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BACKGROUND: Patients with varicose veins are prevented from prolonged standing. Considering that exercise can be implemented in different positions, the aim of the current study was to compare the effects of training at standing and lying positions on quality of life, and clinical symptoms in women with mild varicose veins. METHODS: Twenty-five women with mild varicose veins aged 35-50 years were randomly assigned to three groups; exercise at standing position (n=10), exercise at lying position (n=8) and control (no treatment) group (n=7). Each exercise program involved 6 weeks of training. Quality of life, pain severity, ankle swelling, and lower leg and ankle circumferences were measured using the Aberdeen Varicose Vein Questionnaire, Visual Analog Scale (VAS), four-point pitting edema grading scale, and tape measure, respectively at baseline and at the end of the study. Data were analyzed using one-way analysis of variance (ANOVA) and the least significant difference (LSD) as post hoc test. RESULTS: Following a 6-week exercise program, there was a significant improvement in the quality of life of the participants in both exercise groups, and a significant reduction in pain, ankle swelling, and lower leg and ankle circumferences compared to pre-training and control group (P <0.05). However, there was no significant difference between two exercise groups in terms of study variables (P >0.05). CONCLUSIONS: The current study showed that exercise program comprising standing position exercises can significantly reduce the symptoms of mild varicose veins.
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Terapia por Ejercicio , Calidad de Vida , Várices , Humanos , Femenino , Várices/terapia , Persona de Mediana Edad , Adulto , Terapia por Ejercicio/métodos , Encuestas y Cuestionarios , Postura/fisiología , Dimensión del Dolor , Posición de PieRESUMEN
BACKGROUND: Venipuncture is one of the most commonly performed medical procedures in paediatric care, but it can also be one of the most painful and distressing experiences for patients. Finding effective strategies to manage pain and fear associated with venipuncture is crucial for improving the paediatric patient experience and promoting positive health outcomes. This study aimed to evaluate the efficacy of a combined approach using a topical analgesic cream (TKTX cream) and a distraction technique (Trace Image and Colouring for Kids-Book, TICK-B) in reducing pain intensity and fear levels in children undergoing venipuncture procedures. METHODS: We conducted this randomised controlled trial among 176 children aged 6-12 years undergoing venipuncture. Participants were randomly assigned to four groups: TICK-B, TKTX cream, TICK-B+TKTX cream and a control group. Pain and fear were measured using the Wong-Baker FACES Pain Rating Scale and Children's Fear Scale. The study was carried out from 20 February 2024 to 1 June 2024 at the emergency unit of Heevi paediatric teaching hospital in the Kurdistan region of Iraq. In the intervention groups, TICK-B was applied for 2-3 min before needle insertion, and TKTX cream was applied 20 min before the venipuncture procedure. All outcome measures were evaluated 2-3 min after the completion of the venipuncture procedure. RESULTS: The combined TICK-B (colouring book) and TKTX cream (topical anaesthetic) intervention was the most effective in reducing both pain intensity (mean score 2.80 vs 7.24 in the control, p<0.001) and fear levels (mean score 0.93 vs 2.83 in the control, p<0.001) during and after venipuncture procedures compared with individual interventions and control. CONCLUSIONS: The combined TICK-B distraction and TKTX cream topical anaesthetic intervention was the most effective in reducing pain intensity and fear during and after venipuncture in children, providing a practical strategy for healthcare providers to optimise needle procedure management. TRIAL REGISTRATION NUMBER: NCT06326125.
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Ansiedad , Manejo del Dolor , Flebotomía , Humanos , Flebotomía/efectos adversos , Niño , Masculino , Femenino , Manejo del Dolor/métodos , Ansiedad/terapia , Ansiedad/etiología , Ansiedad/prevención & control , Dimensión del Dolor , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Dolor/psicología , Dolor/prevención & control , Dolor/etiología , Dolor/tratamiento farmacológico , Combinación Lidocaína y Prilocaína , Resultado del Tratamiento , IrakRESUMEN
OBJECTIVES: A high incidence of attention-deficit hyperactivity disorder (ADHD) has been reported in chronic pain (ChP) patients. Furthermore, an association between ChP and muscular dysregulation has been reported in adults with ADHD. The present study investigated whether ADHD was more prevalent among psychiatric outpatients with ChP than those without ChP, and if there was an association between ChP, muscular dysregulation and characteristics of pain in patients with ADHD. METHODS: One-hundred and twenty-one individuals remitted to an outpatient psychiatry unit took part in this naturalistic epidemiological cross-sectional study. They were assessed with a pain self-report form (localization, intensity, and onset) and a test of muscle dysregulation (the Motor Function Neurological Assessment). Prevalence of ADHD among patients with ChP, as well as the qualitative characteristics of ChP within the ADHDgroup are reported. Both ChP and pain intensity correlated with muscular dysregulation through Spearman's rho analysis. Additionally, the relationship between various diagnostic categories (ADHD, affective disorders, anxiety, or personality disorders) and incidence of axial pain was evaluated in logistic regression. RESULTS: ADHD was significantly more prevalent in patients with ChP, than in patients without ChP. In the ADHD group, ChP and pain intensity was associated with muscular dysregulation, particularly with high muscle tone. ChP was more axial and widespread, than for the patients without ADHD, and started at an early age. ADHD diagnosis predicted axial pain, whereas affective-, anxiety-, or personality disorders did not. CONCLUSIONS: The study suggests that ChP in ADHD is associated with muscular dysregulation and is qualitatively different from ChP in psychiatric patients without ADHD. These findings may lead to further understanding of potential mechanisms involved in ADHD and ChP, and in turn to new treatment strategies for both disorders.
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Trastorno por Déficit de Atención con Hiperactividad , Dolor Crónico , Humanos , Trastorno por Déficit de Atención con Hiperactividad/fisiopatología , Trastorno por Déficit de Atención con Hiperactividad/epidemiología , Dolor Crónico/fisiopatología , Dolor Crónico/epidemiología , Masculino , Femenino , Estudios Transversales , Adulto , Persona de Mediana Edad , Prevalencia , Dimensión del Dolor , Adulto JovenRESUMEN
Background There are insufficient data comparing resorbable microspheres (RMs) with permanent trisacryl gelatin microspheres (TAGMs) for uterine artery embolization (UAE). Purpose To compare therapeutic efficacy and clinical outcomes in participants with symptomatic fibroids after UAE with RMs or TAGMs. Materials and Methods This randomized controlled trial included participants undergoing UAE for symptomatic fibroids at a single institution (from May 2021 to May 2023). Participants were randomized one-to-one to undergo UAE with either RMs or TAGMs. Numeric rating scale pain scores and cumulative fentanyl consumption were assessed for 24 hours after undergoing UAE. Anti-Mullerian hormone was measured to assess effects of UAE on ovarian function. MRI was performed before and 3 months after UAE to evaluate fibroid necrosis and uterine artery recanalization. Repeated variables such as pain were analyzed using Mann-Whitney U test with post hoc Bonferroni correction. Results Sixty female participants (mean age, 45.7 years ± 3.6 [SD]) completed the study, with 30 in each group. No evidence of a difference in pain scores was observed between groups (P > .99). Moreover, there was no evidence of a difference in the total fentanyl consumption at 24 hours after UAE between groups (median: RMs, 423 [IQR, 330-530] vs TAGMs, 562 [IQR, 437-780]; P = .15). Serum anti-Mullerian hormone 3 months after UAE showed no evidence of a difference between groups (RMs vs TAGMs, 0.71 ng/mL ± 0.73 vs 0.49 ng/mL ± 0.45, respectively; P = .09). No evidence of a difference in the rate of complete necrosis of the dominant fibroid was observed between groups (97% [29 of 30] for both groups; P > .99). The rate of uterine artery recanalization was higher in RM versus TAGM groups (70% [21 of 30] vs 17% [five of 30], respectively; P < .001). Conclusion UAE with RMs, compared with UAE with TAGMs, showed no evidence of a difference in terms of therapeutic effectiveness or postprocedural pain scores in participants with symptomatic fibroids. Clinical trial registration no. NCT05086770 © RSNA, 2024 See also the editorial by Spies in this issue.
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Resinas Acrílicas , Gelatina , Leiomioma , Embolización de la Arteria Uterina , Humanos , Femenino , Embolización de la Arteria Uterina/métodos , Gelatina/uso terapéutico , Persona de Mediana Edad , Leiomioma/terapia , Leiomioma/diagnóstico por imagen , Resinas Acrílicas/uso terapéutico , Adulto , Microesferas , Neoplasias Uterinas/terapia , Neoplasias Uterinas/diagnóstico por imagen , Resultado del Tratamiento , Dimensión del DolorRESUMEN
Definitions of human pain acknowledge at least two dimensions of pain, affective and sensory, described as separable and thus potentially differentially modifiable. Using electroencephalography, we investigated perceptual and neural changes of emotional pain modulation in healthy individuals. Painful electrical stimuli were applied after presentation of priming emotional pictures (negative, neutral, positive) and followed by pain intensity and unpleasantness ratings. We found that perceptual and neural event-related potential responses to painful stimulation were significantly modulated by emotional valence. Specifically, pain unpleasantness but not pain intensity ratings were increased when pain was preceded by negative compared to neutral or positive pictures. Amplitudes of N2 were higher when pain was preceded by neutral compared to negative and positive pictures, and P2 amplitudes were higher for negative compared to neutral and positive pictures. In addition, a hierarchical regression analysis revealed that P2 alone and not N2, predicted pain perception. Finally, source analysis showed the anterior cingulate cortex and the thalamus as main spatial clusters accounting for the neural changes in pain processing. These findings provide evidence for a separation of the sensory and affective dimensions of pain and open new perspectives for mechanisms of pain modulation.
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Electroencefalografía , Emociones , Dolor , Humanos , Masculino , Femenino , Emociones/fisiología , Dolor/psicología , Dolor/fisiopatología , Adulto Joven , Adulto , Potenciales Evocados/fisiología , Percepción del Dolor/fisiología , Encéfalo/fisiología , Estimulación Eléctrica , Estimulación Luminosa/métodos , Dimensión del Dolor , Mapeo EncefálicoRESUMEN
BACKGROUND: Folate has an important role in the functioning of the musculoskeletal system, including modulation of inflammation, immunity, cartilage regeneration, prevention of osteoporosis, and maintenance of muscle strength, but evidence on the association between folate intake and knee pain, functional scores, and radiographic progression in patients with knee osteoarthritis (OA) is still limited. METHODOLOGY: Our population-based cohort was extracted from the osteoarthritis initiative (OAI), focusing on individuals with prevalent radiographic knee OA (with a Kellgren-Lawrence score ≥2). Folate consumption was determined using the food frequency questionnaire. Data regarding the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and radiographic readings were collected over 48 months. We analyzed the compiled data using generalized additive mixed models. RESULTS: Our cohort consisted of 1472 OA patients (626 men and 846 women, mean [SD] age 62.35 [8.92]). At the 48-month follow-up, we observed a significant correlation between higher folate intake and a slower progression of knee pain and functional scores, as evidenced by a statistically significant decrease in the WOMAC total score, WOMAC pain subscale score, and WOMAC function/disability subscale score (p < .05). The fully adjusted models estimated a reduction of -0.028 points per 50 µg/1000 kcal of daily folate intake on the WOMAC pain subscale, -0.117 points on the WOMAC function subscale, and -0.160 points on the total WOMAC scale. Furthermore, our nonparametric fit analysis suggested that a higher intake of folate might decelerate the radiographic progression of OA. Stratified analyses indicated that an increase in folate consumption might particularly benefit men, older adults, overweight and obese individuals, and those with a higher dietary fiber intake. CONCLUSION: Higher folate intake is correlated with improved knee function and reduced pain in patients with knee OA and might deter the radiographic progression of OA. The benefits appear to be more pronounced in men, older adults, overweight and obese individuals, and those with a higher dietary fiber intake.
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Artralgia , Progresión de la Enfermedad , Ácido Fólico , Articulación de la Rodilla , Osteoartritis de la Rodilla , Dimensión del Dolor , Humanos , Osteoartritis de la Rodilla/diagnóstico por imagen , Osteoartritis de la Rodilla/fisiopatología , Masculino , Femenino , Persona de Mediana Edad , Anciano , Ácido Fólico/administración & dosificación , Artralgia/fisiopatología , Artralgia/diagnóstico , Articulación de la Rodilla/diagnóstico por imagen , Articulación de la Rodilla/fisiopatología , Factores de Tiempo , Radiografía , Evaluación de la DiscapacidadRESUMEN
BACKGROUND: As a frequent disease, prostatic hyperplasia could be treated by transurethral resection of prostate (TURP). However, postoperative pain may affect the prognosis of patients to some extent, so exploring reasonable anaesthetic drugs is an important measure to reduce the recovery period of anaesthesia. This study used the combination of ropivacaine and nalbuphine for intraoperative anaesthesia in patients undergoing TURP to investigate its effect on pain during anaesthesia recovery. METHODS: A retrospective study was conducted on the clinical data of 205 patients with prostatic hyperplasia who underwent TURP in our hospital from June 2020 to December 2022. All patients experienced epidural anaesthesia, and 110 patients who used ropivacaine combined with nalbuphine were included in the study group, whereas 95 patients who used ropivacaine and lidocaine were classified as the control group. The Visual Analogue Scale was used to evaluate the pain conditions of patients. The levels of pain mediators, such as substance P (SP), bradykinin (BK) and histamine (HIS), the stress levels, including cortisol (Cort), adrenocorticotropic hormone (ACTH) and norepinephrine (NE), and the incidence of adverse reactions were compared between the two groups. RESULTS: At T0 (postoperative 30 min), T1 (postoperative 60 min), T2 (postoperative 2 h) and T3 (postoperative 4 h), the study group had significantly lower pain scores (p < 0.01), levels of SP, BK and HIS (p < 0.001), and levels of Cort, ACTH and NE (p < 0.05) than the control group. No statistical difference was observed in the incidences of adverse reactions between the two groups (p > 0.05). CONCLUSIONS: The combination of ropivacaine and nalbuphine has a notable analgesic effect during anaesthesia recovery in patients undergoing TURP. It inhibits the secretion of pain and physical stress indicators and relieves postoperative pain to a large extent.
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Anestésicos Locales , Nalbufina , Dolor Postoperatorio , Hiperplasia Prostática , Ropivacaína , Resección Transuretral de la Próstata , Humanos , Masculino , Ropivacaína/administración & dosificación , Resección Transuretral de la Próstata/efectos adversos , Hiperplasia Prostática/cirugía , Nalbufina/administración & dosificación , Nalbufina/uso terapéutico , Estudios Retrospectivos , Anciano , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Anestésicos Locales/administración & dosificación , Persona de Mediana Edad , Quimioterapia Combinada , Dimensión del DolorRESUMEN
Background: Complex regional pain syndrome (CRPS) presents as persistent regional pain, both spontaneous and triggered. The demand persists for innovative treatments that patients can endure with minimal adverse effects. Hyperbaric oxygen therapy (HBOT) emerges as a possible intervention in this regard. Methods: The main objective of this work is to retrospectively analyse a case series of patients diagnosed with CRPS treated in the Centre of Hyperbaric Medicine Ostrava over two years (period 2018-2019). The HBOT was applied at 2.0-2.4 absolute atmosphere (ATA) once a day. Results: A total of 83 patients with CRPS were treated with HBOT. 98% of cases reported pain, 92% reported limitation of movement of the affected limb, 87% had swelling of the limb, 41% had lividity and 70% had sensory problems. The mean number of HBOT exposures was 22.0 ± 7.1. At the end of HBOT treatment, 86% of cases had symptoms relief. The mean VAS value of pain at rest before the start of HBOT was 3.2±3.0, after treatment it was 1.6±1.9 (p<0.001). In a pain at activity it was 6.1±2.4 and 3.7±2.4 (p<0.001), respectively, at the end of HBOT. The value of the functional assessment of the limb was 7.0±2.0 and 4.3±2.4 (p<0.001), respectively, at the end of treatment. 79 cases were included in the end-of-treatment assessment. 23 cases (29%) were evaluated as large clinically significant response, 48 cases (61%) were evaluated as partial response with minimally important difference. The results showed larger clinical HBOT effect in cases of disease duration up to 3 and 6 months (p=0.029). Conclusions: The majority of patients improved pain and functional state of the affected limb. Our data also suggests the sooner after diagnosis of CRPS is HBOT started, the treatment has larger clinical effect. There was no serious HBOT-related complication or injury.
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Síndromes de Dolor Regional Complejo , Oxigenoterapia Hiperbárica , Humanos , Oxigenoterapia Hiperbárica/métodos , Estudios Retrospectivos , Femenino , Masculino , Síndromes de Dolor Regional Complejo/terapia , Persona de Mediana Edad , Adulto , Resultado del Tratamiento , Anciano , Dimensión del DolorRESUMEN
OBJECTIVE: To systematically review the clinical efficacy (pain, function, quality of life) and safety of platelet-rich plasma (PRP) in the treatment of frozen shoulder through meta-analysis, and provide evidence-based medical evidence for the effectiveness of PRP in the treatment of frozen shoulder. METHODS: A search was conducted on international databases (Pubmed, Web of science, Embase) and Chinese databases (CNKI, Wanfang, VIP) to search the clinical studies on the efficacy of platelet-rich plasma in treating frozen shoulder (adhesive capsulitis/periarthritis/50 shoulder) and their corresponding references published from inception until January 2024. Thoroughly excluded literature not meeting the predetermined inclusion criteria, extracted relevant data from the literature, and input it into RevMan5.4 for meta-analysis. RESULTS: This study ultimately included 14 RCTs, with a total of 1024 patients. The results showed that PRP has significant advantages compared with control groups in VAS (mean difference (MD) =-0.38, 95% confidence interval(CI)(-0.73, -0.03), P = 0.03), UCLA (MD = 3.31, 95% CI (1.02,5.60),P = 0.005), DASH (MD = -4.94,95% CI (-9.34, -0.53),P = 0.03), SPADI (SPADI Total: MD =-16.87, 95% CI (-22.84, -10.91), P < 0.00001; SPADI Pain: MD =-5.38, 95% CI (-7.80, -2.97), P < 0.0001; SPADI Disability: MD =-11.00, 95% CI (-13.61,-8.39), P < 0.00001), and the active and passive Range of Motion (active flexion: MD = 12.70, 95% CI (7.44, 17.95), P < 0.00001; passive flexion: MD = 9.47, 95% CI(3.80, 15.14), P = 0.001; active extension: MD = 3.45, 95% CI(2.39, 4.50), P < 0.00001; active abduction: MD = 13.54, 95% CI(8.42, 18.67), P < 0.00001; passive abduction: MD = 14.26, 95% CI (5.97, 22.56), P = 0.0008; active internal rotation: MD = 5.16, 95% CI (1.84, 8.48), P = 0.002; passive internal rotation: MD = 3.65, 95% CI(1.15, 6.15), P = 0.004; active external rotation: MD = 10.50, 95% CI(5.47, 15.53), P < 0.0001; passive external rotation: MD = 6.00, 95% CI (1.82, 10.19), P = 0.005) except passive extension (MD = 2.25, 95% CI (-0.77, 5.28), P = 0.14). In terms of safety, most studies reported no adverse effects, and only one study reported common complications of joint puncture such as swelling and pain after treatment in both PRP and control groups. Previous studies have shown a risk of osteonecrosis caused by corticosteroids. Therefore, the safety of PRP treatment is more reliable. CONCLUSION: The results showed that PRP was more durable and safer than corticosteroids and other control groups in the treatment of frozen shoulder. STUDY DESIGN: Systematic review. TRIAL REGISTRATION: PROSPERO CRD42022359444, date of registration: 22-09-2022.
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Bursitis , Plasma Rico en Plaquetas , Ensayos Clínicos Controlados Aleatorios como Asunto , Rango del Movimiento Articular , Humanos , Bursitis/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Resultado del Tratamiento , Calidad de Vida , Articulación del Hombro/fisiopatología , Dolor de Hombro/terapia , Dimensión del DolorRESUMEN
BACKGROUND: Thoracoscopic-guided thoracic paravertebral nerve block (TG-TPVB) and thoracoscopic-guided intercostal nerve block (TG-INB) are two postoperative analgesia technology for thoracic surgery. This study aims to compared the analgesic effect of TG-TPVB and TG-INB after uniportal video-asssited thoracic surgery (UniVATS). METHODS: Fifty-eight patients were randomly allocated to the TG-TPVB group and the TG-INB group. The surgical time of nerve block, the visual analog scale (VAS) scores, the consumption of sufentanil and the number of patient-controlled intravenous analgesic (PCIA) presses within 24 h after surgery, the incidence of adverse reactions were compared between the two groups. RESULTS: The VAS scores were significantly lower during rest and coughing at 2, 6, 12, and 24 h in the TG-TPVB group than in the TG-INB group (P < 0.05). The consumption of sufentanil and the number of PCIA presses within 24 h after surgery were significantly lower in the TG-TPVB group than in the TG-INB group (P < 0.001).The surgical time of nerve block was significantly shorter in the TG-TPVB group than in the TG-INB group (P < 0.001). The incidence of bleeding at the puncture point was lower in the TG-TPVB group than that in the TG-INB group (P < 0.05). CONCLUSION: TG-TPVB demonstrated superior acute pain relieve after uniVATS, shorter surgical time and non-inferior adverse effects than TG-INB.
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Nervios Intercostales , Bloqueo Nervioso , Dolor Postoperatorio , Cirugía Torácica Asistida por Video , Humanos , Femenino , Masculino , Bloqueo Nervioso/métodos , Dolor Postoperatorio/prevención & control , Dolor Postoperatorio/etiología , Persona de Mediana Edad , Cirugía Torácica Asistida por Video/métodos , Cirugía Torácica Asistida por Video/efectos adversos , Estudios Prospectivos , Estudios de Seguimiento , Anciano , Pronóstico , Adulto , Toracoscopía/métodos , Toracoscopía/efectos adversos , Dimensión del DolorRESUMEN
STUDY DESIGN: A technical note and retrospective case series. OBJECTIVE: Highly upward-migrated lumbar disc herniation (LDH) is challenging due to its problematic access and incomplete removal. The most used interlaminar approach may cause extensive bony destruction. We developed a novel translaminar approach using the unilateral portal endoscopic (UBE) technique, emphasizing effective neural decompression, and preserving the facet joint's integrity. METHODS: This retrospective study included six patients receiving UBE translaminar discectomy for highly upward-migrated LDHs from May 2019 to June 2021. The migrated disc was removed through a small keyhole on the lamina of the cranial vertebra. The treatment results were evaluated by operation time, hospital stays, complications, visual analog scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA) score, and modified MacNab criteria. RESULTS: The mean pre-operative VAS for back pain (5.0 ± 4.9), VAS for leg pain (9.2 ± 1.0), JOA score (10.7 ± 6.6), and ODI (75.7 ± 25.3) were significantly improved to 0.3 ± 0.5, 1.2 ± 1.5, 27.3 ± 1.8, 5.0 ± 11.3 respectively at the final follow-up. Five patients had excellent, and one patient had good outcomes according to the Modified MacNab criteria. The hospital stay was 2.7 ± 0.5 days. No complication was recorded. The MRI follow-up showed complete disc removal, except for one patient with an asymptomatic residual disc. CONCLUSIONS: UBE translaminar discectomy is a safe and effective minimally invasive procedure for highly upward-migrated LDH with satisfactory treatment outcomes and nearly 100% facet joint preservation.
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Discectomía , Endoscopía , Desplazamiento del Disco Intervertebral , Vértebras Lumbares , Humanos , Desplazamiento del Disco Intervertebral/cirugía , Desplazamiento del Disco Intervertebral/diagnóstico por imagen , Masculino , Estudios Retrospectivos , Femenino , Persona de Mediana Edad , Vértebras Lumbares/cirugía , Vértebras Lumbares/diagnóstico por imagen , Resultado del Tratamiento , Adulto , Endoscopía/métodos , Discectomía/métodos , Anciano , Dimensión del DolorRESUMEN
BACKGROUND: Breakthrough cancer pain (BTcP) has a negative impact on patients' quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25µg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients. METHODS: The trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30). RESULTS: A total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p < 0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs. CONCLUSION: Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.
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Analgésicos Opioides , Dolor Irruptivo , Dolor en Cáncer , Fentanilo , Humanos , Fentanilo/uso terapéutico , Fentanilo/farmacología , Fentanilo/administración & dosificación , Método Doble Ciego , Masculino , Persona de Mediana Edad , Femenino , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Dolor Irruptivo/tratamiento farmacológico , Dolor Irruptivo/etiología , Anciano , Dolor en Cáncer/tratamiento farmacológico , Adulto , Administración por Inhalación , Estudios Cruzados , Dimensión del Dolor/métodos , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
RATIONALE: Central neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot study has shown its potential in SCI neuropathic pain patients. OBJECTIVE: The aim of this study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain. STUDY DESIGN: Multicenter, Randomized, Comparative, Placebo controlled, Double blind clinical trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients. STUDY POPULATION: ⢠Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments. ⢠> 18 years. INTERVENTION: Intrathecal administration of ziconotide via an implanted pump. STUDY OUTCOMES: Primary study outcome Difference in pain intensity for all patients between effective treatment and placebo periods. Secondary study outcomes 1. Continuous evaluation of pain intensity. 2. Percentage of patients with at least 30% of pain reduction. 3. Satisfaction level of the patient pain relief. 4. Declarations of serious adverse events. 5. Duration and intensity of spontaneous and provoked pain. 6. Quality of life. 7. Patient global impression of change. 8. Quantification of daily dosages of analgesic drug intake. 9. Long term memory and neurocognitive effects. 10. Assessment of the patient's physical and emotional distress. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints. A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.
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Estudios Cruzados , Inyecciones Espinales , Neuralgia , Dimensión del Dolor , Traumatismos de la Médula Espinal , omega-Conotoxinas , Humanos , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/uso terapéutico , Método Doble Ciego , Neuralgia/tratamiento farmacológico , Neuralgia/etiología , Neuralgia/diagnóstico , omega-Conotoxinas/administración & dosificación , omega-Conotoxinas/efectos adversos , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Traumatismos de la Médula Espinal/complicaciones , Factores de Tiempo , Resultado del Tratamiento , Estudios Multicéntricos como AsuntoRESUMEN
BACKGROUND: The use of self-report pain scales in persons with aphasia can be challenging due to communication and cognitive problems, while for assessing pain self-report pain is considered the gold standard (Harrison RA, Field TS. Post stroke pain: identification, assessment, and therapy. Cerebrovasc Dis. 2015;39(3-4):190-201.). An observational scale may be used as an alternative. This study examines the validity and reliability of the observational Pain Assessment in Impaired Cognition (PAIC15) scale in persons with aphasia. METHODS: Persons with aphasia were observed during rest and transfer by two observers using the PAIC15. The PAIC15 comprises 15 items covering the three domains of facial expressions, body movements, and vocalizations. When able, the participant completed four self-report pain scales after each observation. The observations were repeated within one week. For criterion validity, correlations between the PAIC15 and self-report pain scales were calculated and for construct validity, three hypotheses were tested. Reliability was determined by assessing internal consistency, and intra- and interobserver agreement. RESULTS: PAIC15 observations were obtained for 71 persons (mean age 75.5 years) with aphasia. Fair positive correlations (rest: 0.35-0.50; transfer: 0.38-0.43) were reported between PAIC15 and almost all self-report pain scales. Results show that significantly more pain was observed in persons with aphasia during transfer than during rest. No differences were found for observed pain between persons with aphasia who use pain medication and those without, or persons who have joint diseases compared to those without. Results showed acceptable internal consistency. Intra- and interobserver agreement was high for most PAIC15 items, particularly for the domains body movements and vocalizations during rest and transfer. CONCLUSIONS: Recognition of pain in persons aphasia using the PAIC15 showed mixed yet promising results.
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Afasia , Dimensión del Dolor , Humanos , Afasia/diagnóstico , Afasia/etiología , Afasia/psicología , Femenino , Masculino , Anciano , Reproducibilidad de los Resultados , Dimensión del Dolor/métodos , Dimensión del Dolor/normas , Anciano de 80 o más Años , Persona de Mediana Edad , Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/psicología , Disfunción Cognitiva/etiología , Autoinforme/normas , Dolor/diagnóstico , Dolor/psicología , Dolor/etiología , Expresión FacialRESUMEN
OBJECTIVE: It is known that neuropathic pain frequently accompanies rheumatological diseases. In this study, neuropathic pain in Ankylosing Spondylitis(AS) and its relationship with disease activity were investigated. METHODS: Forty patients with AS were included. Laboratory data and disease status parameters were recorded. Neuropathic pain questionnaires were administered. Electrophysiological examination was performed on all patients. The relationship between neuropathic pain and disease activity parameters was investigated. RESULTS: According to the Pain Detect and LANSS questionnaire results, the rate of neuropathic pain was 57.5% and 42.5%. ASQoL, BASDAI, and ASDAS-ESH parameters are statistically significantly higher in the group with neuropathic pain according to the PainDetect (p:0.018, p:0.04, p:0.028). MASES, ASQoL, BASDAI, BASFI, and ASDAS-ESH parameters are statistically significantly higher in the group with neuropathic pain according to the LANSS (p:0.004, p:0.005, p: 0.001, p:0.005, p:0.02). Disease activity is higher in patients with neuropathic pain for both scales. Peripheral neuropathy is detected in nine patients. There is a positive correlation between disease activity parameters and neuropathic pain scales. A strong positive correlation was detected between ASQoL and BASDAI parameters and the Pain Detect questionnaire (r:0.533, r:0.606). CONCLUSIONS: The majority of patients with AS have a neuropathic pain. This condition is associated with high disease activity and adversely affects the patient's quality of life.
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Neuralgia , Espondilitis Anquilosante , Humanos , Neuralgia/etiología , Neuralgia/diagnóstico , Neuralgia/fisiopatología , Espondilitis Anquilosante/complicaciones , Espondilitis Anquilosante/fisiopatología , Masculino , Femenino , Estudios Transversales , Adulto , Persona de Mediana Edad , Dimensión del Dolor/métodos , Encuestas y Cuestionarios , Calidad de VidaRESUMEN
Background: Fibromyalgia (FMS) is a common musculoskeletal disorder with many causes. People with fibromyalgia often have the same symptoms as people with celiac disease (CD). Demonstration of the coordination and frequency of FMS and CD is important for effective treatment. Methods: This is a single center cross-sectional clinical study. The study included 60 patients who were diagnosed with CD by the Gastroenterology Clinic based on American College of Gastroenterology (ACG) criteria. Patients were also asked to complete the Widespread Pain Index (WPI), Symptom Severity Scale (SSS), and Fibromyalgia Impact Questionnaire (FIQ) to diagnose fibromyalgia and assess its severity. The results were used to analyze the frequency of concomitance and relationship between the two diseases. Results: The relationship between the clinical types of CD and the presence of fibromyalgia was insignificant. Analysis of the relationship between the pathologic typing of biopsy and fibromyalgia frequency was insignificant. Those with antibodies more frequently met criteria for fibromyalgia (P = 0.04, P = 0.04, respectively). Conclusions: Presence of clinical extraintestinal manifestations in patients with CD should lead clinicians to consider FMS as a possible diagnosis. This points to the importance for clinicians in all subspecialties to be aware of the various symptoms and diseases associated with FMS.
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Enfermedad Celíaca , Fibromialgia , Índice de Severidad de la Enfermedad , Humanos , Fibromialgia/diagnóstico , Fibromialgia/epidemiología , Estudios Transversales , Enfermedad Celíaca/diagnóstico , Enfermedad Celíaca/patología , Enfermedad Celíaca/complicaciones , Femenino , Masculino , Adulto , Persona de Mediana Edad , Encuestas y Cuestionarios , Dimensión del Dolor/métodosRESUMEN
INTRODUCTION: surgical pain is managed with multi-modal anesthesia in total knee arthroplasty (TKA). It is dubious whether including local infiltrative anaesthesia (LIA) before wound closure provides adequate pain control and decreases morbidity. MATERIAL AND METHODS: this was a retrospective conducted to assess postoperative pain control, morbidity index, and opioid consumption in 116 patients who underwent TKA and were divided into two groups based on LIA (Modified Ranawat Regimen) or normal saline infiltration in the wound. RESULTS: the mean NRS score was significantly lower in LIA group (3.2) as compared to the control group (3.9) in the first 24 hours. Functional milestones were relatively achieved earlier in LIA group but the values were not significant. Tramadol consumption was remarkably higher in the control group as compared to LIA group on day 1 and 2. As per the morbidity index the mean score on day one was 16.18 and 23.40 which decreased to 6.37 and 9.21 by day three in LIA and control group respectively indicating morbidity has decreased but more so in LIA group. CONCLUSION: our study concludes that use of modified cocktail regimen in the knee effectively decreased morbidity with excellent to good results, declining NRS score, minimal rescue analgesia requirement, early ambulation with better safety.
INTRODUCCIÓN: el dolor quirúrgico se trata con anestesia multimodal en la artroplastia total de rodilla (ATR). Es dudoso que incluir anestesia local infiltrativa (LIA) antes del cierre de la herida proporcione un control adecuado del dolor y disminuya la morbilidad. MATERIAL Y MÉTODOS: se realizó una retrospectiva para evaluar el control del dolor posoperatorio, el índice de morbilidad y el consumo de opioides en 116 pacientes sometidos a ATR y se dividieron en dos grupos según el LIA (régimen de Ranawat modificado) o la infiltración de solución salina normal en la herida. RESULTADOS: la puntuación media NRS fue significativamente menor en el grupo LIA (3.2) en comparación con el grupo control (3.9) en las primeras 24 horas. Los hitos funcionales se alcanzaron relativamente antes en el grupo LIA, pero los valores no fueron significativos. El consumo de tramadol fue notablemente mayor en el grupo de control en comparación con el grupo de LIA los días 1 y 2. Según el índice de morbilidad, la puntuación media el día uno fue 16.18 y 23.40, que disminuyó a 6.37 y 9.21 en el día tres en el grupo de LIA y control, respectivamente, lo que indica que la morbilidad ha disminuido, pero más en el grupo LIA. CONCLUSIÓN: nuestro estudio concluye que el uso de un régimen de cóctel modificado en la rodilla disminuyó efectivamente la morbilidad con resultados excelentes a buenos, una disminución de la puntuación NRS, un requisito mínimo de analgesia de rescate y una deambulación temprana con mayor seguridad.
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Anestésicos Locales , Artroplastia de Reemplazo de Rodilla , Dolor Postoperatorio , Humanos , Estudios Retrospectivos , Artroplastia de Reemplazo de Rodilla/métodos , Dolor Postoperatorio/tratamiento farmacológico , Dolor Postoperatorio/prevención & control , Femenino , Masculino , Persona de Mediana Edad , Anciano , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Centros de Atención Terciaria , Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/uso terapéutico , Anestesia Local/métodos , Resultado del Tratamiento , Tramadol/administración & dosificación , Tramadol/uso terapéutico , Dimensión del DolorRESUMEN
OBJECTIVE: To explore the efficacy and safety of combination therapy with methotrexate (MTX) plus hydroxychloroquine (HCQ) vs. MTX monotherapy in patients with rheumatoid arthritis (RA). METHODS: Sixty patients without prior RA treatments were randomly allocated in a 1:1 ratio to two groups: one receiving MTX plus HCQ, and the other receiving MTX monotherapy. We conducted a comparative analysis before and after the 12-week trial, evaluating the visual analogue scale (VAS), the disease activity score in 28 joints (DAS), serum inflammatory factor (including serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), as well as the outcome of the World Health Organization Quality of Life Brief Version questionnaire (WHOQOL-BREF) and the treatment-emergent adverse events (TEAEs) for all the participants in the study. RESULTS: At the 12th week of the trial, a more remarkable decrease in pain score (VAS), disease activity score (DAS), and serum inflammatory factor levels could be noticed in individuals on the combination therapy. The quality of life score was as well found to be higher in the MTX + HCQ group than the MTX monotherapy group. The incidence of adverse reactions in the MTX + HCQ and the MTX monotherapy groups were 10.00% and 6.67%, respectively. However, no statistical significance could be observed (p > .05). CONCLUSION: In our study, both the MTX + HCQ combination therapy and MTX monotherapy demonstrated improvements in symptoms, conditions and quality of life for patients with RA. Notably, the combination therapy could achieve better outcomes across all indices compared to MTX monotherapy, highlighting its potential as the optimal first-line treatment for RA. © 2024 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.
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Antirreumáticos , Artritis Reumatoide , Quimioterapia Combinada , Hidroxicloroquina , Metotrexato , Calidad de Vida , Humanos , Metotrexato/efectos adversos , Metotrexato/administración & dosificación , Metotrexato/uso terapéutico , Hidroxicloroquina/efectos adversos , Hidroxicloroquina/administración & dosificación , Hidroxicloroquina/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/sangre , Femenino , Antirreumáticos/efectos adversos , Antirreumáticos/administración & dosificación , Antirreumáticos/uso terapéutico , Masculino , Resultado del Tratamiento , Persona de Mediana Edad , Adulto , Factores de Tiempo , Dimensión del Dolor , Biomarcadores/sangre , Anciano , Mediadores de Inflamación/sangreRESUMEN
Objective: Complex regional pain syndrome (CRPS) represents a rare complication following injury to a limb. The DASH questionnaire (disability of arm, shoulder, and hand) evaluates everyday arm function. We assessed the DASH and its subitems in comparison to patients with brachial plexus lesions or fracture controls, analysed it over time, and in relation to active range of motion (ROM), to determine patients' impairment and trajectory. Methods: The dataset included 193 patients with upper extremity CRPS from the noncoding RNA (ncRNA) Pain cohort, 36 fracture controls, and 12 patients with traumatic brachial plexus lesions. For the clinical and psychological characterisation, questionnaires and a goniometer for the measurement of ROM were utilized. Thirty-three patients were followed up after approximately 2.5 years of guideline treatment. Results: CRPS patients had a similar mean DASH of 54.7 (standard deviation (S.D.) ±21) as brachial plexus lesion patients (M = 51.4, S.D. ± 16.1) but different significantly from fracture controls (M = 21.2, S.D. ± 21.1). Pain and older age were predictors of the DASH. Activities requiring force or impact on the arm, shoulder, or hand were mostly affected in patients with CRPS. After 2.5 years of standard treatment, the mean DASH score fell to 41.3 (S.D. ± 25.2), weakness in leisure activities was recuperated, pain feelings were lessened, and ROM, e.g., wrist flexion, recovered by 36°. Two-thirds of patients improved in both the DASH and the ROM. Conclusions: CRPS is as disabling as a complete loss of arm function in brachial plexus lesions and exhibits only partial recovery. Developing QuickDASH versions for CRPS patients could reduce the load of questions in clinical studies. It would be prudent to consider the unexpected age dependency of the DASH in future studies. This trial is registered with DRKS00008964.
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Síndromes de Dolor Regional Complejo , Rango del Movimiento Articular , Extremidad Superior , Humanos , Femenino , Masculino , Síndromes de Dolor Regional Complejo/fisiopatología , Síndromes de Dolor Regional Complejo/diagnóstico , Persona de Mediana Edad , Extremidad Superior/fisiopatología , Adulto , Estudios Retrospectivos , Anciano , Rango del Movimiento Articular/fisiología , Evaluación de la Discapacidad , Encuestas y Cuestionarios , Adulto Joven , Dimensión del Dolor/métodosRESUMEN
AIM: Pain and anxiety levels in palliative care patients negatively impact their quality of life, highlighting the need for research on non-pharmacological methods. This study aimed to evaluate the effects of music and aromatherapy interventions on pain, anxiety, and stress levels in these patients. MATERIAL AND METHODS: The research was designed as a single-blind, four-group, randomized controlled trial. The sample consisted of 88 patients hospitalized in a palliative care center (receiving palliative care services with terminal or advanced diseases). Patients were randomly assigned to four groups (n = 22, music, aromatherapy, music and aromatherapy, and control group). Patients in the experimental groups received the intervention to which they were assigned for 20 min each day for three consecutive days: music, aromatherapy, or music accompanied by aromatherapy. No intervention was applied to the control group. The patients' levels of pain, anxiety, and stress were assessed before and after the intervention using the Visual Analog Scale (VAS), the Facial Anxiety Scale (FAS), and the Distress Thermometer. RESULTS: No significant differences were found in the demographic characteristics of the groups (p > 0.05). The Wilcoxon Signed-Rank and Kruskal-Wallis tests indicated statistically significant differences in pre- and post-intervention scores for VAS, FAS, and Distress across all experimental groups on all follow-up days (p < 0.05). CONCLUSION: Implementing music, aromatherapy, and their combination effectively reduced pain, anxiety, and stress levels in palliative care patients, suggesting these non-pharmacological interventions can improve their quality of life. TRIAL REGISTRATION: ClinicalTrails.gov (Registration number: NCT06024954) at 05-SEP-2024.