Trials / Terminated
TerminatedNCT03919045
Saline Injections for Prophylactic Treatment of Chronic Migraine
Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Göteborg University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Saline injection | Half of the patients will be randomized to saline injections into the neck and head muscles |
| PROCEDURE | Placebo | Half of the group will be treated with needle stings without injections |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2021-05-21
- Completion
- 2021-05-21
- First posted
- 2019-04-18
- Last updated
- 2022-03-31
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03919045. Inclusion in this directory is not an endorsement.