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

• ClinicalTrials.gov Identifier: NCT01155557
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Last Update Posted: March 19, 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
• Information provided by (Responsible Party): Birte Tornoe, Herlev Hospital

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.

Condition or disease	Intervention/treatment	Phase
Tension-Type Headache	Device: Specific Strength Training; Behavioral: Lifestyle Counseling	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: August 2009
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Specific Strength Training; 10 weeks of specific strength training of neck and shoulder muscles using elastic resistance.	Device: Specific Strength Training; 10 weeks of progressive specific strength training for neck and shoulder muscles.; Other Name: A
Active Comparator: Lifestyle Counseling; 10 weeks of counseling by nurse and physiotherapist in lifestyle changes.	Behavioral: Lifestyle Counseling; 10 weeks of counseling by nurse and physiotherapist in lifestyle changes.; Other Name: B

Outcome Measures

Primary Outcome Measures :

1. Headache [ Time Frame: At baseline ]
   Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
2. 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).

3. Headache [ Time Frame: After the 10 weeks intervention programme ]
   Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
4. Headache [ Time Frame: At 3 months follow up. ]
   Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
5. 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).

6. 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).

Secondary Outcome Measures :

1. TTS [ Time Frame: At baseline ]
   Total Tenderness Score ( palpation of percranial tenderness).
2. Physical fitness [ Time Frame: At baseline ]
   Submaximal ergometer bicycle test
3. TTS [ Time Frame: After the 10 weeks intervention programme ]
   Total Tenderness Score ( palpation of pericranial tenderness).
4. TTS [ Time Frame: At 3 months follow up. ]
   Total Tenderness Score ( palpation of pericranial tenderness).
5. Physical fitness [ Time Frame: After the 10 weeks intervention programme ]
   Submaximal ergometer bicycle test
6. Physical fitness [ Time Frame: At 3 months follow up. ]
   Submaximal ergometer bicycle test

Eligibility Criteria

• Ages Eligible for Study: 9 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• post-trauma headache
• co-morbidity

Contacts and Locations

Locations

Denmark

Birte Tornøe

Copenhagen, Herlev, Denmark, 2730

Sponsors and Collaborators

Herlev Hospital

The University Hospitals Centre for Nursing and Care Research, Copenhagen

The Beckett-Fond

The Fond of Jørgen Holm and Elisa F. Hansen

Investigators

• Principal Investigator: Birte Tornøe, PhD,MSc,PT; Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK

More Information

• Responsible Party: Birte Tornoe, PhD, MSc, PT, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT01155557
• Other Study ID Numbers: H-3-2009-081; 2009-41-3697 ( Other Identifier: The Danish Data Council, Datatilsynet )
• First Posted: July 2, 2010
• Last Update Posted: March 19, 2015
• Last Verified: March 2015

Keywords provided by Birte Tornoe, Herlev Hospital:

Tension-Type Headache; Strength Capacity; Neck and Shoulder

Additional relevant MeSH terms:

Tension-Type Headache; Headache; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases