Change In Pain Intensity Research Articles

Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain

BackgroundOsteoarthritis (OA) is the leading cause of disability among older adults with the knee being the most affected joint. Specifically, there is an urgent need to develop better analgesics for individuals with OA-related pain, since currently used analgesics frequently fail to provide adequate relief or must be discontinued owing to adverse effects. A promising treatment is the neuropeptide oxytocin (OT), which has been shown to play a role in endogenous analgesia with human and animal studies demonstrating anti-nociceptive effects. The primary aims of the study are to examine preliminary analgesic effects of a chronic OT intervention in community-dwelling older individuals with chronic knee osteoarthritis pain.MethodsIn this article, we describe the rationale and design of the Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE) study, a double-blinded intervention in which 80 participants over 45 years of age with knee osteoarthritis pain will be recruited to participate in a cross-over trial of 4 weeks of intranasal oxytocin or placebo administration. Primary study outcomes include preliminary changes in pain intensity and interference as well as multi-modal assessment batteries including circulating biomarkers and neuroimaging measures. Self-reported and quantitative outcomes will be assessed at baseline, post-intervention periods, and up to a 6-month follow-up period.DiscussionThis study will establish preliminary effectiveness of a novel intervention in middle to older aged adults with knee osteoarthritis pain. Achievement of these aims will provide a rich platform for future intervention research targeting improvements in pain and disability among geriatric populations and will serve as a foundation for a fully powered trial to examine treatment efficacy and potential mechanisms of the proposed intervention.Trial registrationClinicalTrials.gov NCT03878589. Registered on March 18th, 2019.

Systematic review and meta-analysis of conventional medical management in a patient population with refractory chronic pain suitable to receive a spinal cord stimulation system.

The aim of this review was to systematically identify all evidence that used conventional medical management (CMM) as a comparator in randomised controlled trials (RCTs) of spinal cord stimulation (SCS) therapy, and to conduct a meta-analysis to investigate if continued CMM provides statistical or clinically meaningful pain relief and whether CMM effects have improved over the last few decades. Databases were searched from inception to June 2024 for RCTs that compared SCS to CMM. The primary outcome of the review was absolute change in pain intensity from baseline to the last available follow-up in the CMM group, measured using a visual analogue scale or numerical rating scale. The measure of treatment effect for absolute change and percentage change in pain intensity from baseline was mean difference (MD) and 95% confidence interval (CI). Risk of bias (RoB) was assessed by using the revised Cochrane RoB tool. The protocol for this review is registered on PROSPERO (CRD42023449215). Meta-analysis of absolute change in pain intensity from baseline to last follow-up shows that CMM is not associated with any significant reductions in pain intensity (MD -0.11; 95% CI: -0.32 to 0.11; moderate certainty). Similar results were observed for percent change in pain intensity from baseline to last follow-up (MD -3.22%; 95% CI: -12.59% to 6.14%; moderate certainty). No significant differences were observed when considering decade of publication of the RCT for absolute (p = 0.065; moderate certainty) or percent change in pain intensity (p = 0.524; moderate certainty). Meta-analysis for 6-month follow-up and sensitivity analysis shows similar numerical results. Our findings show that continued CMM for a population eligible for SCS does not provide meaningful pain relief and has not considerably changed over the last few decades. The use of CMM as the control to evaluate relative SCS treatment effects should be reassessed.

A Randomized Hybrid-Effectiveness Trial Comparing Pharmacogenomics (PGx) to Standard Care: The PGx Applied to Chronic Pain Treatment in Primary Care (PGx-ACT) Trial.

This trial aimed to identify the effects of providing pharmacogenomic (PGx) results and recommendations for patients with chronic pain treated in primary care practices compared to standard care. An open-label, prospective, largely virtual, type-2 hybrid effectiveness trial randomized participants to PGx or standard care arms. Adults with pain ≥ 3 months who were treated with tramadol, codeine, or hydrocodone enrolled. Alternative analgesics were recommended for CYP2D6 intermediate or poor metabolizers (IM/PMs). Prescribing decisions were at providers' discretion. The trial randomized 253 participants. A modified intent-to-treat primary analysis assessed change in pain intensity over 3 months among IM/PMs (PGx: 49; Standard care: 57). The PGx and standard care arms showed no difference in pain intensity change (-0.10 ± 0.63 vs. -0.21 ± 0.75 standard deviation; p = 0.74) or PGx-aligned care (69% vs. 63%; standardized difference [SD] = 0.13). In IM/PMs, secondary analyses of pain intensity change suggested improvements with PGx-aligned (n = 70; -0.21 ± 0.70) vs. unaligned care (n = 36; -0.06 ± 0.69) (SD = -0.22), with this difference increasing when examining IM/PMs with an analgesic change (aligned: n = 31, -0.28 ± 0.76; unaligned: n = 36, -0.06 ± 0.69; SD = -0.31). This approach to PGx implementation for chronic pain was not associated with different prescribing (i.e., similar proportions of PGx-aligned care) or clinical outcomes. Secondary analyses suggest that prescribing aligned with PGx recommendations showed a small improvement in pain intensity. However, the proportion of patients with a clinically meaningful improvement (≥ 30%) in pain intensity was similar. Future efforts should identify effective implementation methods.

Anaesthetic and corticosteroid response immediately following epidural injection in patients with MRI confirmed lumbar disc herniation.

To describe a rapid, community-based assessment, referral and management system for acute symptomatic LDH. To identify and describe specific local anaesthetic and corticosteroid patterns of pain intensity change during the first week post-epidural injection. Private practice, specialist physiotherapy clinic, community-based radiology facility. Cohort study. Consecutive patients with clinical and MRI diagnosis of acute LDH causing radicular pain and/or radiculopathy were referred for lumbar epidural injection. Pre- and post-procedure measures of back, buttock and lower limb pain intensity were acquired at 1,2,4,6h, and at 1 week. Analysis of changes in back, buttock and lower limb pain intensity to identify different patterns that may influence clinical management. A detailed clinical assessment, MRI and epidural steroid injection was completed for 51 patients. Pain intensity change patterns were highly heterogeneous. Three broadly different pain intensity response patterns: "Steroid Responsive" (41%), "Mechanical" (37%) and Unconfirmed Diagnosis (22%), were identified. Psychosocial factors did not influence tendency of patients to follow one clinical pathway versus another. Radicular pain associated with LDH responds to epidural injection in patterns that may be described as "steroid responsive" or "mechanical". LDH is not confirmed as the cause of pain in the remainder. Immediate post procedure anaesthetic and one week corticosteroid responses can guide management pathway and identify a subgroup requiring further diagnostic workup.

Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low-Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial.

The efficacy of tumor necrosis factor inhibitors for treating chronic low-back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic type 1 changes. In this multicenter, randomized, triple-blind, placebo-controlled trial, patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to five months. Secondary outcomes included changes in low-back pain intensity, disability, and health-related quality of life. A linear mixed model was used for efficacy analyses. A total of 128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score (±SD) change was -7.0 (±9.7) in the group who received infliximab and -6.4 (±10.4) in the group who received placebo. The difference in the ODI score change between the two groups was 1.3 ODI points (95% confidence interval -2.1 to 4.6, P = 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups. Infliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.

Pressure pain threshold and perceived impact of pain differentially predict short-term and long-term pain reduction following acupuncture in fibromyalgia.

Acupuncture has demonstrated efficacy as a treatment for fibromyalgia; however, predictors of short- and long-term analgesic response in this population are not well understood. This manuscript describes a secondary analysis of a single-center, blinded, sham-controlled, randomized longitudinal acupuncture clinical trial in fibromyalgia. Baseline characterization included pressure pain threshold and pain interference, while residualized change in pain intensity from baseline to follow-up served as the primary outcome measure. Participants were randomized into groups that received verum (n=36) or sham (n=29) acupuncture treatment over a 12-week period (18 treatments) and were followed for 37weeks from the initiation of treatment. Lower pressure pain thresholds at baseline were associated with greater analgesia only in the sham treatment group immediately following treatment, while those with higher pressure pain thresholds had greater analgesia with verum treatment (B=-13.43, P=0.001). Additionally, greater perceived impact of pain at baseline was predictive of greater short-term analgesia irrespective of treatment. Pressure pain threshold was not found to be predictive of long-term differential treatment response (B=-1.71, P=0.66). There was a significant difference in the relationship between perceived impact of pain at baseline and subsequent long-term analgesia between groups where those with greater perceived impact of pain displayed improved long-term analgesia for verum acupuncture compared to the sham group (B=-11.37, P = 0.004). Our results support the use of a self-reported pain outcome in predicting long-term analgesia following acupuncture in fibromyalgia. Please cite this article as: Murphy AE, Arewasikporn A, Taylor-Swanson L, Williams DA, Harris RE. Pressure pain threshold and perceived impact of pain differentially predict short-term and long-term pain reduction following acupuncture in fibromyalgia. J Integr Med. 2025; Epub ahead of print.

Efficacy of Ultrasound-Guided Platelet-Rich Plasma (PRP) Injection in Patients with Sacroiliac Joint Pain: A Single-Arm, Before and After, Open-Label Clinical Trial

Background: Sacroiliac joint (SIJ) pain poses a significant burden on patients and the healthcare system. Due to its potential for tissue regeneration, minimally invasive administration, and affordability, platelet-rich plasma (PRP) has recently gained attention in the management of SIJ pain. Although PRP is widely used for musculoskeletal conditions, there is limited evidence regarding its application in SIJ pain. Objectives: This study aims to assess the impact of PRP injections in patients with chronic SIJ pain that is unresponsive to conservative treatments. Methods: This study is a single-arm, open-label clinical trial. Patients aged between 30 and 80 years with chronic SIJ pain were included. Platelet-rich plasma was prepared from autologous blood and injected into the SIJ under ultrasound (US) guidance. Pain intensity was assessed using the Numeric Rating Scale (NRS), and functional disability was measured using the Modified Oswestry Disability Index (MODI) before the intervention, as well as one month and three months post-injection. Statistical analysis was performed using repeated measures ANOVA in SPSS version 23 to evaluate changes over time. Results: A total of 16 patients were included in the study. At the one-month follow-up, the mean pain intensity dropped to 5.19 ± 2.66, followed by a slight increase to 5.75 ± 2.54 at the three-month follow-up. The mean MODI score was 67.00 ± 8.42 at baseline, improving to 46.75 ± 21.46 at one month, and slightly increasing to 50.50 ± 19.98 at three months. The overall changes in pain intensity and disability index over the three months were statistically significant (P < 0.001). No significant adverse events were reported. Conclusions: Platelet-rich plasma injection resulted in significant pain reduction and functional improvement for chronic SIJ pain over three months, suggesting its potential as a minimally invasive therapeutic alternative for patients who are unresponsive to conventional therapies. While PRP appears to be a safe modality for SIJ pain management, further studies with larger sample sizes and extended follow-ups are needed to explore its effectiveness and safety.

Anterior Knee Pain after Bone Patellar Tendon Bone Graft for Arthroscopic-Assisted Anterior Cruciate Ligament Reconstruction

Objective: To determine the change in frequency and intensity of anterior knee pain after a bone patellar tendon bone graft for arthroscopic-assisted anterior cruciate ligament reconstruction after 06 months. Study Design: Longitudinal study. Place and Duration of Study: Department of Orthopedics Combined Military Hospital, Rawalpindi Pakistan, from Jul 2019 to Jun 2021. Methodology: We studied 100 patients who underwent Anterior Cruciate Ligament reconstruction and met our inclusion criteria. A Visual Analogue Scale pain score was used to assess anterior knee pain in this group. They were reevaluated at four weeks, eight weeks, and twenty-four weeks. Results: The data of 100 patients (mean age of 29.2±6.71 years) who underwent Anterior Cruciate Ligament reconstruction surgery and followed prescribed rehabilitation protocol was analysed. The VAS scores of all patients at 04 weeks, 08 weeks and 24 weeks were evaluated. The incidence of severe anterior knee pain was 3 patients (3%) at 04 weeks and 1 patient (1%) at 6 months. The frequency of patients in the moderate pain category was 13(13%), 06(06%) and 04(04%) at the 04, 08 and 24 weeks, respectively. At the four-week follow-up, 44 patients (44%) were pain-free, increasing to 70 patients (70%) at the six-month follow-up. Conclusion: At six months following Anterior Cruciate Ligament repair with bone patellar tendon bone graft, there was a significant reduction in the intensity of anterior knee discomfort in patients.

Complex intervention including pain science education and patient-led goal setting-based self-management strategies for management of aromatase inhibitor-induced musculoskeletal symptoms: a single-arm feasibility and pilot study.

Up to 74% of breast cancer survivors (BCS) treated with aromatase inhibitor (AI) experience AI-induced musculoskeletal symptoms (AIMSS). AIMSS is the predominant cause of poor adherence to AI therapy, yet no definitive treatment exists. The primary research objectives of this study were (1) to develop a novel BCS-specific complex intervention to alleviate AIMSS, and to assess its feasibility. The secondary research objective was (2) to assess the preliminary efficacy of this intervention. A single-arm, longitudinal pilot study was conducted involving 15 BCS with AIMSS. The complex intervention, which included pain science education, patient-led goal setting, and self-management strategies, was administered over 3months. Feasibility was assessed by measuring overall participation, treatment completion rates, and satisfaction after 3months of intervention. Additionally, the preliminary efficacy of the intervention was evaluated using a mixed model repeated measures analysis, with the change in pain intensity (brief pain inventory [BPI] worst pain/stiffness intensity) at 3months as the primary endpoint. The feasibility assessment showed promising results, with a 70.7% participation rate, an 83.3% intervention completion rate, and a satisfaction score of 8.2 ± 1.5. The intervention significantly reduced BPI worst pain/stiffness intensity by 2.78 points after 3months (95% CI, - 4.5 to - 0.87, p < 0.01). Secondary outcomes demonstrated significant improvements in disability, quality of life, and pain catastrophizing (p < 0.05). The novel complex intervention appears valuable for management AIMSS in BCS. Future large-scale studies, including randomized controlled trials, are warranted. The study was registered in the Clinical Trials Registry of the University Hospital Medical Information Network (UMIN-CTR: UMIN 000049035) in October 2022. The novel BCS-specific complex intervention program holds the potential to aid in managing AIMSS, improving adherence to AI therapy, and enhancing their quality of life.

A Prospective, Single-Cohort, Open, Multi-Center, Observational Study of Sublingual Fentanyl for Breakthrough Cancer Pain: Effectiveness, Safety, and Tolerability in Korean Cancer Patients.

Fentanyl, a highly lipophilic opioid, was developed as a sublingual fentanyl tablet (SFT) for the management of breakthrough cancer pain (BTcP), and its efficacy and safety were confirmed in a randomized, controlled study. We investigated the effectiveness and safety of SFT administered to alleviate BTcP in a real-world setting. In this prospective, open, single-cohort study, conducted in 13 referral hospitals in South Korea, opioid-tolerant cancer patients receiving around-the-clock opioids for persistent cancer pain were enrolled if the individual had BTcP ≥ 1 episode/day during the preceding week. The primary outcome was the SFT titration success rate. Among 113 patients evaluated for effectiveness, 103 patients (91.2%) had a successful titration of SFT, with an effective dose range between 100 µg and 400 µg. The most frequent dose was 100 µg, administered to 65.0%, 72.1%, and 81.8% of the patients at Week 1, 4, and 12, respectively. The proportion of patients achieving the personalized pain goal assessed in the first week was 75.2%. The mean change in pain intensity measured with a numeric rating scale at 30 and 60 minutes after taking SFT was -2.57 and -3.62, respectively (p<0.0001 for both). The incidence rate of adverse events related to SFT among 133 patients included for safety evaluation was 9.0% (12/133), which included vomiting (3.0%), nausea (2.3%), and headache (1.5%). In a real-world setting, SFT provides rapid and effective analgesia in BTcP, even at the lowest dose (100 μg), and the safety profile was acceptable.

Transcutaneous electrical nerve stimulation of the occipital nerves as treatment for chronic cluster headache.

Chronic cluster headache (CCH) is an excruciatingly painful condition that can be difficult to treat sufficiently with the available medical treatment options. The greater occipital nerves (GON) are of major interest in treating CCH, and various invasive treatment modalities, such as stimulating or blocking the nerves, have been applied. Because the terminal segment of the GON has a superficial course, the nerve is also accessible for non-invasive transcutaneous stimulation. Transcutaneous electrical nerve stimulation (TENS) has been suggested as a treatment for different chronic headaches, but evidence of the efficacy in patients with CCH is scarce. Additionally, no consensus exists on the optimal placement of the transcutaneous stimulation electrodes or the treatment usage pattern. In this explorative open-label clinical study, 36 patients with CCH were treated with TENS of the GON for 8-12 consecutive weeks between August 2021 and October 2023 as a separate part of the study protocol for a trial on stimulation of the GON (Clinicaltrials.gov identifier: NCT05023460). After a baseline period, TENS was used primarily as a preventive treatment, stimulating for 30 min twice daily at a minimum. The primary outcome was a change in attack frequency and safety with TENS treatment. Secondary outcomes were change in attack duration and pain intensity on the numeric rating scale, abortive treatments, and the Patient Global Impression of Change (PGIC) with TENS treatment. The change in attack frequency, duration, pain intensity, and use of abortive treatment was analyzed by comparing the baseline data with 4-weekly data from TENS treatment. The study aimed to systematically investigate the effect of TENS of the GON as a preventive treatment for CCH. Weekly attack frequency decreased from a median of 15.7 (95% confidence interval [CI] 11.2-22.1) at baseline to 11.0 (95% CI 7.4-16.4) with TENS. In all, 13 of the 36 (36%) patients had a minimum 30% reduction in attack frequency. In the group of 30% responders, the number of weekly attacks decreased from 15.8 (95% CI 9.8-24.5) at baseline to 5.8 (95% CI 3.3-10.5) attacks with TENS. Five patients became entirely or nearly attack-free. For the entire cohort, attack duration and pain intensity were also significantly reduced with TENS. The use of oxygen was reduced by 42%, and triptan injections decreased by 55%. Overall, 15 (42%) patients reported a clinically important improvement with TENS treatment, rated on the PGIC scale. The 100 Hz stimulation programs were preferred over 10 Hz. No serious adverse events were registered. Transcutaneous electrical nerve stimulation of the GON significantly reduced the frequency, intensity, and duration of weekly headache attacks in patients with severe CCH. Not all patients benefitted from TENS, but the treatment responders had a substantial improvement in their cluster headache. TENS treatment was well-tolerated with little or no side effects and could be a relevant supplement to conventional preventive treatment. A standard TENS apparatus is low cost, making the treatment accessible to most patients. This paper includes a detailed, comprehensive description of our clinical application of the therapy.

Effectiveness and Safety of Drug Therapy for Migraine in the ED: A Systematic Review and Network Meta-analysis

We performed a systematic review and Bayesian network meta-analysis to determine which pharmacologic therapies are relatively more effective and safer for migraine in adult patients who present to the emergency department (ED). We searched MEDLINE, Embase, and Web of Science from inception to February 9, 2024. Eligible studies were randomized controlled trials that enrolled adult participants presenting to ED with migraine and compared one pharmacologic therapy to another or placebo. Outcomes were as follows: 1) adequate pain relief at 2 hours, 2) change in pain intensity at 1 hour, 3) need for rescue drug at 2 hours, and 4) significant adverse reaction. We extracted data according to PRISMA-network meta-analysis and appraised trials using Cochrane RoB 2. For dichotomous outcomes, we performed Bayesian network meta-analysis to calculate odds ratios with 95% credible intervals; for continuous outcomes, we performed frequentist network meta-analysis to calculate mean differences with 95% confidence intervals. We assessed confidence using Confidence in Network Meta-analysis. We used Surface under the cumulative ranking curve (SUCRA) to rank agents. Chlorpromazine intravenous (IV)/intramuscular (IM) (SUCRA=87.3%) was most likely to be superior for "adequate pain relief at 2 hours" (24 trials; n=2,361); metoclopramide IV-ibuprofen IV (SUCRA=94.6%) was most likely to be superior for "need for rescue drug" (not needing rescue drug) at 2 hours (27 trials; n=2,942); dexamethasone IV (SUCRA=79.5%) was most likely to be superior for "significant adverse reaction" (not causing adverse reaction) (22 trials; n=2,450). The network for change in pain intensity demonstrated statistically significant incoherence at the overall level. Confidence in network meta-analysis estimates (certainty of evidence) varied and was mostly "low" or "very low," limiting the validity of the probabilistic analyses. According to Bayesian network meta-analysis, ibuprofen IV is definitely among the least effective for adequate pain relief; chlorpromazine IV/IM is definitely among the most effective; valproate IV is definitely among the least effective, and ketorolac IV/IM is possibly among the least effective as single agents. The relative safety of the pharmacologic therapies cannot be determined with sufficient certainty.

Mirogabalin as a Therapeutic Option for Neuropathic Pain Emerging Postendodontic Treatment: An Observational Study.

We have recently reported the clinical efficacy of mirogabalin for occlusal pain due to post-traumatic trigeminal neuropathic pain (PTTN-occlusal pain) after endodontic treatment according to the International Classification of Orofacial Pain criteria. This study aimed to determine the mirogabalin administration period and timing of dose reduction and suspension for treating this condition based on managing a certain number of cases. Patients diagnosed with PTTN-occlusal pain after or during endodontic treatment were included in the study. An endodontist retreated if necessary. Patients who initially experienced occlusal pain but gradually adapted to bite well without medication were classified into the provisional restoration group (n=13). Patients who experienced severe pain during mastication and could not chew with a provisional restoration were classified into the mirogabalin medication group (n=15). Mirogabalin (10mg/day) was prescribed once a day before bedtime. The patients receiving visual analog scale (VAS) were instructed to record daily changes in pain intensity in a VAS diary. The practitioners also recorded scores during consultations. In the provisional restoration group, VAS scores significantly decreased from week 6 and plateaued from week 11 (P<.05). This adaptation period was applied to reduction or discontinuation of mirogabalin treatment in the mirogabalin medication group. After initiating mirogabalin, VAS scores significantly decreased gradually from week 1 (P<.05). Although the dose was tapered around week 7 and discontinued by week 11, no recurrence of pain was observed following dose reduction or discontinuation. Mirogabalin was effective in treating PTTN-occlusal pain.

Evaluation of pain intensity and airway changes in non-growing patients treated by MARPE with and without micro-osteoperforation: a randomized clinical trial

Trial designParallel.ObjectivesTo assess the effect of mini-screw assisted rapid palatal expansion (MARPE) with/without micro-osteoperforation (MOP) on the airway and pain intensity in non-growing patients with maxillary transverse deficiency.MethodTwo equal groups of twenty-four individuals aged ≥ 19 years old with maxillary transverse deficit were randomly assigned. MOP-facilitated MARPE was used to treat one group (MMG), and the other group was treated with MARPE without MOP (NMG). For airway evaluation, CBCT images were obtained 2 months before starting the palatal expansion and 3 months after finishing the expansion in 28 days. The Visual Analogue Scale (VAS) was used to measure the pain level.ResultsSignificant suture opening was observed in both groups. All linear measurements of the nasal cavity and volumetric measurements of the nasal passage and oropharyngeal airway increased significantly in both groups, with no significant difference between them. Moderate pain was experienced in the first two weeks of expansion in MMG (5.11 ± 0.30), while more significant pain was recorded in NMG (6.87 ± 0.40). Pain decreased significantly in the following two weeks in MMG (2.77 ± 0.39) and in NMG (5.11 ± 0.32), with a significant difference between the two groups throughout the entire duration of expansion.ConclusionTransverse maxillary deficit was successfully treated with both expansion methods, with and without MOP, with comparable skeletal effects at the nasal levels and airway volumetric improvement. So, MOP did not provide any further advantage in improving the airway volume after maxillary expansion. However, it significantly reduced pain intensity throughout the entire duration of expansion.Trial registrationThe protocol registration and results system (PRS) of ClinicalTrials.gov has this RCT registered under the number NCT06502041 on 13/07/2024.

The Power of a Good Word: Enhancing the Efficacy of Analgesics in Clinical Settings

Introduction: Communication between medical staff and patients about treatment efficacy elicits expectations of benefit and improves treatment outcomes. While demonstrated in multiple studies via different research methodologies, uniform communication protocols have not been adopted in clinical practice. Here, we summarize the results of two sister studies aimed at bridging this gap. Methods: Women undergoing C-section (study 1, randomized controlled trial) and patients undergoing general or otolaryngologic surgeries (study 2, control group design) were recruited and assigned to the “regular communication” (RC) or “enhanced communication” (EC) arms. The EC arm received positive information about treatment, while the RC arm received no such information. In both studies, the primary outcome was change in pain intensity; in study 2, an additional outcome was morphine consumption. Results: Eighty women successfully completed study 1, and 102 patients successfully completed study 2. In both studies, significant time*group interactions were observed (p < 0.001). The analgesic effect was virtually twice as large in the EC arm compared to the RC arm. In study 2, in the last two timepoints of assessment, participants in the EC arm also consumed fewer doses of opioids than participants in the RC arm (p < 0.001). No significant differences were found in vital signs. Conclusions: We provide ecological evidence that positive information about treatment significantly decreases pain and opioid consumption during routine clinical care. This study and others could encourage healthcare providers to harness the powerful effects of patients’ expectations of benefit to improve analgesics outcomes and, potentially, the outcomes of other symptoms. Introduction: Communication between medical staff and patients about treatment efficacy elicits expectations of benefit and improves treatment outcomes. While demonstrated in multiple studies via different research methodologies, uniform communication protocols have not been adopted in clinical practice. Here, we summarize the results of two sister studies aimed at bridging this gap. Methods: Women undergoing C-section (study 1, randomized controlled trial) and patients undergoing general or otolaryngologic surgeries (study 2, control group design) were recruited and assigned to the “regular communication” (RC) or “enhanced communication” (EC) arms. The EC arm received positive information about treatment, while the RC arm received no such information. In both studies, the primary outcome was change in pain intensity; in study 2, an additional outcome was morphine consumption. Results: Eighty women successfully completed study 1, and 102 patients successfully completed study 2. In both studies, significant time*group interactions were observed (p < 0.001). The analgesic effect was virtually twice as large in the EC arm compared to the RC arm. In study 2, in the last two timepoints of assessment, participants in the EC arm also consumed fewer doses of opioids than participants in the RC arm (p < 0.001). No significant differences were found in vital signs. Conclusions: We provide ecological evidence that positive information about treatment significantly decreases pain and opioid consumption during routine clinical care. This study and others could encourage healthcare providers to harness the powerful effects of patients’ expectations of benefit to improve analgesics outcomes and, potentially, the outcomes of other symptoms.

Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity

ObjectiveWe evaluate change in low back pain (LBP) intensity and interference as the mechanism by which chiropractic care affects other biopsychosocial factors in US active-duty military members.DesignWe conducted secondary, exploratory...

Early-stage vs established knee osteoarthritis: A comparative observational study on prevalence and changes in pain, function and quality of life after supervised exercise and education among 10,365 patients

Compare prevalence and changes in outcomes among established and early-stage knee osteoarthritis (KOA) patients undertaking supervised exercise and education. Patients from Good Life with osteoArthritis in Denmark (GLA:D®) were stratified into three groups: established KOA (ACR/EULAR criteria), early-stage KOA (diagnostic-model-outcome ≥70%, Criteria for the Early Diagnosis of knee Osteoarthritis) or potential early-stage KOA (diagnostic-model-outcome 30-69%). Mixed-effects models and the proportion of patients by group achieving minimal clinically important improvements (MCIIs) were used to investigate changes in VAS pain intensity (0-100mm), Knee injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL; 0-100), 40 m Walk test and 30 s chair-stand test at 3 and 12 months. Compared to established KOA (61% of 10,365 patients), early-stage KOA (27%) had similar knee pain at baseline (mean (standard deviation); 51 (22) vs 45 (22)), and improvement in pain (mean (95% CI) -15 (-15 to -14) vs -14 (-15 to -13), ≥MCII: 55% vs 54%) and KOOS QoL (≥MCII: 50% vs 50%) at 12 months, and in walking speed (≥MCII: 56% vs 52%) and chair-stands (≥MCII: 55% vs 52%) at 3 months. Compared to either group, potential early-stage KOA (10%) had lower baseline pain (34 (32.7)) and less improvement in pain (-9.8 (-11.3 to -8.2; ≥MCII: 47%)), but comparable improvements in KOOS QoL (≥MCII: 50%), walking speed (≥MCII: 51%) and chair-stands (≥MCII: 51%). Patients with early-stage KOA achieved comparable improvements at 3 and 12 months to those with established KOA, supporting supervised exercise and education as a viable management strategy for early-stage KOA.

Efficacy of a pain neuroscience educational program in improving executive function and pain intensity in fibromyalgia patients (Fibrobrain project): Study protocol for a randomized controlled clinical trial

Fibromyalgia (FM) is a chronic musculoskeletal condition typically characterized by chronic pain, sleep disturbances, chronic fatigue, and cognitive problems. The present study aims to examine the efficacy of a pain neuroscience education program (PNE) in improving executive functions and pain intensity in patients with FM and compare them with those of standard treatment protocols. This blinded, controlled clinical trial will compare changes in executive function and pain intensity between two groups. The first group will receive standard treatment supplemented with PNE, consisting of ten sessions spread over five weeks, with each session lasting 40-45min. The main objective of this method is to remodel cognitive and emotional reactions to pain, challenging the idea that pain is directly related to injury and highlighting the influence of emotions, sleep, and physical activity on pain perception. The second group will receive only standard pharmacological treatment. The study sample will include 62 adults diagnosed with FM, according to initial sample size estimates based on previous evidence. A baseline assessment of baseline characteristics will be performed, after which patients will be randomly assigned to the PNE group or the control group. The results of the intervention will be evaluated and statistically compared after 5weeks. This protocol complies with all relevant ethical guidelines. It has been approved by two institutional committees (Reference: NR2006; Conbioethics:21-CEI-004-20,170,829). It is anticipated that this intervention will be a cost-effective and superior alternative to standard treatments. NCT05084300.

Impact of prior knee surgery on change in knee pain, quality of life, and walking speed following supervised education and exercise therapy: an analysis of 30,545 people with knee osteoarthritis

To investigate the impact of prior knee surgery on changes in outcomes following an 8-week supervised patient education and exercise therapy program in patients with knee osteoarthritis. Patients were classified according to knee surgery in the most affected knee joint (yes/no) prior to enrolment in the Good Life with osteoArthritis in Denmark (GLA:D®) program. Between-group differences in outcome changes from baseline to 3 months follow-up were evaluated using linear regression stratified by sex. Outcomes were knee pain intensity (VAS, 0–100 mm), joint related quality of life (Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale score (KOOS QOL, 0–100)) and walking speed (40-m fast-paced walk test). To evaluate clinically relevant between-group differences, proportions of patients reaching a threshold of minimal important change in the surgery and non-surgery groups were compared. Among 30,545 patients, 27% (n, 8254) had prior surgery in the most affected knee. The prior surgery and the non-surgery group experienced improvements in all outcomes with minor between-group differences in change in pain intensity (males, 0.03 95% CI − 0.9 to 1.0; females, 1.3 95% CI 0.6 to 2.1); KOOS QOL (males, 0.3 95% CI − 0.4 to 0.9; females 0.02 95% CI − 0.5 to 0.5); and walking speed (males, 0.01 95% CI − 0.01 to 0.02; females 0.01 95% CI 0.003 to 0.02). The responder analysis showed no clinically relevant between-group differences in improvements. Previous knee surgery does not seem to modify the clinical outcome following exercise therapy and patient education in patients with knee osteoarthritis.Key Points• About one in four patients with knee osteoarthritis participating in an 8-week supervised patient education and exercise therapy program had previous knee joint surgery in the most affected knee.• Those with prior knee surgery were more likely to be males, to have prior knee injury, to have a longer symptom duration, and to have a high physical activity level compared to those without previous knee surgery.• Patients with prior knee surgery did not experience clinically relevant less change in knee pain, joint related quality of life, and walking speed after participation in the intervention, compared to those without previous knee surgery.• Patients with previous knee surgery can expect clinical outcomes following exercise therapy and patient education similar to patients without prior knee joint surgery.

Feasibility of a Community-Based Aquatic and Peer Support Intervention for People With Musculoskeletal Disorders Delivered via a Cross-Sector Partnership-A Service Evaluation.

Worldwide, the unmet rehabilitation needs of adults with musculoskeletal disorders are high. Aquatic exercise is clinically effective in managing musculoskeletal disorders, but access to rehabilitative services is limited. To determine the feasibility of a community-based aquatic exercise and peer support intervention for patients with musculoskeletal disorders delivered via a multisector partnership between an NHS physiotherapy service, a leisure operator and a social enterprise that creates personalised exercise programmes delivered through an application on a tablet computer. Cost-sharing was implemented after an initial complimentary session. A mixed method service evaluation was undertaken. Patient demographics, attendance, and patient-reported outcomes were summarised using descriptive statistics. Semi-structured interviews and an online survey were employed to explore patient acceptability of the intervention. Thirty four patients accessed the intervention during the 6-month pilot. Over half were from minority ethnic groups and nearly two thirds were in the bottom three deciles relating to low income. Patients exercised in a group of up to eight, supported by NHS rehabilitation professionals and volunteers. Provision of post-session refreshments encouraged connectivity between patients. Weekly attendance at the programme was high. Patient-reported outcome measures showed favourable changes in pain intensity and function following the intervention. Qualitative data suggest that the intervention was acceptable to patients. Implementation of a community-based aquatic exercise and peer support intervention for people with musculoskeletal disorders via a cross-sector partnership involving the NHS appears feasible and acceptable to patients. Further research is needed to assess the impact on musculoskeletal health and health inequalities.