Effects of Cervical and Thoracic Manipulative Techniques Combined With OnabotulinumtoxinA Prophylaxis in the Management of Chronic Migraine: a Pilot Single-blind Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Manipulative articulatory (ART) and myofascial techniques
- Conditions
- Headache
- Sponsor
- Universita di Verona
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Changes in the number of days without headache
- Last Updated
- 9 years ago
Overview
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.
Investigators
Nicola Smania, MD, Clinical Professor
MD
Universita di Verona
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Manipulative articulatory and myofascial techniques Group
Manipulative and myofascial techniques
Intervention: Manipulative articulatory (ART) and myofascial techniques
Manipulative articulatory and myofascial techniques Group
Manipulative and myofascial techniques
Intervention: OnabotulinumtoxinA (Prophylaxis therapy)
Transcutaneous Electrical Nerve Stimulation Group
Electrical Nerve Stimulation
Intervention: Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation Group
Electrical Nerve Stimulation
Intervention: OnabotulinumtoxinA (Prophylaxis therapy)
Outcomes
Primary Outcomes
Changes in the number of days without headache
Time Frame: Baseline, 1 month
Time frame: from date of randomization up to 1 months.
Secondary Outcomes
- Total time with headache (hrs)(Baseline, 1 month)
- Headache intensity reported as mild, moderate and severe per month.(Baseline, 1 month)
- Average duration of attacks (hrs)(Baseline, 1 month)
- The analgesic consumption reported as the number of total acute analgesic (NSAIDs/Triptans), NSAID and Triptans per month.(Baseline, 1 month)
- Trigger points sensitivity (lbf/kgf or kgf/N)(Baseline, 1 month)
- Cervical Active Range of Motion (Degrees)(Baseline, 1 month)
- Headache Impact Test-6 (HIT-6).(Baseline, 1 month)
- Migraine Disability Assessment Scale (MIDAS).(Baseline, 1 month)
- Number of patients that withdrawn the study (dropouts), and patients reporting side effects(4 weeks)