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Completed

NCT Number: NCT06118190

Mesotherapy 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.

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Key information

Conditions

Chronic Migraine, Headache Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kanni Sultan Suleyman Research and Training Hospital

Istanbul, Kucukcekmece, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of chronic migraine disease

Exclusion criteria

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

Treatment and study plan

Lidocain

Drug

All participants treated with procaine and lidocaine injection for treatment.

Other names: Proxicam

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Baseline

    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

  2. Visual Analog Scale (VAS)

    Time frame: 4th week

    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

  3. Visual Analog Scale (VAS)

    Time frame: 8th week

    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

  4. Visual Analog Scale (VAS)

    Time frame: 12 th week

    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

  5. The frequency of painful days per month

    Time frame: Baseline

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

  6. The frequency of painful days per month

    Time frame: 4th week

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

  7. The frequency of painful days per month

    Time frame: 8th week

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

  8. The frequency of painful days per month

    Time frame: 12th week

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

Secondary outcomes

  1. Duration of attack per month

    Time frame: Baseline

    The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.

  2. Duration of attack per month

    Time frame: 4th week

    The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.

  3. Duration of attack per month

    Time frame: 8th week

    The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.

  4. Duration of attack per month

    Time frame: 12th week

    The participant is questioned about how long each attack lasts within a month. Increased periods indicate prolonged symptom duration.

  5. the number of analgesic per month

    Time frame: Baseline

    The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment

  6. the number of analgesic per month

    Time frame: 4th week

    The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment

  7. the number of analgesic per month

    Time frame: 8th week

    The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment

  8. the number of analgesic per month

    Time frame: 12th week

    The participant is asked how many times he/she uses analgesic medication in a month. Higher numbers indicate an increased need for medical treatment

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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