Non-pharmacological Management of Chronic Migraine
- Conditions
- Headache
- Interventions
- Behavioral: Manipulative articulatory (ART) and myofascial techniquesDevice: Transcutaneous Electrical Nerve Stimulation
- Registration Number
- NCT02953015
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcutaneous Electrical Nerve Stimulation Group OnabotulinumtoxinA (Prophylaxis therapy) Electrical Nerve Stimulation Manipulative articulatory and myofascial techniques Group Manipulative articulatory (ART) and myofascial techniques Manipulative and myofascial techniques Manipulative articulatory and myofascial techniques Group OnabotulinumtoxinA (Prophylaxis therapy) Manipulative and myofascial techniques Transcutaneous Electrical Nerve Stimulation Group Transcutaneous Electrical Nerve Stimulation Electrical Nerve Stimulation
- Primary Outcome Measures
Name Time Method Changes in the number of days without headache Baseline, 1 month Time frame: from date of randomization up to 1 months.
- Secondary Outcome Measures
Name Time Method Total time with headache (hrs) Baseline, 1 month Time frame: from date of randomization up to 1 months.
Headache intensity reported as mild, moderate and severe per month. Baseline, 1 month Time frame: from date of randomization up to 1 months.
Average duration of attacks (hrs) Baseline, 1 month Time frame: from date of randomization up to 1 months.
The analgesic consumption reported as the number of total acute analgesic (NSAIDs/Triptans), NSAID and Triptans per month. Baseline, 1 month Time frame: from date of randomization up to 1 months.
Trigger points sensitivity (lbf/kgf or kgf/N) 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.Cervical Active Range of Motion (Degrees) Baseline, 1 month Time frame: from date of randomization up to 1 months.
Headache Impact Test-6 (HIT-6). Baseline, 1 month Time frame: from date of randomization up to 1 months.
Migraine Disability Assessment Scale (MIDAS). Baseline, 1 month Time frame: from date of randomization up to 1 months.
Number of patients that withdrawn the study (dropouts), and patients reporting side effects 4 weeks
Trial Locations
- Locations (1)
University of Verona
🇮🇹Verona, Italy