Saline Injections for Prophylactic Treatment of Chronic Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2021-05-21

Brief Summary

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In this study, the investigators want to investigate whether saline injections in the neck and head muscles can reduce symptoms of chronic migraine. In existing studies, saline injections (used as placebo treatment) have given patients with chronic migraine an average of 7 headache-free days per month.

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Detailed Description

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Patients who meet the diagnostic criteria for chronic migraine will be invited to participate in the study. All participants will undergo a medical examination. The participants will fill out an electronic headache diary for one month. This will give a picture of the current headache pattern and establish a baseline. The participants will then be randomized into two groups: saline injections or needle sticks without injection. They will not be aware of which group they belong to. The treatment will be repeated on two occasions three months apart. The headache diary will continue during the treatment period and up to three months after the second treatment. The effect will be analyzed by comparing baseline data from the headache diary to data after treatment. The primary outcome of the study is the number of days with headache, during a 28-day period.

Conditions

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Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

No Outcome assessor present in the study.

Study Groups

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Sodium chloride injection

Sodium chloride 9mg/ml by injection

Group Type EXPERIMENTAL

Saline injection

Intervention Type DRUG

Half of the patients will be randomized to saline injections into the neck and head muscles

Needle sting

Brief needle stings without injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Half of the group will be treated with needle stings without injections

Interventions

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Saline injection

Half of the patients will be randomized to saline injections into the neck and head muscles

Intervention Type DRUG

Placebo

Half of the group will be treated with needle stings without injections

Intervention Type PROCEDURE

Other Intervention Names

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Sodium chloride Braun Sodium chloride Fresenius Krabi

Eligibility Criteria

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Inclusion Criteria

* Participants must meet the diagnostic criteria for chronic migraine (headache that have occurred on at least 15 days per month, for at least three months. At least eight of the headache episodes must be typical for migraine).
* Participants must be able to understand and give informed consent to participate in the study.
* Participants must be aged 18-65 years.

Exclusion Criteria

* Participants must not suffer from other medical conditions that may affect the outcome of the study, including Horton's headache, temporal arteritis, trigeminal neuralgia, chronic paroxysmal hemi-crania, atypical facial pain and headache of unknown cause.
* Participants must not have medical conditions that require use of drugs that can affect the headache pattern (for example rheumatic disorders).
* Participants must not suffer from malignant diseases.
* Participants must not plan to make changes to existing prophylactic headache medication during the study. Patients may, if already on treatment, choose to continue this throughout the course of the study, or choose to stop the prophylactic treatment at least one week before the start of the baseline period.
* Participants must not have an ongoing patient-doctor contact with the physician giving the injections.
* Participants must not have an ongoing patient-doctor contact with the monitor of the study.
* Participants must not have received injection therapy in the face, head or neck muscles (medical or cosmetic) less than three months before the start of the study, nor should they plan such treatment during the course of the study.
* Participants must not be pregnant or plan pregnancy during the course of the study.
* Participants must not breastfeed or plan to do so during the study.
* Participants must not have any contraindications to injection therapy (such as disease with increased bleeding tendency or treatment with certain types of blood thinners).
* Participants must have no difficulty understanding or making themselves understood in Swedish.
* Participants must be able to fill out the headache diary and questionnaires.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No