Back to resultsSaline Injections for Prophylactic Treatment of Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Terminated
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Saline injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine focused on measuring Chronic migraine, Saline injection
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.
Sites / Locations
- Rehabilitation clinic, Southern Älvsborg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium chloride injection
Needle sting
Arm Description
Sodium chloride 9mg/ml by injection
Brief needle stings without injection
Outcomes
Primary Outcome Measures
Change in number of Days with headache
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication (AHM)
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
Paracetamol
Aspirin
NSAID
Triptan
Opioid
Ergotamine
Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Change in number of Days with headache
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication.
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
Paracetamol
Aspirin
NSAID
Triptan
Opioid
Ergotamine
Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Secondary Outcome Measures
Number of Days with moderate or severe headache
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Number of Days with moderate or severe headache
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Number of days with acute headache medication
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Number of days with acute headache medication
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Number of days with acute headache medication that requires prescription
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Number of days with acute headache medication that requires prescription
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Change in Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Change in outcome of disease-specific implications: Headache Impact Test (HIT-6)
Change in Headache Impact Test (HIT-6)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03919045
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to Covid-19 the rehabilitation unit where the trial was conducted were closed and the trial active clinician had to work at the hospital intensive care.
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
May 21, 2021 (Actual)
Study Completion Date
May 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
Keywords
Chronic migraine, Saline injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
No Outcome assessor present in the study.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium chloride injection
Arm Type
Experimental
Arm Description
Sodium chloride 9mg/ml by injection
Arm Title
Needle sting
Arm Type
Placebo Comparator
Arm Description
Brief needle stings without injection
Intervention Type
Drug
Intervention Name(s)
Saline injection
Other Intervention Name(s)
Sodium chloride Braun, Sodium chloride Fresenius Krabi
Intervention Description
Half of the patients will be randomized to saline injections into the neck and head muscles
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Half of the group will be treated with needle stings without injections
Primary Outcome Measure Information:
Title
Change in number of Days with headache
Description
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication (AHM)
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
Paracetamol
Aspirin
NSAID
Triptan
Opioid
Ergotamine
Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline 28 day period prior injection1 and 28 day period ending study
Title
Change in number of Days with headache
Description
A headache day is defined as: 1) a day with headache ≥ 4 hours or 2) a day with headache of any duration, where the headache is relieved with acute headache medication.
By AHM is meant a drug that is taken when needed for the purpose of relieving headaches, including any of the following:
Paracetamol
Aspirin
NSAID
Triptan
Opioid
Ergotamine
Dihydroergotamine
The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline and the 28-day period preceding the second injection
Secondary Outcome Measure Information:
Title
Number of Days with moderate or severe headache
Description
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline 28 day period prior injection1 and 28 day period ending study
Title
Number of Days with moderate or severe headache
Description
A headache day with moderate or severe intensity is defined as: 1) a day with headache ≥ 4 hours and with a peak of moderate or severe intensity or 2) a day with headache of any duration or intensity, where the headache is relieved with AHM. The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline and the 28-day period preceding the second injection
Title
Number of days with acute headache medication
Description
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline 28 day period prior injection1 and 28 day period ending study
Title
Number of days with acute headache medication
Description
Number of days the respondent stated that AHM has been taken.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline and the 28-day period preceding the second injection
Title
Number of days with acute headache medication that requires prescription
Description
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline 28 day period prior injection1 and 28 day period ending study
Title
Number of days with acute headache medication that requires prescription
Description
Number of days the respondent stated that he or she has taken acute headache medication that require prescription, ie all drugs in the list in primary outcome above that require prescription by a doctor.The primary efficacy measure is the change between the baseline 28-day period (4 weeks prior injection 1) and the corresponding period during follow-up, i.e. the 28-day period ending the study. a secondary efficacy measure is the change between the baseline and the 28-day period preceding the second injection.
Time Frame
change between baseline and the 28-day period preceding the second injection
Title
Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Description
Change in Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
Time Frame
Change between baseline and 12 weeks after second injection
Title
Change in outcome of disease-specific implications: Headache Impact Test (HIT-6)
Description
Change in Headache Impact Test (HIT-6)
Time Frame
Change between baseline and 12 weeks after second injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Kim, MD
Organizational Affiliation
Rehabilitation clinic, Southern Älvsborg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation clinic, Southern Älvsborg Hospital
City
Borås
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17468941
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.
Results Reference
background
PubMed Identifier
20487038
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.
Results Reference
background
PubMed Identifier
18042229
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.
Results Reference
background
PubMed Identifier
14651416
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.
Results Reference
background
PubMed Identifier
23843470
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.
Results Reference
background
PubMed Identifier
15833086
Citation
Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.
Results Reference
background
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
Results Reference
background
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Saline Injections for Prophylactic Treatment of Chronic Migraine
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