NCT05452330

Brief Summary

The study aims to compare the effects of connective tissue massage on pain severity, attack frequency and duration, migraine-related disability, and quality of life in patients diagnosed with migraine, by comparing them with the classical massage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 6, 2022

Last Update Submit

September 19, 2022

Conditions

Headache, MigraineManuel Therapy

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    The intensity of pain perceived by the subjects will be evaluated with a valid method, the Visual Analogue Scale (VAS). The higher numbers show higher pain intensities.

    8 weeks

Secondary Outcomes (4)

  • Migraine Related Disability

    8 weeks

  • The Quality of Life

    8 weeks

  • Perceived Patient-Reported Change

    8th week (one week)

  • The general descriptive demographic information

    8 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Connective tissue massage

Other: Connective tissue massage

Group 2

EXPERIMENTAL

Classical massage

Other: Classical massage

Interventions

Connective tissue massageOTHER

Connective tissue massage will be applied with short and long pulling strokes to create a reflex effect for 2 days a week, a total of 8 weeks.

Group 1
Classical massageOTHER

Classical massage will be applied with the techniques of stroking, kneading, and friction for 2 days a week, a total of 8 weeks.

Group 2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers with a migraine diagnosis
  • Taking only analgesics for migraine treatment and continuing their routines
  • No problem in reading, writing and understanding Turkish

You may not qualify if:

  • Having any other neurological problems
  • Who had been injected with botulinum toxin in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Zeytinburnu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Arzu Özdinçler, PhD

    Biruni University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical investigator

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

July 18, 2022

Primary Completion

September 9, 2022

Study Completion

September 16, 2022

Last Updated

September 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)