Back to resultsTertiary Care With or Without Manual Therapy for Chronic Migraine
Primary Purpose
Chronic Migraine
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Care as usual
Manual Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
Female adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist
Exclusion Criteria:
Currently having or had manual therapy for neck, shoulder in the last six weeks.
Having a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.
Identification of any medical 'red flags' by the neurologist including
- Evidence of any central nervous system involvement for example:
- Facial palsy (presence of ptosis/Horner's syndrome)
- Visual disturbance (presence of blurred vision, diplopia, hemianopia)
- Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)
- Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)
- Paraesthesia (presence, location such as upper limb/lower limb, face)
- Weakness (presence, location such as upper limb/lower limb)
- Known major psychiatric or psychological conditions not under control
Sites / Locations
- Salford Royal NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Care as usual
Care as usual plus manual therapy
Arm Description
This is the care provided by the neurologist for chronic migraine.
Other
Outcomes
Primary Outcome Measures
Change in migraine-related disability
Headache Impact Test (HIT6). The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and is used in screening and monitoring patients. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, psychological distress and the severity of headache pain.
The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact. The categories used for interpretation of impact are: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
Secondary Outcome Measures
Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)
The 14-item instrument measures how migraines affect daily functioning across three domains: Role function Restrictions (7 items assessing how migraines limit one's daily social and work-related activities); Role function prevention (4 items assessing how migraines prevent these activities); Emotional Functional (3 items assessing the emotions associated with migraines). It uses a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Scores are computed as a sum of item responses and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.
Headache Frequency
Percentage of participants with reduction in headache frequency of greater than 50%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03395457
Brief Title
Tertiary Care With or Without Manual Therapy for Chronic Migraine
Official Title
A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bournemouth 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
The aim of this study is to determine if adding manual therapy to care as usual reduces the discomfort from chronic migraine compared to care as usual alone
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pragmatic randomised control trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Care as usual
Arm Type
Active Comparator
Arm Description
This is the care provided by the neurologist for chronic migraine.
Arm Title
Care as usual plus manual therapy
Arm Type
Experimental
Arm Description
Other
Intervention Type
Drug
Intervention Name(s)
Care as usual
Other Intervention Name(s)
Medication for chronic migraine
Intervention Description
Application of usual pharmacological care for chronic migraine
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
5 sessions of manual therapy over 12 weeks
Primary Outcome Measure Information:
Title
Change in migraine-related disability
Description
Headache Impact Test (HIT6). The six-item Headache Impact Test (HIT-6) provides a global measure of adverse headache impact and is used in screening and monitoring patients. The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, psychological distress and the severity of headache pain.
The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact. The categories used for interpretation of impact are: little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)
Description
The 14-item instrument measures how migraines affect daily functioning across three domains: Role function Restrictions (7 items assessing how migraines limit one's daily social and work-related activities); Role function prevention (4 items assessing how migraines prevent these activities); Emotional Functional (3 items assessing the emotions associated with migraines). It uses a 6-point scale: "none of the time," "a little bit of the time," "some of the time," "a good bit of the time," "most of the time," and "all of the time," which are assigned scores of 1 to 6, respectively. Scores are computed as a sum of item responses and rescaled from a 0 to 100 scale such that higher scores indicate better quality of life.
Time Frame
12 weeks
Title
Headache Frequency
Description
Percentage of participants with reduction in headache frequency of greater than 50%
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female adults 18 years of age or older with a good command of English (to enable informed consent) Existing patients with chronic migraine as diagnosed by a clinical interview with a neurologist in line with the International Classification of Headache Diagnosis criteria (ICHD) Undergoing care as usual from the neurologist
Exclusion Criteria:
Currently having or had manual therapy for neck, shoulder in the last six weeks.
Having a condition contraindicated for manual therapy including but not limited to inflammatory disorders, severe osteoporosis and tumours.
Identification of any medical 'red flags' by the neurologist including
Evidence of any central nervous system involvement for example:
Facial palsy (presence of ptosis/Horner's syndrome)
Visual disturbance (presence of blurred vision, diplopia, hemianopia)
Speech disturbance (presence of dysarthria, dysphonia, dysphasia such as expressive or receptive)
Balance disturbance (presence of dizziness, imbalance, unsteadiness, falls)
Paraesthesia (presence, location such as upper limb/lower limb, face)
Weakness (presence, location such as upper limb/lower limb)
Known major psychiatric or psychological conditions not under control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Clark, Dr
Organizational Affiliation
University Bournemouth
Official's Role
Study Chair
Facility Information:
Facility Name
Salford Royal NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30962877
Citation
Odell J, Clark C, Hunnisett A, Ahmed OH, Branney J. Manual therapy for chronic migraine: a pragmatic randomised controlled trial study protocol. Chiropr Man Therap. 2019 Mar 27;27:11. doi: 10.1186/s12998-019-0232-4. eCollection 2019.
Results Reference
derived
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Tertiary Care With or Without Manual Therapy for Chronic Migraine
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