Primary studies included in this systematic review

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8 articles (8 References) Revert Studify

Primary study

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Comparison between intra-articular Botulinum toxin type a, corticosteroid, and saline in knee osteoarthritis: A randomized controlled trial.

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Journal Clinical rehabilitation
Year 2019
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This article is included in 2 Systematic reviews Systematic reviews (2 references)

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OBJECTIVE: To compare the effectiveness of intra-articular injection (IAI) with Botulinum toxin type A (BTA), triamcinolone hexacetonide (TH), and saline in primary knee osteoarthritis. DESIGN: A randomized controlled trial, with blinded patients and assessor. SETTING: Outpatient rheumatology service. Subjects: Patients with knee osteoarthritis grades II and III. INTERVENTIONS: Patients received IAI with 100 IU BTA, 40 mg TH, or isotonic saline solution (SS) 0.9%. Main measures: Patients were assessed at baseline and at 4, 8, and 12 weeks with the following instruments: visual analog scale for pain during movement (VASm; primary outcome) and visual analog scale for pain at rest (VASr), Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, 6-minute walk test, Timed Up and Go test, Short Form (SF)-36 questionnaire, range of motion of knee, and ultrasound (US) measurement of synovial hypertrophy. RESULTS: In total, 105 patients were randomized, with 35 in each group; 96 were female (91.4%) and 9 were male (8.6%), with a mean age of 64.2 years (± 6.9). At 12 weeks, the TH group showed better results only for VASm. At four weeks, the TH group showed better results than the BTA and SS groups for VASm (–68.9% (37.8) vs. –35.3% (40.3) vs. –35.9% (51.4)), WOMAC pain (–56.0% (30.7) vs. –30.8% (34.3) vs. –30.0% (39.9)), WOMAC stiffness (–53.4% (38.4) vs. –17.2% (59.3) vs. –17.3% (78.1)), WOMAC function (–48.2% (34.6) vs. 30.8% (33.6) vs. –13.6% (64.9)), WOMAC total score (–51.2% (31.0) vs. –30.9% (30.0) vs. –18.8% (54.8)), and US measurement of synovial hypertrophy (–11.6% (44.9) vs. –1.5% (47.9) vs. + 28.6% (81.3)). CONCLUSION: IAI with TH had a higher effectiveness than that with TBA or SS in the short-term assessment (four weeks) for pain in movement, WOMAC, and US measurement of synovial hypertrophy. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Primary study

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Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis

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Journal Arthritis & rheumatology (Hoboken, N.J.)
Year 2018
Links Pubmed DOI PubMed Central

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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Objective: FX006 is a novel, microsphere-based, extended-release formulation of triamcinolone acetonide for intraarticular (IA) injection designed to maintain treatment concentration in the joint and provide prolonged analgesic benefits in patients with osteoarthritis (OA) of the knee. This study was undertaken to compare the analgesic benefits of 2 FX006 doses with saline placebo injection. Methods: In this phase IIb study, participants with knee OA (Kellgren/Lawrence grade 2–3) and average daily pain (ADP) intensity ≥5 to ≤9 (on a 0–10 Numerical Rating Scale) were randomized (1:1:1) to receive single IA injections of FX006 32 mg (n = 104) or 16 mg (n = 102) or saline placebo (n = 100). The primary end point was the least squares mean (LSM) change from baseline to week 12 in weekly mean ADP intensity scores for FX006 32 mg versus saline placebo. Results: The primary end point was not met (LSM change at week 12 −3.1 with FX006 32 mg versus −2.5 with saline placebo; LSM difference [95% confidence interval] −0.58 [−1.22, 0.07]) (P = 0.08). However, improvements in ADP intensity were significantly greater with FX006 32 mg than saline placebo at weeks 1–11 and week 13. Improvements in ADP intensity were significantly greater with FX006 16 mg versus saline placebo at weeks 1–9. A dose-response effect in duration of maximal analgesic effect was evident (13 weeks with 32 mg versus 9 weeks with 16 mg), with FX006 32 mg providing increased therapeutic benefit relative to FX006 16 mg. All treatments were well tolerated. Conclusion: Although the primary end point was not met, our findings indicate a prolonged reduction in symptoms with FX006 with an evident dose response and a safety profile similar to saline placebo.

Primary study

Unclassified

Effects of a Single Intra-Articular Injection of a Microsphere Formulation of Triamcinolone Acetonide on Knee Osteoarthritis Pain: A Double-Blinded, Randomized, Placebo-Controlled, Multinational Study.

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Journal The Journal of bone and joint surgery. American volume
Year 2018
Links Pubmed DOI PubMed Central

This article is included in 3 Systematic reviews Systematic reviews (3 references)

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<b>BACKGROUND: </b>Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs.<b>METHODS: </b>In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit.<b>RESULTS: </b>The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: -3.12 versus -2.14; p &lt; 0.0001) indicating ∼50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p &lt; 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ≤ 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments.<b>CONCLUSIONS: </b>FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point).<b>LEVEL OF EVIDENCE: </b>Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Primary study

Unclassified

Evaluation of the benefit of corticosteroid injection before exercise therapy in patients with osteoarthritis of the knee: a randomized clinical trial.

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Journal JAMA internal medicine
Year 2015
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This article is included in 6 Systematic reviews Systematic reviews (6 references) 1 Broad synthesis Broad syntheses (1 reference)

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IMPORTANCE: Osteoarthritis (OA) of the knee is the most frequent form of arthritis and a cause of pain and disability. Combined nonpharmacologic and pharmacologic treatments are recommended as the optimal treatment approach, but no evidence supports the recommendation. OBJECTIVE: To assess the clinical benefits of an intra-articular corticosteroid injection given before exercise therapy in patients with OA of the knee. DESIGN, SETTING, AND PARTICIPANTS: We performed a randomized, blinded, placebo-controlled clinical trial evaluating the benefit of intra-articular corticosteroid injection vs placebo injection given before exercise therapy at an OA outpatient clinic from October 1, 2012, through April 2, 2014. The participants had radiographic confirmation of clinical OA of the knee, clinical signs of localized inflammation in the knee, and knee pain during walking (score >4 on a scale of 0 to 10). INTERVENTIONS: Participants were randomly allocated (1:1) to an intra-articular 1-mL injection of the knee with methylprednisolone acetate (Depo-Medrol), 40 mg/mL, dissolved in 4 mL of lidocaine hydrochloride (10 mg/mL) (corticosteroid group) or a 1-mL isotonic saline injection mixed with 4 mL of lidocaine hydrochloride (10 mg/mL) (placebo group). Two weeks after the injections, all participants started a 12-week supervised exercise program. MAIN OUTCOMES AND MEASURES: The primary outcome was change in the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (range, 0-100; higher scores indicate greater improvement) at week 14. Secondary outcomes included the remaining KOOS subscales and objective measures of physical function and inflammation. Outcomes were measured at baseline, week 2 (exercise start), week 14 (exercise stop), and week 26 (follow-up). RESULTS: One hundred patients were randomized to the corticosteroid group (n = 50) or the placebo group (n = 50); 45 and 44 patients, respectively, completed the trial. The mean (SE) changes in the KOOS Pain subscale score at week 14 were 13.6 (1.8) and 14.8 (1.8) points in the corticosteroid and placebo groups, respectively, corresponding to a statistically insignificant mean difference of 1.2 points (95% CI, -3.8 to 6.2; P = .64). We found no statistically significant group differences in any of the secondary outcomes at any time point. CONCLUSIONS AND RELEVANCE: No additional benefit results from adding an intra-articular injection of 40 mg of corticosteroid before exercise in patients with painful OA of the knee. Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments. TRIAL REGISTRATION: clinicaltrialsregister.eu Identifier: 2012-002607-18; clinicaltrials.gov Identifier: NCT01945749.

Primary study

Unclassified

Efficacy comparisons of the intraarticular steroidal agents in the patients with knee osteoarthritis.

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Journal Rheumatology international
Year 2012
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This article is included in 8 Systematic reviews Systematic reviews (8 references) 1 Broad synthesis Broad syntheses (1 reference)

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Osteoarthritis is a chronic disease that causes serious pain and limitations in activities. Intraarticular corticosteroid injections combined with pharmacological treatment and physiotherapy have been used for years to control the local inflammation and relieve pain in the patients with osteoarthritis. There are several animal experiments which suggested that the intraarticular corticosteroid injections impair cartilage protein synthesis. However, there are no serious evidences suggesting the increase of cartilage impairment. The aim of our study was to compare the efficacy of placebo and intraarticular corticosteroid agents in the patients with symptomatic knee osteoarthritis. One hundred and twenty patients with painful knee osteoarthritis were included in the prospective, randomized, controlled study. The patients were randomized into four groups. Each group consisted of thirty patients. Intraarticular single dose of methylprednisolone acetate (40 mg, 1 ml), Betametazone disodium phosphate (3 mg, 1 ml), Triamsinolon acetonate (40 mg, 1 ml), and serum physiological (0.09% NaCl, 1 ml) were administrated to the groups, respectively. The patients were evaluated by Visual Analog Scale (0-10 cm [VAS]) for the pain severity, and by Lequesne Functional Index for functional state before treatment, and at the 1st, 3rd, 6th, and 12th weeks. Our results showed that single doses of three agents provided symptomatic and functional relief and their effects reduced at the 12th week. However, methylprednisolone acetate was a statistically more effective analgesic as compared to the other agents until the sixth week.

Publication Thread

Chao, J, Chao J

This thread includes 2 references

Primary study

Unclassified

Effects of joint lavage and steroid injection in patients with osteoarthritis of the knee: results of a multicenter, randomized, controlled trial.

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Journal Arthritis and rheumatism
Year 1999
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This article is included in 13 Systematic reviews Systematic reviews (13 references) 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVE: To evaluate the efficacy of joint lavage and intraarticular steroid injection, alone and in combination, in the treatment of patients with symptomatic knee osteoarthritis (OA). METHODS: Ninety-eight patients with painful tibiofemoral OA were enrolled in a prospective, randomized, controlled, 2 x 2 factorial-design trial of 6 months' duration. The 4 treatment groups consisted of 1) intraarticular placebo (1.5 ml of 0.9% normal saline), 2) intraarticular corticosteroids (3.75 mg of cortivazol in 1.5 ml), 3) joint lavage and intraarticular placebo, and 4) joint lavage and intraarticular corticosteroid. Outcome measures evaluated at baseline, week 1, week 4, week 12, and week 24 included severity of pain (100-mm visual analog scale [VAS]), global status (100-mm VAS), and Lequesne's functional index. RESULTS: No interaction between steroid injection and joint lavage was demonstrated. Patients who had undergone joint lavage had significantly improved pain VAS scores at week 24 (P = 0.020). In contrast, corticosteroid injection had no long-term effect (P = 0.313); corticosteroid injection was associated with a decrease in pain only at week 1 (P = 0.003) and week 4 (P = 0.020). After week 4, Lequesne's functional index was not significantly improved regardless of the assigned treatment. CONCLUSION: Compared with placebo, both treatments significantly relieved pain but did not improve functional impairment. The effects of the 2 treatments were additive. Cortivazol provided short-term relief of pain (up to week 4). The effects of joint lavage persisted up to week 24.

Primary study

Unclassified

Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response.

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Authors Gaffney K , Ledingham J , Perry JD
Journal Annals of the rheumatic diseases
Year 1995
Links Pubmed DOI PubMed Central

This article is included in 14 Systematic reviews Systematic reviews (14 references) 2 Broad syntheses Broad syntheses (2 references)

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OBJECTIVE: To assess the efficacy of a single intra-articular injection of triamcinolone hexacetonide (THA) in knee osteoarthritis (OA) and examine factors which may relate to treatment efficacy. METHODS: Eighty four patients with clinical and radiographic evidence of knee OA were recruited and randomly allocated to receive either THA (20 mg in 1 ml) or placebo (0.9% normal saline, 1 ml). Follow up assessments evaluated the following outcome variables: patient opinion of overall change in the treated knee, visual analogue pain score (VAS), distance walked in one minute (WD), and Health Assessment Questionnaire modified for lower limb function (HAQ). RESULTS: Seventy eight percent of THA and 49% of placebo treated patients reported overall improvement at week 1 (p < 0.05). At week 6, improvement was reported in 57% and 55% of patient groups, respectively. VAS improved in both groups at week 1 (THA, p < 0.001; placebo, p < 0.05) and week 6 (both p < 0.01). Improvement in VAS was significantly greater among THA treated patients at week 1 only (p < 0.01). Subgroup analysis of THA treated patients revealed greater improvement in VAS among patients with clinical evidence of an effusion (p < 0.05), and those who had synovial fluid successfully aspirated at the time of injection (p < 0.01). WD improved in THA treated patients at week 1 (p < 0.001), and in both groups at week 6 (THA, p < 0.001; placebo, p < 0.01). Improvements in HAQ were seen in THA patients only at weeks 1 and 6 (p < 0.05). Regression analysis did not identify any additional clinical, radiographic, or synovial fluid characteristics which influenced the response. CONCLUSIONS: THA provided short term pain relief in knee OA. Increased benefit was associated with both clinical evidence of joint effusion and successful aspiration of synovial fluid at the time of injection.