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Trigger Point Massage in Chronic Tension Headache

Primary Purpose

Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage
Sponsored by
Mazandaran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Massage, Trigger point

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Chronic tension type headache according to IHS criteria
  2. Finding painful trigger point in physical examination
  3. no contraindication for massage
  4. no prophylactic treatment
  5. written inform consent

Exclusion Criteria:

  1. Dementia or severe cognitive impairment
  2. Under Treatment with drugs with prophylactic effect
  3. History of RA or Cervicocephalic fracture or other skeletal deformity
  4. Other complementary treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Trigger point massage

    Treatment with standard drug Nortriptyline

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Headache frequency change
    Number of attacks in week
    Headache duration change
    Time duration ( in minutes)of attacks in week
    Number of analgesic change
    Number of analgesic drugs used during a week

    Full Information

    First Posted
    January 13, 2020
    Last Updated
    January 15, 2020
    Sponsor
    Mazandaran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04232046
    Brief Title
    Trigger Point Massage in Chronic Tension Headache
    Official Title
    Efficacy of Trigger Points Massage in Severity of Chronic Tension Headache:An Unmasked, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 15, 2016 (Actual)
    Primary Completion Date
    March 15, 2019 (Actual)
    Study Completion Date
    March 15, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mazandaran University of Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tension-Type Headache
    Keywords
    Massage, Trigger point

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Case and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Trigger point massage
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Treatment with standard drug Nortriptyline
    Intervention Type
    Other
    Intervention Name(s)
    Massage
    Intervention Description
    Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
    Primary Outcome Measure Information:
    Title
    Headache severity change
    Description
    By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain
    Time Frame
    Mean Visual Analogue Scale sore change in week 4 from the baseline
    Secondary Outcome Measure Information:
    Title
    Headache frequency change
    Description
    Number of attacks in week
    Time Frame
    Change in number of attacks in week 4 from the base line
    Title
    Headache duration change
    Description
    Time duration ( in minutes)of attacks in week
    Time Frame
    Change in Time duration in week 4 from the baseline
    Title
    Number of analgesic change
    Description
    Number of analgesic drugs used during a week
    Time Frame
    Change in Number of analgesic drugs used in week 4 from the baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Trigger Point Massage in Chronic Tension Headache

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