Mesotherapy in the Treatment of Chronic Migraine

Chronic Migraine, Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06118190
• Other study ID #: KAEK/2022.11.225
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 29, 2023

Study information

• Verified date: November 2023
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 29, 2023
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of chronic migraine disease

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Drug:
• Lidocain
All participants treated with procaine and lidocaine injection for treatment.

Locations

Country	Name	City	State
Turkey	Kanni Sultan Suleyman Research and Training Hospital	Istanbul	Kucukcekmece

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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