Clinical trial NCT03919045: Saline Injections for Prophylactic Treatment of Chronic Migraine
Official title: Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Migraine
Keywords: Chronic migraine
Saline injection
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in number of Days with headache
timeFrame: change between baseline 28 day period prior injection1 and 28 day period ending study
measure: Change in number of Days with headache
timeFrame: change between baseline and the 28-day period preceding the second injection
Secondary outcomes:
measure: Number of Days with moderate or severe headache
timeFrame: change between baseline 28 day period prior injection1 and 28 day period ending study
measure: Number of Days with moderate or severe headache
timeFrame: change between baseline and the 28-day period preceding the second injection
measure: Number of days with acute headache medication
timeFrame: change between baseline 28 day period prior injection1 and 28 day period ending study
measure: Number of days with acute headache medication
timeFrame: change between baseline and the 28-day period preceding the second injection
measure: Number of days with acute headache medication that requires prescription
timeFrame: change between baseline 28 day period prior injection1 and 28 day period ending study
measure: Number of days with acute headache medication that requires prescription
timeFrame: change between baseline and the 28-day period preceding the second injection
measure: Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
timeFrame: Change between baseline and 12 weeks after second injection
measure: Change in outcome of disease-specific implications: Headache Impact Test (HIT-6)
timeFrame: Change between baseline and 12 weeks after second injection
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Rehabilitation clinic, Southern Älvsborg Hospital
Study officials:
affiliation: Rehabilitation clinic, Southern Älvsborg Hospital
name: Malin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cole JC, Lin P, Rupnow MF. Validation of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v. 2.1) for patients undergoing prophylactic migraine treatment. Qual Life Res. 2007 Sep;16(7):1231-7. doi: 10.1007/s11136-007-9217-1. Epub 2007 Apr 28.
citation: Dodick DW, Turkel CC, DeGryse RE, Aurora SK, Silberstein SD, Lipton RB, Diener HC, Brin MF; PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010 Jun;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.
citation: Freitag FG, Diamond S, Diamond M, Urban G. Botulinum Toxin Type A in the treatment of chronic migraine without medication overuse. Headache. 2008 Feb;48(2):201-9. doi: 10.1111/j.1526-4610.2007.00963.x. Epub 2007 Nov 28.
citation: Gandek B, Alacoque J, Uzun V, Andrew-Hobbs M, Davis K. Translating the Short-Form Headache Impact Test (HIT-6) in 27 countries: methodological and conceptual issues. Qual Life Res. 2003 Dec;12(8):975-9. doi: 10.1023/a:1026171315263.
citation: Smelt AF, Assendelft WJ, Terwee CB, Ferrari MD, Blom JW. What is a clinically relevant change on the HIT-6 questionnaire? An estimation in a primary-care population of migraine patients. Cephalalgia. 2014 Jan;34(1):29-36. doi: 10.1177/0333102413497599. Epub 2013 Jul 10.
citation: Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.
citation: Kim M, Danielsson A, Ekelund A-C, Kemppainen E, Sjögren P, Svanberg T, Szalo G,Samuelsson O. Title:Botulinum toxin type A for Prophylactic Treatment of Chronic Migraine [Botulinum toxin typ Asom profylaktisk behandling av kronisk migrän]. Göteborg: Västra Götalandsregionen, SahlgrenskaUniversitetssjukhuset, HTA-centrum; 2014. Regional activity-based HTA 2014:70