The effects of neuromodulation through brainwave entrainment on pain in women with fibromyalgia: a randomized controlled clinical trial with follow-up.
de Souza G, Daux Buffon L, Hardt da Silva R, Galassi TO, Dutra AR, Medeiros N, de Paiva BC, de Brito VJ, Nienkotter L, Baldança HDS, Goedert SH, Rezin GT, da Silva MR, de Oliveira MP, Petronilho F, Mathias K, Tiscoski ADB, Mazzardo-Martins L, Traebert ESA, Piovezan AP, Traebert JL, Caumo W, Schleip R, Bobinski F, Cidral-Filho FJ, Martins DF. · Pain medicine (Malden, Mass.) · 2026 · Randomized controlled trial
Original publication · Original publication
Recorded summary
In 84 women with fibromyalgia, eight weeks of headset-based brainwave entrainment produced improvements in pain and anxiety, with changes in quality of life, oxidative stress and circulating BDNF also examined.
Recorded limitations
Music therapy improved several outcomes as well. The abstract does not provide a consistent set of between-group effect estimates; the mixed headset intervention and protein measurements do not establish a gene-expression mechanism.
Evidence and provenance
Chapter Trust Factor uses a minimum of three distinct qualifying studies. Publication records retain their own evidence and assessment.
Study design and assessment
- design
- Randomized controlled trial
- assessment
- category
- peer-reviewed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- assessed At
- 2026-10-26
- registered Masking Basis
- false
- trust Factor
- score
- 2
- scope
- Paper
- status
- assessed
- randomized Controlled Trial
- true
- blinding
- not-confirmed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- review Scope
- Existing publication-specific assessments and bibliographic indexing; no blanket full-text appraisal.
- assessed At
- 2026-10-27
- jadad
- status
- unassessed
- score
- Not recorded
- evidence
- intervention
- BrainTap headset-based brainwave entrainment
- comparator
- Music therapy
- evidence Type
- Clinical or experimental outcomes
- source URLs
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- checked At
- 2026-10-26
- review Scope
- Primary publication abstract and bibliographic identity checked; comprehensive full-text risk-of-bias and Jadad assessment pending.
- discovery Sources
https://europepmc.org/article/MED/42116620
- selection Policy
- Success-focused discovery selection, with material limitations retained; not an exhaustive systematic review.
Topics and recorded topic scores
- key
- sound:i
- title
- Brain entrainment, pain, anxiety and heart-rate variability
- collection
- sound
- trust Score
- 3
Citation snapshot and identifiers
- id
- pmid-42116620
- doi
- 10.1093/pm/pnag064
- pmid
- 42116620
- citation Snapshot
- count
- 0
- source
- Europe PMC
- retrieved At
- 2026-10-26
- url
- https://europepmc.org/article/MED/42116620
- citations By Collection
- sound
- 0
Complete approved library record
- id
- pmid-42116620
- publication Key
- doi:10.1093/pm/pnag064
- aliases
- None recorded
- title
- The effects of neuromodulation through brainwave entrainment on pain in women with fibromyalgia: a randomized controlled clinical trial with follow-up.
- journal
- Pain medicine (Malden, Mass.)
- neurotransmitters
- None recorded
- year
- 2026
- authors
- de Souza G, Daux Buffon L, Hardt da Silva R, Galassi TO, Dutra AR, Medeiros N, de Paiva BC, de Brito VJ, Nienkotter L, Baldança HDS, Goedert SH, Rezin GT, da Silva MR, de Oliveira MP, Petronilho F, Mathias K, Tiscoski ADB, Mazzardo-Martins L, Traebert ESA, Piovezan AP, Traebert JL, Caumo W, Schleip R, Bobinski F, Cidral-Filho FJ, Martins DF.
- design
- Randomized controlled trial
- identity Conflict
- Not recorded
- doi
- 10.1093/pm/pnag064
- pmid
- 42116620
- urls
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- collections
sound
- categories
Clinical & self-report · Molecular biomarkers
- targets
- None recorded
- priority
- 1
- quotes
- None recorded
- summary
- In 84 women with fibromyalgia, eight weeks of headset-based brainwave entrainment produced improvements in pain and anxiety, with changes in quality of life, oxidative stress and circulating BDNF also examined.
- limitation
- Music therapy improved several outcomes as well. The abstract does not provide a consistent set of between-group effect estimates; the mixed headset intervention and protein measurements do not establish a gene-expression mechanism.
- citation Count
- 0
- citation Snapshot
- count
- 0
- source
- Europe PMC
- retrieved At
- 2026-10-26
- url
- https://europepmc.org/article/MED/42116620
- study Design Assessment
- category
- peer-reviewed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- assessed At
- 2026-10-26
- registered Masking Basis
- false
- paper Trust Assessment
- score
- 2
- scope
- Paper
- status
- assessed
- randomized Controlled Trial
- true
- blinding
- not-confirmed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- review Scope
- Existing publication-specific assessments and bibliographic indexing; no blanket full-text appraisal.
- assessed At
- 2026-10-27
- citations By Collection
- sound
- 0
- topics
- key
- sound:i
- title
- Brain entrainment, pain, anxiety and heart-rate variability
- collection
- sound
- trust Score
- 3
- journal Key
- painmedicine
- journal Label
- Pain medicine (Malden, Mass.)
- chapter Entries
- title
- The effects of neuromodulation through brainwave entrainment on pain in women with fibromyalgia: a randomized controlled clinical trial with follow-up.
- journal
- Pain medicine (Malden, Mass.)
- year
- 2026
- authors
- de Souza G, Daux Buffon L, Hardt da Silva R, Galassi TO, Dutra AR, Medeiros N, de Paiva BC, de Brito VJ, Nienkotter L, Baldança HDS, Goedert SH, Rezin GT, da Silva MR, de Oliveira MP, Petronilho F, Mathias K, Tiscoski ADB, Mazzardo-Martins L, Traebert ESA, Piovezan AP, Traebert JL, Caumo W, Schleip R, Bobinski F, Cidral-Filho FJ, Martins DF.
- design
- Randomized controlled trial
- urls
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- doi
- 10.1093/pm/pnag064
- pmid
- 42116620
- targets
- None recorded
- categories
Clinical & self-report · Molecular biomarkers
- citation Count
- 0
- citation Snapshot
- count
- 0
- source
- Europe PMC
- retrieved At
- 2026-10-26
- url
- https://europepmc.org/article/MED/42116620
- study Design Assessment
- category
- peer-reviewed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- assessed At
- 2026-10-26
- registered Masking Basis
- false
- evidence
- intervention
- BrainTap headset-based brainwave entrainment
- comparator
- Music therapy
- evidence Type
- Clinical or experimental outcomes
- source URLs
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- checked At
- 2026-10-26
- review Scope
- Primary publication abstract and bibliographic identity checked; comprehensive full-text risk-of-bias and Jadad assessment pending.
- discovery Sources
https://europepmc.org/article/MED/42116620
- selection Policy
- Success-focused discovery selection, with material limitations retained; not an exhaustive systematic review.
- id
- sound-i-pmid-42116620
- record Id
- pmid-42116620
- quotes
- None recorded
- source Pages
- None recorded
- summary
- In 84 women with fibromyalgia, eight weeks of headset-based brainwave entrainment produced improvements in pain and anxiety, with changes in quality of life, oxidative stress and circulating BDNF also examined.
- limitation
- Music therapy improved several outcomes as well. The abstract does not provide a consistent set of between-group effect estimates; the mixed headset intervention and protein measurements do not establish a gene-expression mechanism.
- paper Trust Assessment
- score
- 2
- scope
- Paper
- status
- assessed
- randomized Controlled Trial
- true
- blinding
- not-confirmed
- peer Reviewed
- true
- basis
- Reported design checked against the primary publication abstract. Blinding terminology reflects the source report, not an independent risk-of-bias rating.
- sources
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- review Scope
- Existing publication-specific assessments and bibliographic indexing; no blanket full-text appraisal.
- assessed At
- 2026-10-27
- publication Key
- doi:10.1093/pm/pnag064
- collection
- sound
- chapter Number
- 1
- topic Id
- i
- topic Title
- Brain entrainment, pain, anxiety and heart-rate variability
- trust Score
- 3
- evidence
- intervention
- BrainTap headset-based brainwave entrainment
- comparator
- Music therapy
- evidence Type
- Clinical or experimental outcomes
- source URLs
https://pubmed.ncbi.nlm.nih.gov/42116620/ · https://doi.org/10.1093/pm/pnag064
- checked At
- 2026-10-26
- review Scope
- Primary publication abstract and bibliographic identity checked; comprehensive full-text risk-of-bias and Jadad assessment pending.
- discovery Sources
https://europepmc.org/article/MED/42116620
- selection Policy
- Success-focused discovery selection, with material limitations retained; not an exhaustive systematic review.
- jadad
- status
- unassessed
- score
- Not recorded
- condition Evidence
- None recorded
- conditions
- None recorded
- topic Trust Scores
3
- full Text
- status
- not-indexed
- retrieval Available
- false