This prospective observational cohort study will evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.
The main purpose of this prospective observational cohort study is to evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders. The study will assess changes in headache impact, pain intensity, neck-related disability, patient global impression of change, medication utilization, and headache-related health care utilization over 12 months. The anticipated impact of this research is improved understanding of whether occipital PNS delivered in standard clinical practice is associated with better patient-reported outcomes, fewer acute care visits, and lower utilization of health system resources, which may ultimately inform clinical decision-making, quality-of-life improvement, and potential cost savings. Planned analyses include within-subject longitudinal comparisons from baseline to 60 days and 12 months, site adjusted modeling of utilization outcomes, and exploratory analyses of predictors of response across headache diagnoses and patient subgroups.
Study Type
OBSERVATIONAL
Enrollment
300
Temporary 60-day occipital nerve PNS as part of routine care.
Change in headache impact
Change in headache impact will be measured using the HIT-6 measures the impact of headache on daily life. Score range: 36-78; Impact Categories: ≤49: Little to no impact, 50-55: Some impact, 56-59: Substantial impact, ≥60: Severe impact. A reduction in score would indicate an improvement in headache.
Time frame: 60 days
Change in health care resource utilization (HCRU)
Change in HCRU will be assesssed by the change in frequency of emergency department visits for headache-related diagnoses during the 12 months after treatment compared with the pre-treatment period.
Time frame: 12 months
Change in numeric rating scale
Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 12 months
Change in neck disability index
Neck Disability Index (NDI), the Range: 0-50, Categories: 0-4: No disability, 5-14: Mild disability, 15-24: Moderate disability, 25-34: Severe disability and 35-50: Complete disability
Time frame: 12 months
Change in global impression of change
Patient Global Impression of Change (PGIC), Seven-point scale: 1. Very much worse 2. Much worse 3. A little worse 4. No change 5. A little improved 6. Much improved 7. Very much improved
Time frame: 12 months
IMMPACT ≥30% pain reduction
IMMPACT ≥30% pain reduction, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 12 months
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IMMPACT Pain Relief ≥50%
≥50% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 60 days
IMMPACT Pain Relief ≥80%
≥80% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 60 days
IMMPACT Pain Relief ≥50%
≥50% pain relief at 12 months, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 12 months
Medication utilization
Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox.
Time frame: 12 months
Healthcare Utilization
Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions.
Time frame: 12 months