OBJECTIVE: Intraarticular (IA) corticosteroid injections are broadly used in knee osteoarthritis (OA); however, the best corticosteroid agent is not well defined. The aim of the present study was to compare the efficacy of triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections in knee OA.
METHODS: Patients with symptomatic knee OA and Kellgren-Lawrence grade II or III were randomized to receive 40 mg of IA TH or MA. Evaluations were performed at 4, 12, and 24 weeks. The primary outcome was a change in the patient's assessment of pain by visual analog scale from baseline to Week 4. Secondary outcomes included a global assessment of the disease by patients and physicians, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index (LI), and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of response. Generalized estimating equations were used in statistical analysis.
RESULTS: The intention-to-treat population included 100 patients; 50 in each study arm. A significant improvement in pain was observed at Week 4 for both groups (p < 0.0001), with no difference between them (p = 0.352). This improvement was sustained up to Week 24. A significant improvement from the baseline was observed for both the patient's and the physician's global assessments, WOMAC questionnaire, and LI, with no differences between the groups. Improvements in the secondary outcomes were sustained during the study. The OMERACT-OARSI criteria of response was achieved by 74% and 72% of patients in the TH and the MA groups, respectively.
CONCLUSION: Both IA therapies are equally effective, and improvement in pain and function can be sustained for up to 24 weeks. Controlled-trials.com identifier: ISRCTN15077843.
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.
<b>PURPOSE: </b>To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements.<b>METHODS: </b>This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (n = 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (n = 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (n = 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26.<b>RESULTS: </b>Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan -0.9 (-1.0, -0.7); 1 × 4 mL hylastan -0.8 (-0.9, -0.7); steroid -0.9 (-1.0, -0.8); all P < 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments.<b>CONCLUSIONS: </b>Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.
<b>BACKGROUND: </b>Intraarticular injections, mainly using long-lasting corticosteroid suspensions, have long been used to treat knee osteoarthritis. Viscosupplementation is a relatively new approach with injection of a variety of agents. When comparing viscosupplementation with intraarticular injections of corticosteroids from baseline to the fourth week, steroids have been more effective for pain relief. By the fourth week they provide similar relief, but beyond that viscosupplementation appears to provide greater pain reduction. The delayed onset of symptomatic improvement combined with reports of reactive synovitis may discourage physicians and patients.<b>Questions/purposes: </b>We therefore addressed three questions: Does the addition of triamcinolone to viscosupplementation (1) improve first-week pain and function compared with viscosupplementation alone, (2) diminish adverse effects of viscosupplementation alone, and (3) alter 6-month pain and function of viscosupplementation alone?<b>METHODS: </b>We prospectively enrolled 104 patients with knee osteoarthritis and randomized them to receive either a single intraarticular injection (6 mL) of hylan GF-20 (Group viscosupplementation [Group VS]), or a single intraarticular injection of hylan GF-20 (6 mL) and 1 mL (20 mg) of triamcinolone hexacetonide (Group VS + T). VAS, WOMAC™, and Lequesne questionnaires were completed at baseline and at Weeks 1, 4, 12, and 24.<b>RESULTS: </b>At Week 1 the WOMAC and VAS scores were lower in Group VS + T, compared with Group VS. There was no difference regarding the adverse effects. At Weeks 4, 12, and 24 there were no differences in the groups.<b>CONCLUSIONS: </b>The addition of triamcinolone hexacetonide improves first-week symptom and functional scores of viscosupplementation, but not beyond. It does not seem to increase the likelihood of adverse effects.<b>LEVEL OF EVIDENCE: </b>Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
Background Intra-articular injection is effective for osteoarthritis, but the best single injection strategy is not known, nor are there established predictors of response. The objectives of this study were to assess and predict response to a single ultrasound-guided injection in moderate to severe hip osteoarthritis. Methods: 77 hip osteoarthritis patients entered a prospective, randomised controlled trial, randomised to one of four groups: standard care (no injection); normal saline; non-animal stabilised hyaluronic acid (durolane) or methylprednisolone acetate (depomedrone). Main Outcome Measures Numerical rating scale (NRS 0-10) 'worst pain', Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain/function. Potential predictors of response (including radiographic severity, ultrasound synovitis and baseline symptom severity) were examined using univariate logistic regression analysis and Fisher's exact test. Results: NRS pain, WOMAC pain and function improved signifi cantly for the steroid arm alone. Effect sizes at week 1 were striking: NRS pain 1.5, WOMAC pain 1.9 and WOMAC function 1.3. Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society responder criteria identifi ed 22 responders (intention-to-treat): steroid 14 (74%; number needed to treat, two); saline, four (21%); durolane, two (11%); and no injection, two (10%; ?2 test between groups, p<0.001). Corticosteroid arm response was maintained over 8 weeks (summary measures analysis of variance, p<0.002 for NRS pain). Synovitis was a signifi cant predictor of response at weeks 4 and 8 (p<0.05, Fisher's exact test; week 4 OR 16.7, 95% CI 1.4 to 204). Conclusions: Ultrasound-guided corticosteroid injections are highly effi cacious; furthermore synovitis on ultrasound is a biomarker of response to injection.
OBJECTIVE: To assess whether inflammation on ultrasound is predictive of clinical response to intraarticular (IA) corticosteroid injections in patients with knee osteoarthritis (OA).
METHODS: Patients with symptomatic knee OA were randomized to receive either an IA injection of 40 mg triamcinolone acetonide in the treatment group or 1 cc 0.9% saline in the placebo group. Clinical response was assessed by changes in baseline Western Ontario and McMaster Universities (WOMAC) index scores and physician global assessment at 4 and 12 weeks. Ultrasounds were performed at each visit. Patients and assessors were blinded to treatment status.
RESULTS: Seventy-nine patients were enrolled into the study. Four-week data were available for 67 patients in the primary analysis comparing change in WOMAC pain score from baseline to 4 weeks. There was almost no change in the WOMAC pain subscale score from baseline to 4 weeks in the control group, but there was a significant improvement in WOMAC pain subscale score from 10.8 (SD +/- 3.2) at baseline to 8.75 (SD +/- 4.0) at 4 weeks in the treatment group (adjusted p = 0.001). Of the 34 patients in the treatment group; 16 (47%) had inflammatory disease and 18 (53%) had noninflammatory disease as determined by ultrasound. There was no difference in the change in WOMAC pain score between the inflammatory and noninflammatory patients in the treatment group at 4 weeks. There was a statistically significant greater improvement in pain subscale scores among noninflammatory patients than among inflammatory patients at 12 weeks.
CONCLUSION: Intraarticular corticosteroid injections are an effective short-term treatment for symptomatic knee OA compared to placebo. Patients with noninflammatory characteristics on ultrasound had a more prolonged benefit from IA corticosteroids compared to inflammatory patients.
OBJECTIVES: Patients with knee osteoarthritis (OA) often suffer pain that is not fully controlled by analgesics and often require intra-articular therapies. The aim of this study was to compare the benefits of intra-articular corticosteroid injections (CSIs) and tidal irrigation (TI) in patients with OA of the knee.
METHODS: We performed a dual-centre, single blind, randomised, parallel group trial comparing TI and CSI. Patients with knee OA were randomised to either irrigation using a 3.2mm arthroscope under local anaesthesia or an intra-articular injection of 40 mg triamcinolone acetonide and 1% lidocaine. Patients were followed for 6 months. The primary outcome measure was the Western Ontario and McMaster Universities OA Index total pain score (visual analogue scale, VAS).
RESULTS: One hundred and fifty patients were recruited of whom 71 received TI and 79 CSI. In both treatment groups, over 80% of patients reported improvement at 2 and 4 weeks. After this time, the benefit of CSI decreased whereas that of TI was maintained: at 26 weeks the pain relief afforded by TI was significantly greater than that of CSI. At 26 weeks 29% of the CSI group reported improvement vs 64% of the TI group (P<0.001). Patients with a knee effusion responded better to both treatments, however, this was most apparent for CSI. Patients with less severe radiographic OA also obtained the greatest improvement from both treatments.
CONCLUSION: Both procedures lead to significant short-term pain relief of at least 4 weeks, however, TI displayed a significantly greater duration of benefit. Patients with effusions and milder radiographic change obtained the best response to treatment.
OBJECTIVE: To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial. METHODS: Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle. RESULTS: The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups. CONCLUSION: This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.
Intraarticular (IA) corticosteroid injections are broadly used in knee osteoarthritis (OA); however, the best corticosteroid agent is not well defined. The aim of the present study was to compare the efficacy of triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections in knee OA.
METHODS:
Patients with symptomatic knee OA and Kellgren-Lawrence grade II or III were randomized to receive 40 mg of IA TH or MA. Evaluations were performed at 4, 12, and 24 weeks. The primary outcome was a change in the patient's assessment of pain by visual analog scale from baseline to Week 4. Secondary outcomes included a global assessment of the disease by patients and physicians, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index (LI), and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria of response. Generalized estimating equations were used in statistical analysis.
RESULTS:
The intention-to-treat population included 100 patients; 50 in each study arm. A significant improvement in pain was observed at Week 4 for both groups (p < 0.0001), with no difference between them (p = 0.352). This improvement was sustained up to Week 24. A significant improvement from the baseline was observed for both the patient's and the physician's global assessments, WOMAC questionnaire, and LI, with no differences between the groups. Improvements in the secondary outcomes were sustained during the study. The OMERACT-OARSI criteria of response was achieved by 74% and 72% of patients in the TH and the MA groups, respectively.
CONCLUSION:
Both IA therapies are equally effective, and improvement in pain and function can be sustained for up to 24 weeks. Controlled-trials.com identifier: ISRCTN15077843.
