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Tertiary Care With or Without Manual Therapy for Chronic Migraine

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ClinicalTrials.gov Identifier: NCT03395457
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bournemouth University

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

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Care as usual Other: Manual Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: pragmatic randomised control trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Care as usual
This is the care provided by the neurologist for chronic migraine.
Drug: Care as usual
Application of usual pharmacological care for chronic migraine
Other Name: Medication for chronic migraine

Experimental: Care as usual plus manual therapy
Other
Drug: Care as usual
Application of usual pharmacological care for chronic migraine
Other Name: Medication for chronic migraine

Other: Manual Therapy
5 sessions of manual therapy over 12 weeks




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1) [ Time Frame: 12 weeks ]
    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.

  2. Headache Frequency [ Time Frame: 12 weeks ]
    Percentage of participants with reduction in headache frequency of greater than 50%



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395457


Contacts
Contact: Jim Odell +447413833690 jodell@bournemouth.ac.uk
Contact: Carol Clark, Dr cclark@bournemouth.ac.uk

Locations
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: James Odell         
Principal Investigator: James Odell         
Sponsors and Collaborators
Bournemouth University
Investigators
Study Chair: Carol Clark, Dr University Bournemouth

Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT03395457     History of Changes
Other Study ID Numbers: Bournemouth 228901
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases