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Non-pharmacological Management of Chronic Migraine (MIGRANE)

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ClinicalTrials.gov Identifier: NCT02953015
Recruitment Status : Unknown
Verified October 2016 by Nicola Smania, MD, Clinical Professor, Universita di Verona.
Recruitment status was:  Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Marialuisa Gandolfi
Information provided by (Responsible Party):
Nicola Smania, MD, Clinical Professor, Universita di Verona

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.

Condition or disease Intervention/treatment Phase
Headache Behavioral: Manipulative articulatory (ART) and myofascial techniques Device: Transcutaneous Electrical Nerve Stimulation Drug: OnabotulinumtoxinA (Prophylaxis therapy) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cervical and Thoracic Manipulative Techniques Combined With OnabotulinumtoxinA Prophylaxis in the Management of Chronic Migraine: a Pilot Single-blind Randomized Controlled Trial
Study Start Date : January 2016
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arm Intervention/treatment
Experimental: Manipulative articulatory and myofascial techniques Group
Manipulative and myofascial techniques
Behavioral: 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.
Other Name: Manipulations

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

Active Comparator: Transcutaneous Electrical Nerve Stimulation Group
Electrical Nerve Stimulation
Device: 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.
Other Name: Electrical stimulations

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




Primary Outcome Measures :
  1. Changes in the number of days without headache [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.


Secondary Outcome Measures :
  1. Total time with headache (hrs) [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  2. Headache intensity reported as mild, moderate and severe per month. [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  3. Average duration of attacks (hrs) [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  4. The analgesic consumption reported as the number of total acute analgesic (NSAIDs/Triptans), NSAID and Triptans per month. [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  5. Cervical Active Range of Motion (Degrees) [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  6. Headache Impact Test-6 (HIT-6). [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  7. Migraine Disability Assessment Scale (MIDAS). [ Time Frame: Baseline, 1 month ]
    Time frame: from date of randomization up to 1 months.

  8. Trigger points sensitivity (lbf/kgf or kgf/N) [ Time Frame: Baseline, 1 month ]

    Trigger point sensitivity will be assessed by measuring the pressure pain threshold (PPT) with a Wagner algometer 162 (Wagner Instruments, Riverside, CT, USA). The PPT corresponds to the force needed to induce a difference between a feeling of simple pressure and a painful sensation. PPT assessment will be performed on the frontalis, temporalis and occipitalis, and upper trapezius muscles.

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


  9. Number of patients that withdrawn the study (dropouts), and patients reporting side effects [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953015


Locations
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Italy
University of Verona
Verona, Italy, 37134
Sponsors and Collaborators
Universita di Verona
Marialuisa Gandolfi
Investigators
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Principal Investigator: Nicola Smania, MD Universita di Verona
Publications:
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Responsible Party: Nicola Smania, MD, Clinical Professor, MD, Universita di Verona
ClinicalTrials.gov Identifier: NCT02953015    
Other Study ID Numbers: MIGRANE
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nicola Smania, MD, Clinical Professor, Universita di Verona:
Chronic Migraine
Manipulative treatments
Transcutaneous Electrical Nerve Stimulation
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents