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Completed

NCT Number: NCT04232046

Trigger Point Massage in Chronic Tension Headache

Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. They will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage.

They report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. Then data based on dairy will be analysis.

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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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Chronic tension type headache according to IHS criteria
  • Finding painful trigger point in physical examination
  • no contraindication for massage
  • no prophylactic treatment
  • written inform consent

Exclusion criteria

  • Dementia or severe cognitive impairment
  • Under Treatment with drugs with prophylactic effect
  • History of RA or Cervicocephalic fracture or other skeletal deformity
  • Other complementary treatment

Treatment and study plan

Massage

Other

Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.

Primary outcomes

  1. Headache severity change

    Time frame: Mean Visual Analogue Scale sore change in week 4 from the baseline

    By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain

Secondary outcomes

  1. Headache frequency change

    Time frame: Change in number of attacks in week 4 from the base line

    Number of attacks in week

  2. Headache duration change

    Time frame: Change in Time duration in week 4 from the baseline

    Time duration ( in minutes)of attacks in week

  3. Number of analgesic change

    Time frame: Change in Number of analgesic drugs used in week 4 from the baseline

    Number of analgesic drugs used during a week

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

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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