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Muscle Strength in Shoulder and Neck Muscles in Tension Type Headache Patients. Effect of Specific Strength Training

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ClinicalTrials.gov Identifier: NCT02984826
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Bjarne Kjeldgaard Madsen, Danish Headache Center

Brief Summary:

Background:

Tension Type Headache (TTH) is highly frequent and is of great socio-economic importance. Andersen et al. 2008 has shown that maximal muscle strength is reduced in women with trapezius myalgia. It is shown that specific strength training leads to prolonged pain relief.

Aim:Test: To investigate the impact of TTH on shoulder, and neck muscle strength in patients with TTH compared to healthy controls.

Intervention: To investigate the effect of specific strength training on patients with TTH compared with control group, receiving training in ergonomics.

Method: Test part. 60 tension headache patients, 30 healthy. Muscle testing of neck and shoulder. Testing conducted by blinded research assistant.

Intervention group: 60 patients with tension headache randomly assigned to the intervention group or control group. Intervention with specific strength training program runs for 10 weeks. The control group will be trained in ergonomics. 3 months follow up.


Condition or disease Intervention/treatment Phase
Tension-Type Headache Other: Strength training Other: Ergonomic and posture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Muscle Strength in Shoulder and Neck Muscles in Adult Tension Type Headache Patients, and the Effect of Specific Strength Training
Study Start Date : May 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Strength training
Intervention with specific strength training program runs for 10 weeks.
Other: Strength training
The specific ST group trained and fulfilled a 10 week training diary. The ST consisted of 4 shoulder exercises. During the training the relative loading was progressively increased from 12 repetitions maximum (RM) (70% of maximal intensity) at the beginning to 8 RM (80 % of the maximal intensity). ST was performed with slow concentric and eccentric muscle contractions with resistance from the elastic bands.

Active Comparator: Ergonomic and posture
Intervention, the control group will be trained in ergonomics and posture.
Other: Ergonomic and posture
The control group was instructed in ergonomics and posture correction (EP). They were instructed to pay attention to their sitting posture, and how they used a computer or other working tools. Further they were asked to do a posture correction exercise 3 times a day with 10 repetitions. The EP were seen twice during the 10 week period, and had a phone call every 2 weeks. After 10 weeks they were instructed that they should stop the exercise but continue to be conscious of their ergonomics and sitting position.




Primary Outcome Measures :
  1. Headache frequency [ Time Frame: Primary outcome headache frequency at (19-22 weeks) ]
    Frequency was calculated and analyzed as days with headache pr. month. primary outcome at follow up.(19-22 weeks)

  2. Headache Duration [ Time Frame: Primary outcome duration of pain at (19-22 weeks) ]
    The duration of the headache was registered in hours for each day with headache.


Secondary Outcome Measures :
  1. Intensity of headache [ Time Frame: Intensity of pain at (19-22 weeks) ]
    The intensity was registered on a 0-10 Numeric Rating Scale (NRS) where 0 is no pain, and 10 is worst possible pain. It was calculated as intensity mean/week and a mean for 4 weeks were produced

  2. Medication intake [ Time Frame: Medication intake at (19-22 weeks) ]
    Use of pain medicine was registered as days of medicine intake throughout the entire trial.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Tension-type headache(TTH), inclusion criteria were age between 18 and 65 years and for patients a diagnosis of TTH ≥8 headache days per month, and ≤3 migraine days per month according to ICHD-II -criteria.

Exclusion Criteria:

  • Exclusion criteria were medication overuse headache (ICHD-II), previous whiplash or head trauma, other major physical or neurological diseases, depression, other mental illness, or being unable to understand and speak Danish. The patients were tested for cervicogenic headache according to Jull, et al 2007, and were excluded if the test was positive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984826


Locations
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Denmark
Danish Headache Center Rigshospitalet - Glostrup
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Bjarne K K Madsen, phd stud. Danish Headache Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bjarne Kjeldgaard Madsen, physiotherapist phd student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02984826     History of Changes
Other Study ID Numbers: H-3-2009-080
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases