Description
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Primary Outcome Measure Information:
Title
Headache
Description
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Time Frame
At baseline
Title
Muscle Capacity
Description
Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).
Time Frame
At baseline
Title
Headache
Description
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Time Frame
After the 10 weeks intervention programme
Title
Headache
Description
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Time Frame
At 3 months follow up.
Title
Muscle Capacity
Description
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
Title
Muscle Capacity
Description
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 Outcome Measure Information:
Title
TTS
Description
Total Tenderness Score ( palpation of percranial tenderness).
Time Frame
At baseline
Title
Physical fitness
Description
Submaximal ergometer bicycle test
Time Frame
At baseline
Title
TTS
Description
Total Tenderness Score ( palpation of pericranial tenderness).
Time Frame
After the 10 weeks intervention programme
Title
TTS
Description
Total Tenderness Score ( palpation of pericranial tenderness).
Time Frame
At 3 months follow up.
Title
Physical fitness
Description
Submaximal ergometer bicycle test
Time Frame
After the 10 weeks intervention programme
Title
Physical fitness
Description
Submaximal ergometer bicycle test
Time Frame
At 3 months follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: primary tension-type headache with no more than one episode of migraine pr. month Exclusion Criteria: post-trauma headache co-morbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birte Tornøe, PhD,MSc,PT
Organizational Affiliation
Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birte Tornøe
City
Copenhagen
State/Province
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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

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