Transcutaneous Electrical Nerve Stimulation Integrated into Pants for the Relief of Postoperative Pain in Hip Surgery Patients: A Randomized Trial.

Background: The effect of transcutaneous electrical nerve stimulation (TENS) on pain and impression of change was assessed during a 2.5-hour intervention on the first postoperative days following hip surgery in a randomized, single-blinded, placebo-controlled trial involving 30 patients. Methods: Mixed-frequency TENS (2 Hz/80 Hz) was administered using specially designed pants integrating modular textile electrodes to facilitate stimulation both at rest and during activity. The treatment outcome was assessed by self-reported pain Numerical Rating Scale (NRS) and Patient Global Impression of Change (PGIC) scores at four time points. The ability to perform a 3-meter walk test and the use of analgesics were also evaluated. Group comparison and repeated-measure analysis were carried out using nonparametric statistics. Results: The active TENS group exhibited significantly higher PGIC scores after 30 minutes, which persisted throughout the intervention (all p ≤ 0.001). A reduction in NRS appeared after one hour of active TENS, persisting throughout the intervention (all p ≤ 0.05). The median group differences in pain ratings were greater than the minimum clinically important difference, and the analysis of pain trajectories confirmed clinical significance at the individual level. Moreover, patients in the active TENS group were more likely able to perform a 3-meter walk test by the end of the intervention (p = 0.04). Analysis of the opioid-sparing effect of TENS was inconclusive (p = 0.066). No postoperative surgical complications or TENS-related side effects were observed during the study. Conclusion: Mixed-frequency TENS integrated in pants could potentially be an interesting addition to the arsenal of treatments for multimodal analgesia following hip surgery. This trial is registered with NCT05678101.

Multimodal Pain Control in Abdominoplasty: A Systematic Review and Algorithm of Optimal Pain Management.

The procedure with the highest rate of opioid prescription in plastic surgery is abdominoplasty. Additionally, plastic surgery patients are at a particularly elevated risk of becoming opioid-dependent. The main objective of this study was to perform a systematic review and create an algorithm for a multimodal pain regimen specific to patients undergoing abdominoplasty. A systematic search of the research literature was performed to summarize the prevailing understanding of multimodal pain control in the management of abdominoplasty. The initial search yielded 448 articles. Sixty-eight manuscripts were identified for full-text review. The effectiveness of current strategies was evaluated by way of pain scores, opioid usage, and length of stay, as well as other measures of physical function such as time to early mobilization. In 32 studies involving 2451 patients, the efficacy of different pain regimens during abdominoplasty was evaluated. Among nontraditional, opioid-sparing analgesia, efficacy of treatment interventions for improved pain and decreased opioid usage was found inall studies. Among local infusion studies, efficacy of treatment interventions for improved pain and decreased opioid usage was found in 78% of studies. Last, among regional block studies, efficacy of treatment interventions for improved pain was found in 87%, with 73% efficacy for decreased opioid usage. Multimodal pain regimens in abdominoplasty have the potential to play an important role in opioid-sparing practices in medicine by incorporating nonopioid pain adjuvants such as nonsteroidal anti-inflammatory drugs and transversus abdominis plane blocks in the preoperative, perioperative, and postoperative periods.

Factors influencing fidelity to guideline implementation strategies for improving pain care at cancer centres: a qualitative sub-study of the Stop Cancer PAIN Trial.

BACKGROUND: The Stop Cancer PAIN Trial was a phase III pragmatic stepped wedge cluster randomised controlled trial which compared effectiveness of screening and guidelines with or without implementation strategies for improving pain in adults with cancer attending six Australian outpatient comprehensive cancer centres (n = 688). A system for pain screening was introduced before observation of a 'control' phase. Implementation strategies introduced in the 'intervention' phase included: (1) audit of adherence to guideline recommendations, with feedback to clinical teams; (2) health professional education via an email-administered 'spaced education' module; and (3) a patient education booklet and self-management resource. Selection of strategies was informed by the Capability, Opportunity and Motivation Behaviour (COM-B) Model (Michie et al., 2011) and evidence for each strategy's stand-alone effectiveness. A consultant physician at each centre supported the intervention as a 'clinical champion'. However, fidelity to the intervention was limited, and the Trial did not demonstrate effectiveness. This paper reports a sub-study of the Trial which aimed to identify factors inhibiting or enabling fidelity to inform future guideline implementation initiatives. METHODS: The qualitative sub-study enabled in-depth exploration of factors from the perspectives of personnel at each centre. Clinical champions, clinicians and clinic receptionists were invited to participate in semi-structured interviews. Analysis used a framework method and a largely deductive approach based on the COM-B Model. RESULTS: Twenty-four people participated, including 15 physicians, 8 nurses and 1 clinic receptionist. Coding against the COM-B Model identified 'capability' to be the most influential component, with 'opportunity' and 'motivation' playing largely subsidiary roles. Findings suggest that fidelity could have been improved by: considering the readiness for change of each clinical setting; better articulating the intervention's value proposition; defining clinician roles and responsibilities, addressing perceptions that pain care falls beyond oncology clinicians' scopes of practice; integrating the intervention within existing systems and processes; promoting patient-clinician partnerships; investing in clinical champions among senior nursing and junior medical personnel, supported by medical leaders; and planning for slow incremental change rather than rapid uptake. CONCLUSIONS: Future guideline implementation interventions may require a 'meta-implementation' approach based on complex systems theory to successfully integrate multiple strategies. TRIAL REGISTRATION: Registry: Australian New Zealand Clinical Trials Registry; number: ACTRN 12615000064505; data: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspxid=367236&isReview=true .

Efficacy of botulinum toxin injection using the right-sided unilateral retrocrural approach for celiac plexus in a cancer survivor with persistent abdominal pain: a case report.

Cancer survivors often face persistent abdominal pain, necessitating optimal pain management. While celiac plexus block (CPB) and botulinum toxin (BT) injection are viable options, traditional methods may encounter challenges due to patient-specific concerns and anatomical complexities. Here, the case of a cancer survivor in his 70 s experiencing recurrent abdominal pain, who declined conventional percutaneous CPB approaches due to anxiety related to aortic puncture, is presented. Following a pancreaticoduodenectomy, the patient developed chronic abdominal pain attributed to adhesions leading to small bowel obstruction. Concurrently, there was notable psychological distress, including anxiety, depression, and heightened concerns regarding tumor recurrence. Considering the patient's specific concerns, a right-sided unilateral retrocrural single-needle technique was proposed, aimed at alleviating pain, while avoiding conventional CPB approaches. Initial right-sided retrocrural CPB offered short-term relief, prompting a subsequent BT injection using the same approach. Following BT injection, the patient reported significant and sustained pain reduction (from 8 to 1 on an 11-point numerical rating scale) at both 12 and 20 weeks post-procedure. Right-sided retrocrural BT injection offers an alternative approach, addressing patient concerns and demonstrating prolonged pain relief. This may benefit cancer survivors with upper abdominal pain, emphasizing the importance of personalized and innovative pain management strategies.

Refining pain management in mice by comparing multimodal analgesia and NSAID monotherapy for neurosurgical procedures.

While neurosurgical interventions are frequently used in laboratory mice, refinement efforts to optimize analgesic management based on multimodal approaches appear to be rather limited. Therefore, we compared the efficacy and tolerability of combinations of the non-steroidal anti-inflammatory drug carprofen, a sustained-release formulation of the opioid buprenorphine, and the local anesthetic bupivacaine with carprofen monotherapy. Female and male C57BL/6J mice were subjected to isoflurane anesthesia and an intracranial electrode implant procedure. Given the multidimensional nature of postsurgical pain and distress, various physiological, behavioral, and biochemical parameters were applied for their assessment. The analysis revealed alterations in Neuro scores, home cage locomotion, body weight, nest building, mouse grimace scales, and fecal corticosterone metabolites. A composite measure scheme allowed the allocation of individual mice to severity classes. The comparison between groups failed to indicate the superiority of multimodal regimens over high-dose NSAID monotherapy. In conclusion, our findings confirmed the informative value of various parameters for assessment of pain and distress following neurosurgical procedures in mice. While all drug regimens were well tolerated in control mice, our data suggest that the total drug load should be carefully considered for perioperative management. Future studies would be of interest to assess potential synergies of drug combinations with lower doses of carprofen.

Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators.

Chronic pain is a prevalent condition with enormous economic burden. Opioids such as tramadol, codeine, and hydrocodone are commonly used to treat chronic pain; these drugs are activated to more potent opioid receptor agonists by the hepatic CYP2D6 enzyme. Results from clinical studies and mechanistic understandings suggest that CYP2D6-guided therapy will improve pain control and reduce adverse drug events. However, CYP2D6 is rarely used in clinical practice due in part to the demand for additional clinical trial evidence. Thus, we designed the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) chronic pain study, a multicenter, pragmatic, randomized controlled clinical trial, to assess the effect of CYP2D6 testing on pain management. The study enrolled 1048 participants who are taking or being considered for treatment with CYP2D6-impacted opioids for their chronic pain. Participants were randomized to receive immediate or delayed (by 6 months) genotyping of CYP2D6 with clinical decision support (CDS). CDS encouraged the providers to follow the CYP2D6-guided trial recommendations. The primary study outcome is the 3-month absolute change in the composite pain intensity score assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) measures. Follow-up will be completed in July 2024. Herein, we describe the design of this trial along with challenges encountered during enrollment.

Emerging innovation in pain medicines.

The treatment of pain remains a critical, unmet public health challenge. According to the CDC, in 2021, an estimated 20.9% of US adults (51.6 million people) endured chronic pain, and 6.9% (17.1 million people) endured high-impact chronic pain. Additionally, the impact of the social determinants of health on pain treatment are beginning to emerge. Treating pain addresses its control and relief, enhancing patient outcomes and quality of life. However, current treatment options have limitations, creating a significant need for innovative solutions. This raises the role of innovation in identifying new pain medicines. Thus, the clinical development of novel pain medicines is an unmet need to address public health worldwide.

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Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial.

INTRODUCTION: Patients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide variety of clinical practices. Recently, there have been new insights into treatment strategies, such as early diagnosis and minimally invasive operative treatment. The aim of this study is to implement an evidence-based and experience-based treatment clinical pathway to improve outcomes in this fragile patient population. METHODS AND ANALYSIS: This study will be a regional stepped-wedge cluster randomised controlled trial. All older adult patients (≥50 years old) who suffered a pelvic fragility fracture after low-energetic trauma are eligible for inclusion. The pathway aims to optimise the diagnostic process, to guide the decision-making process for further treatment (eg, operative or conservative), to structure the follow-up and to provide guidelines on pain management, weight-bearing and osteoporosis workup. The primary outcome is mobility, measured by the Parker Mobility Score. Secondary outcomes are mobility measured by the Elderly Mobility Scale, functional performance, quality of life, return to home rate, level of pain, type and dosage of analgesic medications, the number of falls after treatment, the number of (fracture-related) complications, 1-year and 2-year mortality. Every 6 weeks, a cluster will switch from current practice to the clinical pathway. The aim is a total of 393 inclusions, which provides an 80% statistical power for an improvement in mobility of 10%, measured by the Parker mobility score. ETHICS AND DISSEMINATION: The Medical Research Ethics Committee of Academic Medical Center has exempted the PELVIC study from the Medical Research Involving Human Subjects Act (WMO). Informed consent will be obtained using the opt-out method and research data will be stored in a database and handled confidentially. The final study report will be shared via publication without restrictions from funding parties and regardless of the outcome. TRIAL REGISTRATION NUMBER: NCT06054165. PROTOCOL VERSION: V.1.0, 19 July 2022.

Barriers and facilitators to using a clinical decision support tool for the management of osteoarthritis pain in patients undergoing hemodialysis: a qualitative study.

BACKGROUND: While osteoarthritis is a significant issue within the hemodialysis population and contributes to reduced quality of life, pain related to osteoarthritis is poorly managed by healthcare professionals (HCPs) in hemodialysis settings due to the absence of clinical guidance applicable to this population. The purpose of this study was to explore the perceptions of HCPs on the barriers and facilitators to using a clinical decision support tool for osteoarthritis pain management in the hemodialysis setting. METHODS: A qualitative descriptive study was conducted. Purposeful and snowball sampling techniques were used to recruit hemodialysis clinicians from academic and community settings across multiple Canadian provinces. One-to-one interviews were conducted with clinicians using a semi-structured, open ended interview guide informed by the Theoretical Domains Framework, a behavior change framework. A general inductive approach was applied to identify the main themes of barriers and facilitators. RESULTS: A total of 11 interviews were completed with 3 nephrologists, 2 nurse practitioners and 6 pharmacists. Findings revealed 6 main barriers and facilitators related to the use of the clinical decision support tool. Alignment of the tool with practice roles emerged as a key barrier and facilitator. Other barriers included challenges related to the dialysis environment, varying levels of clinician comfort with pain medications, and limited applicability of the tool due to patient factors. An important facilitator was the intrinsic motivation among clinicians to use the tool. CONCLUSIONS: Most participants across the included hemodialysis settings expressed satisfaction with the clinical decision support tool and acknowledged its overall potential for improving osteoarthritis pain management among patients on hemodialysis. Future implementation of the tool may be limited by existing roles and practices at different institutions. Increased collaboration among hemodialysis and primary care teams may promote uptake of the tool.

Low-intensity focused ultrasound to the posterior insula reduces temporal summation of pain.

BACKGROUND: The insula and dorsal anterior cingulate cortex (dACC) are core brain regions involved in pain processing and central sensitization, a shared mechanism across various chronic pain conditions. Methods to modulate these regions may serve to reduce central sensitization, though it is unclear which target may be most efficacious for different measures of central sensitization. OBJECTIVE/HYPOTHESIS: Investigate the effect of low-intensity focused ultrasound (LIFU) to the anterior insula (AI), posterior insula (PI), or dACC on conditioned pain modulation (CPM) and temporal summation of pain (TSP). METHODS: N = 16 volunteers underwent TSP and CPM pain tasks pre/post a 10 min LIFU intervention to either the AI, PI, dACC or Sham stimulation. Pain ratings were collected pre/post LIFU. RESULTS: Only LIFU to the PI significantly attenuated pain ratings during the TSP protocol. No effects were found for the CPM task for any of the LIFU targets. LIFU pressure modulated group means but did not affect overall group differences. CONCLUSIONS: LIFU to the PI reduced temporal summation of pain. This may, in part, be due to dosing (pressure) of LIFU. Inhibition of the PI with LIFU may be a future potential therapy in chronic pain populations demonstrating central sensitization. The minimal effective dose of LIFU for efficacious neuromodulation will help to translate LIFU for therapeutic options.

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.

Burn pain management in a female patient with severe burn injuries in Nepal: a case study and review.

Burn injuries in low-resource settings like Nepal present significant public health challenges, leading to substantial morbidity, mortality and severe pain. This paper assesses burn pain management in Nepal, emphasizing the need for enhanced strategies. A case study of a female patient with severe burn injuries from a rural village in Western Nepal illustrates current challenges. Reviewing studies on burn pain management in Nepal shows limited access to specialized facilities, inadequate palliative care, medication shortages and insufficient healthcare professionals. Pharmacological interventions are impacted by financial constraints and a lack of protocols, while nonpharmacological approaches have not been explored and contextualized for the Nepalese context due to similar financial issues. Comprehensive burn pain management requires addressing resource constraints through collaborative health-aid partnerships.

Burn injuries are among the most painful conditions. Burn injury treatment poses a significant challenge to low-resource countries like Nepal. This review focuses on the case of a 35-year-old woman from rural Nepal who suffered severe burns from boiling water. It depicts the journey and ordeal of the patient to receive burn pain treatment in Kathmandu, Nepal.Effective management of burn pain requires a multidisciplinary approach, including pharmacological and nonmedical treatments such as wound care and psychological support. However, in Nepal, these treatments are often limited due to resource shortages and a lack of specialized medical centers. The patient was eventually transferred to a burn injury treatment center in Kathmandu, Nepal, where multiple surgeries, including skin grafts donated by family members, helped her survive.The review also discusses various aspects of burn injuries in Nepal and the challenges of burn injury treatment and burn pain management in Nepal. It highlights the necessity for establishing specialized burn injury treatment centers and implementing a comprehensive burn injury management plan. These measures aim to enhance outcomes and alleviate suffering for burn patients in Nepal and other low-resource settings.

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.

Cannabis and opioid perceptions, co-use, and substitution among patients across 4 NCI-Designated Cancer Centers.

Prescription opioids are used for managing pain in persons with cancer, however, there are socioeconomic and racial disparities in medication access. Cannabis is increasingly used for cancer symptom management and as an opioid alternative. Limited data are available about patterns of opioid and cannabis use among patients with cancer. We used survey data from 4 National Cancer Institute-designated cancer centers in 3 states (n = 1220) to assess perceptions, use of cannabis and opioids for pain, their substitution, and racial and ethnic differences in each outcome. Compared with White patients, Black patients were less likely to use opioids for pain (odds ratio [OR] = 0.66; P = .035) and more likely to report that cannabis was more effective than opioids (OR = 2.46; P = .03). Race effects were mitigated (P > .05) after controlling for socioeconomic factors. Further research is needed to understand cannabis and opioid use patterns and how overlapping social determinants of health create a disadvantage in cancer symptom management for Black patients.

Comparison ultrasound-guided adductor canal block and surgeon-performed block for pain management after total knee arthroplasty: a prospective randomized controlled study.

OBJECTIVE: Adductor canal block (ACB) is widely performed for postoperative analgesia for total knee arthroplasty (TKA). The aim of this study is to compare surgeon-assisted and anesthesiologist-assisted (ultrasound-guided) adductor blocks in terms of postoperative analgesic efficacy. METHODS: This study was designed as a double-blind, prospective and randomized trial. A total of 240 participants were randomly allocated to three groups: one where the surgeon performed the adductor canal block (ACBs), another where it was conducted by an anesthetist with ultrasound guidance (ACBa), and a third group without the adductor block. The follow-up management after the Total Knee Arthroplasty (TKA) procedure occurred on the first, third, and tenth days, as well as the twelfth week. Outcome measures comprised pain assessment using the Visual Analog Scale (VAS) and monitoring opioid analgesic consumption. RESULTS: No significant differences in demographic profiles were observed between the groups. Groups ACBa and ACBs exhibited significantly lower VAS scores compared to the control group at both 3 and 12 h after surgery, with group ACBa showing the lowest VAS scores among all groups. However, at 1 day, 3 days, 10 days and 12 weeks after surgery, there was no significant difference in VAS scores between the ACBa and ACBs groups. On the first three days, the ACBa group had the lowest opioid consumption and the lowest total opioid consumption. The differences in VAS scores between the groups began to decrease on the first day after surgery. CONCLUSION: The adductor canal block (ACB) has been demonstrated to be an effective method of reducing pain in patients undergoing total knee replacement (TKR) in the postoperative period. Nevertheless, despite the pronounced impact that ACB performed by an anesthesiologist under ultrasound guidance has on VAS scores according to intraoperative ACB by surgeons, its effect on clinical outcomes has not been demonstrated. TRIAL REGISTRATIONS: This study was retrospectively registered with the Clinical Trials Registry Platform on July 31, 2024 (NCT06533085).

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.

Benefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial.

INTRODUCTION: Lower leg pain and symptoms, and poor leg circulation are common in older adults. These can significantly affect their function and quality of life. Neuromuscular electrical stimulation (NMES) applied via the feet as 'foot NMES' activates the leg musculovenous pump. This study investigated the effects of foot NMES administered at home using Revitive® among community-dwelling older adults with lower leg pain and/or other lower leg symptoms such as cramps, or sensations of tired, aching, and heavy feeling legs. METHODS: A randomised placebo-controlled study with three groups (2 NMES, 1 Sham) and three assessments (baseline, week 8, week 12 follow-up) was carried out. Self-reported function using Canadian occupational performance measure (COPM), leg pain, overall leg symptoms score (heaviness, tiredness, aching, or cramps), and ankle blood flow were assessed. Analysis of covariance (ANCOVA) and logistic regression were used to compare the groups. Statistical significance was set at p < 0.05 (two-sided 5%). RESULTS: Out of 129 participants enrolled, 114 completed the study. The improvement in all outcomes were statistically significant for the NMES interventions compared to Sham at both week 8 (p < 0.01) and week 12 (p < 0.05). The improvement in COPM met the minimal clinically important difference (MCID) for the NMES interventions compared to Sham at both week 8 (p < 0.005) and week 12 (p < 0.05). Improvement in leg pain met MCID at week 8 compared to Sham (p < 0.05). Ankle blood flow increased approximately 3-fold during treatment compared to Sham. Compliance with the interventions was high and no device-related adverse events were reported. CONCLUSIONS: The home-based foot NMES is safe, and significantly improved self-reported function, leg pain and overall leg symptoms, and increased ankle blood flow compared to a Sham among older adults. TRIAL REGISTRATION: The trial was prospectively registered in ISRCTN on 17/06/2019 with registration number ISRCTN10576209. It can be accessed at https://www.isrctn.com/ISRCTN10576209 .

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.