Non-pharmacological Management of Chronic Migraine

NCT ID: NCT02953015

Last Updated: 2016-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

The present study is a single-blind randomized controlled trial conducted according to the Declaration of Helsinki, the guidelines for Good Clinical Practice, and the Consolidated Standards of reporting Trials (CONSORT) Statement guidelines. The examiner will be blinded to group assignment. If eligible, patients will be allocated to the experimental group (EG) or the control group (CG) using an automated randomization system (Allocation ratio 1:1). The group allocation will be kept concealed by means of sealed numbered envelopes. The randomization list was locked in a desk drawer accessible only to the main investigator. All the treatments and assessment will be performed in the Neurorehabilitation Unit of Azienda Ospedaliera Universitaria Integrata of Verona (Italy).

Patients will be asked to complete a daily headache diary, which is routinely administered to all patients with CM admitted at our Unit for OnabotulinumtoxinA prophylaxis. In the context of this study, daily headache diaries during 1 month pre-treatment (T0), during the treatment (treatment phase) and 1 month post-treatment (T1) will be considered.

Moreover, at T0 a questionnaire concerning clinical and demographic data as well as some habits like consumption of coffee and alcohol, and smoking will be administered. According to the nature of the study feasibility and efficacy outcomes will be defined. Feasibility outcomes were the patients' compliance during treatments, any adverse events (i.e. pain, discomfort) occurred during the treatment, and the number of training session performed. Primary and secondary outcome measures will be categorized as efficacy outcomes.

Conditions

Headache

Keywords

Chronic Migraine; Manipulative treatments; Transcutaneous Electrical Nerve Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manipulative articulatory and myofascial techniques Group

Manipulative and myofascial techniques

Group Type: EXPERIMENTAL

Manipulative articulatory (ART) and myofascial techniques

Intervention Type: 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.

OnabotulinumtoxinA (Prophylaxis therapy)

Intervention Type: DRUG

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

Transcutaneous Electrical Nerve Stimulation Group

Electrical Nerve Stimulation

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation

Intervention Type: 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.

OnabotulinumtoxinA (Prophylaxis therapy)

Intervention Type: DRUG

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

Interventions

Manipulative articulatory (ART) and myofascial techniques

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.

Intervention Type: BEHAVIORAL

Transcutaneous Electrical Nerve Stimulation

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.

Intervention Type: DEVICE

OnabotulinumtoxinA (Prophylaxis therapy)

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

Intervention Type: DRUG

Other Intervention Names

Manipulations; Electrical stimulations; OnabotulinumtoxinA injections

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marialuisa Gandolfi

UNKNOWN

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Nicola Smania, MD, Clinical Professor

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicola Smania, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

University of Verona

Verona, Italy, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 22830411 (View on PubMed)

Other Identifiers

MIGRANE

Identifier Type: -

Identifier Source: org_study_id