PMID- 28027657 OWN - NLM STAT- MEDLINE DCOM- 20180208 LR - 20181202 IS - 1552-3365 (Electronic) IS - 0363-5465 (Linking) VI - 45 IP - 11 DP - 2017 Sep TI - The Therapeutic Effect of Intra-articular Normal Saline Injections for Knee Osteoarthritis: A Meta-analysis of Evidence Level 1 Studies. PG - 2647-2653 LID - 10.1177/0363546516680607 [doi] AB - BACKGROUND: Intra-articular normal saline (IA-NS) injections have been utilized as a placebo in a number of randomized controlled trials pertaining to the management of knee osteoarthritis (OA); however, it is believed that these "placebo" injections may have a therapeutic effect that has not been quantified in the literature. PURPOSE: To (1) quantify the effect of IA-NS injections on patient-reported outcomes (PROs) and (2) compare postinjection PROs to established minimal clinically important difference (MCID) criteria to demonstrate a potential therapeutic effect. STUDY DESIGN: Meta-analysis. METHODS: A review was conducted to identify all randomized, placebo-controlled trials on injection therapy for knee OA between 2006 and 2016. Patient demographics and PROs before the injection and at 3 and 6 months after the injection were collected for patients in the IA-NS injection group in each study. A random-effects model was used to compare preinjection scores and scores at each postinjection time point in a pairwise fashion. RESULTS: In total, there were 14 placebo cohorts in 13 studies that were analyzed after meeting inclusion criteria for this meta-analysis. This included 1076 patients (Kellgren-Lawrence grade 1-4), with a weighted mean age of 62.53 years and mean body mass index of 28.67 kg/m(2). There was only sufficient information to perform analyses of visual analog scale (VAS) pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) total scores. At 3 months after the IA-NS placebo injection, there was a significant improvement in VAS pain scores (mean difference [MD], 12.10 [95% CI, 3.27 to 20.93]; P = .007), whereas improvement in the WOMAC total scores approached but did not reach statistical significance (MD, 19.75 [95% CI, -0.50 to 40.09]; P = .06). At 6 months, both VAS pain scores (MD, 16.62 [95% CI, 12.13-21.10]; P < .00001) and WOMAC total scores (MD, 11.34 [95% CI, 7.03-15.65]; P < .00001) were significantly improved in comparison to preinjection values. Furthermore, improvements in both the VAS pain and WOMAC total scores at 6 months were clinically significant (MCID, 1.37 and 9, respectively). CONCLUSION: The administration of an IA-NS placebo injection yields a statistically and clinically meaningful improvement in PROs up to 6 months after the injection in patients with knee OA. This observation supports the notion that the so-called placebo effect for IA-NS injections achieves a clinically meaningful response in patients with OA when provided during comparison studies to an active treatment group (ie, hyaluronic acid). FAU - Saltzman, Bryan M AU - Saltzman BM AD - Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Leroux, Timothy AU - Leroux T AD - Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Meyer, Maximilian A AU - Meyer MA AD - Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Basques, Bryce A AU - Basques BA AD - Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Chahal, Jaskarndip AU - Chahal J AD - Division of Sports Medicine, Department of Orthopedic Surgery, University of Toronto, Toronto, Ontario, Canada. FAU - Bach, Bernard R Jr AU - Bach BR Jr AD - Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Yanke, Adam B AU - Yanke AB AD - Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. FAU - Cole, Brian J AU - Cole BJ AD - Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, USA. LA - eng PT - Journal Article PT - Meta-Analysis PT - Review DEP - 20161227 PL - United States TA - Am J Sports Med JT - The American journal of sports medicine JID - 7609541 RN - 451W47IQ8X (Sodium Chloride) RN - 9004-61-9 (Hyaluronic Acid) SB - IM MH - Humans MH - Hyaluronic Acid/therapeutic use MH - Injections, Intra-Articular MH - Ontario MH - Osteoarthritis, Knee/physiopathology/*therapy MH - Pain/etiology/prevention & control MH - Pain Measurement MH - Patient Reported Outcome Measures MH - Sodium Chloride/*administration & dosage OTO - NOTNLM OT - arthritis OT - arthrocentesis OT - injection OT - knee OT - osteoarthritis OT - placebo OT - saline EDAT- 2016/12/29 06:00 MHDA- 2018/02/09 06:00 CRDT- 2016/12/29 06:00 PHST- 2016/12/29 06:00 [pubmed] PHST- 2018/02/09 06:00 [medline] PHST- 2016/12/29 06:00 [entrez] AID - 10.1177/0363546516680607 [doi] PST - ppublish SO - Am J Sports Med. 2017 Sep;45(11):2647-2653. doi: 10.1177/0363546516680607. Epub 2016 Dec 27.