Solid validity evidence for two tools assessing competences in musculoskeletal ultrasound: a validity study.

OBJECTIVES: Musculoskeletal ultrasound (MSUS) is increasingly used by rheumatologists in daily clinical practice. However, MSUS is only valuable in trained hands, and assessment of trainee competences is therefore essential before independent practice. Thus, this study aimed to establish validity evidence for the EULAR and the Objective Structured Assessment of Ultrasound Skills (OSAUS) tools used for assessing MSUS competences. METHODS: Thirty physicians with different levels of MSUS experience (novices, intermediates, and experienced) performed four MSUS examinations of different joint areas on the same rheumatoid arthritis patient. All examinations were video recorded (n = 120), anonymized, and subsequently assessed in random order by two blinded raters using first the OSAUS assessment tool followed by the EULAR tool 1 month after. RESULTS: The inter-rater reliability between the two raters was high for both the OSAUS and EULAR tools, with a Pearson correlation coefficient (PCC) of 0.807 and 0.848, respectively. Both tools demonstrated excellent inter-case reliability, with a Cronbach's alpha of 0.970 for OSAUS and 0.964 for EULAR. Furthermore, there was a strong linear correlation between the OSAUS and the EULAR performance scores and the participants' experience levels (R2 = 0.897 and R2 = 0.868, respectively) and a significant discrimination between different MSUS experience levels (P < 0.001 for both). CONCLUSIONS: MSUS operator competences can be assessed reliably and valid using either the OSAUS or the EULAR assessment tool, thereby allowing a uniform competency-based MSUS education in the future. Although both tools demonstrated high inter-rater reliability, the EULAR tool was superior to OSAUS. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT05256355.

Development and validation of a new tool for assessment of trainees' interventional musculoskeletal ultrasound skills.

OBJECTIVES: Interventional musculoskeletal ultrasound (MSUS) procedures are routinely performed in rheumatology practice. However, the efficacy and safety of the procedures rely on the competence of the physician, and assessment of skills is crucial. Thus, this study aimed to develop and establish validity evidence for a tool assessing trainees' interventional MSUS skills. METHODS: An expert panel of rheumatologists modified an existing tool for assessing competences in invasive abdominal and thoracic ultrasound procedures. The new tool (the Assessment of Interventional Musculoskeletal Ultrasound Skills (AIMUS) tool) reflects the essential steps in interventional MSUS. To establish validity evidence, physicians with different levels of interventional MSUS experience were enrolled and performed two procedures on a rubber fantom, simulating real patient cases. All performances were video recorded, anonymized, and assessed in random order by two blinded raters using the AIMUS tool. RESULTS: Sixty-five physicians from 21 different countries were included and categorized into groups based on their experience, resulting in 130 videos for analysis. The internal consistency of the tool was excellent, with a Cronbach's alpha of 0.96. The inter-case reliability was good with a Pearson's correlation coefficient (PCC) of 0.74 and the inter-rater reliability was moderate to good (PCC 0.58). The ability to discriminate between different levels of experience was highly significant (p< 0.001). CONCLUSIONS: We have developed and established validity evidence for a new interventional MSUS assessment tool. The tool can be applied in future competency-based educational programs, provide structured feedback to trainees in daily clinical practice, and ensure end-of-training competence.

E-learning and practical performance in musculoskeletal ultrasound: a multicentre randomized study.

OBJECTIVES: To examine the effect of pre-course e-learning on residents' practical performance in musculoskeletal ultrasound (MSUS). METHODS: This was a multicentre, randomized controlled study following the Consolidated Standards of Reporting Trials (CONSORT) statement. Residents with no or little MSUS experience were randomized to either an e-learning group or a traditional group. One week before a 2-day face-to-face MSUS course, the e-learning group received access to an interactive platform consisting of online lectures, assignments, and practical instruction videos aligned with the content of the course. The traditional group only received standard pre-course information (program, venue, and time). All participants performed a pre- and post-course practical MSUS examination and were assessed by two individual raters, blinded to the group allocation, using the validated Objective Structured Assessment of Ultrasound Skills (OSAUS) tool. RESULTS: Twenty-eight participants completed the study. There were no statistically significant differences in the pre- or post-course practical MSUS performance between the e-learning group and the traditional group; the mean pre-course OSAUS score (s.d.) in the -learning group was 5.4 (3.7) compared with 5.2 (2.4) in the traditional group (P = 0.8), whereas the post-course OSAUS score in the e-learning group was 11.1 (2.8) compared with 10.9 (2.4) in the traditional group (P = 0.8). There was a significant difference between the mean pre- and post-course scores (5.74 points, P < 0.001). The OSAUS assessment tool demonstrated good inter-rater reliability (intra-class correlation = 0.84). CONCLUSION: We found no significant impact of pre-course e-learning on novices' acquisition of practical MSUS skills. Hands-on training is of the utmost importance and improves MSUS performance significantly. The OSAUS assessment tool is an applicable tool with high interrater reliability. TRIAL REGISTRATION: https://clinicaltrials.gov/ NCT04959162.

Training and assessment of musculoskeletal ultrasound and injection skills-a systematic review.

OBJECTIVES: To examine how residents are trained and assessed in musculoskeletal US (MSUS), MSUS-guided and landmark-guided joint aspiration and injection. Additionally, to present the available assessment tools and examine their supporting validity evidence. METHODS: A systematic search of PubMed, Cochrane Library and Embase was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and studies published from 1 January 2000 to 31 May 2021 were included. Two independent reviewers performed the search and data extraction. The studies were evaluated using the Medical Education Research Quality Instrument (MERSQI). RESULTS: A total of 9884 articles were screened, and 43 were included; 3 were randomized studies, 21 pre- and post-test studies, 16 descriptive studies and 3 studies developing assessment tools. The studies used various theoretical training modalities, e.g. lectures, anatomical quizzes and e-learning. The practical training models varied from mannequins and cadavers to healthy volunteers and patients. The majority of studies used subjective 'comfort level' as assessment, others used practical examination and/or theoretical examination. All training programs increased trainees' self-confidence, theoretical knowledge, and/or practical performance, however few used validated assessment tools to measure the effect. Only one study met the MERSQI high methodical quality cut-off score of 14. CONCLUSION: The included studies were heterogeneous, and most were of poor methodological quality and not based on contemporary educational theories. This review highlights the need for educational studies using validated theoretical and practical assessment tools to ensure optimal MSUS training and assessment in rheumatology.

Impact of the COVID-19 pandemic on treat-to-target strategies and physical consultations in >7000 patients with inflammatory arthritis.

OBJECTIVES: To explore the impact of the COVID-19 pandemic on treat-to-target strategies (disease activity, remission rates) and access to physical consultations in patients with inflammatory rheumatic disease, as well as to explore characteristics of patients with/without physical consultations in the clinic and the impact of early vs established disease. METHODS: Patients with RA, PsA or axial SpA (axSpA) prospectively followed in the nationwide DANBIO registry answered online questionnaires and reported patient-reported outcomes (PROs) in June and November 2020. Patient characteristics, disease activity and physical consultations in the clinic before and during the pandemic were identified in DANBIO [all patients and subgroups with early disease (disease duration ≤2 years)]. In individual patients, changes in PROs before and during the pandemic were calculated. Characteristics of patients with/without physical consultations were described (age, gender, education level, comorbidities, disease duration, treatment). RESULTS: We included 7836 patients (22% of eligible patients), 12% of which had early disease. PROs were stable before and during the pandemic, with median changes approximating zero, as well as in patients with early disease. Remission rates were stable. The relative decrease in the number of patients with physical consultations was 21-72%, which was highest in axSpA. Characteristics of patients with/without physical consultations were similar. Self-reported satisfaction with treatment options and access was >70%; the preferred contact form was physical consultation (66%). CONCLUSION: In this nationwide study performed during the first 8 months of the pandemic, patient satisfaction was high and the PROs and remission rates remained stable despite the remarkable reduction in physical consultations, as well as in patients with early disease. Characteristics of patients with/without physical consultations appeared similar.

Local infiltration analgesia is comparable to femoral nerve block after anterior cruciate ligament reconstruction with hamstring tendon graft: a randomised controlled trial.

PURPOSE: Arthroscopic anterior cruciate ligament (ACL) reconstruction is a painful procedure requiring intensive postoperative pain management. Femoral nerve block is widely used in ACL surgery. However, femoral nerve block does not cover the donor site of the hamstring tendons. Local infiltration analgesia is a simple technique that has proven effective in postoperative pain management after total knee arthroplasty. Further, local infiltration analgesia covers the donor site and is associated with few complications. It was hypothesised that local infiltration analgesia at the donor site and wounds would decrease pain and opioid consumption after ACL reconstruction with hamstring tendon graft. METHODS: Sixty patients undergoing primary ACL surgery with hamstring tendon graft were randomised to receive either local infiltration analgesia or femoral nerve block. Pain was scored on the numeric rating scale, and use of opioid, range of motion and adverse effects were assessed at the postoperative recovery unit (0 h), 3, 24 and 48 h, postoperatively. RESULTS: There were no significant differences between the groups in pain intensity or total opioid consumption at any of the follow-up points. Further, there were no differences between groups concerning side effects and range of motion. CONCLUSIONS: Local infiltration analgesia and femoral nerve block are similar in the management of postoperative pain after ACL reconstruction with hamstring tendon graft. Until randomised studies have investigated femoral nerve block combined with infiltration at the donor site, we recommend local infiltration analgesia in ACL reconstruction with hamstring tendon graft.

Vagus nerve stimulation as a novel treatment for systemic lupus erythematous: study protocol for a randomised, parallel-group, sham-controlled investigator-initiated clinical trial, the SLE-VNS study.

INTRODUCTION: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease. SLE is treated with immunosuppressants with suboptimal efficacy and high risk of serious side effects. Patients with SLE have increased risk of mortality, organ damage and debilitating treatment-resistant fatigue. Autonomic nervous system dysfunction (AD) is present in approximately half of the patients and may promote autoimmunity by weakening the vagally mediated anti-inflammatory reflex. Recent studies suggest that transcutaneous vagus nerve stimulation (tVNS) has few side effects and beneficial effects on fatigue, pain, disease activity and organ function. This study investigates whether adjuvant tVNS improves measures of fatigue (primary end point), AD, clinical disease activity, inflammation, pain, organ function and quality of life.Hence, this study will contribute to the understanding of AD as a potentially important precursor of fatigue, disease activity, progression and complications in SLE, and how tVNS mechanistically may attenuate this. As adjuvant tVNS use may reduce the need for traditional immunosuppressive therapy, this trial may prompt a shift in the treatment of SLE and potentially other autoimmune disorders. METHODS AND ANALYSIS: Eighty-four patients with SLE with fatigue and AD will be randomised 1:1 to active or sham tVNS in this double-blinded parallel-group study. In period 1 (1 week), participants will receive a 4 min tVNS 4 times daily and report on fatigue daily. After a 2-week pause, period 2 (8 weeks) will entail tVNS twice daily and participants will report on fatigue, pain and disease activity weekly. Secondary end points will be assessed before and after each period and after 1 week in period 2. ETHICS AND DISSEMINATION: The study is approved by the Danish Medical Research Ethical Committees (case no: 2120231) and results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05315739.

The Effect of Transcutaneous Vagus Nerve Stimulation in Patients with Polymyalgia Rheumatica.

(1) Polymyalgia rheumatica (PMR) is an inflammatory disease characterised by pain, morning stiffness, and reduced quality of life. Recently, vagus nerve stimulation (VNS) was shown to have anti-inflammatory effects. We aimed to examine the effect of transcutaneous VNS (t-VNS) on PMR. (2) Fifteen treatment-naïve PMR patients completed the study. Patients underwent a 5-day protocol, receiving 2 min of t-VNS stimulation bilaterally on the neck, three times daily. Cardiac vagal tone (CVT) measured on a linear vagal scale (LVS), blood pressure, heart rate, patient-reported outcome, and biochemical changes were assessed. (3) t-VNS induced a 22% increase in CVT at 20 min after initial stimulations compared with baseline (3.4 ± 2.2 LVS vs. 4.1 ± 2.9 LVS, p = 0.02) and was accompanied by a 4 BPM reduction in heart rate (73 ± 11 BPM vs. 69 ± 9, p < 0.01). No long-term effects were observed. Furthermore, t-VNS induced a 14% reduction in the VAS score for the hips at day 5 compared with the baseline (5.1 ± 2.8 vs. 4.4 ± 2.8, p = 0.04). No changes in CRP or proinflammatory analytes were observed. (4) t-VNS modulates the autonomic nervous system in patients with PMR, but further investigation of t-VNS in PMR patients is warranted.

[Sjögren's syndrome].

Sjögren's syndrome (SS) is a common autoimmune disease with a prevalence of 1%. SS affects primarily women between the age of 30 and 50 years. The classic manifestations are sicca symptoms, musculoskeletal pain and fatigue but the disease can affect all organs. SS is associated with the antibody anti-SSA antibodies. The patients have a 15-20 times higher risk of lymphoma and an increased risk of spontaneous abortion and AV-block in life-born children. In this review, we share the diagnostic process and risk stratification and outline the treatments available from private practice.

Self-protection strategies and health behaviour in patients with inflammatory rheumatic diseases during the COVID-19 pandemic: results and predictors in more than 12 000 patients with inflammatory rheumatic diseases followed in the Danish DANBIO registry.

AIMS: In Danish patients with inflammatory rheumatic diseases to explore self-protection strategies and health behaviour including adherence to disease-modifying antirheumatic treatment (DMARD) during the initial phase of the COVID-19 pandemic and again after the reopening of the society started. Furthermore, to identify characteristics of patients with high levels of anxiety and self-isolation. METHODS: Patients in routine care followed prospectively in the nationwide DANBIO registry were invited to answer an online questionnaire regarding disease activity and COVID-19 infection, behaviour in March and June 2020. Responses were linked to patient data in DANBIO. Characteristics potentially associated with anxiety, self-isolation and medication adherence (gender/age/diagnosis/education/work status/comorbidity/DMARD/smoking/EQ-5D/disease activity) were explored with multivariable logistic regression analyses. RESULTS: We included 12 789 patients (8168 rheumatoid arthritis/2068 psoriatic arthritis/1758 axial spondyloarthritis/795 other) of whom 65% were women and 36% treated with biological DMARD. Self-reported COVID-19 prevalence was 0.3%. Patients reported that they were worried to get COVID-19 infection (March/June: 70%/45%) and self-isolated more than others of the same age (48%/38%). The fraction of patients who changed medication due to fear of COVID-19 were 4.1%/0.6%. Female gender, comorbidities, not working, lower education, biological treatment and poor European Quality of life, 5 dimensions were associated with both anxiety and self-isolation. CONCLUSION: In >12 000 patients with inflammatory arthritis, we found widespread anxiety and self-isolation, but high medication adherence, in the initial phase of the COVID-19 pandemic. This persisted during the gradual opening of society during the following months. Attention to patients' anxiety and self-isolation is important during this and potential future epidemics.

Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year.

OBJECTIVE: To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. METHODS: A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee osteoarthritis (clinical and laboratory) and with a Lequesne algofunctional index score (LFI) of 10 or greater. Patients received a hyaluronan product (sodium hyaluronate; Hyalgan) (n=167) or saline (n=170) intra-articularly weekly for 5 weeks and were followed up to 1 year. Time to recurrence was the primary efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. RESULTS: Time to recurrence showed no significant treatment effect (ITT analysis, p=0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol consumption, patients' global assessment, responder rates and AE displayed no significant difference between treatment groups, analysed by both ITT and PP. Treatment compliance was 95% in the hyaluronan group and 99% in the placebo group. No safety problems were registered. CONCLUSION: In patients fulfilling the ACR criteria for osteoarthritis of the knee with moderate to severe disease activity (LFI > or = 10), five intra-articular injections of hyaluronan did not improve pain, function, paracetamol consumption or other efficacy parameters 3, 6, 9 and 12 months after the treatment.

High-Intensity Resistance Training Does Not Produce Immediate Ultrasonographic Changes in Muscle Tendons.

BACKGROUND: Chronic overload injuries to tendons can be visualized using ultrasonography, with characteristics such as tendon thickening and darkening. PURPOSE: To investigate whether these characteristics are evident in the patellar and Achilles tendons immediately after 1 session of high-intensity resistance training. STUDY DESIGN: Controlled laboratory study. METHODS: A total of 18 volunteers were randomized to an experimental group (n = 10) and a sham group (n = 8). The experimental group performed 5 circuits at maximum effort consisting of 5 weighted front squats, 10 box jumps (60/50 cm), and 15 double-under jump-rope jumps. The sham group performed a similar circuit consisting of 5 weighted shoulder presses, 10 push-ups, and 15 weighted biceps curls. Ultrasonograms were obtained before and after exercise, for a total of 30 minutes at intervals of 2.5 minutes for the first 10 minutes and 5 minutes for the remaining time. Tendon thickness and tendon matrix signals were measured. Statistics were performed using repeated-measures mixed analysis of variance (ANOVA). RESULTS: Tendon thickness did not increase significantly over 30 minutes after both circuits. The mean grayscale value for the patellar and Achilles tendons increased for both the experimental and the sham groups. ANOVA showed that the experimental group was not a significant explanatory variable; however, the increased work of both groups was. A post hoc analysis found that the maximum increase in the tendon signal was a grayscale value of 10.8 for the patellar tendon (99.4% CI, 3.7-17.9; P = .002). CONCLUSION: This trial failed to reproduce an earlier study in which tendon thickness increased after high-intensity training. The tendons produced a hyperechoic signal after high-intensity resistance training, regardless of loading to the tendon. Chronic overload characteristics on ultrasonography were not evident immediately after acute loading of tendons. CLINICAL RELEVANCE: There is a need for prognostic and diagnostic markers of tendinopathy especially because of the protracted course of subclinical development of an injury. This study assessed whether clinical findings for a chronic overload injury can be detected during acute overloading.

Correction: Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study.

[This corrects the article DOI: 10.1371/journal.pone.0171723.].

[Acromegaly].

Acromegaly is a rare and disabling disease with a plethora of symptoms and signs attributed to sustained elevations and actions of growth hormone and insulin-like growth factor 1. Acromegaly is characterised by excessive somatic growth and multiple comorbidities in addition to occasional compression of the optic nerve and hypopituitarism due to the underlying adenoma. The course of the disease is insidious, and a diagnostic delay of 5-10 years is typical, and this pre-diagnostic period is also associated with increased morbidity. Effective treatment is available, once the diagnosis is established.

Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial.

OBJECTIVE: To test the effect of patient-reported outcome (PRO)-based tele-health followup for tight control of disease activity in patients with rheumatoid arthritis (RA), and the differences between tele-health followup performed by rheumatologists or rheumatology nurses. METHODS: A total of 294 patients were randomized (1:1:1) to either PRO-based tele-health followup carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional outpatient followup by physicians. The primary outcome was a change in the Disease Activity Score in 28 joints (DAS28) after week 52. Secondary outcomes were physical function, quality of life, and self-efficacy. The noninferiority margin was a DAS28 score change of 0.6. Mean differences were estimated following per protocol, intent-to-treat (ITT), and multivariate imputation analysis. RESULTS: Overall, patients had low disease activity at baseline and end followup. Demographics and baseline characteristics were similar between groups. Noninferiority was established for the DAS28. In the ITT analysis, mean differences in the DAS28 score between PRO-TR versus control were -0.10 (90% confidence interval [90% CI] -0.30, 0.13) and -0.19 (90% CI -0.41, 0.02) between PRO-TN versus control. When including 1 yearly visit to the outpatient clinic, patients in PRO-TN had mean ± SD 1.72 ± 1.03 visits/year, PRO-TR had 1.75 ± 1.03 visits/year, and controls had 4.15 ± 1.0 visits/year. This included extra visits due to inflammatory flare. CONCLUSION: Among RA patients with low disease activity or remission, a PRO-based tele-health followup for tight control of disease activity in RA can achieve similar disease control as conventional outpatient followup. The degree of disease control did not differ between patients seen by rheumatologists or rheumatology nurses.

Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study.

Opioids are increasingly used for treatment of chronic pain. However, they are only effective in a subset of patients and have multiple side effects. Thus, studies using biomarkers for response are highly warranted. The current study prospectively examined 63 opioid-naïve patients initiating opioid use for diverse types of chronic pain at five European centers. Quantitative sensory testing, electroencephalography (EEG) recordings, and assessment of pain catastrophizing were performed prior to treatment. The co-primary outcomes were change from baseline in ratings of chronic pain and quality of life after 14 days of opioid treatment. Secondary outcomes included patient's global impression of clinical change and side effects. Logistic regression models adjusted for age and sex were used to identify biomarkers predictive for successful treatment, defined as at least a 30% reduction in average pain intensity or an improvement in quality of life of at least 10 scale points. Fifty-nine patients (94%) completed the study. The mean age was 55 ± 16 years and 69% were females. Pain reduction was predicted by cold pain intensity (OR: 0.69; P = 0.01), pain catastrophizing (OR: 0.82; P = 0.03), relative delta (OR: 0.76; P = 0.03) and beta EEG activity (OR: 1.18; P = 0.04) induced by experimental cold pain. None of the study variables were related to improvement in quality of life. For the first time, individual pain processing characteristics have been linked to opioid response in a mixed chronic pain population. This has the potential to personalize treatment of chronic pain and restrict opioid use to patients with high likelihood for response.

Situational but Not Dispositional Pain Catastrophizing Correlates With Early Postoperative Pain in Pain-Free Patients Before Surgery.

UNLABELLED: Pain catastrophizing may be assessed as a dispositional measure using a previous painful experience as a reference or as a situational measure using an actual ongoing pain as a reference. The latter has shown more robust correlations with pain-related outcomes; the relative influence of dispositional and situational pain catastrophizing remains unknown in relation to populations with no pain before surgery. Forty-two consecutive patients who underwent corrective surgery for funnel chest were asked to complete the Pain Catastrophizing Scale with reference to 1) a previous painful experience (dispositional pain catastrophizing), 2) experimental pain during a 2-minute cold pressor test (situational experimental pain catastrophizing), and 3) clinical pain 3 days after surgery (situational clinical pain catastrophizing) to investigate whether these measures predicted immediate pain intensity and unpleasantness in the early postoperative period. Thirty-four patients were available for analyses. Dispositional pain catastrophizing was unrelated to situational experimental and situational clinical pain catastrophizing and to postoperative pain and unpleasantness (P > .05). In contrast, the 2 situation-specific pain catastrophizing measures were strongly associated (ρ = .59, P = .0002). In analyses adjusted for preoperative anxiety, depression, and cold pressor pain sensitivity, situational experimental and situational clinical pain catastrophizing correlated with postoperative movement-evoked pain (ß = 1.36, P = .01 and ß = 1.24, P = .02, respectively) and unpleasantness (ß = 1.32, P = .01 and ß = 1.36, P = .01, respectively). PERSPECTIVE: Pain catastrophizing should be captured in relation to specific painful events in otherwise healthy patients. Future studies might benefit from assessing situational pain catastrophizing to identify patients at risk for increased postoperative pain to optimize stratified pain treatment.

Perioperative gabapentin for the prevention of persistent pain after thoracotomy: a randomized controlled trial.

OBJECTIVES: To evaluate the effect of perioperative gabapentin treatment for the prevention of persistent post-thoracotomy pain and to establish whether gabapentin has a significant therapeutic impact on acute postoperative pain. METHODS: Consecutive patients with pulmonary malignancies scheduled for anterior thoracotomy were enrolled in this randomized, double-blinded, placebo-controlled trial. Patients were given 1200 mg gabapentin or placebo 2 h before surgery followed by increasing doses during 5 postoperative days: 600 mg for day 1; 900 mg for day 2; and 1200 mg for days 3-5. Effective pain relief was provided with perioperative multimodal analgesia with epidural infusion of bupivacaine and morphine for 72 h, and oral acetaminophen, ibuprofen and morphine. The main outcome was persistent post-thoracotomy pain at 6 months. Secondary outcomes included measures of early postoperative post-thoracotomy pain, morphine requirements, recovery and analgesia-related adverse effects over the first 3 weeks as well as persistent post-thoracotomy pain at 3 months. RESULTS: A total of 104 patients were randomly assigned to the intervention or control group; 86 (83%) patients were available for the 14-day analysis, 76 (73%) for the 3-month analysis and 67 (64%) for the 6-month follow-up. At 6 months postoperatively, 47% of patients treated with gabapentin reported persistent post-thoracotomy pain compared with 49% in the placebo group (P = 0.9). No overall clinically or statistically significant differences were observed between groups receiving placebo and gabapentin, respectively, for the secondary outcome measures and treatment-related adverse events. CONCLUSIONS: We found no evidence for the superiority of gabapentin over placebo for the treatment of acute pain following thoracotomy or for the prevention of persistent post-thoracotomy pain.

Conditioned pain modulation and situational pain catastrophizing as preoperative predictors of pain following chest wall surgery: a prospective observational cohort study.

BACKGROUND: Variability in patients' postoperative pain experience and response to treatment challenges effective pain management. Variability in pain reflects individual differences in inhibitory pain modulation and psychological sensitivity, which in turn may be clinically relevant for the disposition to acquire pain. The aim of this study was to investigate the effects of conditioned pain modulation and situational pain catastrophizing on postoperative pain and pain persistency. METHODS: Preoperatively, 42 healthy males undergoing funnel chest surgery completed the Spielberger's State-Trait Anxiety Inventory and Beck's Depression Inventory before undergoing a sequential conditioned pain modulation paradigm. Subsequently, the Pain Catastrophizing Scale was introduced and patients were instructed to reference the conditioning pain while answering. Ratings of movement-evoked pain and consumption of morphine equivalents were obtained during postoperative days 2-5. Pain was reevaluated at six months postoperatively. RESULTS: Patients reporting persistent pain at six months follow-up (n = 15) were not significantly different from pain-free patients (n = 16) concerning preoperative conditioned pain modulation response (Z = 1.0, P = 0.3) or level of catastrophizing (Z = 0.4, P = 1.0). In the acute postoperative phase, situational pain catastrophizing predicted movement-evoked pain, independently of anxiety and depression (ß = 1.0, P = 0.007) whereas conditioned pain modulation predicted morphine consumption (ß = -0.005, P = 0.001). CONCLUSIONS: Preoperative conditioned pain modulation and situational pain catastrophizing were not associated with the development of persistent postoperative pain following funnel chest repair. Secondary outcome analyses indicated that conditioned pain modulation predicted morphine consumption and situational pain catastrophizing predicted movement-evoked pain intensity in the acute postoperative phase. These findings may have important implications for developing strategies to treat or prevent acute postoperative pain in selected patients. Pain may be predicted and the malfunctioning pain inhibition mechanism as tested with CPM may be treated with suitable drugs augmenting descending inhibition.