scholarly journals A RANDOMIZED CONTROLLED TRIAL OF CURCUMIN AND DICLOFENAC COMBINATION IN KNEE OSTEOARTHRITIS

Author(s):  
DHANESHWAR SHEP ◽  
CHITRA KHANWELKAR ◽  
PRAKASHCHANDRA GADE ◽  
SATYANAND KARAD

Objective: The objective of the study was to evaluate pain relief and safety of the combination of curcumin and diclofenac versus diclofenac alone in the treatment of knee osteoarthritis (OA). Methods: 140 patients of knee OA meeting inclusion criteria were randomized to receive either curcumin 500 mg with diclofenac 50 mg twice daily or diclofenac 50 mg tablet al. one twice daily for 28 d. Patients were assessed at baseline, Day 14 and Day 28. Primary efficacy measure was severity of pain (VisualAnalogue Scale) at day 14 and day 28. Safety after treatment was evaluated by recording side effects and laboratory investigations. Results: Patients receiving curcumin plus diclofenac showed significantly superior improvement in severity of pain at each study visit (p<0.001) when compared to diclofenac. Adverse effects were significantly less in the curcumin plus diclofenac group (p<0.001). Conclusion: Combination of curcumin and diclofenac showed a significant improvement in pain on the basis of VAS when compared to diclofenac which may be due to the synergistic effect between curcumin and diclofenac

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.


2020 ◽  
Author(s):  
Linda C Li ◽  
Lynne M Feehan ◽  
Hui Xie ◽  
Na Lu ◽  
Christopher D Shaw ◽  
...  

BACKGROUND Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. CLINICALTRIAL ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323


2020 ◽  
Author(s):  
Aysha I. Adhama ◽  
Mukadas O. Akindele ◽  
Aminu A. Ibrahim

Abstract Background: Knee osteoarthritis (OA) is a common painful and disabling condition that affects older individuals. Proprioceptive training programs in the form of kinesthesia, balance and agility (KBA) exercises have been reported to be beneficial for individuals with knee OA. However, the most optimal treatment dosage of KBA exercise is still unclear. The aim of this study is to determine the effects of different frequencies of KBA treatment (i.e. twice-weekly or thrice-weekly) in adults with knee OA.Methods: A single (assessor) blind, three-arm parallel, multi-center randomized controlled trial will be conducted. Eighty-four adults with knee OA will be recruited from four tertiary hospitals in Northwestern Nigeria and randomly assigned into one of three intervention groups; twice-weekly KBA (n = 28), thrice-weekly KBA (n = 28), and conventional physiotherapy or control (n = 28) in the ratio of 1:1:1. Participants in the conventional therapy group will receive two sessions of brief patient education, and 16 sessions of ultrasound therapy, stretching and strengthening exercises for 8 weeks. Participants in the two different KBA groups will receive KBA exercise according to the designed sessions for 8 weeks in addition to the conventional therapy. All groups will be assessed pre-intervention, immediately post-intervention and at 8 weeks, 3-month, 4-month, and 6-month post-randomization. The primary outcome will be physical function (Ibadan Knee and Hip Osteoarthritis Outcome Measure) while the secondary outcomes will be pain (Visual Analogue Scale for pain), knee stability (Knee Outcome Survey-Activities of Daily Living Scale), proprioception (electronic goniometer), and quality of life (Osteoarthritis Knee and Hip Quality of Life Questionnaire).Discussion: Findings of this study may provide evidence on the effectiveness of KBA exercise and the ideal number of sessions needed to achieve the highest effectiveness in adults with knee OA.Trial registration: Pan African Clinical Trials Registry, (PACTR201810713260138), Retrospectively registered on 28 November 2017.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Aniek A. O. M. Claassen ◽  
Henk J. Schers ◽  
Vincent J. J. F. Busch ◽  
Petra J. C. Heesterbeek ◽  
Frank H. J. van den Hoogen ◽  
...  

Abstract Background To evaluate the effect of a stand-alone mobile and web-based educational intervention (eHealth tool) compared to usual preparation of a first orthopedic consultation of patients with hip or knee osteoarthritis (OA) on patients’ satisfaction. Methods A two-armed randomized controlled trial involving 286 patients with (suspicion of) hip or knee OA, randomly allocated to either receiving an educational eHealth tool to prepare their upcoming consultation (n = 144) or usual care (n = 142). Satisfaction with the consultation on three subscales (range 1–4) of the Consumer Quality Index (CQI - primary outcome) and knowledge (assessed using 22 statements on OA, range 0–22), treatment beliefs (assessed by the Treatment beliefs in OsteoArthritis questionnaire, range 1–5), assessment of patient’s involvement in consultation by the surgeon (assessed on a 5-point Likert scale) and patient satisfaction with the outcome of the consultation (numeric rating scale), were assessed. Results No differences between groups were observed on the 3 subscales of the CQI (group difference (95% CI): communication 0.009 (− 0.10, 0.12), conduct − 0.02 (− 0.12, 0.07) and information provision 0.02 (− 0.18, 0.21)). Between group differences (95% CI) were in favor of the intervention group for knowledge (1.4 (0.6, 2.2)), negative beliefs regarding physical activities (− 0.19 (− 0.37, − 0.002) and pain medication (− 0.30 (− 0.49, − 0.01)). We found no differences on other secondary outcomes. Conclusions An educational eHealth tool to prepare a first orthopedic consultation for hip or knee OA does not result in higher patient satisfaction with the consultation, but it does influence cognitions about osteoarthritis. Trial registration Dutch Trial Register (trial number NTR6262). Registered 30 January 2017.


2010 ◽  
Vol 90 (3) ◽  
pp. 356-366 ◽  
Author(s):  
Joshua N. Farr ◽  
Scott B. Going ◽  
Patrick E. McKnight ◽  
Shelley Kasle ◽  
Ellen C. Cussler ◽  
...  

Background Prescription of resistance training (RT) exercises is an essential aspect of management for knee osteoarthritis (OA). However, whether patients with knee OA who are randomly assigned to receive RT simply substitute RT for other modes of physical activity remains unclear. Objective The aim of this study was to determine the effect of a structured RT intervention on overall levels of moderate- and vigorous-intensity physical activity (MVPA) in patients with early-onset knee OA. The study compared patients with early-onset OA who participated in an RT program, those who participated in a self-management (SM) program, and those who participated in both RT and SM. Because participants randomly assigned to receive the RT intervention may simply switch activity modes, resulting in little net effect, we assessed total MVPA in addition to tracking changes in strength (force-generating capacity). Design and Intervention This study was a randomized controlled trial comparing the effectiveness of SM alone, RT alone, and combined RT+SM on MVPA in patients with early OA of the knee. Setting The study was conducted on a university campus, with patient recruitment from the local community. Participants The participants in this study were 171 patients (74% women, 26% men) with knee OA. They had a mean age of 55.1 (SD=7.1) years, a mean body mass index of 27.6 (SD=4.2) kg/m2, and radiographic status of grade II OA (and no higher) in at least one knee, as defined by the Kellgren and Lawrence classification. They wore an accelerometer while awake (X̄=14.2 [SD=2.2] hours) for 5 to 7 contiguous days (X̄=6.8 [SD=0.5] days) at baseline and at 3 and 9 months of intervention. Results The participants engaged in MVPA a mean of 26.2 (SD=19.3) minutes per day at baseline. Both groups significantly increased their MVPA from baseline to 3 months (RT group by 18% [effect size (d)=0.26]; SM group by 22% [effect size (d)=0.25]), but only the RT group sustained those changes at 9 months (RT group maintained a 10% increase [effect size (d)=0.15]; SM group maintained a 2% increase [effect size (d)=0.03]). A significant group × time interaction for MVPA indicated that the RT group maintained higher MVPA levels than the SM group. Limitations Lack of direct measures of energy expenditure and physical function was a limitation of the study. Conclusions Patients with early-onset OA of the knee can engage in an RT program without sacrificing their overall MVPA levels. These results support the value of RT for management of knee OA.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Aline Mizusaki Imoto ◽  
Stella Peccin ◽  
Kelson Nonato Gomes da Silva ◽  
Lucas Emmanuel Pedro de Paiva Teixeira ◽  
Marcelo Ismael Abrahão ◽  
...  

Objectives. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.Design. Randomized controlled trial.Setting. A specialty outpatient clinic.Participants. Patients (N=100; women = 86, men = 14; age range, 50–75 years) with knee OA.Interventions. Participants were randomly assigned to NMES + Ex or Ex group.Outcome Measures. Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed. For the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS (P=0.52), TUG test (P=0.12), and aspects of WOMAC: pain (P=0.26), function (P=0.23), and stiffness (P=0.63).Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical Trials Registry (ACTRN012607000357459).


2007 ◽  
Vol 87 (1) ◽  
pp. 32-43 ◽  
Author(s):  
Rana S Hinman ◽  
Sophie E Heywood ◽  
Anthony R Day

Background and Purpose Aquatic physical therapy is frequently used in the management of patients with hip and knee osteoarthritis (OA), yet there is little research establishing its efficacy for this population. The purpose of this study was to evaluate the effects of aquatic physical therapy on hip or knee OA. Subjects A total of 71 volunteers with symptomatic hip OA or knee OA participated in this study. Methods The study was designed as a randomized controlled trial in which participants randomly received 6 weeks of aquatic physical therapy or no aquatic physical therapy. Outcome measures included pain, physical function, physical activity levels, quality of life, and muscle strength. Results The intervention resulted in less pain and joint stiffness and greater physical function, quality of life, and hip muscle strength. Totals of 72% and 75% of participants reported improvements in pain and function, respectively, compared with only 17% (each) of control participants. Benefits were maintained 6 weeks after the completion of physical therapy, with 84% of participants continuing independently. Discussion and Conclusion Compared with no intervention, a 6-week program of aquatic physical therapy resulted in significantly less pain and improved physical function, strength, and quality of life. It is unclear whether the benefits were attributable to intervention effects or a placebo response.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aysha I. Adhama ◽  
Mukadas O. Akindele ◽  
Aminu A. Ibrahim

Abstract Background Knee osteoarthritis (OA) is a common painful and disabling condition that affects older individuals. Proprioceptive training programs in the form of kinesthesia, balance and agility (KBA) exercises have been reported to be beneficial for individuals with knee OA. However, the most optimal training dosage of KBA exercises is still unclear. The aim of this study is to determine the effects of different frequencies of KBA training (i.e., twice-weekly or thrice-weekly) in adults with knee OA. Methods A single (assessor) blind, three-arm parallel, multi-center randomized controlled trial will be conducted. One hundred twenty adults with knee OA will be recruited from four tertiary hospitals in Northwestern Nigeria and randomly assigned into one of three intervention groups; twice-weekly KBA (n = 40), thrice-weekly KBA (n = 40), and conventional physiotherapy (n = 40) in the ratio of 1:1:1. Participants in the conventional physiotherapy group will receive two sessions of brief patient education, and sixteen sessions of ultrasound therapy, and stretching and strengthening exercises for 8 weeks. Participants in the two different KBA groups will receive KBA training according to the designed sessions for 8 weeks in addition to the conventional physiotherapy program. All groups will be assessed pre-intervention, immediately post-intervention and at 3 months, 4 months, and 6 months post-randomization. The primary outcome will be physical function (Ibadan Knee and Hip Osteoarthritis Outcome Measure) whereas the secondary outcomes will be pain intensity (Visual Analogue Scale for pain), knee stability (Knee Outcome Survey-Activities of Daily Living Scale), proprioception (electronic goniometer), and quality of life (Osteoarthritis Knee and Hip Quality of Life Questionnaire). Discussion The findings of this study may provide evidence on the effectiveness of KBA exercise training and the ideal number of sessions needed to achieve the highest effectiveness in adults with knee OA. Trial registration Pan African Clinical Trials Registry (PACTR201810713260138). Registered on 28 November 2017.


2021 ◽  
Author(s):  
Ruiyang Li ◽  
Pingping Sun ◽  
Yu Zhan ◽  
Xuetao Xie ◽  
Weibing Yan ◽  
...  

Abstract Background Knee osteoarthritis (OA) is a leading cause of global disability. According to guidelines, thus far, exercise is the most recommended and important non-surgical treatment for knee OA. However, the best type of exercise for this condition remains unclear. There is evidence showing that traditional Chinese exercises may be more effective. Therefore, the current prospective, two-armed, single-center randomized controlled trial (RCT) aimed to identify an effective physiotherapy for knee OA. Methods/design: In total, 128 patients with painful knee OA will be recruited from the orthopaedic outpatient department of Shanghai Jiao Tong University Affiliated Sixth People’s Hospital. To compare the therapeutic effect of two different home-based exercise programs, the participants will be randomly assigned into the experimental group (leg swing exercise) or the control group (quadriceps strengthening exercise). Each participant in both groups will be required to attend five individual sessions with a physiotherapist who will teach the exercise program and monitor progress. Participants will be instructed to perform the exercises at home every day for 12 weeks. Clinical outcomes will be assessed at baseline and 12 and 24 weeks after starting the intervention. The primary outcomes are average overall knee pain and physical function in daily life. The secondary outcomes include other measures of knee pain, physical function, patient-perceived satisfactory improvement, health-related quality of life, physical activity and performance, muscle strength of the lower limb, and adherence. Discussion This study will provide more evidence on the effects of traditional Chinese exercise on improving physical function and relieving joint pain among patients with knee OA. If proven effective, leg swing exercise can be used as a non-surgical treatment for knee OA in the future. Trial registration: Chinese Clinical Trial Registry reference: ChiCTR2000039005, registered 13/10/2020. http://www.chictr.org.cn/showproj.aspx?proj=62497


Author(s):  
Muhibbah Fatati ◽  
◽  
Setyo Sri Rahardjo ◽  
Hanung Prasetya ◽  
◽  
...  

ABSTRACT Background: The increase in rates of knee replacement for osteoarthritis has made the identification of effective nonsurgical treatments a high priority. One type of treatment for medial knee osteoarthritis involves reducing medial loading to ease the physical stress applied to that compartment of the joint. The wedge is placed under the sole of the foot and angulated so that it is thicker over the lateral than the medial edge, transferring loading during weight bearing from the medial to the lateral knee compartment. This study aimed to investigate the effect of lateral wedge insole uptake in reducing pain in patients with knee osteoarthritis. Subjects and Method: A meta-analysis and systematic review conducted by search published articles from PubMed, Science Direct, Google Scholar, Mendeley, and Clinical key databases. Keywords used “Lateral Wedge Insole” OR “Insole” AND “Foot Orthosis “AND “osteoarthritis” AND “patellofemoral osteoarthritis” AND “knee pain” AND “medial knee osteoarthritis “AND” effect lateral wedge insole for osteoarthritis” AND “randomized controlled trial”. The inclusion criteria were full text, using randomized controlled trial (RCT) study design, and reporting effect size (mean and standard deviation). The intervention was lateral wedge insole with comparison non lateral wedge insole. The study outcome was pain. The data were analyzed by Revman 5.3. Results: 6 studies were met the inclusion criteria. This study showed that the use of lateral wedge insole reduced pain in patients with knee osteoarthritis (Mean Difference= -0.17; 95% CI= -0.51 to 0.18; p= 0.340) with heterogeneity I2= 77%. Conclusion: Lateral wedge insole use reduced pain in patients with knee osteoarthritis. Keywords: knee osteoarthritis, lateral wedge insole, randomized control trial Correspondence: Muhibbah Fatati, Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: [email protected]. Mobile: 089633466598. DOI: https://doi.org/10.26911/the7thicph.05.45


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