Jorge Orduña-Valls, Nuno Ferreira-Silva, Carlos Acevedo, Tomas Cuñat, Ricardo Araujo-Cernuda, Ricardo Vallejo, Tomás Ribeiro-da-Silva, Isaac Peña, Guilherme Ferreira-Dos-Santos
Background: Chronic knee joint pain, resulting from osteoarthritis, post-surgical sequelae, or traumatic injuries, represents a debilitating clinical condition. Interventional approaches to manage chronic knee joint pain have been employed for decades, yielding variable outcomes in terms of pain relief, sustainability of analgesic effects, and functional restoration. The term "genicular nerves" is commonly used to refer to the primary sensory innervation of the knee joint capsule. However, recent studies have increasingly recognized the significance of additional neural structures, such as the nerve to vastus medialis.
Methods: This descriptive, prospective anatomical study involved 20 healthy volunteers. The nerve to vastus medialis was assessed using ultrasound. The following was documented: (a) confirmation of the presence of the nerve to vastus medialis; (b) number of branches/distribution patterns; (c) distance from the division of the NVM into its distal branches to the medial femoral epicondyle; and (d) positional relationship of the branches in the distal region of the knee.
Results: The presence of the nerve to vastus medialis was confirmed in all participants. The nerve exhibited considerable variability in terms of the number of branches (2 to 5). Two distinct types of branches were identified: (a) trans/intramuscular branches, which were present in varying numbers (0 to 3) in the proximal thigh likely providing motor innervation to the muscle; (b) extramuscular branches, (typically 2 or 3), located in the distal thigh, presumed to have a sensory function. The distance from the division of the NVM into its distal branches to the medial femoral epicondyle was 13.07 ± 3.40 cm. The depths of the distal branches ranged from 1.0 to 4.4 cm.
Conclusion: The findings from this study offer a standardized approach to the identification and mapping of the nerve to vastus medialis distal branches, essential for interventional treatments.
{"title":"The nerve to vastus medialis as a target for treating chronic medial knee joint pain: an ultrasound-based anatomical localization study in healthy subjects.","authors":"Jorge Orduña-Valls, Nuno Ferreira-Silva, Carlos Acevedo, Tomas Cuñat, Ricardo Araujo-Cernuda, Ricardo Vallejo, Tomás Ribeiro-da-Silva, Isaac Peña, Guilherme Ferreira-Dos-Santos","doi":"10.1093/pm/pnaf111","DOIUrl":"10.1093/pm/pnaf111","url":null,"abstract":"<p><strong>Background: </strong>Chronic knee joint pain, resulting from osteoarthritis, post-surgical sequelae, or traumatic injuries, represents a debilitating clinical condition. Interventional approaches to manage chronic knee joint pain have been employed for decades, yielding variable outcomes in terms of pain relief, sustainability of analgesic effects, and functional restoration. The term \"genicular nerves\" is commonly used to refer to the primary sensory innervation of the knee joint capsule. However, recent studies have increasingly recognized the significance of additional neural structures, such as the nerve to vastus medialis.</p><p><strong>Methods: </strong>This descriptive, prospective anatomical study involved 20 healthy volunteers. The nerve to vastus medialis was assessed using ultrasound. The following was documented: (a) confirmation of the presence of the nerve to vastus medialis; (b) number of branches/distribution patterns; (c) distance from the division of the NVM into its distal branches to the medial femoral epicondyle; and (d) positional relationship of the branches in the distal region of the knee.</p><p><strong>Results: </strong>The presence of the nerve to vastus medialis was confirmed in all participants. The nerve exhibited considerable variability in terms of the number of branches (2 to 5). Two distinct types of branches were identified: (a) trans/intramuscular branches, which were present in varying numbers (0 to 3) in the proximal thigh likely providing motor innervation to the muscle; (b) extramuscular branches, (typically 2 or 3), located in the distal thigh, presumed to have a sensory function. The distance from the division of the NVM into its distal branches to the medial femoral epicondyle was 13.07 ± 3.40 cm. The depths of the distal branches ranged from 1.0 to 4.4 cm.</p><p><strong>Conclusion: </strong>The findings from this study offer a standardized approach to the identification and mapping of the nerve to vastus medialis distal branches, essential for interventional treatments.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"170-176"},"PeriodicalIF":3.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144883400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"RESET trial: comparative effectiveness, exposure equity, and the next generation of peripheral nerve stimulation evidence.","authors":"Charles A Odonkor, Muhammad Uzair Siddique","doi":"10.1093/pm/pnaf169","DOIUrl":"10.1093/pm/pnaf169","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"234-235"},"PeriodicalIF":3.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145743663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Steven T Abriola, Jennifer B Oliver, Robert W Hurley
{"title":"Clinical perspectives: navigating buprenorphine formulations for pain treatment and opioid use disorder-a case-based approach.","authors":"Steven T Abriola, Jennifer B Oliver, Robert W Hurley","doi":"10.1093/pm/pnaf094","DOIUrl":"10.1093/pm/pnaf094","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":"216-218"},"PeriodicalIF":3.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12865098/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144682839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marcos Lisboa Neves, Bernardo Diniz Coutinho, Guilherme Fleury Fina Speretta, Scheila Iria Kraus, Jeane Bachi Ferreira, Pedro André H Amaral, Juliana Elizabete Dos Santos Bud, Ana Merian Da Silva, Vinícius Alexandre Wippel, Igor Kunze Rodrigues, Marta Maria Medeiros Frescura Duarte, Jocemar Ilha, Morgana Duarte da Silva
Background: Auricular vagus nerve stimulation (aVNS) has emerged as a noninvasive neuromodulatory strategy with the potential to modulate central sensitization and inflammatory pathways. However, its role in fibromyalgia (FM) remains insufficiently explored.
Objective: To investigate whether stimulation laterality (left vs. right auricular branch of the vagus nerve, ABVN) differentially influences clinical and biological outcomes in women with FM.
Methods: In this randomized, double-blind, sham-controlled trial, 51 women with FM were allocated to sham stimulation, right-sided aVNS (aVNS-R), or left-sided aVNS (aVNS-L). Participants underwent weekly sessions for four weeks and were followed for 12 weeks. Pain intensity was the primary outcome. Secondary outcomes included psychological symptoms, sleep, functional status, quality of life, and circulating biomarkers (pro- and anti-inflammatory cytokines, brain-derived neurotrophic factor [BDNF]).
Results: While no significant between-group differences were observed in pain intensity, left-sided stimulation (aVNS-L) was associated with a modest but significant reduction in global symptom severity. Importantly, aVNS-L produced consistent immunomodulatory effects, including decreased IL-1β and TNF-α levels, and increased IL-4, IL-10, and BDNF concentrations.
Conclusions: This exploratory trial suggests that stimulation laterality may shape the biological response to aVNS in FM. Although clinical pain relief was not superior to sham, left-sided stimulation promoted an anti-inflammatory profile and enhanced neuroplasticity markers. These findings support further investigation of aVNS laterality as a targeted neuromodulatory approach for FM.
{"title":"Laterality-Dependent Biological Effects of Manual Acupuncture Stimulation of the Auricular Vagus Nerve in Women with Fibromyalgia: A Randomized, Sham-Controlled Trial.","authors":"Marcos Lisboa Neves, Bernardo Diniz Coutinho, Guilherme Fleury Fina Speretta, Scheila Iria Kraus, Jeane Bachi Ferreira, Pedro André H Amaral, Juliana Elizabete Dos Santos Bud, Ana Merian Da Silva, Vinícius Alexandre Wippel, Igor Kunze Rodrigues, Marta Maria Medeiros Frescura Duarte, Jocemar Ilha, Morgana Duarte da Silva","doi":"10.1093/pm/pnag013","DOIUrl":"https://doi.org/10.1093/pm/pnag013","url":null,"abstract":"<p><strong>Background: </strong>Auricular vagus nerve stimulation (aVNS) has emerged as a noninvasive neuromodulatory strategy with the potential to modulate central sensitization and inflammatory pathways. However, its role in fibromyalgia (FM) remains insufficiently explored.</p><p><strong>Objective: </strong>To investigate whether stimulation laterality (left vs. right auricular branch of the vagus nerve, ABVN) differentially influences clinical and biological outcomes in women with FM.</p><p><strong>Methods: </strong>In this randomized, double-blind, sham-controlled trial, 51 women with FM were allocated to sham stimulation, right-sided aVNS (aVNS-R), or left-sided aVNS (aVNS-L). Participants underwent weekly sessions for four weeks and were followed for 12 weeks. Pain intensity was the primary outcome. Secondary outcomes included psychological symptoms, sleep, functional status, quality of life, and circulating biomarkers (pro- and anti-inflammatory cytokines, brain-derived neurotrophic factor [BDNF]).</p><p><strong>Results: </strong>While no significant between-group differences were observed in pain intensity, left-sided stimulation (aVNS-L) was associated with a modest but significant reduction in global symptom severity. Importantly, aVNS-L produced consistent immunomodulatory effects, including decreased IL-1β and TNF-α levels, and increased IL-4, IL-10, and BDNF concentrations.</p><p><strong>Conclusions: </strong>This exploratory trial suggests that stimulation laterality may shape the biological response to aVNS in FM. Although clinical pain relief was not superior to sham, left-sided stimulation promoted an anti-inflammatory profile and enhanced neuroplasticity markers. These findings support further investigation of aVNS laterality as a targeted neuromodulatory approach for FM.</p><p><strong>Trial registration: </strong>Brazilian Clinical Trials Registry RBR-10d3crcf.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146097421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Corrigendum to: Exploring the interplay between catastrophizing and endometriosis pain through 2-wave and intensive longitudinal data.","authors":"","doi":"10.1093/pm/pnaf141","DOIUrl":"https://doi.org/10.1093/pm/pnaf141","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kyril L Cole, Derrick K Wong, Troy A Hutchins, Lubdha M Shah, Miriam E Peckham
Background and purpose: Intra-articular injection of the lateral atlantoaxial joint is used for occipital pain; however, limited literature exists on technique demonstration, adverse event reporting, and real-world clinical outcomes. This study was designed to characterize procedural technique, describe clinical outcomes, and report subsequent cervical fusion rates following lateral atlantoaxial joint injections.
Materials and methods: A retrospective cohort analysis was conducted on all lateral atlantoaxial joint injections performed at our institution from January 1, 2002, through August 1, 2024. Descriptive statistics characterized the cohort, procedural features, pain score changes, and cervical fusion rates during follow-up.
Results: 140 lateral atlantoaxial joint injections were performed on 104 patients (mean age 72.6 ± 12.4 years, 68.3% female), primarily by fluoroscopy (77.1%). Mean pre-injection pain was 5.99 ± 1.96, with immediate post-injection pain at 1.84 ± 2.33 and 1-month clinic visit pain at 4.28 ± 2.68. Significant reductions in pain from pre-injection were observed immediately post-injection (p < 0.0001) and at 1-month (p < 0.0001). Most injections were successful on first attempt (97.1%), with no serious adverse events identified throughout follow-up documentation. Overall, 26.9% of patients underwent cervical fusion involving the C1-C2 level during available follow-up.
Conclusion: This study comprises the largest cohort of patients with image-guided lateral atlantoaxial joint injections and provides descriptive data on technique, clinical outcomes, adverse events, and observed subsequent cervical fusion rates. Short-term reductions in pain were common 1-month from injections with no serious adverse events identified throughout follow-up and only one-quarter of patients undergoing eventual cervical fusion. This study adds valuable data to an uncommonly performed procedure.
{"title":"Lateral Atlantoaxial (C1-C2) Joint Steroid Injections: A 22-Year Retrospective Characterization of Technique and Clinical Outcomes.","authors":"Kyril L Cole, Derrick K Wong, Troy A Hutchins, Lubdha M Shah, Miriam E Peckham","doi":"10.1093/pm/pnag017","DOIUrl":"https://doi.org/10.1093/pm/pnag017","url":null,"abstract":"<p><strong>Background and purpose: </strong>Intra-articular injection of the lateral atlantoaxial joint is used for occipital pain; however, limited literature exists on technique demonstration, adverse event reporting, and real-world clinical outcomes. This study was designed to characterize procedural technique, describe clinical outcomes, and report subsequent cervical fusion rates following lateral atlantoaxial joint injections.</p><p><strong>Materials and methods: </strong>A retrospective cohort analysis was conducted on all lateral atlantoaxial joint injections performed at our institution from January 1, 2002, through August 1, 2024. Descriptive statistics characterized the cohort, procedural features, pain score changes, and cervical fusion rates during follow-up.</p><p><strong>Results: </strong>140 lateral atlantoaxial joint injections were performed on 104 patients (mean age 72.6 ± 12.4 years, 68.3% female), primarily by fluoroscopy (77.1%). Mean pre-injection pain was 5.99 ± 1.96, with immediate post-injection pain at 1.84 ± 2.33 and 1-month clinic visit pain at 4.28 ± 2.68. Significant reductions in pain from pre-injection were observed immediately post-injection (p < 0.0001) and at 1-month (p < 0.0001). Most injections were successful on first attempt (97.1%), with no serious adverse events identified throughout follow-up documentation. Overall, 26.9% of patients underwent cervical fusion involving the C1-C2 level during available follow-up.</p><p><strong>Conclusion: </strong>This study comprises the largest cohort of patients with image-guided lateral atlantoaxial joint injections and provides descriptive data on technique, clinical outcomes, adverse events, and observed subsequent cervical fusion rates. Short-term reductions in pain were common 1-month from injections with no serious adverse events identified throughout follow-up and only one-quarter of patients undergoing eventual cervical fusion. This study adds valuable data to an uncommonly performed procedure.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146086760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lindsey Mountcastle, Christopher D King, Susmita Kashikar-Zuck, Kristen E Jastrowski Mano
{"title":"Comparative Analysis of Executive Functioning and Sleep in Female Adolescents with Juvenile Onset Fibromyalgia Versus Healthy Controls.","authors":"Lindsey Mountcastle, Christopher D King, Susmita Kashikar-Zuck, Kristen E Jastrowski Mano","doi":"10.1093/pm/pnag014","DOIUrl":"https://doi.org/10.1093/pm/pnag014","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hoa Ngan Doan, Mathieu Boudier-Revéret, Min Cheol Chang
Objective: Lumbar epidural steroid injections (ESIs) are widely used to treat chronic low back pain. We conducted a systematic review and narrative synthesis to evaluate the effectiveness and safety of varying lumbar ESI corticosteroid doses.
Methods: We searched PubMed, Embase, and Web of Science for English-language studies in humans comparing corticosteroid doses for lumbar ESI, published through 12 August 2025. Of 1,553 records, 14 studies were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Risk of Bias in Non-randomized Studies-of Interventions tool for non-randomized studies.
Results: Methylprednisolone was most frequently used (7 of 14 studies), followed by dexamethasone and triamcinolone (3 studies each), and betamethasone (1 study). Across studies, higher corticosteroid doses did not yield significantly greater improvements in pain relief or function than lower doses but were linked to greater risks of adverse effects, particularly endocrine complications such as hyperglycemia and hypothalamic-pituitary-adrenal axis suppression.
Conclusions: Pain relief and functional outcomes after lumbar ESI do not improve linearly with corticosteroid dose, whereas adverse effects tend to increase with higher doses. These findings support using the lowest effective corticosteroid dose. The lowest reported doses with efficacy not statistically different from higher doses in lumbar ESI include dexamethasone 4 mg, methylprednisolone 20 mg, triamcinolone 10 mg, and betamethasone 3 mg. Our review is expected to help develop standardized protocols for comparing corticosteroid doses in lumbar ESIs and to identify the lowest effective dose.
目的:腰硬膜外类固醇注射(ESIs)被广泛用于治疗慢性腰痛。我们进行了一项系统综述和叙事综合来评估不同腰椎ESI皮质类固醇剂量的有效性和安全性。方法:我们检索了PubMed、Embase和Web of Science,检索了截至2025年8月12日发表的关于腰椎ESI患者皮质类固醇剂量比较的人类英文研究。在1553项记录中,包括14项研究。使用Cochrane随机对照试验的偏倚风险2工具评估偏倚风险,使用非随机研究的干预措施工具评估非随机研究的偏倚风险。结果:使用甲基强的松龙最多(14项研究中有7项),其次是地塞米松和曲安奈德(各3项研究),倍他米松(1项研究)。在所有研究中,高剂量皮质类固醇在缓解疼痛或功能方面并没有比低剂量产生更大的改善,但与更大的不良反应风险有关,特别是内分泌并发症,如高血糖和下丘脑-垂体-肾上腺轴抑制。结论:腰椎ESI后的疼痛缓解和功能结局并没有随着皮质类固醇剂量的增加而线性改善,相反,不良反应倾向于随着剂量的增加而增加。这些发现支持使用最低有效皮质类固醇剂量。腰椎ESI报告的最低剂量与高剂量疗效无统计学差异,包括地塞米松4mg,甲基强的松20mg,曲安奈德酮10mg,倍他米松3mg。我们的回顾有望帮助制定标准的方案来比较腰椎ESIs的皮质类固醇剂量,并确定最低有效剂量。
{"title":"Comparative Effectiveness and Safety of Varying Corticosteroid Doses for Lumbar Epidural Steroid Injections: A Systematic Review and Narrative Synthesis.","authors":"Hoa Ngan Doan, Mathieu Boudier-Revéret, Min Cheol Chang","doi":"10.1093/pm/pnag016","DOIUrl":"https://doi.org/10.1093/pm/pnag016","url":null,"abstract":"<p><strong>Objective: </strong>Lumbar epidural steroid injections (ESIs) are widely used to treat chronic low back pain. We conducted a systematic review and narrative synthesis to evaluate the effectiveness and safety of varying lumbar ESI corticosteroid doses.</p><p><strong>Methods: </strong>We searched PubMed, Embase, and Web of Science for English-language studies in humans comparing corticosteroid doses for lumbar ESI, published through 12 August 2025. Of 1,553 records, 14 studies were included. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Risk of Bias in Non-randomized Studies-of Interventions tool for non-randomized studies.</p><p><strong>Results: </strong>Methylprednisolone was most frequently used (7 of 14 studies), followed by dexamethasone and triamcinolone (3 studies each), and betamethasone (1 study). Across studies, higher corticosteroid doses did not yield significantly greater improvements in pain relief or function than lower doses but were linked to greater risks of adverse effects, particularly endocrine complications such as hyperglycemia and hypothalamic-pituitary-adrenal axis suppression.</p><p><strong>Conclusions: </strong>Pain relief and functional outcomes after lumbar ESI do not improve linearly with corticosteroid dose, whereas adverse effects tend to increase with higher doses. These findings support using the lowest effective corticosteroid dose. The lowest reported doses with efficacy not statistically different from higher doses in lumbar ESI include dexamethasone 4 mg, methylprednisolone 20 mg, triamcinolone 10 mg, and betamethasone 3 mg. Our review is expected to help develop standardized protocols for comparing corticosteroid doses in lumbar ESIs and to identify the lowest effective dose.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046912","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Naji Riachi, Ahmed Shatila, Sehriban Diab, Hasan Jaber, Mais Jawhari, Joseph G Mattar, Jean-Pascal Lefaucheur, Moussa A Chalah, Samar S Ayache
Background: Neuromodulation via transcutaneous electrical stimulation shows promise in fibromyalgia, but conventional devices have limited coverage. The EXOPULSE Mollii Suit is a full-body garment with 58 electrodes, potentially addressing widespread pain. This study evaluated repeated Mollii Suit sessions on disease impact, pain, and fibromyalgia-related symptoms.
Methods: In this double-blind, randomized, sham-controlled crossover trial (phase 1), adults with fibromyalgia received two weeks of daily active or sham stimulation (1 hour/day), followed by a ≥ 2-week washout and crossover. Participants were offered a four-week open-label extension (phase 2). The primary outcome was the Fibromyalgia Impact Questionnaire (FIQtotal). Secondary outcomes included pain, anxiety, depression, and quality of life.
Results: Twenty-two patients completed phase 1 and 20 completed phase 2. In phase 1, FIQtotal scores significantly decreased following the active intervention (66.06 ± 13.46 to 50.81 ± 23.22, Friedman's p < 0.01, Bonferroni-adjusted Dunn's p < 0.05), whereas no significant effects were observed following the sham intervention. Improvements were also observed in several secondary measures (pain catastrophizing and some quality of life domains). Phase 2 also revealed significant benefits in FIQtotal as well as several secondary outcomes. No severe adverse events occurred at any time.
Conclusions: EXOPULSE Mollii Suit led to clinically meaningful improvements in fibromyalgia impact and related outcomes. The results of this work are in line with those of previous trials and support its potential as a home-based neuromodulation therapy for fibromyalgia. Future large-scale studies would help further understand the effects of this medical device.
{"title":"The effects of EXOPULSE Mollii suit in patients with fibromyalgia: A double-blind randomized sham controlled trial (EXOFIB2).","authors":"Naji Riachi, Ahmed Shatila, Sehriban Diab, Hasan Jaber, Mais Jawhari, Joseph G Mattar, Jean-Pascal Lefaucheur, Moussa A Chalah, Samar S Ayache","doi":"10.1093/pm/pnag010","DOIUrl":"https://doi.org/10.1093/pm/pnag010","url":null,"abstract":"<p><strong>Background: </strong>Neuromodulation via transcutaneous electrical stimulation shows promise in fibromyalgia, but conventional devices have limited coverage. The EXOPULSE Mollii Suit is a full-body garment with 58 electrodes, potentially addressing widespread pain. This study evaluated repeated Mollii Suit sessions on disease impact, pain, and fibromyalgia-related symptoms.</p><p><strong>Methods: </strong>In this double-blind, randomized, sham-controlled crossover trial (phase 1), adults with fibromyalgia received two weeks of daily active or sham stimulation (1 hour/day), followed by a ≥ 2-week washout and crossover. Participants were offered a four-week open-label extension (phase 2). The primary outcome was the Fibromyalgia Impact Questionnaire (FIQtotal). Secondary outcomes included pain, anxiety, depression, and quality of life.</p><p><strong>Results: </strong>Twenty-two patients completed phase 1 and 20 completed phase 2. In phase 1, FIQtotal scores significantly decreased following the active intervention (66.06 ± 13.46 to 50.81 ± 23.22, Friedman's p < 0.01, Bonferroni-adjusted Dunn's p < 0.05), whereas no significant effects were observed following the sham intervention. Improvements were also observed in several secondary measures (pain catastrophizing and some quality of life domains). Phase 2 also revealed significant benefits in FIQtotal as well as several secondary outcomes. No severe adverse events occurred at any time.</p><p><strong>Conclusions: </strong>EXOPULSE Mollii Suit led to clinically meaningful improvements in fibromyalgia impact and related outcomes. The results of this work are in line with those of previous trials and support its potential as a home-based neuromodulation therapy for fibromyalgia. Future large-scale studies would help further understand the effects of this medical device.</p>","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146030515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Comments on Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms-single-arm study with in-clinic randomized crossover testing.","authors":"Peng-Bo Zhou, Hong-Tao Sun","doi":"10.1093/pm/pnag007","DOIUrl":"https://doi.org/10.1093/pm/pnag007","url":null,"abstract":"","PeriodicalId":19744,"journal":{"name":"Pain Medicine","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146019192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}