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

Tension-Type Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984826
• Other study ID #: H-3-2009-080
• Status: Completed
• Phase: N/A
• First received: November 23, 2016
• Last updated: December 6, 2016
• Start date: May 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2016
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Danish Headache Center Rigshospitalet - Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache frequency	Frequency was calculated and analyzed as days with headache pr. month. primary outcome at follow up.(19-22 weeks)	Primary outcome headache frequency at (19-22 weeks)	No
Primary	Headache Duration	The duration of the headache was registered in hours for each day with headache.	Primary outcome duration of pain at (19-22 weeks)	No
Secondary	Intensity of headache	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	Intensity of pain at (19-22 weeks)	No
Secondary	Medication intake	Use of pain medicine was registered as days of medicine intake throughout the entire trial.	Medication intake at (19-22 weeks)	No