Mesotherapy in the Treatment of Chronic Migraine

The Effectiveness of Mesotherapy (Lidocaine and Proxicam) in the Treatment of Chronic Migraine

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.

Study Overview

• Status: Completed
• Conditions: Chronic Migraine, Headache
• Intervention / Treatment: Drug: Lidocain

Detailed Description

Migraine is one of the types of headaches. For the diagnosis of chronic migraine, the headache must last more than 15 days. Nerve blocks, oral medication and neuromodulation are recommended for migraine treatment.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. This study was planned to show the effectiveness of mesotherapy in patients with migraine.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kucukcekmece
    • Istanbul, Kucukcekmece, Turkey, 34303
      • Kanni Sultan Suleyman Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Clinical diagnosis of chronic migraine disease

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mesotherapy; 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; All participants treated with procaine and lidocaine injection for treatment.; Other Names: Proxicam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of attack per month	The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.	Baseline
Duration of attack per month	The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.	4th week
Duration of attack per month	The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.	8th week
Duration of attack per month	The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.	12th week
the number of analgesic per month	The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment	Baseline
the number of analgesic per month	The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment	4th week
the number of analgesic per month	The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment	8th week
the number of analgesic per month	The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment	12th week

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Elif Ozyigit, MD, Kanuni Sultan Suleyman Research and Training Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): October 29, 2023

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: pain; muscle; headache; Chronic Migraine; Mesotherapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: KAEK/2022.11.225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators were undecided

Drug and device information, study documents

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