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Completed

NCT Number: NCT03395457

Tertiary Care With or Without Manual Therapy for 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

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Key information

Conditions

Chronic Migraine

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care as usual

Drug

Application of usual pharmacological care for chronic migraine

Other names: Medication for chronic migraine

Manual therapy

Other

5 sessions of manual therapy over 12 weeks

Primary outcomes

  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 outcomes

  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%

Sponsors and collaborators

Lead sponsor

Bournemouth University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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