Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review

Reynaud, Vivien; Verdilos, Anargyros; Pereira, Bruno; Boisgard, Stéphane; Costes, Frédéric; Coudeyre, Emmanuel

doi:10.3390/jcm9082439

Cited by 25 publications

(17 citation statements)

References 99 publications

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“…Several studies concluded that the WOMAC and the Medical Outcomes Study Short-Form 36 (SF-36) could be recommended as primary measures in treatment studies [ 23 ]. A systemic review also showed that, overall, regarding patient-reported outcome measures, the KOOS, WOMAC, and SF-36 are the most comprehensively tested tools in this population and are worth considering [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

The Efficacy of High-Intensity Preoperative Physiotherapy Training on Postoperative Outcomes in Greek Patients Undergoing Total Knee Arthroplasty: A Quasi-Experimental Study

Vasileiadis¹,

Drosos²,

Charitoudis³

et al. 2022

Cureus

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Purpose: Several studies have shown that patients with severe osteoarthritis (OA) of the knee can reduce their knee pain, improve their quadriceps strength, and improve their functional ability through regular exercise training. The purpose of this study was to investigate the efficacy of a six-week supervised highintensity preoperative training program on muscle strength, functional performance, and patient-reported outcomes in patients undergoing total knee arthroplasty (TKA).Methods: Ninety-eight patients scheduled for unilateral TKA for severe OA were allocated to an intervention group (N = 49) who completed a six-week preoperative training program, five days per week prior to surgery, and a control group (N=49) who did not follow any preoperative training program. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Physical Functioning Scale of the Short Form-36 questionnaire (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS), quadriceps strength, 20meter walk test, and 30-second chair stand test were assessed at six weeks before surgery (T0), just before surgery (T1), four weeks (T2) and finally 12 weeks (T3) after TKA.Results: Of 98 patients included in our study, 10 individuals withdrew from the study at different stages. Finally, 44 patients were allocated to the intervention group and 44 patients to the control group. When comparing the changes from baseline to the primary test points at T1, T2, and T3, we found a significant group difference in favor of the intervention group for quadriceps strength (<0.001, 0.001, 0.009), 20-meter walk test (<0.001, 0.023, 0.032), 30-second chair stand test (0.001, <0.001, <0.001) and all patient-reported outcomes WOMAC (<0.001, 0.001, 0.007) except from KOOS that showed significant difference only at T1 (<0.001) at T2 (0.048) but not at T3 (0.087).Conclusions: Our study demonstrated that a six-week preoperative physiotherapy training program supervised by a physiotherapist before TKA is efficacious for decreasing knee pain, improving knee function, and enhancing daily living activities.

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Section: Methodsmentioning

confidence: 99%

The Efficacy of High-Intensity Preoperative Physiotherapy Training on Postoperative Outcomes in Greek Patients Undergoing Total Knee Arthroplasty: A Quasi-Experimental Study

Vasileiadis¹,

Drosos²,

Charitoudis³

et al. 2022

Cureus

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“…PPTs are quantitative sensory tests that are widely used in the prediction and evaluation of clinical therapeutic effects in patients with KOA [ 40 – 43 ]. An experienced trained clinician (CXG) will perform all PPT measurements using the FDX-50 portable pain tester (Wagner Instruments, Greenwich, CT, USA) to minimize measurement variability.…”

Section: Methodsmentioning

confidence: 99%

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial

Zhao

Xinyu

et al. 2022

Trials

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Background Opposing needling is a unique method used in acupuncture therapy to relieve pain, acting on the side contralateral to the pain. Although opposing needling has been used to treat pain in various diseases, it is not clear how opposing needling affects the activity of the central nervous system to relieve acute pain. We herein present the protocol for a randomized sham-controlled clinical trial aiming to explore the cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty (TKA). Methods This is a randomized sham-controlled single-blind clinical trial. Patients will be allocated randomly to two parallel groups (A: opposing electroacupuncture group; B: sham opposing electroacupuncture group). The Yinlingquan (SP9), Yanglingquan (GB34), Futu (ST32), and Zusanli (ST36) acupoints will be used as the opposing needling sites in both groups. In group A, the healthy lower limbs will receive electroacupuncture, while in group B, the healthy lower limbs will receive sham electroacupuncture. At 72 h after unilateral TKA, patients in both groups will begin treatment once per day for 3 days. Functional magnetic resonance imaging will be performed on all patients before the intervention, after unilateral TKA, and at the end of the intervention to detect changes in brain activity. Changes in pressure pain thresholds will be used as the main outcome for the improvement of knee joint pain. Secondary outcome indicators will include the visual analogue scale (including pain during rest and activity) and a 4-m walking test. Surface electromyography, additional analgesia use, the self-rating anxiety scale, and the self-rating depression scale will be used as additional outcome indices. Discussion The results will reveal the influence of opposing needling on cerebral activity in patients with acute pain after unilateral TKA and the possible relationship between cerebral activity changes and improvement of clinical variables, which may indicate the central mechanism of opposing needling in managing acute pain after unilateral TKA. Trial registration Study on the brain central mechanism of opposing needling analgesia after total kneearthroplasty based on multimodal MRI ChiCTR2100042429. Registered on January 21, 2021

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“…PPTs are quantitative sensory tests that are widely used in the prediction and evaluation of clinical therapeutic effects in patients with KOA [40][41][42][43]. An experienced trained clinician (CXG) will perform all PPT measurements using the FDX-50 portable pain tester (Wagner Instruments, Greenwich, CT, USA) to minimize measurement variability.…”

Section: Primary Outcomementioning

confidence: 99%

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: Study protocol for a randomized, sham-controlled clinical trial

Zhao

Kang

et al. 2021

Preprint

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Background: Opposing needling is a unique method used in acupuncture therapy to relieve pain, acting on the side contralateral to the pain. Although opposing needling has been used to treat pain in various diseases, it is not clear how opposing needling affects the activity of the central nervous system to relieve acute pain. We herein present the protocol for a randomized sham-controlled clinical trial aiming to explore the cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty (TKA).Methods: This is a randomized sham-controlled single-blind clinical trial. Patients will be allocated randomly to two parallel groups (A: opposing electroacupuncture group; B: sham opposing electroacupuncture group). The YINLINGQUAN (SP9), YANGLINGQUAN (GB34), FUTU (ST32), and ZUSANLI (ST36) acupoints will be used as the opposing needling sites in both groups. In group A, the healthy lower limbs will receive electroacupuncture, while in group B, the healthy lower limbs will receive sham electroacupuncture. At 72 h after unilateral TKA, patients in both groups will begin treatment once per day for 3 days. Functional magnetic resonance imaging will be performed on all patients before the intervention, after unilateral TKA, and at the end of the intervention to detect changes in brain activity. Changes in pressure pain thresholds will be used as the main outcome for the improvement of knee joint pain. Secondary outcome indicators will include the visual analogue scale (including pain during rest and activity) and a 4-m walking test. Surface electromyography, additional analgesia use, the self-rating anxiety scale, and the self-rating depression scale will be used as additional outcome indices.Discussion: The results will reveal the influence of opposing needling on cerebral activity in patients with acute pain after unilateral TKA and the possible relationship between cerebral activity changes and improvement of clinical variables, which may indicate the central mechanism of opposing needling in managing acute pain after unilateral TKA.Trial registration: ChiCTR2100042429, registered on January 21, 2021.

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Core Outcome Measurement Instruments for Clinical Trials of Total Knee Arthroplasty: A Systematic Review

Cited by 25 publications

References 99 publications

The Efficacy of High-Intensity Preoperative Physiotherapy Training on Postoperative Outcomes in Greek Patients Undergoing Total Knee Arthroplasty: A Quasi-Experimental Study

The Efficacy of High-Intensity Preoperative Physiotherapy Training on Postoperative Outcomes in Greek Patients Undergoing Total Knee Arthroplasty: A Quasi-Experimental Study

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: Study protocol for a randomized, sham-controlled clinical trial

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