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Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.

ABSTRACT: Purpose:In this study, we compared the clinical efficacy of JOINS (SKI306X, SK Chemicals) with placebo on cartilage protection using magnetic resonance imaging (MRI). Materials and Methods:Sixty-nine patients were randomized to the JOINS group (200 mg, three times daily for 1 year; n=33) or the placebo group (n=36). Changes in cartilage volume and thickness were measured using MRI. Changes in the delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) index, subchondral bone marrow abnormality scores, and clinical scores including knee pain visual analog scale (VAS) score and Korean Western Ontario and McMaster Universities Osteoarthritis Index (K-WOMAC) were also evaluated. Results:Changes in cartilage thickness and volume and subarticular bone marrow abnormality scores were not different between groups. Changes in the dGEMRIC index in the lateral tibial plateau were greater in the JOINS group than in the placebo group (19.64±114.33 msec vs. -57.77±123.30 msec; p=0.011). Significantly greater changes in VAS were observed in the JOINS group than in the placebo group (-26.00±12.25 vs. -12.47±21.54; p=0.002) and K-WOMAC (-15.42 ± 7.73 vs. -8.15±13.71; p=0.003). Conclusions:Compared with placebo, JOINS had superior clinical efficacy in regard to cartilage protection.

SUBMITTER: Kim JI

PROVIDER: S-EPMC5596397 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.

Kim Joong Il JI Choi Ja Young JY Kim Kwang Gi KG Lee Myung Chul MC

Knee surgery & related research 20170901 3

<h4>Purpose</h4>In this study, we compared the clinical efficacy of JOINS (SKI306X, SK Chemicals) with placebo on cartilage protection using magnetic resonance imaging (MRI).<h4>Materials and methods</h4>Sixty-nine patients were randomized to the JOINS group (200 mg, three times daily for 1 year; n=33) or the placebo group (n=36). Changes in cartilage volume and thickness were measured using MRI. Changes in the delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) index, subchondral bone marrow ...[more]

PMID: 28854768

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Project description:BackgroundThe aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms.MethodsThis study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers.ResultsThe trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742.ConclusionsThe combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect.

Project description:Certain exercises could overload the osteoarthritic knee. We developed an exercise program from yoga postures with a minimal knee adduction moment for knee osteoarthritis. The purpose was to compare the effectiveness of this biomechanically-based yoga exercise (YE), with traditional exercise (TE), and a no-exercise attention-equivalent control (NE) for improving pain, self-reported physical function and mobility performance in women with knee osteoarthritis.Single-blind, three-arm randomized controlled trial.Community in Southwestern Ontario, Canada.A convenience sample of 31 women with symptomatic knee osteoarthritis was recruited through rheumatology, orthopaedic and physiotherapy clinics, newspapers and word-of-mouth.Participants were stratified by disease severity and randomly allocated to one of three 12-week, supervised interventions. YE included biomechanically-based yoga exercises; TE included traditional leg strengthening on machines; and NE included meditation with no exercise. Participants were asked to attend three 1-hour group classes/sessions each week.Primary outcomes were pain, self-reported physical function and mobility performance. Secondary outcomes were knee strength, depression, and health-related quality of life. All were assessed by a blinded assessor at baseline and immediately following the intervention.The YE group demonstrated greater improvements in KOOS pain (mean difference of 22.9 [95% CI, 6.9 to 38.8; p = 0.003]), intermittent pain (mean difference of -19.6 [95% CI, -34.8 to -4.4; p = 0.009]) and self-reported physical function (mean difference of 17.2 [95% CI, 5.2 to 29.2; p = 0.003]) compared to NE. Improvements in these outcomes were similar between YE and TE. However, TE demonstrated a greater improvement in knee flexor strength compared to YE (mean difference of 0.1 [95% CI, 0.1 to 0.2]. Improvements from baseline to follow-up were present in quality of life score for YE and knee flexor strength for TE, while both also demonstrated improvements in mobility. No improvement in any outcome was present in NE.The biomechanically-based yoga exercise program produced clinically meaningful improvements in pain, self-reported physical function and mobility in women with clinical knee OA compared to no exercise. While not statistically significant, improvements in these outcomes were larger than those elicited from the traditional exercise-based program. Though this may suggest that the yoga program may be more efficacious for knee OA, future research studying a larger sample is required.ClinicalTrials.gov (NCT02370667).

Project description:BACKGROUND:Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. METHODS:This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of "ashi", if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. DISCUSSION:This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03287570 . Registered on 19 September 2017.

Project description:BackgroundPatients with osteoarthritis (OA) take a variety of health supplements in an attempt to reduce pain and improve function. The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.MethodsThis study was a prospective, randomized, double-blind, controlled clinical trial. Forty nine men and women 45-90 (mean 68 ± SD 7.3) years of age with knee OA according to the American College of Rheumatology clinical criteria for OA of the knee and with radiographic confirmed knee OA were enrolled in the study and randomly assigned into 2 groups: One received MSM in doses of 1.125 grams 3 times daily for 12 weeks and the other received a placebo in the same dosing frequency. The primary outcomes were the WOMAC Osteoarthritis Index for pain, stiffness and physical function, the Aggregated Locomotor Function (ALF) test that evaluates each patient's physical function, the SF-36 quality of life health survey and the visual-analogue-scale (VAS) for pain. The secondary outcomes were Knee Society Clinical Rating System for Knee Score (KSKS) and Function Score (KSFS). Patients were assessed at baseline, 6 weeks and 12 weeks. All continuous variables were tested by the Kolmogorov-Smirnov test for Normal distribution. Changes within the groups and differences between the groups were calculated by repeated measures of analysis (ANOVA) with one nested variable.ResultsThere were significant differences between treatment groups over time in WOMAC physical function (14.6 mm [CI: 4.3, 25.0]; p = 0.04) and in WOMAC total score (15.0 mm [CI: 5.1, 24.9]; p = 0.03). Treatment groups did not differ significantly in WOMAC pain (12.4 mm [CI: 0.0, 24.8]); p = 0.08) or WOMAC stiffness (27.2 mm [CI: 8.2, 46.2]; p = 0.08). There was a non-significant difference in SF-36 total score between treatment groups (11.6 [CI: 1.0, 22.1]; p = 0.54). A significant difference was found between groups in VAS for pain (0.7 s [CI: -0.9, 2.4]; p = 0.05). Secondary outcomes showed non-significant differences between the two groups.ConclusionsPatients with OA of the knee taking MSM for 12 weeks showed an improvement in pain and physical function. These improvements, however, are small and it is yet to be determined if they are of clinical significance.Trial registrationClinicalTrials.gov: NCT01188213.

Project description:BackgroundOsteoarthritis (OA) is the most common joint disease, and is most frequently seen in the knees. However, there is no effective therapy to relieve the progression of knee OA. Metformin is a safe, well-tolerated oral medication that is extensively used as first-line therapy for type 2 diabetes. Previous observational studies and basic researches suggested that metformin may have protective effects on knee OA, which needs to be verified by clinical trials. This study, therefore, aims to examine the effects of metformin versus placebo on knee cartilage volume loss and knee symptoms in overweight knee OA patients by a randomized controlled trial over 24 months.MethodsThis protocol describes a multicenter, randomized, double-blind, and placebo-controlled clinical trial aiming to recruit 262 overweight knee OA patients. Participants will be randomly allocated to the two arms of the study, receiving metformin hydrochloride sustained-release tablets or identical inert placebo for 24 months (start from 0.5 g/day for the first 2 weeks, and increase to 1 g/day for the second 2 weeks, and further increase to 2 g/day for the remaining period if tolerated). Primary outcomes will be changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 24 months. Secondary outcomes will be changes in visual analogue scale (VAS) knee pain, tibiofemoral cartilage defects, effusion-synovitis volume, and tibiofemoral bone marrow lesions maximum size over 24 months. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per-protocol analyses will be performed as the secondary analyses.DiscussionIf metformin is proved to slow knee cartilage volume loss and to relieve knee symptoms among overweight knee OA patients, it will have the potential to become a disease modifying drug for knee OA. Metformin is a convenient intervention with low cost, and its potential effects on slowing down the structural progression and relieving the symptoms of knee OA would effectively reduce the disease burden worldwide.Trial registrationClinicalTrials. gov NCT05034029 . Registered on 30 Sept 2021.

Project description:BackgroundEvidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs.ObjectiveTo examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).DesignRandomized controlled trial. (ClinicalTrials.gov: NCT02653768).Setting2 U.S. Department of Veterans Affairs sites.Participants345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis.InterventionParticipants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks.MeasurementsPrimary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models.ResultsIn the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement.LimitationParticipants were mostly male veterans, and follow-up was limited.ConclusionVeterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis.Primary funding sourceDepartment of Veterans Affairs, Health Services Research and Development Service.

Dataset Information

Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.

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Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.

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