Non-pharmacological Management of Chronic Migraine

NCT02953015 | Unknown DMC

• 1 other identifier: MIGRANE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Headache

Keywords

Chronic Migraine; Manipulative treatments; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in the number of days without headache

  Time frame: from date of randomization up to 1 months.

  Baseline, 1 month

Secondary Outcomes (9)

• Total time with headache (hrs)

  Baseline, 1 month

• Headache intensity reported as mild, moderate and severe per month.

  Baseline, 1 month

• Average duration of attacks (hrs)

  Baseline, 1 month

• The analgesic consumption reported as the number of total acute analgesic (NSAIDs/Triptans), NSAID and Triptans per month.

  Baseline, 1 month

• Cervical Active Range of Motion (Degrees)

  Baseline, 1 month

Study Arms (2)

Manipulative articulatory and myofascial techniques Group

EXPERIMENTAL

Manipulative and myofascial techniques

Behavioral: Manipulative articulatory (ART) and myofascial techniques; Drug: OnabotulinumtoxinA (Prophylaxis therapy)

Transcutaneous Electrical Nerve Stimulation Group

ACTIVE COMPARATOR

Electrical Nerve Stimulation

Device: Transcutaneous Electrical Nerve Stimulation; Drug: OnabotulinumtoxinA (Prophylaxis therapy)

Interventions

Manipulative articulatory (ART) and myofascial techniques BEHAVIORAL

Three manipulative articulatory (ART) and myofascial techniques will be performed to improve cervical and thoracic spine joint mobility and reducing soft tissue stiffness in the cervico-thoracic spine. ART technique is a low velocity to high amplitude technique where each joint is carried through its full motion to increase range of movement. The activating force is either a repetitive springing motion or repetitive concentric movement of the joint through the restrictive barrier. Myofascial technique is directed at the muscle and fascia treatment. It engages continual palpatory feedback to achieve release of myofascial tissues. During each treatment session, each technique will be carried out for 10 minutes including 2 minutes of resting.

Also known as: Manipulations

Manipulative articulatory and myofascial techniques Group

Transcutaneous Electrical Nerve Stimulation DEVICE

Transcutaneous Electrical Nerve Stimulation (TENS) of the upper trapezius muscle will be applied by a portable machine Master 932 (Elettronica Pagani SRL, Milan, Italy) that generates symmetric, bi-phasic rectangular pulses with 140μ sec duration. The current frequency will be set at 150 Hz and intensity will be increased up to patient's perception of paresthesia. The negative electrode will be placed on the active TrPs of the upper trapezius muscle and the positive one was on acromial tendon insertional site. The total duration of each application will be 20 minutes. Treatment frequency and duration will be the same of the EG treatment (1 session/week for 4 weeks). Each session will consist of 20 min of TENS and 10 min of resting in sitting position with the head lean on a pillow.

Also known as: Electrical stimulations

Transcutaneous Electrical Nerve Stimulation Group

OnabotulinumtoxinA (Prophylaxis therapy) DRUG

Prophylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site).

Also known as: OnabotulinumtoxinA injections

Manipulative articulatory and myofascial techniques Group; Transcutaneous Electrical Nerve Stimulation Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead
• Marialuisa Gandolfi: collaborator

Study Sites (1)

University of Verona

Verona, Italy, 37134, Italy

Location

Related Publications (1)

• Buse DC, Manack AN, Fanning KM, Serrano D, Reed ML, Turkel CC, Lipton RB. Chronic migraine prevalence, disability, and sociodemographic factors: results from the American Migraine Prevalence and Prevention Study. Headache. 2012 Nov-Dec;52(10):1456-70. doi: 10.1111/j.1526-4610.2012.02223.x. Epub 2012 Jul 25.

  PMID: 22830411 BACKGROUND

MeSH Terms

Conditions

Headache

Interventions

Transcutaneous Electric Nerve Stimulation; Electric Stimulation; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Physical Stimulation; Investigative Techniques; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Nicola Smania, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: November 2, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 2, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)