An interventional study of Care as usual and Manual Therapy in Chronic Migraine, sponsored by Bournemouth University. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Bournemouth University · Not applicable, Interventional, and Treatment
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
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
This is the care provided by the neurologist for chronic migraine.
Drug: Care as usual
Other
Drug: Care as usual · Other: Manual Therapy
Application of usual pharmacological care for chronic migraine
Also known as: Medication for chronic migraine
5 sessions of manual therapy over 12 weeks
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).
Time frame: 12 weeks
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.
Time frame: 12 weeks
Headache Frequency
Percentage of participants with reduction in headache frequency of greater than 50%
Time frame: 12 weeks
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Bournemouth University