Efficacy of JOINS on Cartilage Protection in Knee Osteoarthritis: Prospective Randomized Controlled Trial.
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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
Publications
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]
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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.
| S-EPMC8252338 | biostudies-literature
Project description:ObjectiveCertain 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.DesignSingle-blind, three-arm randomized controlled trial.SettingCommunity in Southwestern Ontario, Canada.ParticipantsA convenience sample of 31 women with symptomatic knee osteoarthritis was recruited through rheumatology, orthopaedic and physiotherapy clinics, newspapers and word-of-mouth.InterventionsParticipants 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.MeasurementsPrimary 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.ResultsThe 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.ConclusionsThe 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.Trial registrationClinicalTrials.gov (NCT02370667).
| S-EPMC5903657 | biostudies-literature
Project description:PurposeKnee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis.MethodsNinety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used.ResultsNo baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events.ConclusionsProlotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
| S-EPMC3659139 | biostudies-literature
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.
| S-EPMC5836464 | biostudies-literature
Project description:BackgroundOsteoarthritis is the prevailing form of inflammatory condition in joints of adults and the aging population, leading to long-term disability and chronic pain. Current therapeutic options have variable therapeutic efficacy and/or several side effects.MethodsA randomized, placebo-controlled, double-blind clinical trial was conducted in 62 participants using a nutraceutical [standardized Boswellia serrata Roxb. gum resin (300 mg) and Apium graveolens L. seed extract (250 mg)], to determine its safety and efficacy for supporting cartilage health and reduction in knee osteoarthritis symptoms. All participants were assessed for physical function and pain with the help of WOMAC, VAS, Physicians' Global Assessment for the six-minute walk test/pain. Knee X-ray, KOOS questionnaire score, and FACIT-F score were assessed. Additionally, inflammatory, cartilage degeneration and regeneration biomarkers in serum and urine were evaluated at baseline and after 90 days of treatment.ResultsOral administration of the nutraceutical resulted in prolonged symptomatic relief with reduced pain, stiffness, and swelling. Inflammatory (serum IL-7, IL-1, IL-6, hs-CRP, TNF-α, ESR) and cartilage degeneration biomarkers (serum CTX-II, COMP, MMP-3 and urinary CTX-II) were decreased in the nutraceutical group compared to baseline and placebo. Furthermore, serum N-propeptide of collagen IIA (PIIANP) and procollagen-type-C propeptide (PIICP) levels were increased in the nutraceutical group, suggesting collagen synthesis contributing to cartilage regeneration. At given doses for 90 days, there were no adverse effects based on the clinical examination, biochemical, hematological, and ECG analysis.ConclusionsTaken together, the combination of Boswellia and celery could be a safe and promising herbal nutraceutical option for managing osteoarthritis and cartilage health effectively.
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Project description:BackgroundExercise therapy is recommended by international guidelines as a core treatment for patients with knee osteoarthritis. However, there is a significant gap between recommendations and practice in health care. Digital exercise apps are promising to help solve this undersupply.ObjectiveThis study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health-related outcomes, performance measures, and adherence in patients with knee osteoarthritis.MethodsThis closed user group trial included participants with moderate to severe unicondylar painful knee osteoarthritis. Randomization was 1:1:2 into an intervention group (IG) with 2 subgroups (app-based training [IG A] and app-based training and a supportive knee brace [IG AB]) and a control group (CG). The intervention included a 12-week home exercise program with 3 sessions per week. Instructions for the exercises were given via the app and monitored using 2 accelerometers placed below and above the affected knee joint. Participants in the CG did not receive any study intervention but were allowed to make use of usual care. Osteoarthritis-specific pain (Knee Injury and Osteoarthritis Outcome Score) was defined as the primary outcome, and secondary outcomes included all other Knee Injury and Osteoarthritis Outcome Score subscales, general health-related quality of life (Veterans RAND 12-item Health Survey), psychological measures (eg, exercise self-efficacy), performance measures (strength and postural control), and the monitoring of adherence and safety. Outcomes were assessed at baseline and after 12 weeks. Intervention effects were calculated using baseline-adjusted analysis of covariance for the joint comparison of IG A and IG AB versus the CG using a per-protocol approach. Subgroup analyses were conducted for each IG separately.ResultsA total of 61 participants were included (IG: n=30, 49%; CG: n=31, 51%; male: n=31, 51%; female: n=30, 49%; mean age 62.9, SD 8.5 years; mean BMI 27.7, SD 4.5 kg/m2). Analysis revealed statistically significant effects in favor of the IG for pain reduction (P<.001; effect size [ES]=0.76), improvements in physical function (P<.001; ES=0.64), improvements in symptoms (P=.01; ES=0.53), improvements in sport and recreation activities (P=.02; ES=0.47), improvements in knee-related quality of life (P<.001; ES=0.76), and improvements in the physical component of general health-related quality of life (P<.001; ES=0.74). Mean differences ranged from 6.0 to 13.2 points (scale range 0-100). ESs indicated small to medium effects. No effects were found for psychological and performance measures. Participants adhered to 92.5% (899/972) of all scheduled exercise sessions.ConclusionsIndividuals with knee osteoarthritis undergoing a 12-week sensor-assisted app-based exercise intervention with or without an additional knee brace experienced clinically meaningful treatment effects regarding pain relief and improvements in physical function as well as other osteoarthritis-specific concerns compared to controls.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00023269; https://drks.de/search/de/trial/DRKS00023269.
| S-EPMC11420596 | biostudies-literature
Project description:BackgroundAyurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients.MethodsA total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied.ResultsThe RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 ± 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%.ConclusionsThese secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models.
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Project description:IntroductionVarious acupuncture techniques are widely applied in clinics for pain control and dysfunction relief in patients with knee osteoarthritis (KOA). The purpose of this trial was to investigate whether the different acupuncture techniques were more effective in treating joint pain and dysfunction than were sham acupuncture or drug treatment in patients with KOA and to determine the differences in efficacy among them.MethodsIn this multi-center, single-blind, randomized, controlled trial, participants were randomly assigned to the manual acupuncture (MA), electroacupuncture (EA), warm-needling acupuncture (WA), mild moxibustion (MM), sham acupuncture (SA), or drug treatment (Celebrex) groups. Each participant in the above groups received individual treatments for 4 consecutive weeks. The primary outcome measures included the visual analog scale score (VAS) and the physical function score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).ResultsCompared with the SA group, the acupuncture technique groups (MA, EA, WA, and MM) had markedly lower patient VAS scores (- 0.61; 95% CI - 1.09 to - 0.13; P = 0.01) and lower WOMAC physical function scores (- 13.84; 95% CI - 21.14 to - 6.54; P < 0.01). Compared with Celebrex, EA had a significant advantage in reducing the VAS score (1.14; 95% CI 0.55 to 1.72; P < 0.01) and WOMAC physical function score (14.81; 95% CI 5.69 to 23.93; P < 0.01).ConclusionsThe observed acupuncture techniques effectively relieve pain and ameliorate knee joint dysfunction in patients with KOA. EA is the most effective method of alleviating pain intensity in treating KOA.Trial registrationThe trial was registered on ClinicalTrials.gov (NCT03563690).
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Project description:ObjectiveThe aim of this study was to investigate the difference of efficacy between conventional moxibustion (CM) and smoke-free moxibustion (SM) for patients with osteoarthritis of the knee (KOA).MethodsThis is a multicentre, randomized, single blinded, parallel-group clinical trial. Patients with KOA were randomly allocated to CM group (69) and SM group (69) in 7 hospitals of China. Moxibustion treatment in 12 sessions over 4 weeks was administrated at 3 acupuncture points (EX-LE4, ST35, and ST36). Patients completed standard questionnaires at baseline and after 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. The secondary outcomes include Visual Analogue Scale (VAS) and Patient Global Assessment score (PGA).ResultsAnalyses showed that the WOMAC score improved in pain (95% CI,-0.1[-1.2 to 0.9], p=0.76), stiffness (95% CI,-0.1 [-0.5 to 0.3], p=0.71), and function (95% CI, 2.2 [-1.3 to 5.8], p=0.22) compared between the two groups at 4 weeks, as well as the VAS score (95% CI,0.1 [-0.3 to 0.6], p=0.60). Similar results presented at 8 and 12 weeks. No statistically significant difference was observed between CM and SM groups for outcome measurements.ConclusionsIt suggested that smoke generated during moxibustion treatment does not affect the efficacy of moxibustion in the treatment of KOA, which should be taken into account to be removed for the sake of reducing environmental pollution or moxa smoke exposure of acupuncturists or patients. This trial is registered with Clinical Trials.gov, NCT02772055.
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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.
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