Tertiary Care With or Without Manual Therapy for Chronic Migraine

NCT ID: NCT03395457

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2019-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

pragmatic randomised control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Care as usual

This is the care provided by the neurologist for chronic migraine.

Group Type ACTIVE_COMPARATOR

Care as usual

Intervention Type DRUG

Application of usual pharmacological care for chronic migraine

Care as usual plus manual therapy

Other

Group Type EXPERIMENTAL

Care as usual

Intervention Type DRUG

Application of usual pharmacological care for chronic migraine

Manual Therapy

Intervention Type OTHER

5 sessions of manual therapy over 12 weeks

Interventions

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Care as usual

Application of usual pharmacological care for chronic migraine

Intervention Type DRUG

Manual Therapy

5 sessions of manual therapy over 12 weeks

Intervention Type OTHER

Other Intervention Names

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Medication for chronic migraine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bournemouth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Clark, Dr

Role: STUDY_CHAIR

University Bournemouth

Locations

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Salford Royal NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 30962877 (View on PubMed)

Other Identifiers

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Bournemouth 228901

Identifier Type: -

Identifier Source: org_study_id

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