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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06118190
Other study ID # KAEK/2022.11.225
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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