Tertiary Care With or Without Manual Therapy for Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

A Pragmatic Randomised Controlled Trial on the Effectiveness of Manual Therapy as an Adjunct to Tertiary Management in Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395457
• Other study ID #: Bournemouth 228901
• Status: Completed
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: Bournemouth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• Care as usual
Application of usual pharmacological care for chronic migraine

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

Locations

Country	Name	City	State
United Kingdom	Salford Royal NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Bournemouth University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 weeks
Secondary	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.	12 weeks
Secondary	Headache Frequency	Percentage of participants with reduction in headache frequency of greater than 50%	12 weeks