Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint

2022 ◽  
pp. 036354652110672
Author(s):  
Jeyanesh R.S. Tambiah ◽  
Ismail Simsek ◽  
Christopher J. Swearingen ◽  
Sarah Kennedy ◽  
Brian J. Cole ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Womac Pain ◽  
Time Points ◽  
Knee Oa ◽  
Patient Reported ◽  
Mean Differences ◽  
Numeric Rating

Background: Durable, meaningful symptom responses to intra-articular saline placebo injections are observed in knee osteoarthritis (OA) trials, but it is unclear if these are due to physiological effects. Purpose: To perform a prospective comparison of patient-reported outcome responses among participants with knee OA who underwent intra-articular injection of saline-based placebo or sham (dry needle). Study Design: Randomized controlled trial; Level of evidence, 2. Methods: From a 24-week randomized double-blind trial, participants with moderate to severe knee OA received 2-mL intra-articular injections of saline-based placebo (PBO; 99.45% PBS) or sham (dry needle) to the target knee. Least squares mean differences of changes from baseline to week 24 were compared between the PBO and sham groups for the following: pain Numeric Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function; and patient global assessment. Bang Blinding Index was used to evaluate all-group blinding on day 1 and week 24. Results: In total, 116 and 117 participants were randomized to the PBO and sham groups, respectively. Within the full trial population, the mean ± SD age and body mass index were 59.0 ± 8.5 years and 28.97 ± 4.01, respectively. An overall 406 (58.4%) were female, and 394 (57.3%) had Kellgren-Lawrence grade 3 target knee OA. The PBO and sham groups demonstrated clinically meaningful improvements (≥10%) from baseline in all patient-reported outcomes at all time points (ie, weeks 4-24). Mean differences (95% CI) at week 24 between the PBO and sham groups were as follows: pain Numeric Rating Scale, –0.10 (–0.79 to 0.59; P = .78); WOMAC pain, –2.89 (–9.70 to 3.92; P = .40); WOMAC stiffness, –2.37 (–9.37 to 4.63; P = .51); and WOMAC function, –1.39 (–8.06 to 5.29; P = .68). Bang Blinding Index indicated that blinding was maintained. Conclusion: PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological. Registration: NCT03122860 (ClinicalTrials.gov identifier).

T1026 Measuring IBS Patient Reported Outcomes with a Single Item Numeric Rating Scale: Results from the PROOF Cohort

2008 ◽  
Vol 134 (4) ◽  
pp. A-467 ◽  
Author(s):  
Brennan M. Spiegel ◽  
Lucinda A. Harris ◽  
Susan L. Lucak ◽  
Emeran A. Mayer ◽  
Bruce D. Naliboff ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Single Item ◽  
Patient Reported ◽  
Numeric Rating

The efficacy of transcatheter arterial embolization for knee pain on patients with knee osteoarthritis: A case series

2021 ◽  
pp. 1-6
Author(s):  
Kun Yung Kim ◽  
Gi-Wook Kim
Keyword(s):  
Conservative Treatment ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Transcatheter Arterial Embolization ◽  
Rating Scale ◽  
Case Series ◽  
Arterial Embolization ◽  
Numeric Rating Scale ◽  
Knee Oa ◽  
Before And After

BACKGROUND: Knee osteoarthritis (OA) is accompanied by inflammation and angiogenesis. Modifying angiogenesis through transcatheter arterial embolization (TAE) can be a potential treatment for knee OA. OBJECTIVE: We subjected five OA knees in three patients to TAE and report the results of our post-treatment observations. CASE DESCRIPTION: Three patients that had experienced knee pain for a minimum of one year prior to the study, and whose pain had persisted despite conservative treatment, were included in this study. Patients more often chose conservative treatment over surgical treatment. Pain and functional scales were evaluated before, immediately, and 1 month after TAE using the Numeric Rating Scale (NRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). TAE was performed by an experienced interventional radiologist. The average values of NRS evaluated before and after 5 TAEs were 5.2 before TAE, 3 immediately after TAE, and 3.6 after 1 month of TAE, and the average values of WOMAC were 52, 38.4, and 36.4, respectively. There were no major adverse effects. CONCLUSION: The examined cases support the conclusion that TAE is an effective treatment for patients with knee OA. Substantial pain relief and WOMAC improvement were observed both immediately and one month after TAE.

Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials

2021 ◽  
pp. rapm-2020-102238
Author(s):  
Jonathan M Hagedorn ◽  
Timothy R Deer ◽  
Nicholas C Canzanello ◽  
Stephen M Covington ◽  
Darrell R Schroeder ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Pain Scale ◽  
Concordance Correlation ◽  
Percentage Improvement ◽  
Patient Reported ◽  
The Mean ◽  
Numeric Rating

IntroductionSpinal cord stimulation is frequently used for the treatment of intractable chronic pain conditions. Trialing of the spinal cord stimulator device is recommended to assess the patient’s response to neurostimulation before permanent implantation. The trial response is often assessed by Numeric Rating Scale changes and patient-reported percentage pain improvement. Using number rating scale changes between prespinal and postspinal cord stimulation trial, a calculated percentage pain improvement can be obtained. The aim of this study was to assess the difference between calculated and patient-reported percentage improvement in pain scale during spinal cord stimulation trials.MethodsThis study was a retrospective single center review of all spinal cord stimulation trials from January 1 2017 to July 1 2019. A total of 174 patients were included. The paired t-test was used to compare numeric pain scores obtained prestimulation versus poststimulation. The mean difference between methods (patient-reported minus calculated) was compared with zero using the 1-sample t-test. Lin’s concordance correlation coefficient was computed with a 95% CI, calculated using Fisher z-transformation; and a bootstrapping approach was used to compare the concordance correlation coefficient between groups. In all cases, two-tailed tests were used with p<0.05 considered statistically significant.ResultsBased on prestimulation and poststimulation numeric rating scale scores, the mean±SD calculated percentage improvement in pain scale was 54±28. The mean±SD patient-reported percentage improvement in pain scale was 59±25. The overall 95% limits of agreement for the two methods are −30% to +41%. The overall concordance correlation coefficient was 0.76 (95% CI 0.69 to 0.81).ConclusionAlthough the two methods are highly correlated, there is substantial lack of agreement between patient-reported and calculated percentage improvement in pain scale, suggesting that these measures should not be used interchangeably for spinal cord stimulator trial outcome assessment. This emphasizes the need for improved metrics to better measure patient response to neuromodulation therapies. Additionally, patient-reported percentage improvement in pain was found to be higher than calculated percentage improvement in pain, potentially highlighting the multidimensional experience of pain and the unpredictability of solely using Numeric Rating Scale scores to assess patient outcomes.

scholarly journals Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series

Pain Medicine ◽  
2020 ◽  
Vol 21 (12) ◽  
pp. 3344-3349
Author(s):  
Edvin Koshi ◽  
Cole W Cheney ◽  
Beau P Sperry ◽  
Aaron Conger ◽  
Zachary L McCormick
Keyword(s):  
Radiofrequency Ablation ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Case Series ◽  
Numeric Rating Scale ◽  
Vastus Medialis ◽  
The Novel ◽  
Chronic Knee Pain ◽  
Numeric Rating

Abstract Background Genicular nerve radiofrequency ablation (RFA) for the treatment of chronic knee pain has traditionally targeted the superomedial, superolateral, and inferomedial genicular nerves. However, recent cadaveric studies of knee neuroanatomy demonstrate varied locations of these specific nerves as well as additional articular nerves. This work suggests that traditional genicular nerve RFA lesion locations may be inadequate. Objective 1) To describe a novel protocol utilizing a three-tined RFA electrode to target the superomedial (SMGN), superolateral (SLGN), and inferomedial genicular nerves (IMGN), as well as the terminal articular branches of the nerves to the vastus medialis (NVM), intermedius (NVI), and lateralis (NVL). 2) To assess the ability of this technique to reduce chronic knee pain. Methods Case series of consecutive patients with six or more months of refractory knee pain who underwent genicular nerve RFA according to the novel protocol described. Seven discrete RFA lesions were placed to target the SMGN, NVM, NVI, NVL, SLGN, and IGMN. Results Eleven patients underwent RFA, nine with knee osteoarthritis and two postarthroplasty. At one month, 91% (95% CI = 59–100%), 82% (95% CI = 48–98%), and 9% (95% CI = 2–41%), of patients reported ≥50%, ≥80%, and 100% improvement in knee pain on the numeric rating scale, respectively. These results were sustained at six months. There were no complications. Discussion/Conclusions These preliminary data suggest the feasibility and possible effectiveness of genicular nerve RFA using the described novel protocol including a three-tined electrode. Larger-scale studies with comparative groups are warranted.

scholarly journals Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e000928 ◽  
Author(s):  
Dafna Gladman ◽  
Peter Nash ◽  
Hitoshi Goto ◽  
Julie A Birt ◽  
Chen-Yen Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Psychometric Properties ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Routine Clinical Practice ◽  
Patient Reported ◽  
Test Retest Reliability ◽  
Numeric Rating

ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

scholarly journals High molecular weight Intraarticular hyaluronic acid for the treatment of knee osteoarthritis: a network meta-analysis

2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charles D. Hummer ◽  
Felix Angst ◽  
Wilson Ngai ◽  
Craig Whittington ◽  
Sophie S. Yoon ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Treated Patient ◽  
Meta Analysis ◽  
Credible Interval ◽  
Pain Scale ◽  
Womac Pain ◽  
Knee Oa ◽  
Mean Differences

Abstract Background The 2013 American Academy of Orthopaedic Surgeons (AAOS) guidelines made strong recommendations against intraarticular hyaluronic acid (IAHA) for patients with knee osteoarthritis (OA), as evidence supporting improvements in pain did not meet the minimal clinically important improvement (MCII) threshold. However, there may be important distinctions based on IAHA molecular weight (MW). Hence our objective was to evaluate the efficacy of IAHAs in knee OA based on molecular weight. Methods Randomized controlled trials were searched within MEDLINE, Embase, and CENTRAL and selected based on AAOS criteria. A pain measure hierarchy and longest follow-up were used to select one effect size from each trial. Mean differences between interventions were converted to standardized mean differences (SMDs) and incorporated into a random-effects Bayesian network meta-analysis. High MW (HMW) was defined as ≥6000 kDa, and low MW (LMW) as < 750 kDa. Results HMW IAHA was associated with a statistically significant and possibly clinically significant improvement in pain (SMD − 0.57 (95% credible interval [Crl]: − 1.04, − 0.11), exceeding the − 0.50 MCII threshold. LMW IAHA had a lesser, non-significant improvement (− 0.23, 95% Crl: − 0.67, 0.20). Back-transforming SMDs to the WOMAC pain scale indicated a 14.65 (95% CI: 13.93, 15.62) point improvement over IA placebo, substantially better than the 8.3 AAOS MCII threshold. Conclusions Unlike LMW IAHA, HMW IAHA exceeded the MCII threshold for pain relief, suggesting that improvements can be subjectively perceived by the treated patient. Amalgamation of LMW and HMW may have blurred the benefits of IAHA in the past, leading to negative recommendations. Differentiation according to MW offers refined insight for treatment with IAHA.

scholarly journals Prevalence of Neuropathic Pain Varies in Patients With Knee Osteoarthritis in Different Treatment Stages

2021 ◽  
Author(s):  
Li Li ◽  
Zhaohui Zeng ◽  
Hanle Zhang ◽  
Yuanyuan Lin ◽  
Linghui Xu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Neuropathic Pain ◽  
Knee Osteoarthritis ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Nociceptive Pain ◽  
Womac Pain ◽  
Increased Risk ◽  
Outpatient Group ◽  
Paindetect Questionnaire

Abstract Background: Pain is the main symptom of knee osteoarthritis (KOA) and can be classified as nociceptive pain and neuropathic pain (NP). However, the prevalence and risk factors of NP in patients with KOA at different treatment stages vary in countries and are still unclear in China.Methods: Patients in this retrospective study were divided into three groups according to treatment stage, including outpatient stage, preoperative total knee arthroplasty (pre-TKA) stage and postoperative TKA stage (post-TKA). A numeric rating scale (NRS) and PainDETECT questionnaire were used to evaluate nociceptive pain and NP. Patient demographics, radiological assessments using Kellgren-Lawrence (K-L) grades, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were analyzed.Results: Of the 921 patients, the prevalence of possible and likely NP was 17.5% (56/320) and 2.5% (8/320) in the pre-TKA group compared with 3.4% (8/233) and 0.4% (1/233) in the outpatient group and 1.4% (5/368) and 0.5% (2/368) in the post-TKA group, respectively. In the pre-TKA group, higher NRS (NRS>3; OR=10.65, 95% CI: 3.25-34.92, p<0.001) and WOMAC pain (WOMAC>10; OR=4.88, 95% CI: 2.38-10.01, p<0.001) scores conferred an increased risk of unclear pain. Age, gender, BMI and K-L grade showed no significant differences among the unlikely, possible and likely NP groups.Discussion: Different prevalence of NP occur in KOA patients at different treatment stages. Due to the low prevalence of NP in the outpatient and post-TKA groups, we suggest not regularly screening for NP in these patients, while it may be essential to screen for NP in patients waiting for TKA. In the latter group, higher NRS and WOMAC pain scores are important risk factors of NP.

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