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Clinical Trials/NCT04232046
NCT04232046CompletedNot Applicable

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

Mazandaran University of Medical Sciences0 sites80 target enrollmentStarted: February 15, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Primary Endpoint
Headache severity change

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Intervention

Experimental

Trigger point massage

Intervention: Massage (Other)

Control

Active Comparator

Treatment with standard drug Nortriptyline

Intervention: Massage (Other)

Outcomes

Primary Outcomes

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

  • Headache duration change(Change in Time duration in week 4 from the baseline)
  • Headache frequency change(Change in number of attacks in week 4 from the base line)
  • Number of analgesic change(Change in Number of analgesic drugs used in week 4 from the baseline)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Athena Sharifi Razavi

Assistant Professor in Neurology

Mazandaran University of Medical Sciences

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