CEFALY,
does it really help with Increased freedom from pain at two hours during an acute migraine attack?
research showsCEFALY increases the chance of two-hour pain freedom during an acute migraine attack but is rated C. TEAM randomized 538 participants and included all 538 in the intention-to-treat analysis. Both coprimary outcomes succeeded: two-hour pain freedom was 25.5% versus 18.3% (difference 7.2 percentage points, P=0.043), and freedom from the most bothersome symptom was 56.4% versus 42.3% (difference 14.1 percentage points, P=0.001). ACME also found a positive one-hour pain-intensity result in 106 randomized and analyzed participants, but its endpoint differed and both trials had funding, device, or investigator links to CEFALY Technology, leaving no independent replication.
ads claimDelivery of a specified electrical waveform should not be expanded into guaranteed complete relief of every attack or guaranteed replacement of medication. Only 25.5% of treated participants in TEAM were pain-free at two hours.
Useful facts when choosing a product
- The official technical instructions specify an acute mode delivering 100 Hz, 250 microseconds, and up to 16 mA during a 60-minute session. Electrical delivery is measurable but does not itself establish pain freedom.
- TEAM evaluated two continuous hours of stimulation, which should be distinguished from the 60-minute consumer session listed in the technical instructions.
- Verdict 1866, which is C with 54 points, concerns prevention; this verdict concerns acute attack treatment.
Chamgap Semantic Classification Code
Candidate index · review held
P.cefaly-external-trigeminal-nerve-stimulation-device.transdermal.freedom-from-pain-at-during-an-acute-migraine-attack.increase.MULTIProcedures, devices and tests > CEFALY external trigeminal nerve stimulation device > Transdermal > freedom from pain at during an acute migraine attack > Increase claim > Multiple: primary unresolved
An automated migration candidate, not an issued permanent code; exact claim scope remains under review. This machine-generated migration candidate helps retrieval but is not a permanent assignment. The original verdict ID and URL remain authoritative.
What the research actually shows
TEAM randomized and analyzed 538 participants by intention to treat. Both coprimary outcomes succeeded: pain freedom was 25.5% versus 18.3% (P=0.043), and freedom from the most bothersome symptom was 56.4% versus 42.3% (P=0.001). ACME randomized and analyzed 106 participants; its single primary one-hour visual analogue change was -3.46 versus -1.78 (P<0.0001). ACME explicitly received CEFALY Technology funding and its research and development department generated the allocation sequence; TEAM also received company funding. Verdict 1866 is confirmed as C with 46 points, but its prevention trial had Walloon Region public funding. The independence difference reflects trial-specific funding, not inconsistent treatment of the same device.
Why this is classified as C (50)
Both patient-important TEAM coprimary outcomes succeeded and ACME supports acute pain reduction. Both trials were funded by CEFALY Technology, and ACME was a small 106-person trial with a one-hour endpoint, giving C with 50 points.
Counterpoint. The device offers a real additional chance of relief for people who cannot or prefer not to use medication. C reflects limited independence and modest effect size, not a null result.
Rejudgment record. Cross-check applied — Success of both TEAM coprimary outcomes and supportive acute pain reduction in ACME, tempered because both trials were manufacturer-funded and ACME was small and short
| Endpoint | P | Symptom or function itself is the target - including patient reports and performance tests |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
Stored derived and displayed grades match; this is not a current recalculation or validity check (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Pain freedom at two hours | C | TEAM succeeded at 25.5% versus 18.3%, P=0.043. |
| Freedom from the most bothersome symptom at two hours | C | TEAM succeeded at 56.4% versus 42.3%, P=0.001. |
| Sustained pain freedom at 24 hours | C | The TEAM secondary outcome was 22.8% versus 15.8%, P=0.039. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Kuruvilla DE et al. 2022 (TEAM) | Multicenter randomized double-blind sham-controlled phase 3 trial | 538 randomized and 538 analyzed by intention to treat | Supported by CEFALY Technology; the manufacturer's global medical director was an author | Coprimary two-hour pain freedom and freedom from the most bothersome symptom | Both coprimary outcomes succeeded: 25.5% versus 18.3% (P=0.043) and 56.4% versus 42.3% (P=0.001). | Pivotal manufacturer-linked confirmatory trial |
| Chou DE et al. 2019 (ACME) | Three-center randomized double-blind sham-controlled trial | 106 randomized and 106 analyzed by intention to treat | Funded by CEFALY Technology; the manufacturer's research and development department generated the allocation sequence | Primary change in visual analogue pain intensity at one hour | The primary outcome succeeded at -3.46 versus -1.78, P<0.0001. | Small, short manufacturer trial with 106 participants and a one-hour endpoint |
Receipt — 3 References
All 3 cited sources were verified for existence at the original page (as of 2026-07-24).
Final verification and publication gate: Codex · Evidence date: 2026-07-24 · Corrections: none
Cite this verdict
[Chamgap] CEFALY x two-hour pain freedom in acute migraine — Evidence Grade C·50. 3 cited sources checked. Source: https://chamgap.com/en/verdicts/cognition/cefaly-acute-migraine-two-hour-pain-freedom/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.