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

Tension-Type Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155557
• Other study ID #: H-3-2009-081
• Secondary ID: 2009-41-3697
• Status: Completed
• Phase: N/A
• First received: June 28, 2010
• Last updated: March 18, 2015
• Start date: August 2009
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• post-trauma headache

• co-morbidity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

Device:
• Specific Strength Training
10 weeks of progressive specific strength training for neck and shoulder muscles.

Behavioral:
• Lifestyle Counseling
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.

Locations

Country	Name	City	State
Denmark	Birte Tornøe	Copenhagen	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Herlev Hospital	The Beckett-Fond, The Fond of Jørgen Holm and Elisa F. Hansen, The University Hospitals Centre for Nursing and Care Research, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache	Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.	At baseline	No
Primary	Muscle Capacity	Neck and shoulder muscle function variables: MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).	At baseline	No
Primary	Headache	Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.	After the 10 weeks intervention programme	No
Primary	Headache	Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.	At 3 months follow up.	No
Primary	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	No
Primary	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.	No
Secondary	TTS	Total Tenderness Score ( palpation of percranial tenderness).	At baseline	No
Secondary	Physical fitness	Submaximal ergometer bicycle test	At baseline	No
Secondary	TTS	Total Tenderness Score ( palpation of pericranial tenderness).	After the 10 weeks intervention programme	No
Secondary	TTS	Total Tenderness Score ( palpation of pericranial tenderness).	At 3 months follow up.	No
Secondary	Physical fitness	Submaximal ergometer bicycle test	After the 10 weeks intervention programme	No
Secondary	Physical fitness	Submaximal ergometer bicycle test	At 3 months follow up.	No