- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155557
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Herlev
-
Copenhagen, Herlev, Denmark, 2730
- Birte Tornøe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- primary tension-type headache with no more than one episode of migraine pr. month
Exclusion Criteria:
- post-trauma headache
- co-morbidity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Specific Strength Training
10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.
|
10 weeks of progressive specific strength training for neck and shoulder muscles.
Other Names:
|
Active Comparator: Lifestyle Counseling
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
|
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache
Time Frame: At baseline
|
Number of headache days/ 4 weeks.
Mean VAS Score (pain)/4 weeks.
|
At baseline
|
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). |
At baseline
|
Headache
Time Frame: After the 10 weeks intervention programme
|
Number of headache days/ 4 weeks.
Mean VAS Score (pain)/4 weeks.
|
After the 10 weeks intervention programme
|
Headache
Time Frame: At 3 months follow up.
|
Number of headache days/ 4 weeks.
Mean VAS Score (pain)/4 weeks.
|
At 3 months follow up.
|
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). |
After the 10 weeks intervention programme
|
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). |
At 3 months follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTS
Time Frame: At baseline
|
Total Tenderness Score ( palpation of percranial tenderness).
|
At baseline
|
Physical fitness
Time Frame: At baseline
|
Submaximal ergometer bicycle test
|
At baseline
|
TTS
Time Frame: After the 10 weeks intervention programme
|
Total Tenderness Score ( palpation of pericranial tenderness).
|
After the 10 weeks intervention programme
|
TTS
Time Frame: At 3 months follow up.
|
Total Tenderness Score ( palpation of pericranial tenderness).
|
At 3 months follow up.
|
Physical fitness
Time Frame: After the 10 weeks intervention programme
|
Submaximal ergometer bicycle test
|
After the 10 weeks intervention programme
|
Physical fitness
Time Frame: At 3 months follow up.
|
Submaximal ergometer bicycle test
|
At 3 months follow up.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Birte Tornøe, PhD,MSc,PT, Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-3-2009-081
- 2009-41-3697 (Other Identifier: The Danish Data Council, Datatilsynet)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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