Tertiary Care With or Without Manual Therapy for Chronic Migraine

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Migraine
• Intervention / Treatment: Drug: Care as usual; Other: Manual Therapy

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Medication for chronic migraine; Other: Manual Therapy; 5 sessions of manual therapy over 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Headache Frequency	Percentage of participants with reduction in headache frequency of greater than 50%	12 weeks

Collaborators and Investigators

• Sponsor: Bournemouth University
• Investigators: Study Chair: Carol Clark, Dr, University Bournemouth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: Bournemouth 228901

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No