PAIN®Pub Date : 2024-11-01Epub Date: 2024-05-14DOI: 10.1097/j.pain.0000000000003270
Dale J Langford, Remington P Mark, Fallon O France, Mahd Nishtar, Meghan Park, Sonia Sharma, Isabel C Shklyar, Thomas J Schnitzer, Philip G Conaghan, Dagmar Amtmann, Bryce B Reeve, Dennis C Turk, Robert H Dworkin, Jennifer S Gewandter
{"title":"Use of patient-reported global assessment measures in clinical trials of chronic pain treatments: ACTTION systematic review and considerations.","authors":"Dale J Langford, Remington P Mark, Fallon O France, Mahd Nishtar, Meghan Park, Sonia Sharma, Isabel C Shklyar, Thomas J Schnitzer, Philip G Conaghan, Dagmar Amtmann, Bryce B Reeve, Dennis C Turk, Robert H Dworkin, Jennifer S Gewandter","doi":"10.1097/j.pain.0000000000003270","DOIUrl":"10.1097/j.pain.0000000000003270","url":null,"abstract":"<p><strong>Abstract: </strong>Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":" ","pages":"2445-2454"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140922661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01Epub Date: 2024-04-02DOI: 10.1097/j.pain.0000000000003241
Sarah Nelson, Morgan Mitcheson, Bridget Nestor, Michelle Bosquet Enlow, David Borsook
{"title":"Biomarkers of stress as mind-body intervention outcomes for chronic pain: an evaluation of constructs and accepted measurement.","authors":"Sarah Nelson, Morgan Mitcheson, Bridget Nestor, Michelle Bosquet Enlow, David Borsook","doi":"10.1097/j.pain.0000000000003241","DOIUrl":"10.1097/j.pain.0000000000003241","url":null,"abstract":"","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":" ","pages":"2403-2408"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11445401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140336496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01Epub Date: 2024-06-04DOI: 10.1097/j.pain.0000000000003281
Nadine Attal
{"title":"\"Belief-based\" medicine is not evidence-based medicine.","authors":"Nadine Attal","doi":"10.1097/j.pain.0000000000003281","DOIUrl":"https://doi.org/10.1097/j.pain.0000000000003281","url":null,"abstract":"","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":"165 11","pages":"2401-2402"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01DOI: 10.1097/j.pain.0000000000003302
Frank Lobbezoo, Karl G H Parisius, Merel C Verhoeff
{"title":"Orofacial pain and dysfunction in patients with special needs, with a focus on interdisciplinarity.","authors":"Frank Lobbezoo, Karl G H Parisius, Merel C Verhoeff","doi":"10.1097/j.pain.0000000000003302","DOIUrl":"10.1097/j.pain.0000000000003302","url":null,"abstract":"<p><strong>Abstract: </strong>People with special needs, like those with Down syndrome, Parkinson disease, or dementia, frequently suffer from orofacial pain conditions and dysfunction of the masticatory system. However, the accurate assessment of orofacial pain and dysfunction in such individuals is challenging. In this review, the complexities of assessing and managing orofacial pain and dysfunction in special needs populations will be described, along with their comorbid orofacial conditions like impaired oral health, salivary problems, and movement disorders of the masticatory system. In addition, the importance of maintaining or restoring a good quality of life will be highlighted, while the urgent need for oral care as part of palliative care will be stressed as well. To accomplish all this, interdisciplinary collaboration between medical doctors and dentists should be promoted in research, education, prevention, and care provision. Therefore, this review focuses specifically on this important topic.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":"165 11S","pages":"S15-S22"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01DOI: 10.1097/j.pain.0000000000003304
Katelynn E Boerner, Neil L Schechter, Tim F Oberlander
{"title":"Pain and development: interacting phenomena.","authors":"Katelynn E Boerner, Neil L Schechter, Tim F Oberlander","doi":"10.1097/j.pain.0000000000003304","DOIUrl":"10.1097/j.pain.0000000000003304","url":null,"abstract":"<p><strong>Abstract: </strong>For decades, clinicians and researchers have observed bidirectional relationships between child development and the pain experience in childhood. Pain in childhood is an inherently developmental phenomenon, embedded in an iterative, time-dependent process that reflects individual biological, behavioral, social, psychological, and environmental characteristics that unfold across the early life span. Childhood pain can have wide ranging effects on brain development in ways that contribute-for better and worse-to social, emotional, and cognitive well-being in childhood and on into adulthood. Atypical trajectories of development in the context of disorders such as autism, cerebral palsy, ADHD, and mood/anxiety disorders also contribute to unique childhood pain experiences. In this paper, pain will be considered as a determinant of development, and conversely development will be considered as a key determinant of a child's pain experience. We will discuss how intersectional identities (eg, gender, race, socioeconomic status) and associated social, structural, systemic, and physical environments influence the relationship between development and pain. Finally, we will identify what might be needed to think \"developmentally\" in ways that extend from the \"bench side\" in the lab to the \"curb side\" in the community, integrating a developmental perspective into research and clinical practice to achieve health accessibility and equity in pain care for all children across the developmental spectrum.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":"165 11S","pages":"S82-S91"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regenerative medicine for spinal cord injury using induced pluripotent stem cells: from animals to humans.","authors":"Narihito Nagoshi, Shogo Hashimoto, Hideyuki Okano, Masaya Nakamura","doi":"10.1097/j.pain.0000000000003306","DOIUrl":"10.1097/j.pain.0000000000003306","url":null,"abstract":"<p><strong>Abstract: </strong>Spinal cord injury (SCI) results in permanent neurological dysfunction and neuropathic pain. To address this pathology, we recently conducted a clinical study in which we transplanted neural precursor cells (NPCs) derived from human induced pluripotent stem cells into patients during the subacute phase of SCI. One of the therapeutic mechanisms of cell transplantation is the formation of synaptic connections with the host's neural tissues, which we demonstrated using a chemogenetic tool. In addition, we have developed innovative strategies to enhance the effectiveness of cell transplantation through gene therapy. Moreover, our current study is focused on developing cell therapy for chronic SCI, a more challenging pathology characterized by the formation of cavities and scar tissue. In such situations, transplanting NPCs with neurogenic properties could effectively penetrate scar tissue and form functional synapses with the host neurons. To improve the outcomes of cell transplantation alone, we have found that incorporating rehabilitation is beneficial. In animal models of SCI, we have established an effective rehabilitative training program in which NPCs were transplanted during the chronic phase. Robotic rehabilitation has demonstrated improvements in gait ability and trunk function in clinical situations. Therefore, regenerative medicine shows promise for chronic SCI, particularly when rehabilitation strategies are incorporated.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":"165 11S","pages":"S76-S81"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142668512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A systematic literature review on patient-reported outcome domains and measures in nonsurgical efficacy trials related to chronic pain associated with endometriosis: an urgent call to action.","authors":"Daniela Constanze Rosenberger, Emilia Mennicken, Iris Schmieg, Terkia Medkour, Marie Pechard, Juliane Sachau, Fabian Fuchtmann, Judy Birch, Kathrin Schnabel, Katy Vincent, Ralf Baron, Didier Bouhassira, Esther Miriam Pogatzki-Zahn","doi":"10.1097/j.pain.0000000000003290","DOIUrl":"10.1097/j.pain.0000000000003290","url":null,"abstract":"<p><strong>Abstract: </strong>Endometriosis, a common cause for chronic pelvic pain, significantly affects quality of life, fertility, and overall productivity of those affected. Therapeutic options remain limited, and collating evidence on treatment efficacy is complicated. One reason could be the heterogeneity of assessed outcomes in nonsurgical clinical trials, impeding meaningful result comparisons. This systematic literature review examines outcome domains and patient-reported outcome measures (PROMs) used in clinical trials. Through comprehensive search of Embase, MEDLINE, and CENTRAL up until July 2022, we screened 1286 records, of which 191 were included in our analyses. Methodological quality (GRADE criteria), information about publication, patient population, and intervention were assessed, and domains as well as PROMs were extracted and analyzed. In accordance with IMMPACT domain framework, the domain pain was assessed in almost all studies (98.4%), followed by adverse events (73.8%). By contrast, assessment of physical functioning (29.8%), improvement and satisfaction (14.1%), and emotional functioning (6.8%) occurred less frequently. Studies of a better methodological quality tended to use more different domains. Nevertheless, combinations of more than 2 domains were rare, failing to comprehensively capture the bio-psycho-social aspects of endometriosis-associated pain. The PROMs used showed an even broader heterogeneity across all studies. Our findings underscore the large heterogeneity of assessed domains and PROMs in clinical pain-related endometriosis trials. This highlights the urgent need for a standardized approach to both, assessed domains and high-quality PROMs ideally realized through development and implementation of a core outcome set, encompassing the most pivotal domains and PROMs for both, stakeholders and patients.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":" ","pages":"2419-2444"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141538340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01Epub Date: 2024-07-09DOI: 10.1097/j.pain.0000000000003284
Nicole M Alberts, Wendy Leisenring, Jillian Whitton, Kayla Stratton, Lindsay Jibb, Jessica Flynn, Alex Pizzo, Tara M Brinkman, Kathryn Birnie, Todd M Gibson, Aaron McDonald, James Ford, Jeffrey E Olgin, Paul C Nathan, Jennifer N Stinson, Gregory T Armstrong
{"title":"Characterization of chronic pain, pain interference, and daily pain experiences in adult survivors of childhood cancer: a report from the Childhood Cancer Survivor Study.","authors":"Nicole M Alberts, Wendy Leisenring, Jillian Whitton, Kayla Stratton, Lindsay Jibb, Jessica Flynn, Alex Pizzo, Tara M Brinkman, Kathryn Birnie, Todd M Gibson, Aaron McDonald, James Ford, Jeffrey E Olgin, Paul C Nathan, Jennifer N Stinson, Gregory T Armstrong","doi":"10.1097/j.pain.0000000000003284","DOIUrl":"10.1097/j.pain.0000000000003284","url":null,"abstract":"<p><strong>Abstract: </strong>Although survivors of childhood cancer are at an increased risk, little is known about the prevalence of chronic pain, associated interference, and daily pain experiences. Survivors (N = 233; mean age = 40.8 years, range 22-64 years; mean time since diagnosis = 32.7 years) from the Childhood Cancer Survivor Study completed pain and psychosocial measures. Survivors with chronic pain completed 2-week, daily measures assessing pain and psychological symptoms using mHealth-based ecological momentary assessment. Multivariable-modified Poisson and linear regression models estimated prevalence ratio estimates (PR) and mean effects with 95% confidence intervals (CI) for associations of key risk factors with chronic pain and pain interference, respectively. Multilevel mixed models examined outcomes of daily pain and pain interference with prior day symptoms. Ninety-six survivors (41%) reported chronic pain, of whom 23 (24%) had severe interference. Chronic pain was associated with previous intravenous methotrexate treatment (PR = 1.6, 95% CI 1.1-2.3), respiratory (PR = 1.8, 95% CI 1.2-2.5), gastrointestinal (PR = 1.6, 95% CI 11.0-2.3), and neurological (PR = 1.5, 95% CI 1.0-2.1) chronic health conditions, unemployment (PR = 1.4, 95% CI 1.0-1.9) and clinically significant depression and anxiety (PR = 2.9, 95% CI 2.0-4.2), as well as a diagnosis of childhood Ewing sarcoma or osteosarcoma (PR = 1.9, 95% CI 1.0-3.5). Higher pain interference was associated with cardiovascular and neurological conditions, unemployment and clinical levels of depression and/or anxiety, and fear of cancer recurrence. For male, but not female survivors, low sleep quality, elevated anxiety, and elevated depression predicted high pain intensity and interference the next day. A substantial proportion of childhood cancer survivors experience chronic pain and significant associated interference. Chronic pain should be routinely evaluated, and interventions are needed.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":" ","pages":"2530-2543"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141563967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01Epub Date: 2024-07-30DOI: 10.1097/j.pain.0000000000003275
Elizabeth I Sypek, Adrien Tassou, Hannah Y Collins, Karen Huang, William M McCallum, Alexandra T Bourdillon, Ben A Barres, Christopher J Bohlen, Grégory Scherrer
{"title":"Diversity of microglial transcriptional responses during opioid exposure and neuropathic pain.","authors":"Elizabeth I Sypek, Adrien Tassou, Hannah Y Collins, Karen Huang, William M McCallum, Alexandra T Bourdillon, Ben A Barres, Christopher J Bohlen, Grégory Scherrer","doi":"10.1097/j.pain.0000000000003275","DOIUrl":"10.1097/j.pain.0000000000003275","url":null,"abstract":"<p><strong>Abstract: </strong>Microglia take on an altered morphology during chronic opioid treatment. This morphological change is broadly used to identify the activated microglial state associated with opioid side effects, including tolerance and opioid-induced hyperalgesia (OIH). Microglia display similar morphological responses in the spinal cord after peripheral nerve injury (PNI). Consistent with this observation, functional studies have suggested that microglia activated by opioids or PNI engage common molecular mechanisms to induce hypersensitivity. In this article, we conducted deep RNA sequencing (RNA-seq) and morphological analysis of spinal cord microglia in male mice to comprehensively interrogate transcriptional states and mechanistic commonality between multiple models of OIH and PNI. After PNI, we identify an early proliferative transcriptional event across models that precedes the upregulation of histological markers of microglial activation. However, we found no proliferative transcriptional response associated with opioid-induced microglial activation, consistent with histological data, indicating that the number of microglia remains stable during morphine treatment, whereas their morphological response differs from PNI models. Collectively, these results establish the diversity of pain-associated microglial transcriptomic responses and point towards the targeting of distinct insult-specific microglial responses to treat OIH, PNI, or other central nervous system pathologies.</p>","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":" ","pages":"2615-2628"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141788768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PAIN®Pub Date : 2024-11-01Epub Date: 2024-06-07DOI: 10.1097/j.pain.0000000000003285
Lauren C Heathcote
{"title":"Pain after cancer: navigating the complexities and embracing psychological insights.","authors":"Lauren C Heathcote","doi":"10.1097/j.pain.0000000000003285","DOIUrl":"https://doi.org/10.1097/j.pain.0000000000003285","url":null,"abstract":"","PeriodicalId":19921,"journal":{"name":"PAIN®","volume":"165 11","pages":"2396-2397"},"PeriodicalIF":5.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}