Non-pharmacological Management of Chronic Migraine

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic migraine (CM) is a very disabling disorder with grave socioeconomic consequences. Pharmacological approaches can affect mechanisms of pain production, while rehabilitation such as Transcutaneous Electrical Nerve Stimulation and Manual Therapy may reduce the neuromuscular contributing factors. The main aim of the study is to evaluate the effects of cervical and thoracic manipulative techniques combined with OnabotulinumtoxinA prophylaxis on headache frequency in patients with Chronic Migraine (CM). The second aim is to evaluate the training effects on the intensity of headache attacks, analgesic consumption, cervical range of motion, TrPs sensitivity and disability. The hypothesis is that the manipulative treatment would alleviate CM symptoms and, in turn, decrease the analgesic consumption.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universita di Verona
• Collaborator: Marialuisa Gandolfi
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion criteria will be:

• age between 18 and 65 years;

• diagnosis of CM according to fhe International Classification of Headache Criteria-III;

• ineffective assumption of at least 3 different drug classes recommended by the international guidelines of migraine treatment;

• intolerance to/inefficacy of primary prophylaxis therapy;

• prophylactic treatment with OnabotulinumtoxinA according to the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) protocol;

• at least two consecutive OnabotulinumtoxinA injections.

Exclusion criteria will be:

• contraindications to onaBoNTA injection;

• presence of other neurologic disorders that can cause/sustain migraine;

• onaBoNTA treatment for purposes other than those of this study;

• other non-pharmacological treatments for migraine (e.g. massage, acupuncture);

• severe and unstable cardiovascular and cerebrovascular disease;

• presence of infections, psychiatric diseases or functional disorders in any head structure;

• severe osteoporosis;

• vertebral or arm fractures; alcohol/drug abuse;

• relevant medical therapy changes during the trial;

• incomplete headache diaries with missing information.