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出境医 / 临床实验 / Saline Injections for Prophylactic Treatment of Chronic Migraine

Saline Injections for Prophylactic Treatment of Chronic Migraine

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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Saline injection Procedure: Placebo Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: No Outcome assessor present in the study.
Primary Purpose: Treatment
Official Title: Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Sodium chloride injection
Sodium chloride 9mg/ml by injection
 Drug: Saline injection
Half of the patients will be randomized to saline injections into the neck and head muscles
Other Names:
  • Sodium chloride Braun
  • Sodium chloride Fresenius Krabi
Placebo Comparator: Needle sting
Brief needle stings without injection
 Procedure: Placebo
Half of the group will be treated with needle stings without injections
Outcome Measures
Primary Outcome Measures :
  1. Change in number of Days with headache [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]

    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.


  2. Change in number of Days with headache [ Time Frame: change between baseline and the 28-day period preceding the second injection ]

    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 :
  1. Number of Days with moderate or severe headache [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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.

  2. Number of Days with moderate or severe headache [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  3. Number of days with acute headache medication [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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.

  4. Number of days with acute headache medication [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  5. Number of days with acute headache medication that requires prescription [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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.

  6. Number of days with acute headache medication that requires prescription [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.

  7. Change in outcome of disease-specific quality of Life: Migraine-specific Quality of Life Questionnaire (MSQ v2.1) [ Time Frame: Change between baseline and 12 weeks after second injection ]
    Change in Migraine-specific Quality of Life Questionnaire (MSQ v2.1)

  8. Change in outcome of disease-specific implications: Headache Impact Test (HIT-6) [ Time Frame: Change between baseline and 12 weeks after second injection ]
    Change in Headache Impact Test (HIT-6)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Anna Grimby Ekman, Assoc Prof +4676 618 31 23 anna.ekman@gu.se
Contact: Malin Kim, MD +4633281645 malin.kim@vgregion.se

Locations
Layout table for location information
Sweden
Rehabilitation clinic, Southern Älvsborg Hospital Recruiting
Borås, Sweden
Contact: Malin Kim, MD         
Principal Investigator: Malin Kim, MD         
Sponsors and Collaborators
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Malin Kim, MD Rehabilitation clinic, Southern Älvsborg Hospital
Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Change in number of Days with headache [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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 [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Number of Days with moderate or severe headache [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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 [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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 [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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 [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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 [ Time Frame: change between baseline 28 day period prior injection1 and 28 day period ending study ]
    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 [ Time Frame: change between baseline and the 28-day period preceding the second injection ]
    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) [ Time Frame: Change between baseline and 12 weeks after second injection ]
    Change in Migraine-specific Quality of Life Questionnaire (MSQ v2.1)
  • Change in outcome of disease-specific implications: Headache Impact Test (HIT-6) [ Time Frame: Change between baseline and 12 weeks after second injection ]
    Change in Headache Impact Test (HIT-6)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Saline Injections for Prophylactic Treatment of Chronic Migraine
Official Title  ICMJE Saline Injections for Prophylactic Treatment of Chronic Migraine - a Randomized Controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
No Outcome assessor present in the study.
Primary Purpose: Treatment
Condition  ICMJE Chronic Migraine
Intervention  ICMJE
  • Drug: Saline injection
    Half of the patients will be randomized to saline injections into the neck and head muscles
    Other Names:
    • Sodium chloride Braun
    • Sodium chloride Fresenius Krabi
  • Procedure: Placebo
    Half of the group will be treated with needle stings without injections
Study Arms  ICMJE
  • Experimental: Sodium chloride injection
    Sodium chloride 9mg/ml by injection
    Intervention: Drug: Saline injection
  • Placebo Comparator: Needle sting
    Brief needle stings without injection
    Intervention: Procedure: Placebo
Publications *
  • 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. Epub 2007 Apr 28.
  • 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.
  • 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. Epub 2007 Nov 28.
  • 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.
  • 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.
  • Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Grimby Ekman, Assoc Prof +4676 618 31 23 anna.ekman@gu.se
Contact: Malin Kim, MD +4633281645 malin.kim@vgregion.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919045
Other Study ID Numbers  ICMJE Migraine1
2018-003868-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Göteborg University
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Malin Kim, MD Rehabilitation clinic, Southern Älvsborg Hospital
PRS Account Göteborg University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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