Tertiary Care With or Without Manual Therapy for Chronic Migraine

NCT03395457 | Completed

• 1 other identifier: Bournemouth 228901
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Migraine Specific Quality of Life Questionnaire Score (MSQoL 2.1)

  12 weeks

• Headache Frequency

  12 weeks

Study Arms (2)

Care as usual

ACTIVE COMPARATOR

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

Drug: Care as usual

Care as usual plus manual therapy

EXPERIMENTAL

Other

Drug: Care as usual; Other: Manual Therapy

Interventions

Care as usual DRUG

Application of usual pharmacological care for chronic migraine

Also known as: Medication for chronic migraine

Care as usual; Care as usual plus manual therapy

Manual Therapy OTHER

5 sessions of manual therapy over 12 weeks

Care as usual plus manual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bournemouth University: lead

Study Sites (1)

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30962877 DERIVED

MeSH Terms

Interventions

Dosage Forms; Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Carol Clark, Dr

  University Bournemouth

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic randomised control trial

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 10, 2018
• Study Start: August 3, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

GB (1)