Tension-Type HeadacheNCT01155557
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years
A study testing Specific Strength Training and Lifestyle Counseling in people with Tension-Type Headache, run by Herlev Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Specific Strength Training and Lifestyle Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- primary tension-type headache with no more than one episode of migraine pr. month
Who cannot join
- post-trauma headache
- co-morbidity
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Tension-Type Headache
- Being tested
- Specific Strength Training, Lifestyle Counseling
- Keywords
- Tension-Type Headache, Strength Capacity, Neck and Shoulder
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Strength TrainingDevice
Also called A
10 weeks of progressive specific strength training for neck and shoulder muscles.
Lifestyle CounselingBehavioural
Also called B
10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
| Study group | Role | What they receive |
|---|---|---|
| Specific Strength Training | Active comparator | 10 weeks of specific strength training of neck and shoulder muscles using elastic resistance. Receives: Device: Specific Strength Training |
| Lifestyle Counseling | Active comparator | 10 weeks of counseling by nurse and physiotherapist in lifestyle changes. Receives: Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Measured: At baseline
Muscle Capacity
Neck and shoulder muscle function variables:
MVC(maximal voluntary static capacity). RFD(rate of force development). FS (Force-steadiness).
Measured: At baseline
Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Measured: After the 10 weeks intervention programme
Headache
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Measured: 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).
Measured: 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).
Measured: At 3 months follow up.
Secondary outcomes (6)
TTS
Total Tenderness Score ( palpation of percranial tenderness).
Measured: At baseline
Physical fitness
Submaximal ergometer bicycle test
Measured: At baseline
TTS
Total Tenderness Score ( palpation of pericranial tenderness).
Measured: After the 10 weeks intervention programme
TTS
Total Tenderness Score ( palpation of pericranial tenderness).
Measured: At 3 months follow up.
Physical fitness
Submaximal ergometer bicycle test
Measured: After the 10 weeks intervention programme
Physical fitness
Submaximal ergometer bicycle test
Measured: At 3 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionSep 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University Hospitals Centre for Nursing and Care Research, Copenhagen, The Beckett-Fond, The Fond of Jørgen Holm and Elisa F. Hansen
- Responsible party
- Principal investigator, Birte Tornoe, Herlev Hospital
- Investigators
- Birte Tornøe, PhD,MSc,PT, Principal investigator, Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155557
- Sponsor's protocol ID
- H-3-2009-081
- Other IDs
- 2009-41-3697
- Status last verified
- Mar 2015
- First submitted
- 28 Jun 2010
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01155557
- Acronym / sponsor ID
- H-3-2009-081
- Conditions
- Tension-Type Headache
- Keywords
- Tension-Type Headache, Strength Capacity, Neck and Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- The University Hospitals Centre for Nursing and Care Research, Copenhagen, The Beckett-Fond, The Fond of Jørgen Holm and Elisa F. Hansen
- Study start
- Aug 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Strength Training | Active comparator | Device: Specific Strength Training10 weeks of specific strength training of neck and shoulder muscles using elastic resistance. |
| Lifestyle Counseling | Active comparator | Behavioral: Lifestyle Counseling10 weeks of counseling by nurse and physiotherapist in lifestyle changes. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- primary tension-type headache with no more than one episode of migraine pr. month
Key exclusion criteria (2 listed)
- post-trauma headache
- co-morbidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Strength TrainingAlso: A10 weeks of progressive specific strength training for neck and shoulder muscles. | Device | Specific Strength Training |
| Lifestyle CounselingAlso: B10 weeks of counseling by nurse and physiotherapist in lifestyle changes. | Behavioural | Lifestyle Counseling |
Primary outcome
Headache
Time frame: At baseline
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
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).
Headache
Time frame: After the 10 weeks intervention programme
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
Headache
Time frame: At 3 months follow up.
Number of headache days/ 4 weeks. Mean VAS Score (pain)/4 weeks.
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).
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).
6 secondary outcomes
TTS
Time frame: At baseline
Physical fitness
Time frame: At baseline
TTS
Time frame: After the 10 weeks intervention programme
TTS
Time frame: At 3 months follow up.
Physical fitness
Time frame: After the 10 weeks intervention programme
Physical fitness
Time frame: At 3 months follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birte Tornøe, PhD,MSc,PT principal investigator
Children's Headache Clinic, Herlev University Hospital, 2730 Herlev, Copenhagen-DK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Strength Training and Lifestyle Counseling in people with Tension-Type Headache, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.