Trigger Point Massage in Chronic Tension Headache | NCT04232046

Studies
Trigger Point Massage in Chronic Tension Headache

NCT04232046

Sponsor

Mazandaran University of Medical Sciences

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Tension-Type Headache

Interventions

Massage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2016Actual

Primary Completion Date

Mar 15, 2019Actual

Completion Date

Mar 15, 2019Actual

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Jan 15, 2020

First Posted Date

Jan 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2020

Last Update Posted Date

Jan 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Athena Sharifi Razavi, Assistant Professor in Neurology, Mazandaran University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mazandaran University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Trigger point massage	Other: Massage
Control	Active Comparator	Treatment with standard drug Nortriptyline	Other: Massage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Massage	Other	Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.	Control Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018781	Tension-Type Headache

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided