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Objective This study evaluates the efficacy of a novel mucoadhesive patch containing Nigella sativa 10% extract compared to triamcinolone 0.1% in alleviating symptoms and reducing lesion severity in patients with erosive‐atrophic oral lichen planus. Methods and Materials A pilot study comprising two groups, each with 10 patients, was conducted. The intervention group received mucoadhesive patches containing N. sativa 10% extract, while the control group received triamcinolone acetonide 0.1% patches. Pain and burning intensity, measured through visual analog scale, and lesion severity based on the Thongprasom scale were assessed weekly for 4 weeks. Descriptive records were kept for side effects and patient satisfaction. Results Pain and burning intensity decreased in both groups throughout the sessions, with the N. sativa group showing a greater reduction than the triamcinolone group. The reduction in burning intensity within each group was significant (p < .001), and there was a significant difference between groups only in the second session (p = .045). The overall difference between groups was not significant (p > .05). Lesion severity also decreased significantly in both groups (p < .001), with a significant difference between groups observed in the third session (p = .043) and overall throughout the study (p = .006). Conclusion The use of N. sativa extract in mucoadhesive patches was as effective as corticosteroids in reducing pain, burning, and lesion severity in patients with oral lichen planus, with N. sativa showing superior results in some sessions. Notably, no significant complications were observed with N. sativa use, making it a promising treatment option for lichen planus.

Triamcinolone acetonide extended-release (ER) 32 mg (Zilretta ® ) is approved in the USA for the management of osteoarthritis (OA) pain of the knee and is administered as a single, 5 mL intra-articular (IA) injection. Although the therapeutic effects from IA corticosteroids are typically short-lived, triamcinolone acetonide ER is formulated in poly (lactic-co-glycolic acid) (PLGA) microspheres that slowly release triamcinolone acetonide in the synovium, enabling their prolonged presence in the joint. This reduces systemic exposure and lessens corticosteroid-related systemic adverse reactions, such as blood glucose elevations. In a 24-week, randomized, phase III clinical trial, triamcinolone acetonide ER 32 mg significantly improved mean average daily pain intensity in patients with knee OA relative to placebo, and pain, stiffness and physical function (according to WOMAC criteria) relative to placebo and triamcinolone acetonide crystalline suspension (CS). Triamcinolone acetonide ER was generally well tolerated, with a tolerability profile similar to that of triamcinolone acetonide CS and placebo. Findings from a single-arm phase IIIb study indicated that a repeat administration of triamcinolone acetonide ER may be similarly efficacious to an initial injection without having deleterious effects on cartilage or other aspects of joint structure. Thus, triamcinolone acetonide ER expands the treatment options available for the management of OA pain of the knee.

Keloid scars are characterized by the excessive proliferation of fibroblasts and an imbalance between the production and degradation of collagen, leading to its buildup in the dermis. There is no “gold standard” treatment for this condition, and the recurrence is frequent after surgical procedures removal. In vitro studies have demonstrated that photobiomodulation (PBM) using the blue wavelength reduces the proliferation speed and the number of fibroblasts as well as the expression of TGF-β. There are no protocols studied and established for the treatment of keloids with blue LED. Therefore, the purpose of this study is to determine the effects of the combination of PBM with blue light and the intralesional administration of the corticoid triamcinolone hexacetonide on the quality of the remaining scar by Vancouver Scar Scale in the postoperative period of keloid surgery. A randomized, controlled, double-blind, clinical trial will be conducted involving two groups: 1) Sham (n = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and 2) active PBM combined with IAC (n = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid region in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 400 mW, 4J per point on 10 linear points). The patients will answer two questionnaires: one for the assessment of quality of life (Qualifibro-UNIFESP) and one for the assessment of satisfaction with the scar (PSAQ). The team of five plastic surgeons will answer the Vancouver Scar Scale (VSS). All questionnaires will be administered one, three, six, and twelve months postoperatively. The keloids will be molded in silicone prior to the onset of treatment and prior to excision to assess pre-treatment and post-treatment size. The same will be performed for the remaining scar at one, three, six, and twelve months postoperatively. The removed keloid will be submitted to histopathological analysis for the determination of the quantity of fibroblasts, the organization and distribution of collagen (picrosirius staining), and the genic expression of TGF-β (qPCR). All data will be submitted to statistical analysis. Trial registration: This study is registered in ClinicalTrials.gov (ID: NCT04824612 ).

BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).

ObjectivesGuidelines recommend intra-articular glucocorticoid injection in patients with painful hip osteoarthritis. However, intra-articular hip injection is an invasive procedure. The efficacy of systemic glucocorticoid treatment for pain reduction in hip osteoarthritis is unknown. This randomised, double-blind, trial assessed effectiveness in hip pain reduction of an intramuscular glucocorticoid injection compared with a placebo injection in patients with hip osteoarthritis.MethodsPatients with painful hip osteoarthritis were randomised to either 40 mg triamcinolone acetate or placebo with an intramuscular injection into the gluteus muscle. The primary outcomes were severity of hip pain at rest, during walking (0–10) and WOMAC pain at 2-week postinjection. We used linear mixed models for repeated measurements at 2, 4, 6 and 12 weeks for the intention-to-treat data analysis.ResultsOf the 107 patients randomised, 106 could be analysed (52 in the glucocorticoid group, 54 in the placebo group). At 2-week follow-up, compared with placebo injection, the intramuscular glucocorticoid injection showed a significant and clinically relevant difference in hip pain reduction at rest (difference −1.3, 95% CI −2.3 to −0.3). This effect persisted for the entire 12-week follow-up. For hip pain during walking, the effect was present at 4-week, 6-week and 12-week follow-ups, and for WOMAC pain the effect was present at 6-week and 12-week follow-up.ConclusionsAn intramuscular glucocorticoid injection showed effectiveness in patients with hip osteoarthritis on one of the three primary outcomes at 2-week postinjection. All primary outcomes showed effectiveness from 4 to 6 weeks, up to a 12-week follow-up.Trial registration numberNTR2966.

Background Recurrent Aphthous Stomatitis (RAS) is one of the most common lesions of the oral mucosa. Herbal medicine can be used for the treatment of this disease. The present study aimed to compare the effects of topical application of Sage (Salvizan) and triamcinolone acetonide gels on RAS. Methods This double-blind clinical study recruited sixty patients with minor aphthous ulcers. Half of the patients were treated with Salvizan gel, and the other half were treated with oral triamcinolone acetonide gel. The effect of Salvizan topical gel was evaluated and compared with that of oral triamcinolone acetonide gel. Factors such as Pain recovery time, wound healing time, and pain level was evaluated. Data were analyzed by SPSS version 22 using independent t-test, paired t-test, repeated measures ANOVA, and survival analysis, including Kaplan-Meier and Cox regression. Results The mean duration of pain recovery was 1.5 days for Salvizan and 2.5 days for triamcinolone acetonide ( p  < 0.001). Moreover, the duration of wound healing was 3.3 days for Salvizan and 6 days for triamcinolone acetonide ( p  < 0.001). Patients’ satisfaction from factors such as taste and smell had no significant difference between the two groups. Conclusion The results of this study showed that Salvizan gel is very effective in the treatment of RAS. It was significantly better than triamcinolone acetonide in the pain recovery and wound healing. These promising results favor herbal treatments and show that they can be used more commonly for treating diseases such as RAS. Trial registration This study was approved by the ethics committee of Isfahan University of Medical Sciences (IR.MUI.RESEARCH.REC.1399.834) on 17/03/2021. It was also registered in the Iranian Registry of Clinical Trials (IRCT20100202003251N7).

ObjectiveTo evaluate the effectiveness of intra-articular injections (IAIs) with triamcinolone hexacetonide (TH) combined with a progressive resistance exercise program (PREP) in improving pain, function, muscle strength, and quality of life in elderly patients with knee osteoarthritis (OA).MethodsFifty-nine elderly individuals with knee OA were randomized into three groups: IAI with TH (IAI-TH) + PREP, IAI with saline solution (IAI-SS) + PREP, and IAI with placebo + PREP. The IAIs were administered once, one week before starting PREP, which was performed twice weekly for 12 weeks. Outcomes assessed at baseline and at 2, 6, and 12 weeks post-IAI included pain (Numerical Pain Scale - NPS), swelling, function (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC), quality of life (Short Form-36 - SF-36), performance tests (Six-Minute Walk Test − 6MWT, Timed Up and Go Test - TUGT, Short Physical Performance Battery - SPPB), and muscle strength (one-repetition maximum test − 1RM). Due to the COVID-19 pandemic, only 15 participants per group completed the study protocol.ResultsAll groups showed significant intragroup improvements over time in pain, function, muscle strength, and quality of life. However, no statistically significant differences were found between the groups for any of the assessed outcomes. The bodily pain domain of the SF-36 and analgesic consumption were the only measures showing differences over time.ConclusionThe combination of IAI-TH and a 12-week PREP (twice weekly) was not superior to IAI-SS or placebo combined with the same PREP in improving pain, function, or quality of life in elderly patients with knee OA. These findings highlight the role of exercise as a key therapeutic strategy, regardless of prior IAI. Future studies with larger sample sizes and long-term follow-ups are needed to better assess the role of intra-articular corticosteroid injections in OA rehabilitation.Clinical trial numberensaiosclinicos.gov.br (RBR-556md5g). Registered 27 October 2022.

Background To evaluate the efficacy of subconjunctival triamcinolone injection for treating upper eyelid retraction caused by thyroid-associated ophthalmopathy (TAO). Methods Prospective single blind randomized clinical trial. Patients diagnosed with TAO-associated eyelid retraction and/or swelling <6 months before study onset were randomly assigned to triamcinolone-injected (group I; 55 patients, 75 eyes) or observation-only (group II; 40 patients, 59 eyes) populations. Group I received 1–3 injections of 20 mg triamcinolone acetate into the subconjunctival eyelid, between the conjunctiva and Muller’s muscle, at 3-week intervals. Group I was followed up at 3, 6, 9, and 24 weeks post-injection, and group II was evaluated at 9 and 24 weeks after initial visit. Eyelid swelling and retraction were each graded on a 0-3 scale. Treatment was stopped after 1–2 injections if both swelling and retraction resolved completely or if retraction and swelling scored 0/1 or 1/0 without functional or cosmetic patient concerns. Treatment success was defined at 9 and 24 weeks post-injection if eyelids were normal or when treatment was terminated because of early clinical resolution. We compared baseline clinical data between success and failure group evaluated at 9 and 24 weeks in group I, and investigated short-term and long-term success prognostic factor using multiple logistic regression analysis in each group I and II. Results Swelling and retraction decreased significantly more in group I than in group II. Significantly more eyes had severe swelling (≥ grade 2) in group I (67 %) than in group II (34 %) upon initial evaluation ( p  < 0.01); this difference disappeared at 9 and 24 weeks. Fewer severely retracted eyes were observed in group I than in group II at 9 and 24 weeks ( p  < 0.01). Significantly more eyes in group I achieved success at both 9 and 24 weeks (59 %, 75 %) than in group II (39 %, 57 %) ( p  = 0.03, p  = 0.04 respectively). Higher initial retraction grades (2–3) predicted a higher chance of post-injection failure versus the reference group (grade 0–1) at 9 and 24 weeks in group I, with adjusted odds ratios (aOR) 45.4 (95 % CI = 5.9–351.1, p  < 0.01) and aOR 11.6 (95 % CI = 2.3–58.5, p  < 0.01) respectively. Similarly in group II, initial retraction grade was associated with the failure at 9 and 24 weeks, with aOR 10.3 (95 % CI = 1.8–59.6, p  < 0.01) and aOR 5.9 (95 % CI = 1.3–25.9, p  < 0.05) respectively. Transient intraocular pressure elevation was observed in three eyes of two patients, although all ocular pressures were normalized within 1 month using anti-glaucoma medication. Conclusions Subconjunctival triamcinolone injections were very effective in resolving eyelid swelling and retraction in recent-onset TAO. However, the symptom-reducing effect of triamcinolone was modest and less effective in patients initially presenting with severe retraction grades. As intraocular pressure may rise after steroid injection at upper eyelid, the treatment should be avoided in patients suspected to have glaucoma.

AbstractObjectiveTo compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis.DesignPragmatic, three arm, parallel group, single blind, randomised controlled trial.SettingTwo community musculoskeletal services in England.Participants199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine.InterventionsBCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received.Main outcome measuresThe primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months.ResultsMean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference −1.43 (95% confidence interval −2.15 to −0.72), P<0.001; standardised mean difference −0.55 (−0.82 to −0.27). No difference in hip pain intensity over six months was reported between BCT plus ultrasound-triamcinolone-lidocaine compared with BCT plus ultrasound-lidocaine (−0.52 (−1.21 to 0.18)). The presence of ultrasound confirmed synovitis or effusion was associated with a significant interaction effect favouring BCT plus ultrasound-triamcinolone-lidocaine (−1.70 (−3.10 to −0.30)). One participant in the BCT plus ultrasound-triamcinolone-lidocaine group with a bioprosthetic aortic valve died from subacute bacterial endocarditis four months after the intervention, deemed possibly related to the trial treatment.ConclusionsUltrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis.Trial registrationEudraCT 2014-003412-37; ISRCTN50550256.