Evidence map›Paper›PMID 40391557›Full record

Trial reportHeadache

A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache.

Genaro G Gutierrez, Zachary L McCormick, Mitchell P Engle, Christopher A Gilmore, Matthew J Pingree, Jason E Pope, David J DiBenedetto, Narayan R Kissoon, Puneet K Sayal, Claire A Zurn and 2 more

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Headache. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Genaro G GutierrezPain Specialists of America, Austin, Texas, USA.
Zachary L McCormickDepartment of Physical Medicine and Rehabilitation, University of Utah School of Medicine, Salt Lake City, Utah, USA.ORCID 0000-0003-4250-8745
Mitchell P EngleInstitute of Precision Pain Medicine, Corpus Christi, Texas, USA.
Christopher A GilmoreCenter for Clinical Research, Winston-Salem, North Carolina, USA.ORCID 0000-0002-8001-6867
Matthew J PingreeAnesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0001-9741-5058
Jason E PopeEvolve Restorative Center, Santa Rosa, California, USA.
David J DiBenedettoMedVadis Research, Waltham, Massachusetts, USA.ORCID 0000-0001-8116-3407
Narayan R KissoonAnesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-6686-8537
Puneet K SayalInstitute of Precision Pain Medicine, Corpus Christi, Texas, USA.
Claire A ZurnSPR Therapeutics, Cleveland, Ohio, USA.
Nathan D CrosbySPR Therapeutics, Cleveland, Ohio, USA.ORCID 0000-0001-6181-0806
Joseph W BoggsSPR Therapeutics, Cleveland, Ohio, USA.ORCID 0000-0002-7973-7990

Funding

SPR Therapeutics
6 · The paper itself

Abstract

objectiveThe aim of this study was to evaluate the efficacy and safety of a 60-day peripheral nerve stimulation (PNS) treatment targeting the occipital nerves for reducing pain and improving function in individuals diagnosed with cervicogenic headache or occipital neuralgia.

backgroundHeadache conditions are prevalent and commonly disabling, and conventional therapeutic strategies are often insufficient. Development of a percutaneous 60-day PNS treatment has created new opportunities to evaluate PNS of the occipital nerves.

methodsThis study was an institutional review board-approved, multicenter, prospective, single-arm study that enrolled participants from October 2022 to March 2024. Participants with cervicogenic headache or occipital neuralgia received a 60-day PNS treatment targeting the occipital nerves. The primary endpoint was the proportion reporting clinically significant (≥30%) reductions in average pain and/or pain interference at end of treatment (EOT). Additional analysis included the proportion of participants with ≥50% reduction in average pain intensity and/or pain interference and additional outcomes including Patient Global Impression of Change, six-item Headache Impact Test, and Neck Disability Index.

resultsAt EOT, 90% of participants (18/20) met the primary endpoint. Further, 85% (17/20) and 83% (15/18) reported ≥50% reductions in pain and/or pain interference at EOT and 3 months, respectively. Clinically meaningful improvements were observed in functional and headache-related disability and quality-of-life measures. All study-related adverse events were non-serious.

conclusionMost participants reported significant reductions in pain and/or pain interference following 60-day PNS targeting the occipital nerves. Outcomes through 3 months demonstrate how 60-day PNS offers an effective approach for the treatment of headache.

Indexed as

NeuralgiaOutcome Assessment, Health CarePost-Traumatic HeadacheSpinal NervesTranscutaneous Electric Nerve StimulationAdultAgedFemaleHumansMaleMiddle AgedProspective Studies60‐day PNScervicogenic headacheheadacheoccipital nervesoccipital neuralgiaperipheral nerve stimulation

Identifiers

PMID40391557
PMCPMC12638517

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.