Non-pharmacological Management of Chronic Migraine (MIGRANE)

November 1, 2016 updated by: Nicola Smania, MD, Clinical Professor, Universita di Verona

Effects of Cervical and Thoracic Manipulative Techniques Combined With OnabotulinumtoxinA Prophylaxis in the Management of Chronic Migraine: a Pilot Single-blind Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • University of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Manipulations
Drug: OnabotulinumtoxinA (Prophylaxis therapy)
Prophylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site).
Other Names:
  • OnabotulinumtoxinA injections
Active Comparator: Transcutaneous Electrical Nerve Stimulation Group
Electrical Nerve Stimulation
Drug: OnabotulinumtoxinA (Prophylaxis therapy)
Prophylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site).
Other Names:
  • OnabotulinumtoxinA injections
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 Names:
  • Electrical stimulations

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total time with headache (hrs)
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Baseline, 1 month
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.
Baseline, 1 month
Average duration of attacks (hrs)
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Baseline, 1 month
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.
Baseline, 1 month
Cervical Active Range of Motion (Degrees)
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Baseline, 1 month
Headache Impact Test-6 (HIT-6).
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Baseline, 1 month
Migraine Disability Assessment Scale (MIDAS).
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Baseline, 1 month
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.
Baseline, 1 month
Number of patients that withdrawn the study (dropouts), and patients reporting side effects
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Collaborators

Marialuisa Gandolfi

Investigators

  • Principal Investigator: Nicola Smania, MD, Universita di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIGRANE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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