Objectives: Current research highlights the importance of assessing the risk of opioid misuse in people with chronic noncancer pain (CNCP) before initiating treatment with these medications. Existing instruments to assess this risk demonstrate limited predictive capacity and lack psychological variables that previous research has found to be associated with opioid misuse. The research reported here aimed to develop an instrument to measure the risk of prescription opioid misuse and evaluate its psychometric properties. Methods: The internal structure of the new instrument was examined using confirmatory factor analysis. Analyses were performed on the polychoric correlation matrix of the instrument items, employing maximum likelihood and robust estimation methods. Cronbach’s α and corrected item-factor correlations were calculated to assess internal consistency. Correlation analyses were conducted to test criterion and predictive validity. Finally, a prospective analysis was performed to determine its predictive validity. Results: The Prescription Opioid Misuse Risk Detection Scale (Spanish acronym: EDRIMO) is a 25-item instrument with a unidimensional structure, good internal consistency, excellent test-retest reliability, good levels of validity, high sensitivity, and a moderate level of specificity. Discussion: The EDRIMO was designed for easy administration to facilitate its use in clinical settings. It could provide clinicians with information on areas that may increase patients’ risk of misuse, which should be addressed before prescribing opioids.
Depression is prevalent in individuals with cancer-related pain, impacting quality of life and survival. The Edmonton Symptom Assessment System (ESAS) includes a single depression item (ESAS-D) used to screen for depressive symptoms in this population. While promising for detecting Major Depressive Disorder (MDD) in those with cancer-related pain, its ability to assess depression severity remains unclear. The Montgomery–Asberg Depression Rating Scale (MADRS) is a standard tool used by trained clinicians to assess depression severity and is used to classify individuals as having none, mild, moderate, and severe depression. This study aimed to evaluate the validity of different cutoffs for the ESAS-D for classifying depression severity using the MADRS. Forty-nine individuals with cancer pain completed the ESAS-D. Within two weeks, a psychiatrist interviewed the participants to complete the clinician-rated MADRS to assess depression severity, as well as to determine if the participants did or did not meet the criteria for MDD based on the DSM-5 criteria. Twenty participants met DSM-5 criteria for MDD. An ESAS-D score ≥ 3 yielded the best balance between sensitivity (81%) and specificity (82%) for identifying moderate depression on the MADRS. An ESAS-D score ≥ 5 yielded a sensitivity of 100% and specificity of 74% for identifying individuals with severe depression on the MADRS. The ESAS-D item appears to be valid for classifying depression levels in individuals with cancer-related pain at a single point in time. The thresholds identified in this study could prove valuable in initial screening and guiding the management of depression in the cancer pain population. The ESAS-D’s responsiveness to clinical changes over time warrants further longitudinal investigation.
Objective: Total knee arthroplasty (TKA) is a common operation for geriatric patients. Knowing the factors leading to acute post-TKA pain will lead to personalized pain care. Material and Methods: We recruited 843 patients who underwent TKA. Preoperative, intraoperative, and postoperative data were obtained retrospectively. Results: Moderate to severe postoperative pain in the first 24 hours was found in 87%. Factors associated with moderate to severe postoperative pain were being female [adjusted odd ratio (AOR) 2.34, 95% confidence interval (95% CI) 1.23-4.46], having an ASA physical status classification of II (AOR 9.22, 95% CI 1.9-44.67) or III (AOR 6.75, 95% CI 1.32-34.63), a longer tourniquet time (AOR 1.01, 95% CI 1.01-1.02), and postoperative use of aspirin (AOR 2.04, 95% CI 1.25-3.32). Factors found to be associated with mild postoperative pain were being younger (AOR 0.97, 95% CI 0.94-0.99), being given intrathecal fentanyl (AOR 0.3, 95% CI 0.12-0.73), having a peripheral nerve block (AOR 0.28, 95% CI 0.12-0.66), and taking a systemic corticosteroid (AOR 0.26, 95% CI 0.13-0.55), parecoxib (AOR 0.39, 95% CI 0.19-0.78) or ketorolac (AOR 0.47, 95% CI 0.23-0.99). Conclusion: Being female, having an ASA physical status classification of II or III, a longer tourniquet time, and postoperative use of aspirin were significantly related to having moderate to severe postoperative pain within the first 24 hours after TKA. Factors associated with mild postoperative pain included being younger, intrathecal fentanyl, having a peripheral nerve block, receiving a systemic corticosteroid, and use of parecoxib and ketorolac.
OBJECTIVES:Current research highlights the importance of assessing the risk of opioid misuse in people with chronic noncancer pain (CNCP) before initiating treatment with these medications. Existing instruments to assess this risk demonstrate limited predictive capacity and lack psychological variables that previous research has found to be associated with opioid misuse. The research reported here aimed to develop an instrument to measure the risk of prescription opioid misuse and evaluate its psychometric properties. METHODS:The internal structure of the new instrument was examined using confirmatory factor analysis. Analyses were performed on the polychoric correlation matrix of the instrument items, employing maximum likelihood and robust estimation methods. Cronbach's α and corrected item-factor correlations were calculated to assess internal consistency. Correlation analyses were conducted to test criterion and predictive validity. Finally, a prospective analysis was performed to determine its predictive validity. RESULTS:The Prescription Opioid Misuse Risk Detection Scale (Spanish acronym: EDRIMO) is a 25-item instrument with a unidimensional structure, good internal consistency, excellent test-retest reliability, good levels of validity, high sensitivity, and a moderate level of specificity. DISCUSSION:The EDRIMO was designed for easy administration to facilitate its use in clinical settings. It could provide clinicians with information on areas that may increase patients' risk of misuse, which should be addressed before prescribing opioids.
This study aimed to evaluate the effectiveness of therapeutic hypnosis as an alternative to or adjunct treatment with opioid medications for post-operative pain management following shoulder replacement surgery. A prior pilot study assessed the feasibility of a clinical trial by comparing standard care and hypnosis therapy groups, finding moderate reductions in pain and opioid consumption in the therapeutic hypnosis group. The design of the current trial was informed by findings from the pilot study. Participants in the therapeutic hypnosis group were given access to a video with therapeutic hypnosis narration, while the control group viewed the video without narration. Pain intensity (primary outcome) was assessed at baseline, at the preoperative visit, as well as 10 and 49 days post-surgery. Secondary outcomes included anxiety, pain medication use, and sleep disruption. Despite initial positive results from the pilot, the current trial revealed no significant differences between the treatment groups across all measures. Further research should consider alternative control conditions and examine outcomes in the immediate post-surgical period to better capture potential effects.
Purpose:The objective of this study was to replicate and extend prior evidence regarding the concurrent associations among pain self-efficacy, sleep disturbance, and pain intensity in adults with chronic pain, and to evaluate their temporal associations over time. Patients and Methods:This prospective study enrolled 300 Thai chronic pain outpatients from Siriraj Hospital, of whom 50 were excluded due to loss to follow-up, yielding a final sample of 250 participants. Standard questionnaires were administered to assess pain severity, pain self-efficacy, and sleep disturbance at baseline (initial visit) and again at a follow-up assessment conducted about 6 weeks later (range 4-8 weeks). Longitudinal associations were examined using cross-lagged panel models with covariate adjustment, and moderation analyses were conducted using multiple linear regression with interaction terms. Results:Participants were primarily female with a mean age of 54 years; neuropathic pain was the most common condition. Due to the COVID-19, about half of the participants (52%) did not return to the hospital for follow-up. However, they did return completed follow-up questionnaires via email. The average time between two assessments was 6.25 ± 1.77 weeks. Concurrent associations among pain intensity, sleep disturbance, and pain-related self-efficacy were observed in expected directions (correlations ranging from r's = 0.42 to 0.47). After controlling for age, birth sex, education level, and pain duration, each primary study variable was significantly correlated with its corresponding variable at follow-up (r's = 0.42 to 0.56). The only significant cross-lagged association to emerge was between pain-related self-efficacy at the initial visit and pain intensity at follow-up (β = 0.17, p < 0.01). In unadjusted regression, T1 self-efficacy was negatively associated with T2 pain intensity (β = -0.11, p = 0.08), but the direction reversed and became significant after adjustment (β = 0.18, p < 0.01), indicating a statistical suppression effect. Conclusion:Medium to large concurrent associations were observed in expected directions between measures of pain severity, pain self-efficacy, and sleep disturbance; each of these measures were also stable over time. Only one significant cross-lagged effect emerged, which may reflect statistical suppression rather than a true adverse temporal effect. The temporal associations between these domains require further longitudinal evaluation.
There is a significant need for culturally appropriate psychological treatments for chronic pain among American Indian/Alaska Native (AI/AN) peoples. This study used Indigenous community-based participatory research methods with the Portland Area Indian Health Services—Yakama Service Unit (YSU) to gather information needed for developing culturally adapted psychological treatments for AI/AN individuals with chronic pain. This study included remote semi-structured focus groups with 16 AI/AN individuals with chronic pain to identify pain treatment preferences (Aim 1) and priorities for pain treatment outcome domains (Aim 2). Thematic analyses were conducted with Atlas.ti (version 23.2.1). Results indicated a high interest in psychological interventions and concern that referral to psychological treatment meant that pain is “not real.” Pain intensity and pain interference were identified as the most important outcome domains. To measure pain intensity, the 0 to 10 Numerical Rating Scale was most preferred. The findings support the potential utility of culturally adapted psychological treatments for chronic pain for AI/AN individuals and provided information regarding the adaptations that would be most useful.
Introduction: Chronic low back pain (CLBP) is among the most prevalent musculoskeletal disorders that significantly affects the quality of life of those with this condition. Clinical hypnosis is a psychological intervention that can be used to reduce the intensity and impact of chronic pain. Systematic reviews and meta-analyses have concluded that clinical hypnosis is effective for general chronic pain conditions; however, meta-analytic research on its impact specifically on CLBP remains scarce. This study protocol describes a systematic review and metaanalysis aimed at evaluating the efficacy of hypnosis in reducing pain and associated symptoms in individuals with CLBP, as investigated in randomized controlled trials (RCTs). Methodology: The review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A comprehensive search of eight electronic databases (Scopus, PubMed, CINAHL, Cochrane Central Register of Controlled Trials, EMBASE, PEDro, ScieELO, and LILACS) will be conducted to retrieve relevant studies published up to the date that we conduct the primary analyses, and then repeated just before we submit the article (with any additional articles identified incorporated into the review). Studies with RCTs, involving adults with CLBP (>= 3 months), where hypnosis intervention was used as monotherapy or an adjunct therapy, will be eligible for inclusion. The primary outcome will be pain intensity, while secondary outcomes will include disability, sleep disturbances, and adverse events. Selection of studies, extraction of relevant data, and assessing risk of bias using Cochrane risk of bias tool-2 will be performed by two independent reviewers. Any discrepancies will be addressed through mutual discussion or by consulting a third independent reviewer if required. Meta-analysis will be performed using standardized mean differences for pain and secondary outcomes. Heterogeneity will be assessed and subgroup analyses are planned. Conclusion: The review will provide an extensive overview of the available evidence on the efficacy of hypnosis on individuals with CLBP and identify knowledge. The results are intended to support the development of clinical recommendations and assist healthcare providers who are considering incorporating clinical hypnosis into interdisciplinary pain management strategies. Trial Registration: PROSPERO 2025 CRD420251016398 on 29th March 2025.
ABSTRACT:Chronic pain in children and adolescents affects physical, psychological, social, and academic function. Although physical activity may play a role, its direct effects and its interactions with sleep difficulties and psychological symptoms remain unclear. This cross-sectional study examined whether physical activity is associated with chronic pain, and whether these associations vary by sleep difficulties and psychological symptoms. We analyzed data from 212,105 individuals (49% girls, age: 11-15 years) from the 2018 Health Behavior in School-aged Children study. Chronic pain, psychological symptoms, sleep difficulties, moderate-to-vigorous physical activity (MVPA), and vigorous physical activity (VPA) were assessed using validated self-report measures. Three multivariate logistic regression models (for chronic back pain, stomachache, and headache) examined main and moderation effects, adjusting for age, gender identity, and socioeconomic status. In adjusted main-effects models, higher MVPA was associated with higher odds of chronic back pain (aOR 1.15, 95% CI 1.06-1.25) and stomachache (aOR 1.02, 95% CI 1.00-1.09) but not headache. Interaction models indicated that MVPA associations differed by sleep difficulties, and the VPA-pain association differed by psychological symptoms. In stratified analyses, several MVPA frequency categories (vs 0 d/wk) were associated with lower odds of back pain and stomachache in both low and high sleep-difficulty groups. Vigorous physical activity was associated with lower odds of back pain and stomachache among adolescents with moderate or high psychological symptoms but not those with low symptom frequency. Overall, physical activity was not uniformly protective; associations were pain-type specific and varied according to adolescents sleep and psychological profiles.
ABSTRACT:Results suggest that psychosocial treatments for chronic pain work via several mechanisms, and that they often do so to similar degrees and in similar ways. Extant research, however, has focused on individual and/or independent effects of mechanisms on outcomes. Whether successful outcomes are also partly because of sequential and meaningful relationships among and between mechanisms-mechanism-to-mechanism effects-has not been examined. Secondary analyses were conducted of an RCT that compared cognitive therapy, mindfulness-based stress reduction, and behavior therapy to treatment as usual in a sample (N = 521) of people with chronic low back pain. Results of hierarchical linear modeling revealed that (1) Treatment Condition × Mechanism interactions predicting changes in other mechanisms were nonsignificant; (2) lagged prior session mechanism changes predicted next session changes in another mechanism; (3) lagged relationships between pain catastrophizing and pain self-efficacy were reciprocal, whereas links between lagged pain catastrophizing and mindfulness changes and lagged pain catastrophizing changes and behavioral activation changes were unidirectional; and (4) individual differences in the strengths of mechanism-to-mechanism relationships predicted pre- to post-treatment changes in outcomes. Results reveal heretofore hidden therapeutic processes that cognitive therapy, mindfulness-based stress reduction, and behavior therapy may share. Namely, that mechanism-to-mechanism lagged effects do indeed emerge beyond mechanism-to-outcome effects. Findings show not only that mechanisms may change in definable sequences relative to each other but that individual differences in the strengths of mechanism-to-mechanism relationships may themselves be predictive of outcomes.
ABSTRACT:Evidence suggests that pain interference is linked to depression and anxiety in youth with chronic pain, yet the contributions of the social environment to these associations remain unclear. Guided by the Stress-Buffering Model of Social Support, this study tested theory-driven mediation and moderation models to examine whether peer relationships and bullying contribute to or modify concurrent and short-term longitudinal associations between pain interference and psychological function. A cross-sectional sample of 744 youth with chronic pain from the EPIDOL project (61% girls; mean age = 11.9 years, SD = 2.6) completed measures of pain characteristics, pain interference, peer relationship quality, bullying, and psychological function (depressive and anxiety symptoms). A short-term longitudinal subsample of 357 youth who reported chronic pain 12 months later completed measures at both assessments. Peer relationships significantly mediated the association between pain interference and depressive symptoms in both samples. No mediating effects were observed for anxiety symptoms or for being bullied. In the cross-sectional sample, being bullied in the past significantly moderated the association between pain interference and depressive symptoms; in the longitudinal sample, this effect was moderated by peer relationship quality. For anxiety, only concurrent moderation was observed, with past bullying amplifying its association with pain interference. These findings extend theoretical models by demonstrating that supportive and adverse peer experiences influence psychological adjustment through distinct contextual pathways. They highlight the importance of assessing the social environment in clinical evaluations and suggest that strengthening peer support may be a valuable target for intervention in youth with chronic pain.
Fibromyalgia (FM) is characterized by widespread musculoskeletal pain accompanied by diverse psychological and physical symptoms. The current study assessed the feasibility of an intervention that combines hypnotic cognitive therapy (HYP-CT) with therapeutic exercise for individuals with FM. Randomization of 16 participants was conducted in one of two treatment conditions: (1) HYP-CT (HYP-CT combined with therapeutic exercise) or (2) attention control (AC; attention control combined with therapeutic exercise). All predetermined feasibility criteria were exceeded, evidenced by high recruitment rates, complete data completion, treatment adherence, and no serious adverse events. Intervention acceptability was notably high, with participants allocated to the HYP-CT group indicating higher satisfaction and perceived improvement compared to those in the AC group, along with interest in continuin with the intervention. Overall, the findings indicate that the study procedures and intervention were feasible, safe, and acceptable, supporting progression to a fully powered randomized controlled trial.
Research supports the efficacy of music-based interventions (MBIs) for pain management, but understanding of their underlying mechanisms is lagging. This scoping review aims to map existing mechanism-focused MBI research, identify knowledge gaps, and highlight the strengths and weaknesses of this body of research. Studies were eligible if they tested a mechanism, moderator, or predictor of the effects of MBIs on clinical or experimental pain and were published in English in a peer-reviewed journal. Following the Joanna Briggs Institute scoping review methodology, we searched MEDLINE, Embase, PsycINFO, PubMed, and Scopus from inception through February 2026. Two reviewers completed screening and data extraction, with discrepancies resolved by a third reviewer. From 663 records screened, 57 studies were included. Most studies employed experimental pain models with healthy volunteers. All but 4 studies examined the mechanisms of music audio recordings; the remaining studies examined active music-making. We identified convergent evidence for several candidate mechanisms, including positive emotional valence, cognitive agency, and sensorimotor synchronization. Evidence from neuroimaging studies point to the impact of music on early stages of pain processing as well as on higher-order cognitive and affective interpretation of pain. Finally, preliminary evidence suggests that music may restore default mode network connectivity involved in self-referential thoughts. Across studies, several methodological limitations constrained inferences. Future research should (1) employ rigorous designs that distinguish between competing mechanistic models and, when feasible, incorporate causal manipulations to test hypothesized mechanisms and (2) examine whether music influences pain processing differently in populations with vs without clinical pain.
BACKGROUND:Cross-sectional studies have reported associations between pain catastrophizing and pain medication use in youth with chronic pain; however, the factors underlying this association remain unclear. Guided by the paediatric Fear-Avoidance model, this cohort study examined whether pain interference played a role in the longitudinal association between pain catastrophizing and subsequent pain medication use. METHODS:Participants were drawn from the EPIDOL project and included 180 adolescents (mean age = 13.56 years; 78% female) with chronic pain at both first assessment (T1) and 12-month follow-up (T2). Self-report measures assessed demographics (birth sex and age), pain characteristics (location, extent, and intensity), pain interference, pain catastrophizing, and pain medication use. Generalized structural equation models tested theory-guided autoregressive and cross-lagged panel specifications. Models adjusted for age, birth sex, and pain intensity and accounted for temporal stability. RESULTS:Pain catastrophizing and pain medication use showed moderate to high temporal stability. No significant association was observed between pain catastrophizing at T1 and pain medication use at T2. In contrast, pain interference at T1 was significantly associated with pain medication use at T2, even when controlling for pain catastrophizing at T1. Findings were consistent across model specifications. CONCLUSIONS:The findings suggest that pain interference may represent a functional factor prospectively associated with subsequent pain medication use. Future research should examine its potential role in linking pain catastrophizing and pain medication use when such associations are observed. Overall, the results support assessing both cognitive and functional dimensions when evaluating pain-related management patterns in youth with chronic pain. SIGNIFICANCE STATEMENT:This longitudinal study found that the association between pain catastrophizing and pain medication use inadolescents with chronic pain was accounted for indirectly by pain interference. These findings highlight theimportance of addressing both functional interference and pain-related cognitions in paediatric pain management.
Kinesiophobia plays a central role in understanding adult pain mechanisms, yet its assessment and theoretical relevance in pediatric pain remain poorly understood. Research to clarify the role of kinesiophobia in pediatric populations requires a valid and reliable measure of the construct. The most commonly used measure is the Tampa Scale of Kinesiophobia (TSK). Unfortunately, prior research in pediatric populations with different TSK versions has shown suboptimal psychometric performance, leaving the field without a reliable tool to evaluate fear-avoidance processes. This study provides the first comprehensive evaluation of the validity of the 11-item TSK (TSK-11) in pediatric populations. A total of 536 participants aged 8-18 years were recruited across three hospital units in Spain. Participants completed the TSK-11 in Spanish plus measures of pain intensity, pain interference, pain catastrophizing, pain anxiety, and physical functioning. A subsample (n=50) completed the TSK-11 again 3 months later. Internal consistency was good for the total score (α=.88) and the Activity Avoidance (α=.82) and Harm (α=.85) subscales. Test-retest reliability was excellent (ICC=.89). CFA supported the expected two-factor structure. Participants with chronic pain (totals score 24.70) and chronic post-surgical pain (M=27.81) had higher TSK-11 scores than participants without chronic pain (M=22.89), with significant differences for the total score and Harm subscale. Large correlations were observed with pain interference (r=.63), anxiety (r=.59), catastrophizing (r=.56), fear of pain (r=.58), and pain intensity (r=.55). Findings support the TSK-11 as a reliable, valid, and theoretically coherent brief kinesiophobia measure capable of advancing mechanistic and clinical research in pediatric populations. PERSPECTIVE: This study provides the first comprehensive validation of the TSK-11 in pediatric populations, supporting its reliability, validity, and theoretical coherence for assessing kinesiophobia. The findings offer researchers and clinicians a brief, psychometrically sound tool to advance understanding of fear-avoidance mechanisms in pediatric chronic pain.
Affordable home-based electroencephalography (EEG) headsets could widen access to EEG assessment, but require rigorous validation before research or clinical use. Here, we evaluated a custom-developed 2-channel sensorimotor headset (PainWaive) intended for remote neurofeedback and longitudinal monitoring in chronic pain. Eighty participants (47 female; mean age 24.0 years, SD 7.9) completed two resting-state sessions with PainWaive and a research-grade 64-channel EEG system (LiveAmp), under eyes-open (EO) and eyes-closed (EC) conditions. Alpha, beta and theta power and peak alpha frequency (PAF) were derived from homologous sensorimotor channels (C1/C2). Relative reliability was quantified with intraclass correlation coefficients (ICCs), absolute reliability with SEM%, and cross-device consistency with between-device ICCs and Pearson correlations of overall spectral shape. ICCs/correlations were interpreted using pre-specified thresholds: fair 0.20-0.39, moderate 0.40-0.59, good 0.60-0.79, excellent >0.80. PainWaive and LiveAmp showed comparable absolute reliability across metrics (similar SEM%). Under EC, PainWaive reliability was excellent for alpha (0.81), theta (0.85) and PAF (0.94), and good for beta (0.72). Under EO, reliability was excellent for alpha (0.82), good for beta and PAF (0.61-0.72), and moderate for theta (0.59). Spectral-shape correlations between devices were excellent (r>0.90). Cross-device ICCs were good under EC for alpha/theta/PAF (ICC=0.66-0.77) though fair for beta (0.35). Under EO, ICCs were good for alpha (0.62), moderate for PAF (0.53), and fair for beta/theta (0.26-0.32). To assess performance under real-world use, we additionally analysed 2 clinical samples of individuals (total n = 8) with chronic pain who each completed 20 home-based neurofeedback sessions using PainWaive (160 sessions total). Within-session stability was good-to-excellent across metrics (ICCs>0.72). Overall, our findings suggest PainWaive is a reliable tool for the assessment of EEG metrics, supporting its use in re-search and clinical applications. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by National Health and Medical Research Council Ideas Grant (2001653) and Rebecca L. Cooper Medical Research Foundation Fellowship awarded to Sylvia M Gustin ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: All provided written informed consent, and the study was approved by the UNSW Human Research Ethics Advisory Panel (iRECS#8344, iRECS8134 and HC230351). Participation was voluntary, with the option to withdraw at any time. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes De-identified data are available to qualified researchers on reasonable request, in accord-ance with the ethics approvals and study protocols governing this research.
Research Objectives To determine whether hypnotic cognitive therapy (HYP-CT) reduces chronic pain intensity and improves depression, pain interference and other outcomes in people living with spinal cord injury. Design Single blind, parallel group trial with 1:1 randomization to HYP-CT delivered by telephone or zoom versus usual care (UC) controls. We used computerized permuted block randomization with variable block sizes and stratified on sex and worst pain type. Outcomes were assessed at baseline, end of treatment (6 weeks) and follow-up (12 weeks) by trained staff who were kept unaware of the participant's condition. Setting Single site, tele-health study Participants Community residing adults with SCI and moderate to severe chronic pain recruited nationally through consumer organizations, support groups, and Facebook groups. Interventions Treatment consisted of six weekly 45 to 60-minute sessions of hypnosis enhanced cognitive therapy for chronic pain delivered by a pain psychologist. Participants were instructed to listen to the recorded sessions and practice brief self-hypnosis daily. Those in UC were encouraged to use existing healthcare to treat pain. Main Outcome Measures Primary outcome was average pain intensity assessed with a 0-10 numerical rating scale (NRS) four times per week via telephone interview and averaged. Depression, pain interference, and other secondary outcomes were assessed by structured telephone interviews. The primary endpoint was 6 weeks (end of treatment); follow-up assessments were at 12 weeks. Results 127 participants were randomized to HYP-CT (n=64) versus UC (n=63). 48% were treated via telephone and 52% via Zoom. Participants were, on average, 51.3 years old, 15.4 years post-SCI, and had mean baseline pain intensity of 5.93 on a 0-10 NRS; 58% were male, 79% identified as White, and 60% had tetraplegia. 57% reported their worst pain problem was neuropathic. Average pain intensity decreased significantly more in HYP-CT versus UC at 6 (-1.17 vs. -0.58; p=.030) and 12 weeks (-1.47 vs. -0.65; p=.002). The effect of HYP-CT was similar when provided via telephone or Zoom. Depression also declined significantly more in HYP-CT vs. UC at 6 and 12 weeks. Planned moderator analyses showed that HYP-CT led to a greater decrease in people with neuropathic pain (-1.73) compared to mixed pain (-0.25; p=.015) at 12 weeks. Conclusions HYP-CT delivered by telephone or Zoom significantly reduces chronic pain intensity in SCI, especially neuropathic pain.
Psychological interventions have reliable but modest effects on chronic pain outcomes, but our understanding of the mechanisms that underlie these effects remains limited. This paper presents the findings from a series of secondary analyses using data from a randomized clinical trial (clinicalTrials.gov, NCT02653664). Three hundred and twenty-eight Veterans of the US Armed Forces with chronic pain were randomized to receive clinical hypnosis, mindfulness meditation training, or pain education via 8 in-person group sessions. Of 17 candidate mediator variables assessed before and after treatment, 10 changed with treatment. Three of these were associated significantly with reductions in pain intensity and interference across all three treatment conditions: greater willingness to tolerate pain, greater engagement in valued activities despite pain, and reduced catastrophizing. A fourth candidate mediator assessed during treatment working alliance was significantly associated with reductions in pain intensity for those receiving clinical hypnosis. When comparing effects between treatments, catastrophizing appeared to play a larger role for the effects of mindfulness training on pain intensity and interference, and pain willingness appeared to play a larger role in the effect of therapeutic hypnosis on pain interference. Further research is needed to validate the reliability of the mediators identified in this study. If the findings from the current study replicate in other samples, they would support the importance of focusing treatment on thoughts about pain, pain avoidance, engagement in valued activities, and working alliance. Perspective Three psychological variables were identified as being possible mediators of the beneficial effects of mindfulness, clinical hypnosis, and pain education on pain. Additional research is needed to definitively test these variables as potential mediators of psychological pain treatments.
BACKGROUND:Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery. METHODS:We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes. RESULTS:Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0-6 h, at 6-24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey. CONCLUSIONS:We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery. SYSTEMATIC REVIEW PROTOCOL:Open Science Framework (10.17605/OSF.IO/DJQFE).