A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Care as usual
- Conditions
- Chronic Migraine
- Sponsor
- Bournemouth University
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Change in migraine-related disability
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
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)
Arms & Interventions
Care as usual plus manual therapy
Other
Intervention: Care as usual
Care as usual
This is the care provided by the neurologist for chronic migraine.
Intervention: Care as usual
Care as usual plus manual therapy
Other
Intervention: Manual Therapy
Outcomes
Primary Outcomes
Change in migraine-related disability
Time Frame: 12 weeks
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 Outcomes
- Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)(12 weeks)
- Headache Frequency(12 weeks)