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Completed

NCT Number: NCT02984826

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

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.

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Key information

Conditions

Tension-type Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strength training

Other

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.

Ergonomic and posture

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

Muscle Strength in Shoulder and Neck Muscles in Adult Tension Type Headache Patients, and the Effect of Specific Strength Training

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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