Trigger Point Massage in Chronic Tension Headache

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

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.

Study Overview

• Status: Completed
• Conditions: Tension-Type Headache
• Intervention / Treatment: Other: Massage

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Trigger point massage	Other: Massage; Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
Active Comparator: Control; Treatment with standard drug Nortriptyline	Other: Massage; Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache severity change	By Visual Analogue Scale score,from 0 that indicate no pain to 10 that indicate severe pain	Mean Visual Analogue Scale sore change in week 4 from the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache frequency change	Number of attacks in week	Change in number of attacks in week 4 from the base line
Headache duration change	Time duration ( in minutes)of attacks in week	Change in Time duration in week 4 from the baseline
Number of analgesic change	Number of analgesic drugs used during a week	Change in Number of analgesic drugs used in week 4 from the baseline

Collaborators and Investigators

• Sponsor: Mazandaran University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2016
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Massage; Trigger point
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: 1288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No