HeadacheMIGRANENCT02953015
Non-pharmacological Management of Chronic Migraine
A study testing Manipulative articulatory (ART) and myofascial techniques, Transcutaneous Electrical Nerve Stimulation and OnabotulinumtoxinA (Prophylaxis therapy) in people with Headache, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- Manipulative articulatory (ART) and myofascial techniques, Transcutaneous Electrical Nerve Stimulation and OnabotulinumtoxinA (Prophylaxis therapy)
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- severe osteoporosis;
- vertebral or arm fractures; alcohol/drug abuse;
- relevant medical therapy changes during the trial;
- incomplete headache diaries with missing information.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Manipulative articulatory (ART) and myofascial techniques, Transcutaneous Electrical Nerve Stimulation, OnabotulinumtoxinA (Prophylaxis therapy)
- Keywords
- Chronic Migraine, Manipulative treatments, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulative articulatory (ART) and myofascial techniquesBehavioural
Also called Manipulations
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.
Transcutaneous Electrical Nerve StimulationDevice
Also called Electrical stimulations
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)Drug
Also called OnabotulinumtoxinA injections
Prophylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site).
| Study group | Role | What they receive |
|---|---|---|
| Manipulative articulatory and myofascial techniques Group | Experimental | Manipulative and myofascial techniques Receives: Behavioral: Manipulative articulatory (ART) and myofascial techniques; Drug: OnabotulinumtoxinA (Prophylaxis therapy) |
| Transcutaneous Electrical Nerve Stimulation Group | Active comparator | Electrical Nerve Stimulation Receives: Device: Transcutaneous Electrical Nerve Stimulation; Drug: OnabotulinumtoxinA (Prophylaxis therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the number of days without headache
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Secondary outcomes (9)
Total time with headache (hrs)
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Headache intensity reported as mild, moderate and severe per month.
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Average duration of attacks (hrs)
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
The analgesic consumption reported as the number of total acute analgesic (NSAIDs/Triptans), NSAID and Triptans per month.
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Cervical Active Range of Motion (Degrees)
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Headache Impact Test-6 (HIT-6).
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Migraine Disability Assessment Scale (MIDAS).
Time frame: from date of randomization up to 1 months.
Measured: Baseline, 1 month
Trigger points sensitivity (lbf/kgf or kgf/N)
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.
Measured: Baseline, 1 month
Number of patients that withdrawn the study (dropouts), and patients reporting side effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Marialuisa Gandolfi
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
- Investigators
- Nicola Smania, MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953015
- Sponsor's protocol ID
- MIGRANE
- Acronym
- MIGRANE
- Status last verified
- Oct 2016
- First submitted
- 19 Sep 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22830411
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02953015
- Acronym / sponsor ID
- MIGRANE / MIGRANE
- Conditions
- Headache
- Keywords
- Chronic Migraine, Manipulative treatments, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Marialuisa Gandolfi
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulative articulatory and myofascial techniques Group | Experimental | Behavioral: Manipulative articulatory (ART) and myofascial techniques, Drug: OnabotulinumtoxinA (Prophylaxis therapy)Manipulative and myofascial techniques |
| Transcutaneous Electrical Nerve Stimulation Group | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation, Drug: OnabotulinumtoxinA (Prophylaxis therapy)Electrical Nerve Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulative articulatory (ART) and myofascial techniquesAlso: ManipulationsThree 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. | Behavioural | Manipulative articulatory and myofascial techniques Group |
| Transcutaneous Electrical Nerve StimulationAlso: Electrical stimulationsTranscutaneous 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. | Device | Transcutaneous Electrical Nerve Stimulation Group |
| OnabotulinumtoxinA (Prophylaxis therapy)Also: OnabotulinumtoxinA injectionsProphylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site). | Drug | Manipulative articulatory and myofascial techniques Group, Transcutaneous Electrical Nerve Stimulation Group |
Primary outcome
Changes in the number of days without headache
Time frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
9 secondary outcomes
Total time with headache (hrs)
Time frame: Baseline, 1 month
Headache intensity reported as mild, moderate and severe per month.
Time frame: Baseline, 1 month
Average duration of attacks (hrs)
Time frame: 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
Cervical Active Range of Motion (Degrees)
Time frame: Baseline, 1 month
Headache Impact Test-6 (HIT-6).
Time frame: Baseline, 1 month
Migraine Disability Assessment Scale (MIDAS).
Time frame: Baseline, 1 month
Trigger points sensitivity (lbf/kgf or kgf/N)
Time frame: Baseline, 1 month
Number of patients that withdrawn the study (dropouts), and patients reporting side effects
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 22830411Buse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Smania, MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulative articulatory (ART) and myofascial techniques, Transcutaneous Electrical Nerve Stimulation and OnabotulinumtoxinA (Prophylaxis therapy) in people with Headache, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the number of days without headache (time frame: Baseline, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.