Background
Knee osteoarthritis is a leading cause of chronic pain, disability, and decreased quality of life. Despite the long‐standing use of intra‐articular corticosteroids, there is an ongoing ...debate about their benefits and safety. This is an update of a Cochrane review first published in 2005.
Objectives
To determine the benefits and harms of intra‐articular corticosteroids compared with sham or no intervention in people with knee osteoarthritis in terms of pain, physical function, quality of life, and safety.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and EMBASE (from inception to 3 February 2015), checked trial registers, conference proceedings, reference lists, and contacted authors.
Selection criteria
We included randomised or quasi‐randomised controlled trials that compared intra‐articular corticosteroids with sham injection or no treatment in people with knee osteoarthritis. We applied no language restrictions.
Data collection and analysis
We calculated standardised mean differences (SMDs) and 95% confidence intervals (CI) for pain, function, quality of life, joint space narrowing, and risk ratios (RRs) for safety outcomes. We combined trials using an inverse‐variance random‐effects meta‐analysis.
Main results
We identified 27 trials (13 new studies) with 1767 participants in this update. We graded the quality of the evidence as 'low' for all outcomes because treatment effect estimates were inconsistent with great variation across trials, pooled estimates were imprecise and did not rule out relevant or irrelevant clinical effects, and because most trials had a high or unclear risk of bias. Intra‐articular corticosteroids appeared to be more beneficial in pain reduction than control interventions (SMD ‐0.40, 95% CI ‐0.58 to ‐0.22), which corresponds to a difference in pain scores of 1.0 cm on a 10‐cm visual analogue scale between corticosteroids and sham injection and translates into a number needed to treat for an additional beneficial outcome (NNTB) of 8 (95% CI 6 to 13). An I2 statistic of 68% indicated considerable between‐trial heterogeneity. A visual inspection of the funnel plot suggested some asymmetry (asymmetry coefficient ‐1.21, 95%CI ‐3.58 to 1.17). When stratifying results according to length of follow‐up, benefits were moderate at 1 to 2 weeks after end of treatment (SMD ‐0.48, 95% CI ‐0.70 to ‐0.27), small to moderate at 4 to 6 weeks (SMD ‐0.41, 95% CI ‐0.61 to ‐0.21), small at 13 weeks (SMD ‐0.22, 95% CI ‐0.44 to 0.00), and no evidence of an effect at 26 weeks (SMD ‐0.07, 95% CI ‐0.25 to 0.11). An I2 statistic of ≥ 63% indicated a moderate to large degree of between‐trial heterogeneity up to 13 weeks after end of treatment (P for heterogeneity≤0.001), and an I2 of 0% indicated low heterogeneity at 26 weeks (P=0.43). There was evidence of lower treatment effects in trials that randomised on average at least 50 participants per group (P=0.05) or at least 100 participants per group (P=0.013), in trials that used concomittant viscosupplementation (P=0.08), and in trials that used concomitant joint lavage (P≤0.001).
Corticosteroids appeared to be more effective in function improvement than control interventions (SMD ‐0.33, 95% CI ‐0.56 to ‐0.09), which corresponds to a difference in functions scores of ‐0.7 units on standardised Western Ontario and McMaster Universities Arthritis Index (WOMAC) disability scale ranging from 0 to 10 and translates into a NNTB of 10 (95% CI 7 to 33). An I2 statistic of 69% indicated a moderate to large degree of between‐trial heterogeneity. A visual inspection of the funnel plot suggested asymmetry (asymmetry coefficient ‐4.07, 95% CI ‐8.08 to ‐0.05). When stratifying results according to length of follow‐up, benefits were small to moderate at 1 to 2 weeks after end of treatment (SMD ‐0.43, 95% CI ‐0.72 to ‐0.14), small to moderate at 4 to 6 weeks (SMD ‐0.36, 95% CI ‐0.63 to ‐0.09), and no evidence of an effect at 13 weeks (SMD ‐0.13, 95% CI ‐0.37 to 0.10) or at 26 weeks (SMD 0.06, 95% CI ‐0.16 to 0.28). An I2 statistic of ≥ 62% indicated a moderate to large degree of between‐trial heterogeneity up to 13 weeks after end of treatment (P for heterogeneity≤0.004), and an I2 of 0% indicated low heterogeneity at 26 weeks (P=0.52). We found evidence of lower treatment effects in trials that randomised on average at least 50 participants per group (P=0.023), in unpublished trials (P=0.023), in trials that used non‐intervention controls (P=0.031), and in trials that used concomitant viscosupplementation (P=0.06).
Participants on corticosteroids were 11% less likely to experience adverse events, but confidence intervals included the null effect (RR 0.89, 95% CI 0.64 to 1.23, I2=0%). Participants on corticosteroids were 67% less likely to withdraw because of adverse events, but confidence intervals were wide and included the null effect (RR 0.33, 95% CI 0.05 to 2.07, I2=0%). Participants on corticosteroids were 27% less likely to experience any serious adverse event, but confidence intervals were wide and included the null effect (RR 0.63, 95% CI 0.15 to 2.67, I2=0%).
We found no evidence of an effect of corticosteroids on quality of life compared to control (SMD ‐0.01, 95% CI ‐0.30 to 0.28, I2=0%). There was also no evidence of an effect of corticosteroids on joint space narrowing compared to control interventions (SMD ‐0.02, 95% CI ‐0.49 to 0.46).
Authors' conclusions
Whether there are clinically important benefits of intra‐articular corticosteroids after one to six weeks remains unclear in view of the overall quality of the evidence, considerable heterogeneity between trials, and evidence of small‐study effects. A single trial included in this review described adequate measures to minimise biases and did not find any benefit of intra‐articular corticosteroids.
In this update of the systematic review and meta‐analysis, we found most of the identified trials that compared intra‐articular corticosteroids with sham or non‐intervention control small and hampered by low methodological quality. An analysis of multiple time points suggested that effects decrease over time, and our analysis provided no evidence that an effect remains six months after a corticosteroid injection.
Background:
Intra-articular injection of adipose-derived stem cells (ASCs) has shown promise for improving symptoms and cartilage quality in the treatment of osteoarthritis (OA). However, while most ...preclinical studies have been performed with plastic-adherent ASCs, most clinical trials are being conducted with the stromal vascular fraction (SVF), prepared from adipose tissue without prior culture.
Purpose:
To directly compare clinical outcomes of intra-articular injection with ASCs or SVF in patients with knee OA.
Study Design:
Cohort study; Level of evidence, 3.
Methods:
The authors retrospectively compared 6-month outcomes in 42 patients (59 knees) receiving intra-articular injection with 12.75 million ASCs and 38 patients (69 knees) receiving a 5-mL preparation of SVF. All patients had Kellgren-Lawrence grade 2, 3, or 4 knee OA and had failed standard medical therapy. The visual analog scale (VAS) pain score and Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline and 1, 3, and 6 months after injection were considered as outcomes. Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) criteria were also used to assess positive response. A repeated measures analysis of variance was used for comparison between the treatment groups.
Results:
No major complications occurred in either group. The SVF group had a higher frequency of knee effusion (SVF 8%, ASC 2%) and minor complications related to the fat harvest site (SVF 34%, ASC 5%). Both groups reported improvements in pain VAS and KOOS domains. Specifically, in the ASC group, symptoms improved earlier (by 3 months; P < .05) and pain VAS decreased to a greater degree (55%; P < .05) compared with the SVF group (44%). The proportion of OMERACT-OARSI responders in the ASC group was slightly higher (ASCs, 61%; SVF, 55%; P = .25).
Conclusion:
It was observed that both ASCs and SVF resulted in clinical improvement in patients with knee OA, but that ASCs outperform SVF in the early reduction of symptoms and pain with less comorbidity.
Background
Adhesive capsulitis (also termed frozen shoulder) is commonly treated by manual therapy and exercise, usually delivered together as components of a physical therapy intervention. This ...review is one of a series of reviews that form an update of the Cochrane review, 'Physiotherapy interventions for shoulder pain.'
Objectives
To synthesise available evidence regarding the benefits and harms of manual therapy and exercise, alone or in combination, for the treatment of patients with adhesive capsulitis.
Search methods
We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL Plus, ClinicalTrials.gov and the WHO ICTRP clinical trials registries up to May 2013, unrestricted by language, and reviewed the reference lists of review articles and retrieved trials, to identify potentially relevant trials.
Selection criteria
We included randomised controlled trials (RCTs) and quasi‐randomised trials, including adults with adhesive capsulitis, and comparing any manual therapy or exercise intervention versus placebo, no intervention, a different type of manual therapy or exercise or any other intervention. Interventions included mobilisation, manipulation and supervised or home exercise, delivered alone or in combination. Trials investigating the primary or adjunct effect of a combination of manual therapy and exercise were the main comparisons of interest. Main outcomes of interest were participant‐reported pain relief of 30% or greater, overall pain (mean or mean change), function, global assessment of treatment success, active shoulder abduction, quality of life and the number of participants experiencing adverse events.
Data collection and analysis
Two review authors independently selected trials for inclusion, extracted the data, performed a risk of bias assessment and assessed the quality of the body of evidence for the main outcomes using the GRADE approach.
Main results
We included 32 trials (1836 participants). No trial compared a combination of manual therapy and exercise versus placebo or no intervention. Seven trials compared a combination of manual therapy and exercise versus other interventions but were clinically heterogeneous, so opportunities for meta‐analysis were limited. The overall impression gained from these trials is that the few outcome differences between interventions that were clinically important were detected only up to seven weeks. Evidence of moderate quality shows that a combination of manual therapy and exercise for six weeks probably results in less improvement at seven weeks but a similar number of adverse events compared with glucocorticoid injection. The mean change in pain with glucocorticoid injection was 58 points on a 100‐point scale, and 32 points with manual therapy and exercise (mean difference (MD) 26 points, 95% confidence interval (CI) 15 points to 37 points; one RCT, 107 participants), for an absolute difference of 26% (15% to 37%). Mean change in function with glucocorticoid injection was 39 points on a 100‐point scale, and 14 points with manual therapy and exercise (MD 25 points, 95% CI 35 points to 15 points; one RCT, 107 participants), for an absolute difference of 25% (15% to 35%). Forty‐six per cent (26/56) of participants reported treatment success with manual therapy and exercise compared with 77% (40/52) of participants receiving glucocorticoid injection (risk ratio (RR) 0.6, 95% CI 0.44 to 0.83; one RCT, 108 participants), with an absolute risk difference of 30% (13% to 48%). The number reporting adverse events did not differ between groups: 56% (32/57) reported events with manual therapy and exercise, and 53% (30/57) with glucocorticoid injection (RR 1.07, 95% CI 0.76 to 1.49; one RCT, 114 participants), with an absolute risk difference of 4% (‐15% to 22%). Group differences in improvement in overall pain and function at six months and 12 months were not clinically important.
We are uncertain of the effect of other combinations of manual therapy and exercise, as most evidence is of low quality. Meta‐analysis of two trials (86 participants) suggested no clinically important differences between a combination of manual therapy, exercise, and electrotherapy for four weeks and placebo injection compared with glucocorticoid injection alone or placebo injection alone in terms of overall pain, function, active range of motion and quality of life at six weeks, six months and 12 months (though the 95% CI suggested function may be better with glucocorticoid injection at six weeks). The same two trials found that adding a combination of manual therapy, exercise and electrotherapy for four weeks to glucocorticoid injection did not confer clinically important benefits over glucocorticoid injection alone at each time point. Based on one high quality trial (148 participants), following arthrographic joint distension with glucocorticoid and saline, a combination of manual therapy and supervised exercise for six weeks conferred similar effects to those of sham ultrasound in terms of overall pain, function and quality of life at six weeks and at six months, but provided greater patient‐reported treatment success and active shoulder abduction at six weeks. One trial (119 participants) found that a combination of manual therapy, exercise, electrotherapy and oral non‐steroidal anti‐inflammatory drug (NSAID) for three weeks did not confer clinically important benefits over oral NSAID alone in terms of function and patient‐reported treatment success at three weeks.
On the basis of 25 clinically heterogeneous trials, we are uncertain of the effect of manual therapy or exercise when not delivered together, or one type of manual therapy or exercise versus another, as most reported differences between groups were not clinically or statistically significant, and the evidence is mostly of low quality.
Authors' conclusions
The best available data show that a combination of manual therapy and exercise may not be as effective as glucocorticoid injection in the short‐term. It is unclear whether a combination of manual therapy, exercise and electrotherapy is an effective adjunct to glucocorticoid injection or oral NSAID. Following arthrographic joint distension with glucocorticoid and saline, manual therapy and exercise may confer effects similar to those of sham ultrasound in terms of overall pain, function and quality of life, but may provide greater patient‐reported treatment success and active range of motion. High‐quality RCTs are needed to establish the benefits and harms of manual therapy and exercise interventions that reflect actual practice, compared with placebo, no intervention and active interventions with evidence of benefit (e.g. glucocorticoid injection).
Purpose To determine (1) whether platelet-rich plasma (PRP) injection significantly improves validated patient-reported outcomes in patients with symptomatic knee osteoarthritis (OA) at 6 and 12 ...months postinjection, (2) differences in outcomes between PRP and corticosteroid injections or viscosupplementation or placebo injections at 6 and 12 months postinjection, and (3) similarities and differences in outcomes based on the PRP formulations used in the analyzed studies. Methods PubMed, Cochrane Central Register of Controlled Trials, SCOPUS, and Sport Discus were searched for English-language, level I evidence, human in vivo studies on the treatment of symptomatic knee OA with intra-articular PRP compared with other options, with a minimum of 6 months of follow-up. A quality assessment of all articles was performed using the Modified Coleman Methodology Score (average, 83.3/100), and outcomes were analyzed using 2-proportion z -tests. Results Six articles (739 patients, 817 knees, 39% males, mean age of 59.9 years, with 38 weeks average follow-up) were analyzed. All studies met minimal clinical important difference criteria and showed significant improvements in statistical and clinical outcomes, including pain, physical function, and stiffness, with PRP. All but one study showed significant differences in clinical outcomes between PRP and hyaluronic acid (HA) or PRP and placebo in pain and function. Average pretreatment Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were 52.36 and 52.05 for the PRP and HA groups, respectively ( P = .420). Mean post-treatment WOMAC scores for PRP were significantly better than for HA at 3 to 6 months (28.5 and 43.4, respectively; P = .0008) and at 6 to 12 months (22.8 and 38.1, respectively; P = .0062). None of the included studies used corticosteroids. Conclusions In patients with symptomatic knee OA, PRP injection results in significant clinical improvements up to 12 months postinjection. Clinical outcomes and WOMAC scores are significantly better after PRP versus HA at 3 to 12 months postinjection. There is limited evidence for comparing leukocyte-rich versus leukocyte-poor PRP or PRP versus steroids in this study. Level of Evidence Level I, systematic review of Level I studies.
IMPORTANCE: The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical ...patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. OBJECTIVE: To provide new and updated evidence-based recommendations for the prevention of SSI. EVIDENCE REVIEW: A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. FINDINGS: Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. CONCLUSIONS AND RELEVANCE: This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.
There is no cure for knee osteoarthritis (KOA) and typically patients live approximately 30-years with the disease. Most common medical treatments result in short-term palliation of symptoms with ...little consideration of long-term risk. This systematic review aims to appraise the current evidence for the long-term (≥12 months) safety of common treatments for knee osteoarthritis (KOA).
Cochrane Database of Systematic Reviews, Medline and PubMed were systematically searched from 1990 to July 2017, inclusive. Inclusion criteria were 1) peer-reviewed publications investigating treatments for KOA referred to in the Australian Clinical Care Standard and/or Therapeutic Guidelines: Rheumatology 2) specifically addressing safety of the treatments 3) with ≥12 months of follow-up and 4) Downs and Black quality score ≥ 13.
Thirty-four studies fulfilled the inclusion criteria. Lifestyle modifications (moderate exercise and weight loss), paracetamol, glucosamine, Intraarticular Hyaluronic Acid (IAHA) and platelet-rich-plasma (PRP) injections have a low risk of harm and beneficial ≥12 month outcomes. Although Nonsteroidal Anti-inflammatory Drugs (NSAIDs) provide pain relief, they are associated with increased risk of medical complications. Cortisone injections are associated with radiological cartilage degeneration at > 12 months. Arthroscopy for degenerative meniscal tears in KOA leads to a 3-fold increase in total knee arthroplasty (TKA). TKA improves primary outcomes of KOA but has a low rate of significant medical complications.
Given the safety and effectiveness of lifestyle interventions such as weight loss and exercise, these should be advocated in all patients due to the low risk of harm. The use of NSAIDs should be minimized to avoid gastrointestinal complications. Treatment with opioids has a lack of evidence for use and a high risk of long-term harm. The use of IAHA and PRP may provide additional symptomatic benefit without the risk of harm. TKA is associated with significant medical complications but is justified by the efficacy of joint replacement in late-stage disease.
PROSPERO International prospective register for systematic reviews; registration number CRD42017072809 .
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Aim
Intra‐articular corticosteroid injections (IACIs) can reduce osteoarthritis‐related pain, with differing levels of response across patient groups. This systematic review investigates what is ...known about the positive and negative predictors of outcomes in patients with osteoarthritis who undergo IACIs.
Methods
We systematically searched the Medline, Embase, and Cochrane databases to May 2023 for studies that evaluated patients undergoing IACIs for osteoarthritis and reported on predictors of outcomes in these patients.
Results
Eight studies were included. Two were placebo‐controlled trials, six were observational studies. Due to the heterogeneity of outcomes and variables between the studies, it was not possible to pool the results for formal meta‐analysis. Higher baseline pain, older age, higher BMI, lower range of movement, higher Kellgren‐Lawrence radiographic score, joint effusion, and aspiration were shown to be predictors of a positive response to IACIs in some of the included studies. However, other studies showed no difference in response with these variables, or a negative correlation with response. Sex, smoking, mental health status, hypertension/ischaemic heart disease, diabetes mellitus, duration of symptoms, and socioeconomic status did not demonstrate any correlation with the prediction of positive or negative outcomes after IACIs.
Conclusion
Several patient features have been identified as positive predictors of outcomes following IACIs. However, this systematic review has identified inconsistent and variable findings across the existing literature. Further research with standardization of IACI administration and outcome measures is required to facilitate further analysis of the reliability and significance of predictive factors for response to IACIs.
Purpose To use meta-analysis techniques to evaluate the efficacy and safety of platelet-rich plasma (PRP) injections for the treatment knee of osteoarthritis (OA). Methods We performed a systematic ...literature search in PubMed, Embase, Scopus, and the Cochrane database through April 2016 to identify Level I randomized controlled trials that evaluated the clinical efficacy of PRP versus control treatments for knee OA. The primary outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores. The primary outcomes were compared with their minimum clinically important differences (MCID)—defined as the smallest difference perceived as important by the average patient. Results We included 10 randomized controlled trials with a total of 1069 patients. Our analysis showed that at 6 months postinjection, PRP and hyaluronic acid (HA) had similar effects with respect to pain relief (WOMAC pain score) and functional improvement (WOMAC function score, WOMAC total score, International Knee Documentation Committee score, Lequesne score). At 12 months postinjection, however, PRP was associated with significantly better pain relief (WOMAC pain score, mean difference −2.83, 95% confidence interval CI −4.26 to −1.39, P = .0001) and functional improvement (WOMAC function score, mean difference −12.53, 95% CI −14.58 to −10.47, P < .00001; WOMAC total score, International Knee Documentation Committee score, Lequesne score, standardized mean difference 1.05, 95% CI 0.21-1.89, P = .01) than HA, and the effect sizes of WOMAC pain and function scores at 12 months exceeded the MCID (−0.79 for WOMAC pain and −2.85 for WOMAC function score). Compared with saline, PRP was more effective for pain relief (WOMAC pain score) and functional improvement (WOMAC function score) at 6 months and 12 months postinjection, and the effect sizes of WOMAC pain and function scores at 6 months and 12 months exceeded the MCID. We also found that PRP did not increase the risk of adverse events compared with HA and saline. Conclusions Current evidence indicates that, compared with HA and saline, intra-articular PRP injection may have more benefit in pain relief and functional improvement in patients with symptomatic knee OA at 1 year postinjection. Level of Evidence Level I, meta-analysis of Level I studies.
Objective
To update the 2009 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations for the spectrum of manifestations affecting patients with ...psoriatic arthritis (PsA).
Methods
GRAPPA rheumatologists, dermatologists, and PsA patients drafted overarching principles for the management of PsA, based on consensus achieved at face‐to‐face meetings and via online surveys. We conducted literature reviews regarding treatment for the key domains of PsA (arthritis, spondylitis, enthesitis, dactylitis, skin disease, and nail disease) and convened a new group to identify pertinent comorbidities and their effect on treatment. Finally, we drafted treatment recommendations for each of the clinical manifestations and assessed the level of agreement for the overarching principles and treatment recommendations among GRAPPA members, using an online questionnaire.
Results
Six overarching principles had ≥80% agreement among both health care professionals (n = 135) and patient research partners (n = 10). We developed treatment recommendations and a schema incorporating these principles for arthritis, spondylitis, enthesitis, dactylitis, skin disease, nail disease, and comorbidities in the setting of PsA, using the Grading of Recommendations, Assessment, Development and Evaluation process. Agreement of >80% was reached for approval of the individual recommendations and the overall schema.
Conclusion
We present overarching principles and updated treatment recommendations for the key manifestations of PsA, including related comorbidities, based on a literature review and consensus of GRAPPA members (rheumatologists, dermatologists, other health care providers, and patient research partners). Further updates are anticipated as the therapeutic landscape in PsA evolves.
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