NCT06118190

Brief Summary

Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 30, 2023

Last Update Submit

November 3, 2023

Conditions

Chronic Migraine, Headache

Keywords

MesotherapyChronic Migrainepainmuscleheadache

Outcome Measures

Primary Outcomes (8)

  • Visual Analog Scale (VAS)

    VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity

    Baseline

  • Visual Analog Scale (VAS)

    VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity

    4th week

  • Visual Analog Scale (VAS)

    VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity

    8th week

  • Visual Analog Scale (VAS)

    VAS rates pain on a scale of zero to 10. It is explained to the participant that 10 points means unbearable pain, zero points means no pain, and the patient is asked to rate his pain between zero and ten. Higher scores indicate increased pain severity

    12 th week

  • The frequency of painful days per month

    The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days

    Baseline

  • The frequency of painful days per month

    The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days

    4th week

  • The frequency of painful days per month

    The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days

    8th week

  • The frequency of painful days per month

    The participant is asked how many days she/he feels pain in a month.Higher numbers indicate increased frequency of painful days

    12th week

Secondary Outcomes (8)

  • Duration of attack per month

    Baseline

  • Duration of attack per month

    4th week

  • Duration of attack per month

    8th week

  • Duration of attack per month

    12th week

  • the number of analgesic per month

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

mesotherapy

EXPERIMENTAL

All participants who received mesotherapy were monitored regularly for the following three months to assess their prognosis and ensure patient adherence to treatment.

Drug: Lidocain

Interventions

LidocainDRUG

All participants treated with procaine and lidocaine injection for treatment.

Also known as: Proxicam
mesotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Clinical diagnosis of chronic migraine disease

You may not qualify if:

  • Infection disease
  • Thyroid disease
  • Anemia disease
  • Systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanni Sultan Suleyman Research and Training Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

Location

Related Publications (2)

  • Costantino C, Marangio E, Coruzzi G. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial. Evid Based Complement Alternat Med. 2011;2011:317183. doi: 10.1155/2011/317183. Epub 2010 Sep 1.

    PMID: 20953425BACKGROUND

  • Ravishankar K, Tayade H, Mandlik R. Sublingual piroxicam in migraine without aura. J Assoc Physicians India. 2011 Aug;59:494-7.

    PMID: 21887905BACKGROUND

MeSH Terms

Conditions

HeadachePain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elif Ozyigit, MD

    Kanuni Sultan Suleyman Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Retrospective analysis of the group that received treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 7, 2023

Study Start

January 1, 2019

Primary Completion

December 30, 2020

Study Completion

October 29, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

TU(1)