Headache
Conditions
Keywords
Peripheral Nerve Stimulation, Occipital Nerves
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOccipital nerve peripheral nerve stimulation (PNS)
Temporary 60-day occipital nerve PNS as part of routine care.
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of a headache disorder for which the treating clinician has independently made the clinical decision to proceed with temporary 60-day occipital nerve PNS as part of routine care, including: * Occipital neuralgia * Chronic migraine * Chronic tension-type headache * Chronic cluster headache * Cervicogenic headache * Clinically scheduled to undergo temporary 60-day occipital PNS as part of routine care. * Ability to provide informed consent.
Exclusion criteria
* Inability to provide informed consent. * Coagulopathy that would prohibit PNS placement. * Severe psychiatric illness interfering with participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in headache impact | 60 days | 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. |
| Change in health care resource utilization (HCRU) | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in numeric rating scale | 12 months | Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain). |
| Change in neck disability index | 12 months | 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 |
| Change in global impression of change | 12 months | 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 |
| IMMPACT ≥30% pain reduction | 12 months | IMMPACT ≥30% pain reduction, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain). |
| IMMPACT Pain Relief ≥50% | 60 days | ≥50% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain). |
| IMMPACT Pain Relief ≥80% | 60 days | ≥80% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain). |
| Medication utilization | 12 months | Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox. |
| Healthcare Utilization | 12 months | Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles A Odonkor, MD
Yale University
Outcome results
None listed