Protocol for a randomized controlled trial of an internet-based prevention intervention for young children at-risk for functional abdominal pain.

BACKGROUND: Chronic pain often clusters in families, where parents and their offspring both experience chronic pain conditions. Young children of parents with irritable bowel syndrome (IBS) represent an at-risk group for the development of abdominal pain, disability, and excess health care visits in later childhood. Parental solicitous responses to children's expressions of discomfort and maternal modeling of their own illness behavior contribute to a greater focus on somatic sensations, leading to illness behaviors in children. This randomized controlled trial will test the effectiveness of an early preventive web-based psychosocial intervention (REACH)[TM] vs. an educational web-based safety comparison condition delivered to parents with IBS to alter parental responses and lead to improved child health and decreased health care costs. METHODS: Parents with IBS who have children ages 4-7 years are recruited via community-based approaches (e.g., social media advertisements, school electronic distribution, research networks) and health care providers. The target sample is 460 parents randomized to REACH, a web-based social learning and cognitive behavior therapy (SLCBT) intervention or an educational web-based safety comparison condition (EC). Participants will be assessed at baseline, 6-week (immediate post-intervention), 6-month, 12-month, and 18-month follow-up periods (months post-completion of intervention). The primary outcome is change in parental solicitous/protective behaviors. Secondary outcomes include parent risk and protective factors, child health and symptom outcomes, and health care utilization and cost savings. DISCUSSION: This study adapts a validated, parent-delivered intervention to treat chronic pain in children to a web-based application designed to prevent the development of chronic pain in very young, high-risk children. If successful, this strategy can both prevent adverse sequelae of this condition from developing as well as be widely accessible. Furthermore, the availability of a prevention model for parent training could result in significant short- and long-term health benefits across a broad spectrum of conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT05730491. Registered on February 15, 2023.

Impact of 25 Years of Mobile Health Tools for Pain Management in Patients With Chronic Musculoskeletal Pain: Systematic Review.

BACKGROUND: Mobile technologies are increasingly being used in health care and public health practice for patient communication, monitoring, and education. Mobile health (mHealth) tools have also been used to facilitate adherence to chronic musculoskeletal pain (CMP) management, which is critical to achieving improved pain outcomes, quality of life, and cost-effective health care. OBJECTIVE: The aim of this systematic review was to evaluate the 25-year trend of the literature on the adherence, usability, feasibility, and acceptability of mHealth interventions in CMP management among patients and health care providers. METHODS: We searched the PubMed, Cochrane CENTRAL, MEDLINE, EMBASE, and Web of Science databases for studies assessing the role of mHealth in CMP management from January 1999 to December 2023. Outcomes of interest included the effect of mHealth interventions on patient adherence; pain-specific clinical outcomes after the intervention; and the usability, feasibility, and acceptability of mHealth tools and platforms in chronic pain management among target end users. RESULTS: A total of 89 articles (26,429 participants) were included in the systematic review. Mobile apps were the most commonly used mHealth tools (78/89, 88%) among the included studies, followed by mobile app plus monitor (5/89, 6%), mobile app plus wearable sensor (4/89, 4%), and web-based mobile app plus monitor (1/89, 1%). Usability, feasibility, and acceptability or patient preferences for mHealth interventions were assessed in 26% (23/89) of the studies and observed to be generally high. Overall, 30% (27/89) of the studies used a randomized controlled trial (RCT), cohort, or pilot design to assess the impact of the mHealth intervention on patients' adherence, with significant improvements (all P<.05) observed in 93% (25/27) of these studies. Significant (judged at P<.05) between-group differences were reported in 27 of the 29 (93%) RCTs that measured the effect of mHealth on CMP-specific clinical outcomes. CONCLUSIONS: There is great potential for mHealth tools to better facilitate adherence to CMP management, and the current evidence supporting their effectiveness is generally high. Further research should focus on the cost-effectiveness of mHealth interventions for better incorporating these tools into health care practices. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42024524634; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=524634.

Effectiveness of a physiotherapy self-management programme for adult patients with chronic non-specific low back pain in low- and middle-income countries: protocol for a systematic review and meta-analysis.

INTRODUCTION: Chronic non-specific low back pain (CNLBP) is among the most common musculoskeletal system conditions reported worldwide; however, few studies are available from low- and middle-income countries (LMICs). Self-management is a set of tasks performed by the patient aiming at managing their symptoms and interference in activities, mood and relationships due to pain. A physiotherapy-guided self-management programme (SMP) following a biopsychosocial approach has been reported as effective and affordable in the management of CNLBP in high-income countries. The objective of this systematic review is to determine the overall effectiveness of SMPs for adults with CNLBP in LMICs. METHODS AND ANALYSIS: In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol (PRISMA-P) guidelines will be followed. A three-step search strategy will be used to search the electronic databases (PubMed, MEDLINE, SPORTDiscus, Scopus and CINAHL, Academic Search Complete and PEDro) for randomised controlled trials assessing the effectiveness of physiotherapy-guided self-management for CNLBP among adult participants in LMICs. The processes of screening search results for eligible studies, extracting data from included studies and appraising will be done independently by at least two review authors. Random effects meta-analysis will be used to synthesise results and heterogeneity will be assessed using the I2 test statistic and χ2 test. ETHICS AND DISSEMINATION: Ethics clearance was obtained for the broader PhD study on the development of a physiotherapy-guided SMP for adult people with CNLBP in Limpopo Province, South Africa. The results of the manuscript for this protocol will be published in peer-reviewed journals and also presented at conferences, symposia, and congresses. PROSPERO REGISTRATION NUMBER: CRD42023399572.

A retrospective assessment of the effectiveness of pulsed radiofrequency ablation in the treatment of chronic pain caused by advanced knee osteoarthritis.

INTRODUCTION: Patients suffering from severe chronic pain often have problems finding an appropriate combination of painkillers. We retrospectively evaluated the effectiveness and safety of pulsed radiofrequency ablation (pRFA) of the genicular nerves in 96 patients with knee osteoarthritis (KO). We hypothesized that age, sex, and body mass index (BMI) may influence the quality of the pRFA treatment. MATERIAL AND METHODS: A diagnostic blockade with total volume of 9 ml of 1% lidocaine (WZF, Poland) combined with 4 mg of dexamethasone with subsequent pRFA with a radio frequency of 300-500 kHz under ultrasound guidance was used during the procedure. The study participants were assessed during regular monthly visits until 12 months. RESULTS: The nerves' ultrasound identification was successful in 90.62% of the cases. According to the numeric rating scale (NRS), pain was reduced by 50% or more in 64.06% of the cases. The average pain relief period lasted just over 7 and a half months. There were no pRFA-related complications or side effects of the drugs used. CONCLUSIONS: pRFA seems to be safe and effective for the treatment of chronic pain in KO. The outcome of the treatment may be related to the patient's age (block duration increased with patient age) and sex (in women, the therapeutic effect was more effectively prolonged) in our study group. There was also higher effectiveness of pRFA in high-BMI patients, which was close to statistical significance ( P = 0.053).

Revisiting the effects of rTMS over the dorsolateral prefrontal cortex on pain: An updated systematic review and meta-analysis.

BACKGROUND: Our previous study synthesized the analgesic effects of repetitive Transcranial Magnetic Stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) trials up to 2019. There has been a significant increase in pain trials in the past few years, along with methodological variabilities such as sample size, stimulation intensity, and rTMS paradigms. OBJECTIVES/METHODS: This study therefore updated the effects of DLPFC-rTMS on chronic pain and quantified the impact of methodological differences across studies. RESULTS: A total of 36 studies were included. Among them, 26 studies were clinical trials (update = 9, 307/711 patients), and 10 (update = 1, 34/249 participants) were provoked pain studies. The updated meta-analysis does not support an effect on neuropathic pain after including the additional trials (pshort-term = 0.20, pmid-term = 0.50). However, there is medium-to-large analgesic effect in migraine trials extending up to six weeks follow-up (SMDmid-term = -0.80, SMDlong-term = -0.51), that was not previously reported. Methodological differences wthine the studies were considered. DLPFC-rTMS also induces potential improvement in the emotional aspects of pain (SMDshort-term = -0.28). CONCLUSIONS: The updated systematic meta-analysis continues to support analgesic effects for chronic pain overall. However, the updated results no longer support DLPFC-rTMS for pain relief in neuropathic pain, and do supports DLPFC-rTMS in the management of migraine. There is also evidence for DLPFC-rTMS to improve emotional aspects of pain.

The "future" pain clinician: Competencies needed to provide psychologically informed care.

BACKGROUND & OBJECTIVE: Psychologically informed care has been proposed to improve treatment outcomes for chronic pain and aligns with a person-centered approach. Yet implementation lags behind, and studies suggest that a lack of competency leads to poor results. It is unclear what training clinicians require to deliver this care. We examine how we might improve psychologically informed care guided by the needs of the patient and in congruence with the scientific literature with a particular focus on how competencies might be upgraded and implementation enhanced. METHODS: We selectively review the literature for psychologically informed care for pain. The patient's view on what is needed is contrasted with the competencies necessary to meet these needs and how treatment should be evaluated. RESULTS: Patient needs and corresponding competencies are delineated. A number of multi-professional skills and competencies are required to provide psychologically informed care. Single-subject methodologies can determine whether the care has the desired effect for the individual patient and facilitate effectiveness. We argue that becoming a competent "pain clinician" requires a new approach to education that transcends current professional boundaries. CONCLUSIONS: Providing person-centered care guided by the needs of the patient and in line with the scientific literature shows great potential but requires multiple competencies. We propose that training the pain clinician of the future should focus on psychologically informed care and the competencies required to meet the individual's needs. Single-subject methodology allows for continual evaluation of this care.

A functional intervention within a cognitive approach to chronic cervical radiculopathy : Description of the non-surgical treatment arm in a randomised controlled trial evaluating the effectiveness of surgery.

BACKGROUND: Most patients with cervical radiculopathy improve within the first months without treatment or with non-surgical treatment. A systematic review concluded that these patients improve, regardless of their intervention. Still, many patients are offered surgery, despite limited evidence regarding the indications for surgical treatments. The aim of this article is to describe the intervention that is going to be followed in the non-surgical treatment arm of a randomised controlled trial (RCT) comparing the effectiveness of surgical and non-surgical treatment for patients with cervical radiculopathy. METHODS: The non-surgical intervention is a functional intervention within a cognitive approach founded on previous experiences, and current recommendations for best practice care of musculoskeletal pain and cervical radiculopathy. It is based on the biopsychosocial rather than a biomedical perspective, comprises an interdisciplinary approach (physicians, physiotherapy specialists), and includes brief intervention and graded activities. The intervention consists of 6 sessions over 12 weeks. The primary goals are first, to validate the patients´ symptoms and build a therapeutic alliance, second, to explore the understanding and promote alternatives, and third, to explore problems and opportunities based on patients´ symptoms and function. Motivational factors toward self-management are challenging. We will attempt shared decision-making in planning progress for the individual patient and emphasise learning of practical self-help strategies and encouragement to stay active (reinforcing the positive natural course). General physical activities such as walking will be promoted along with simple functional exercises for the neck- and shoulder region. We will also explore social activity, comorbidities, pain location, sleep, and work-related factors. The health providers will set individualised goals together with each patient. DISCUSSION: The aim of the intervention is to describe a functional intervention within a cognitive approach for patients with chronic cervical radiculopathy. The effectiveness of the present program will be compared to surgery in a randomised controlled trial.

A critical appraisal of"effects of exercise therapy on disability, mobility, and quality of life in the elderly with chronic low back pain: a systematic review and meta-analysis of randomised controlled trials."

This response letter addresses the comments received on our paper. The main points of our response include: Clarification of the definitions of primary and secondary indexes; Justification for the use of the RoB2 tool for quality assessment; Measures to improve sensitivity analysis and data consistency; Explanation and improvement plans regarding the timing of Prospero registration. We have provided detailed explanations of the study design and outlined specific measures for future improvements to enhance research transparency and quality.

Rehabilitation interventions for neuropathic pain: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Rehabilitation interventions for chronic pain typically include education, cognitive behavioural therapy, and exercise therapy, or a combination of these. A systematic review and meta-analysis of rehabilitation interventions for neuropathic pain was conducted. DESIGN: Randomized controlled trials were identified in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and PsycINFO databases from inception up to 3 March 2022. SUBJECTS/PATIENTS: Adults with chronic (> 3 months) neuropathic pain. METHODS: Primary outcomes were pain intensity, pain-related disability, and work participation. Secondary outcomes were quality of life, emotional strain, insomnia, and adverse outcomes, according to VAPAIN guidelines. Analyses were made post-intervention, which was defined as the assessment point immediately following the intervention or at the first-time measurement conducted after the intervention period. RESULTS: In total, 15 studies (total population, n = 764) were incorporated. Most common interventions were cognitive behavioural programmes including acceptance and commitment therapy (n = 4), mindfulness-based interventions (n = 5), and yoga (n = 2). Psychological interventions reduced both pain intensity (SMD -0.49, 95% CI -0.88 to -0.10) and pain-related disability (SMD -0.51, 95% CI -0.98 to -0.03), whereas other interventions had an effect on pain intensity but not on pain-related disability. CONCLUSION: Rehabilitation interventions, and psychological interventions in particular, seem to be of value for patients with chronic neuropathic pain.

Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation: A RCT-study protocol of the PIANISSIMO study.

BACKGROUND: Spinal Cord Stimulation (SCS) may provide pain relief in patients with therapy-refractory Persistent Spinal Pain Syndrome Type II (PSPS-T2). Despite the evidence that SCS can reduce disability and reduce pain medication usage, only 25% of the patients is able to completely omit pain medication usage after 12 months of SCS. To tackle the high burden of patients who consume a lot of pain medication, tapering programs could be initiated before starting a trajectory with SCS. The current objective is to examine whether a pain medication tapering program before SCS alters disability in PSPS-T2 patients compared to no tapering program. METHODS AND DESIGN: A three-arm, parallel-group multicenter randomized controlled trial will be conducted including 195 patients who will be randomized (1:1:1) to either (a) a standardized pain medication tapering program, (b) a personalized pain medication tapering program, or (c) no tapering program before SCS implantation, all with a follow-up period until 12 months after implantation. The primary outcome is disability. The secondary outcomes are pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication usage, psychological constructs, sleep, symptoms of central sensitization, and healthcare expenditure. DISCUSSION: Within the PIANISSIMO project we propose a way to reduce the risks of adverse events, medication-induced hyperalgesia, tolerance, and dependence by providing pain medication tapering before SCS. Due to the lack of a commonly accepted in-hospital tapering approach, two different tapering programs will be evaluated in this study. If pain medication tapering programs are deemed to be more effective than no tapering on disability, this would add to the evidence towards an improved patient-centered care model in this patient group and set a clear path to advocate for pain medication tapering before SCS as the new standard treatment guideline for these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT05861609. Registered on May 17, 2023.

A Functional Restoration Program for Active Duty Service Members With Chronic Pain: Examining the Impact of Co-occurring PTSD on Treatment Response.

INTRODUCTION: Standard medical intervention for chronic pain may be less effective in the presence of co-occurring PTSD. Functional restoration programs (FRPs), which combine psychological interventions and progressive exercise rehabilitation, represent an alternative to standard medical intervention for chronic pain. The objective of the current study is to evaluate a FRP serving Active Duty Service Members with chronic pain and to examine whether co-occurring PTSD symptoms are associated with differential treatment response. METHODS: This is a retrospective observational study of data previously collected at Naval Medical Center San Diego approved by the Naval Medical Center San Diego Institutional Review Board. The study included 81 Active Duty Service Members, primarily Sailors and Marines, who completed a FRP, and examined pre- to post-treatment changes in Pain Impact Score-a composite measure of pain intensity, pain interference, and physical functioning-as well as measures of mental health and pain cognitions. Co-occurring PTSD symptoms were examined as a potential moderator of treatment response. RESULTS: Twenty-three patients (28.4%) screened positive for PTSD during baseline assessments. Repeated measures analysis of variance showed statistically significant improvement in Pain Impact Score for the full sample (P <.001). Although no significant interactions with probable PTSD were demonstrated for measures of pain intensity and physical functioning (both Ps >.05), patients screening positive for PTSD demonstrated a lesser decrease in pain interference compared to patients screening negative for PTSD (P <.01). Improvements in measures of mental health and pain cognitions were also statistically significant for the full sample (all P values <.05) and did not differ as a function of PTSD symptoms (all P values >.05). CONCLUSION: This FRP primarily serving Sailors and Marines contributed to broad overall improvements in the domains of pain and functioning as well as mental health and pain cognitions. Co-occurring PTSD symptoms were not associated with poorer treatment response on most measured outcomes.

Sex Differences in Pain Sensitivity in a Dutch Cohort: Cross-Sectional and Web-Based Multidimensional Study.

BACKGROUND: Sex is an important factor influencing the development and treatment of chronic pain, but the extent of its influence is still unclear. Other demographic factors as well as nonpharmacological interventions might influence pain sensitivity differently in men and women. OBJECTIVE: In this study, we aimed to investigate the influence of sex and other demographic, lifestyle, behavioral, clinical, and environmental factors on pain sensitivity in the Dutch population. Different films were used to investigate how they would impact pain sensitivity and what influence sex and other variables have on the effect of this simple intervention. METHODS: We performed a study consisting of 2 parts: (1) a cross-sectional research to investigate pain sensitivity differences between men and women and the influence of other demographic variables on the pain sensitivity in a Dutch cohort and (2) an internet intervention study to determine whether a short film could skew pain sensitivity. RESULTS: All respondents filled in a web-based demographic questionnaire and were randomized into 4 groups. The control group filled in the Pain Sensitivity Questionnaire without watching a preliminary film. A cross-sectional analysis was performed in the control group (n=1746). The other 3 groups watched short films: one group watched a film with scenes of nature (n=2650), another group watched a film on laughing people (n=2735), and the last group watched a film on physically painful events (n=2708). Immediately after the film viewing, participants were directed to the Pain Sensitivity Questionnaire to measure their pain sensitivity. The Pain Sensitivity Questionnaire score was stated as a mean per question on the numeric rating scale from 0-1. The cross-sectional study revealed no significant differences between men and women but showed male-female differences in the Pain Sensitivity Questionnaire when specific background factors were present. Watching a short film had a positive impact on the pain sensitivity of the respondents who had chronic pain, with a higher effect observed in female respondents. CONCLUSIONS: Scientists performing pain research need to account for factors that can influence the outcome of their study and be aware that these factors can be sex-dependent, and pain sensitivity should be analyzed accordingly. Even relatively small interventions such as watching a film can impact pain sensitivity, especially in respondents with current chronic pain. This effect can vary as well when different background factors are present. Our findings warrant further explorations of the possibilities that simple interventions bring for patients in personalized medicine. TRIAL REGISTRATION: Landelijk Trial Register NTR-new NL8182; https://onderzoekmetmensen.nl/en/trial/29537.

Development and internal validation of a multivariable prognostic model to predict chronic pain after a new episode of non-specific idiopathic, non-traumatic neck pain in physiotherapy primary care practice.

OBJECTIVE: To develop and internally validate a prognostic model to predict chronic pain after a new episode of acute or subacute non-specific idiopathic, non-traumatic neck pain in patients presenting to physiotherapy primary care, emphasising modifiable biomedical, psychological and social factors. DESIGN: A prospective cohort study with a 6-month follow-up between January 2020 and March 2023. SETTING: 30 physiotherapy primary care practices. PARTICIPANTS: Patients with a new presentation of non-specific idiopathic, non-traumatic neck pain, with a duration lasting no longer than 12 weeks from onset. BASELINE MEASURES: Candidate prognostic variables collected from participants included age and sex, neck pain symptoms, work-related factors, general factors, psychological and behavioural factors and the remaining factors: therapeutic relation and healthcare provider attitude. OUTCOME MEASURES: Pain intensity at 6 weeks, 3 months and 6 months on a Numeric Pain Rating Scale (NPRS) after inclusion. An NPRS score of ≥3 at each time point was used to define chronic neck pain. RESULTS: 62 (10%) of the 603 participants developed chronic neck pain. The prognostic factors in the final model were sex, pain intensity, reported pain in different body regions, headache since and before the neck pain, posture during work, employment status, illness beliefs about pain identity and recovery, treatment beliefs, distress and self-efficacy. The model demonstrated an optimism-corrected area under the curve of 0.83 and a corrected R2 of 0.24. Calibration was deemed acceptable to good, as indicated by the calibration curve. The Hosmer-Lemeshow test yielded a p-value of 0.7167, indicating a good model fit. CONCLUSION: This model has the potential to obtain a valid prognosis for developing chronic pain after a new episode of acute and subacute non-specific idiopathic, non-traumatic neck pain. It includes mostly potentially modifiable factors for physiotherapy practice. External validation of this model is recommended.

Impact of Vojta therapy combined with standard care on psychometric and functional parameters in patients with chronic lower back pain: a randomized controlled trial.

Chronic low back pain (LBP) is very common, resulting in functional deficits and significant socio-economic burden. Non-pharmacological treatments, such as physical-psychological therapy, are frequently utilized. Vojta therapy (VT) is a type of physical therapy that effectively enhances the automatic control of body posture. This study aimed to evaluate the effects of combining VT with the usual standard of care (USC) therapy on psychometric and functional parameters in patients with chronic LBP. A total of 148 patients diagnosed with chronic LBP were recruited and randomized into two groups: LBP-VT (n = 82) and LBP-USC (n = 66). Patients were assessed for demographic characteristics, comorbid conditions, clinical findings, health status, pain symptom scales, psychometric, and functional parameters. The LBP-VT group received VT in addition to USC and electrotherapy, while the LBP-USC group received only USC. Initial Hamilton Depression Scale assessments indicated moderate depression, which improved to mild depression post-treatment. The effect of the treatment on self-esteem was significant for the LBP-VT group and moderate for the LBP-USC group. Functional parameters improved in both groups, with the LBP-VT group having significantly better results. Combining VT with standard care, electrotherapy, and massage significantly improved posture, reduced depression associated with functional deficits, and enhanced self-esteem in patients with chronic LBP.

Immersive and Nonimmersive Virtual Reality-Assisted Active Training in Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis.

BACKGROUND: Virtual reality (VR) in different immersive conditions has been increasingly used as a nonpharmacological method for managing chronic musculoskeletal pain. OBJECTIVE: We aimed to assess the effectiveness of VR-assisted active training versus conventional exercise or physiotherapy in chronic musculoskeletal pain and to analyze the effects of immersive versus nonimmersive VR on pain outcomes. METHODS: This systematic review of randomized control trials (RCTs) searched PubMed, Scopus, and Web of Science databases from inception to June 9, 2024. RCTs comparing adults with chronic musculoskeletal pain receiving VR-assisted training were included. The primary outcome was pain intensity; secondary outcomes included functional disability and kinesiophobia. Available data were pooled in a meta-analysis. Studies were graded using the Cochrane Risk-of-Bias Tool version 2. RESULTS: In total, 28 RCTs including 1114 participants with some concerns for a high risk of bias were identified, and 25 RCTs were included in the meta-analysis. In low back pain, short-term outcomes measured post intervention showed that nonimmersive VR is effective in reducing pain (standardized mean difference [SMD] -1.79, 95% CI -2.72 to -0.87; P<.001), improving disability (SMD -0.44, 95% CI -0.72 to -0.16; P=.002), and kinesiophobia (SMD -2.94, 95% CI -5.20 to -0.68; P=.01). Intermediate-term outcomes measured at 6 months also showed that nonimmersive VR is effective in reducing pain (SMD -8.15, 95% CI -15.29 to -1.01; P=.03), and kinesiophobia (SMD -4.28, 95% CI -8.12 to -0.44; P=.03) compared to conventional active training. For neck pain, immersive VR reduced pain intensity (SMD -0.55, 95% CI -1.02 to -0.08; P=.02) but not disability and kinesiophobia in the short term. No statistical significances were detected for knee pain or other pain regions at all time points. In addition, 2 (8%) studies had a high risk of bias. CONCLUSIONS: Both nonimmersive and immersive VR-assisted active training is effective in reducing back and neck pain symptoms. Our study findings suggest that VR is effective in alleviating chronic musculoskeletal pain. TRIAL REGISTRATION: PROSPERO CRD42022302912; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=302912.

Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study.

INTRODUCTION: Chronic pain increases the risk of prescription opioid misuse or opioid use disorder (OUD). Non-pharmacological treatments are needed to dually address pain and opioid risks. The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain relief skills intervention for chronic pain ('Empowered Relief' (ER); tailored to people at risk for opioid misuse or with opioid misuse/OUD) to a one-session digital health education intervention ('Living Better'; no pain management skills). METHODS AND ANALYSIS: MOBILE Relief is an international online randomised controlled clinical trial. Study participants are adults with chronic, non-cancer pain (≥6 months) with daily pain intensity ≥3/10, taking ≥10 morphine equivalent daily dose and score ≥6 on the Current Opioid Misuse Measure. Participants are recruited through clinician referrals and clinic advertisements. Study procedures include electronic eligibility screening, informed consent, automated 1:1 randomisation to the treatment group, baseline measures, receipt of assigned digital treatment and six post-treatment surveys spanning 3 months. Study staff will call participants at baseline and 1-month and 3 months post-treatment to verify the opioid prescription. The main statistical analyses will include analysis of covariance and mixed effects model for repeated measurements regression. MAIN OUTCOMES: Primary outcomes are self-reported pain catastrophising, pain intensity, pain interference, opioid craving and opioid misuse at 1-month and 3 months post-treatment. We will determine the feasibility of ER (≥50% participant engagement, ≥70% treatment appraisal ratings). We hypothesise the ER group will be superior to the Living Better group in the reduction of multiprimary pain outcomes at 1-month post-treatment and opioid outcomes at 1-month and 3 months post-treatment. ETHICS AND DISSEMINATION: The study protocol was approved by the Stanford University School of Medicine Institutional Review Board (IRB 61643). We will publish results in peer-reviewed journals; National Institute of Drug Abuse (funder) and MOBILE Relief participants will receive result summaries. TRIAL REGISTRATION NUMBER: NCT05152134.

The MuscleSCS Technique (4-8Hz BurstDRTM Octrode™): A Randomized Clinical Study of MuscleSCS Stimulation in the Treatment of Chronic Back Pain.

BACKGROUND: MuscleSCS is a new technique that combines spinal cord stimulation (SCS) with muscle stimulation to relieve pain. OBJECTIVES: In this clinical study, we wanted to use rod electrodes to investigate the MuscleSCS method's effectiveness in the treatment of chronic lower back pain. One of our hypotheses was that the combined use of MuscleSCS and BurstDRTM would further improve the treatment. STUDY DESIGN: A prospective, single-center, single-blinded, randomized crossover study. SETTING: A university medical center. METHODS: Patients with chronic lower back pain had previously (one to 10 years ago) received an SCS system (Octrode™). In this study, they were randomly treated for 2 weeks each with BurstDRTM stimulation alone, MuscleSCS stimulation alone, or a combination of BurstDRTM stimulation and MuscleSCS stimulation. Thereafter, the patients were treated for another 6 weeks with one of the 3 methods (crossover possible). Pain ratings on the visual analog scale (VAS) were recorded and compared. A Pain Disability Index (PDI) questionnaire was used at the baseline and at 3 months. RESULTS: We included 24 patients in this study (11 women, mean age 62.3 yrs.) The values of the second week of the stimulation were the only ones used for the calculations. The first week of the stimulation was used as a wash-out period.The combined application of BurstDRTM and MuscleSCS stimulation was associated with the best results (P = 0.032). PDI scores did not improve during this treatment. No serious adverse events occurred during this study. Seventy-one and a half percent of the patients experienced an improvement in their pain as a result of the additional MuscleSCS stimulation. LIMITATIONS: In this study, only one fixed contact setting (3 & 4) was used to ensure uniform conditions for all patients and the ability to compare the different treatment modes. CONCLUSION: This study showed that the combined application of SCS (BurstDRTM) and additional MuscleSCS stimulation using a rod electrode could significantly improve outcomes for patients suffering from chronic back pain.

Cognitive Behavioral Therapy for Insomnia in Pain Management for Nonspecific Chronic Spinal Pain: A Randomized Clinical Trial.

Importance: Insomnia is highly prevalent in patients with nonspecific chronic spinal pain (nCSP). Given the close interaction between insomnia and pain, targeting sleep problems during therapy could improve treatment outcomes. Objective: To evaluate the effectiveness of cognitive behavioral therapy for insomnia (CBTi) integrated in best-evidence pain management (BEPM) vs BEPM only in patients with nCSP and insomnia. Design, Setting, and Participants: A multicenter randomized clinical trial with 1-year follow-up was conducted between April 10, 2018, and April 30, 2022. Data and statistical analysis were performed between May 1, 2022, and April 24, 2023. Patients with nCSP and insomnia were evaluated using self-report and at-home polysomnography, to exclude underlying sleep pathologic factors. Participants were treated at the University Hospital Brussels or University Hospital Ghent, Belgium. Intention-to-treat analysis was performed. Interventions: Participants were randomized to either CBTi-BEPM or BEPM only. Both groups received 18 treatment sessions over 14 weeks. The CBTi-BEPM treatment included 6 CBTi sessions and 12 BEPM sessions. The BEPM treatment included pain neuroscience education (3 sessions) and exercise therapy (9 sessions in the CBTi-BEPM group, 15 sessions in the BEPM-only group). Main Outcomes and Measures: The primary outcome was change in mean pain intensity (assessed with Brief Pain Inventory [BPI]) at 12 months after the intervention. Exploratory secondary outcomes included several pain- and sleep-related outcomes. Blinded outcome assessment took place at baseline, posttreatment, and at 3-, 6-, and 12-month follow-up. Results: A total of 123 patients (mean [SD] age, 40.2 [11.18] years; 84 women [68.3%]) were included in the trial. In 99 participants (80.5%) with 12-month BPI data, the mean pain intensity at 12 months decreased by 1.976 points (reduction of 40%) in the CBTi-BEPM group and 1.006 points (reduction of 24%) points in the BEPM-only group. At 12 months, there was no significant difference in pain intensity change between groups (mean group difference, 0.970 points; 95% CI, -0.051 to 1.992; Cohen d, 2.665). Treatment with CBTi-BEPM resulted in a response for BPI average pain with a number needed to treat (NNT) of 4 observed during 12 months. On a preliminary basis, CBTi-BEPM was, consistently over time and analyses, more effective than BEPM only for improving insomnia severity (Cohen d, 4.319-8.961; NNT for response ranging from 2 to 4, and NNT for remission ranging from 5 to 12), sleep quality (Cohen d, 3.654-6.066), beliefs about sleep (Cohen d, 5.324-6.657), depressive symptoms (Cohen d, 2.935-3.361), and physical fatigue (Cohen d, 2.818-3.770). No serious adverse effects were reported. Conclusions and Relevance: In this randomized clinical trial, adding CBTi to BEPM did not further improve pain intensity reduction for patients with nCSP and comorbid insomnia more than BEPM alone. Yet, as CBTi-BEPM led to significant and clinically important changes in insomnia severity and sleep quality, CBTi integrated in BEPM should be considered in the treatment of patients with nCSP and comorbid insomnia. Further research can investigate the patient characteristics that moderate the response to CBTi-BEPM in terms of pain-related outcomes, as understanding of these moderators may be of utmost clinical importance. Trial Registration: Clinical Trials.gov Identifier: NCT03482856.

Investigating the efficacy of transcranial direct current stimulation on chronic pain management in endometriosis patients: A randomized controlled trial protocol.

INTRODUCTION: Similar to chronic pain conditions, individuals with endometriosis can be affected by central sensitization syndrome (CSS), which is characterized by a loss of analgesia and central amplification of pain. Transcranial direct current stimulation (tDCS) has shown potential as an effective intervention to improve pain generated by other chronic pain conditions impacted by CSS, such as fibromyalgia and chronic pelvic issues. This study aims to evaluate the effectiveness of tDCS on pain, fatigue, and quality of life among patients affected by endometriosis. METHODS: This is a single-center, parallel, double-blinded, randomized, controlled clinical trial protocol study. We aim to recruit 40 participants affected by endometriosis (active group, n = 20; sham group, n = 20). Anodal tDCS will be delivered at an intensity of 2mA, applied over the primary motor cortex for 20 minutes per day for 10 consecutive days. There will be four assessment times: 1 week before beginning the intervention; on the 10th day following the last tDCS session; and 1 and 2 months after the last tDCS session. Pain evaluated by the algometry will be the primary outcome. Pain intensity, quality of life, fatigue, and global perception of change will be the secondary outcomes. We will calculate the effects of the active versus sham stimulation on primary and secondary outcomes by using generalized estimated equations or mixed model analysis. The effect size calculation will represent the effect measure. We expect that only the active group show reductions in pain, fatigue, and quality of life. The results of this trial will produce an important first step in providing evidence on the effectiveness of neuromodulation for the management of pain and will provide data to support new studies on tDCS. REGISTRATION: Brazilian Clinical Trials Registry (RBR-4q69573).