scholarly journals Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017652 ◽  
Author(s):  
Christelle Nguyen ◽  
Isabelle Boutron ◽  
Gabriel Baron ◽  
Emmanuel Coudeyre ◽  
Francis Berenbaum ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
The Mean ◽  
Anti Inflammatory

IntroductionOsteoarthritis (OA) pathophysiology is driven in part by joint inflammation. Resveratrol has in vitro anti-inflammatory properties. We aim to assess the efficacy of oral resveratrol for knee pain at 3 months in people with knee OA.Methods and analysisWe will conduct a randomised double-blind placebo-controlled trial. Overall, 164 individuals with knee OA fulfilling 1986 American College of Rheumatology criteria will be recruited in three tertiary care centres in France and randomised to receive oral resveratrol, 40 mg (two caplets) two times per day for 1 week, then 20 mg (one caplet) two times per day or a matching placebo for a total of 6 months. Randomisation will be centralised and stratified by centre. The allocation ratio of assignments will be 1:1. The primary outcome will be the mean change from baseline in knee pain on a self-administered 11-point pain Numeric Rating Scale at 3 months. Secondary outcomes will be the mean change in knee pain at 6 months, the function subscore of the Western Ontario and McMaster Universities Arthritis Index score, patient global assessment, proportion of responders according to the Osteoarthritis Research Society International–Outcome Measures in Rheumatology criteria at 3 and 6 months, and self-reported number of intra-articular injections of corticosteroids or hyaluronic acid and consumption of analgesics and non-steroidal anti-inflammatory drugs since the last contact. Other interventions will be allowed and self-reported. Adherence will be monitored by capsule counts and a booklet and adverse events recorded at 3 and 6 months. Statisticians, treating physicians and participants will be blinded to the allocated treatment.Ethics and disseminationThe oral resveratrol in knee osteoarthritis (ARTHROL) trial has been authorised by theAgenceNationale de Sécurité du Médicament et des Produits de Santéand ethics were approved by theComité deProtection des Personnes Île-de-FranceIII. The findings of the study will be published in a peer-reviewed journal and disseminated at conferences. The design of ARTHROL will warrant the translation of its findings into clinical practice.Trial registration numberClinicalTrials.gov identifier:NCT02905799. Pre-results. First received: 14 September 2016. Last updated: 16 September 2016. Status: not yet recruiting.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus

2017 ◽  
Vol 46 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Vandana S. Mathur ◽  
Jayant Kumar ◽  
Paul W. Crawford ◽  
Howard Hait ◽  
Thomas Sciascia ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Opioid Antagonist ◽  
Opioid Agonist ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Uremic Pruritus ◽  
The Mean

Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

scholarly journals Effect of liraglutide on body weight and pain in patients with overweight and knee osteoarthritis: protocol for a randomised, double-blind, placebo-controlled, parallel-group, single-centre trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024065 ◽  
Author(s):  
Henrik Gudbergsen ◽  
Marius Henriksen ◽  
Eva Ejlersen Wæhrens ◽  
Anders Overgaard ◽  
Henning Bliddal ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Single Centre ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Parallel Group ◽  
Pain Subscale

IntroductionWith an increasing prevalence of citizens of older age and with overweight, the health issues related to knee osteoarthritis (OA) will intensify. Weight loss is considered a primary management strategy in patients with concomitant overweight and knee OA. However, there are no widely available and feasible methods to sustain weight loss in patients with overweight and knee OA. The present protocol describes a randomised controlled trial evaluating the efficacy and safety of the glucagon-like peptide-1 receptor agonist liraglutide in a 3 mg/day dosing in patients with overweight and knee OA.Methods and analysis150 volunteer adult patients with overweight or obesity and knee OA will participate in a randomised, double-blind, placebo-controlled, parallel-group and single-centre trial. The participants will partake in a run-in diet intervention phase (week −8 to 0) including a low calorie diet and dietetic counselling. At week 0, patients will be randomised to either liraglutide 3 mg/day or liraglutide placebo 3 mg/day for 52 weeks as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. The co-primary outcomes are changes in body weight and the Knee Injury and Osteoarthritis Outcome Score pain subscale from week 0 to week 52.Ethics and disseminationThe trial has been approved by the regional ethics committee in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. An external monitoring committee (The Good Clinical Practice Unit at Copenhagen University Hospitals) will oversee the trial. The results will be presented at international scientific meetings and through publications in peer-reviewed journals.Trial registration numbers2015-005163-16,NCT02905864, U1111-1171-4970Based on protocol versionV.6; 30 January 2017, 15:30 hours

scholarly journals AB1261 DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF PULSED ELECTROMAGNETIC FIELD THERAPY IN KNEE OSTEOARTHRITIS (PRELIMINARY RESULTS)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1922.2-1922
Author(s):  
D. Karateev ◽  
A. Makevnina ◽  
A. Tangieva ◽  
E. Luchikhina ◽  
H. Hamhoeva
Keyword(s):  
Electromagnetic Field ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Low Frequency ◽  
Clinical Parameters ◽  
Pulsed Electromagnetic Field ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Knee Oa ◽  
Pulsed Electromagnetic

Background:Pulsed electromagnetic field (PEMF) therapy is widely used in different areas of medicine. There are a lot of portable PEMF therapeutic devices on the market around the world. Nevertheless, the role of PEMF in treatment of rheumatic conditions is not clear. Current evidence is of low and very low quality.Objectives:To study efficacy and safety of PEMF therapy in primary and secondary osteoarthritis (OA) of the knee in controlled clinical trial.Methods:This abstract presents the preliminary results of an ongoing double-blind placebo-controlled trial of PEMF portable therapeutic device “ALMAG+” (Certificate EN ISO 13485:2012+AC:2012 reg.-No 44221 117836, Yelatma Instrument-Making Enterprise, Russian Federation, Reg. Num.: 3007075140). The device is intended for physiotherapeutic treatment and rehabilitation with a low-frequency low-intensity PEMF in medical institutions, as well as at home after the recommendation of a doctor. Patients with primary and secondary (as a part of inflammatory rheumatic disease) OA of knee with Kellgren-Lawrence Grade I-III included in the study (in patients with inflammatory conditions disease activity should be minimal on stable drug therapy). Three courses of PEMF of 20 procedures for 1 year planned in active treatment group and placebo (inactive device) group of 35 patients each. Efficacy is evaluated by pain VAS, WOMAC, Lequesne index, and quality of life studied using SF-36, EuroQoL 5D tools. Instrumental control with knee ultrasound and MRI investigations will be performed. The study protocol was approved by local Ethical Committee.Results:To date 23 patients (7 males, 16 females, age 54,6±11,2 years, primary knee OA – 16 pts, RA- 6 pts, AS – 1 pt) completed 1stcourse of PEMF. Table presents differences (Δ) in the main clinical parameters in active treatment and placebo device groups. No significant difference in ESR or CRP levels was found. No treatment-related adverse events has been reported.Table.Differences (Δ) in the main clinical parameters after a 1stcourse of PEMF.ParameterActive device (n=11)Placebo device (n=12)pΔ VAS pain in movement15 [0; 38,5]5 [1,25; 10,5]0,053Δ VAS pain in rest10 [0; 34]1 [0; 2,75]0,043Δ WOMAC3 [2; 10]2 [0; 4,5]0,174Δ Lequesne index3 [0; 4]1 [0,25; 2,5]0,258Conclusion:In this preliminary analysis pulsed electromagnetic field (PEMF) therapy showed significant impact on pain in rest in knee OA after one course of procedures.References:Negm A, Lorbergs A, Macintyre NJ. Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1281-9. doi: 10.1016/j.joca.2013.06.015Disclosure of Interests:Dmitry Karateev Consultant of: Abbvie, Pfizer, Biocad, Sanofi, Novartis, Lilly, Speakers bureau: Abbvie, Roche, Pfizer, Biocad, MSD, Sanofi, Johnson & Johnson, Glaxo, UCB, Celgene, Novartis, Lilly, Bayer, Alexandra Makevnina Speakers bureau: Sanofi, Aminat Tangieva: None declared, Elena Luchikhina Consultant of: Abbvie, Biocad, Sanofi, Celgene, Speakers bureau: Abbvie, Roche, Pfizer, Biocad, MSD, Sanofi, Johnson & Johnson, Glaxo, UCB, Celgene, Novartis, Hava Hamhoeva: None declared

scholarly journals Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110240
Author(s):  
Man Soo Kim ◽  
In Jun Koh ◽  
Yong Gyu Sung ◽  
Dong Chul Park ◽  
Sung Cheol Yang ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Therapeutic Effect ◽  
Combination Treatment ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Knee Oa ◽  
Anti Inflammatory

Background: The 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. Methods: This 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. Results: The 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. Conclusions: The 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.

scholarly journals Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 383 ◽  
Author(s):  
Jin-Tao Liu ◽  
De-Zhi Tang ◽  
Xiao-Feng Li ◽  
Zhi-Gang Zhang ◽  
Wan-Bo Ji ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Study Protocol ◽  
Pain Therapy ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

A randomized, double-blind, placebo-controlled trial on the efficacy and tolerability of sertraline in Iranian veterans with post-traumatic stress disorder

2011 ◽  
Vol 41 (10) ◽  
pp. 2159-2166 ◽  
Author(s):  
Y. Panahi ◽  
B. Rezazadeh Moghaddam ◽  
A. Sahebkar ◽  
M. Abbasi Nazari ◽  
F. Beiraghdar ◽  
...  
Keyword(s):  
Placebo Group ◽  
Post Traumatic Stress Disorder ◽  
Traumatic Stress ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Traumatic ◽  
The Mean

BackgroundUnlike civilian post-traumatic stress disorder (PTSD), the efficacy of sertraline for the treatment of combat-related PTSD has not yet been proven. The present study aimed to evaluate the clinical efficacy of sertraline against combat-related PTSD in a randomized, double-blind, placebo-controlled trial.MethodSeventy Iranian veterans of the Iran–Iraq war who met the DSM-IV criteria for diagnosis of PTSD were randomized to receive either flexibly dosed sertraline (50–200 mg/day) (n=35, completers=32) or placebo (n=35, completers=30) for 10 weeks. Efficacy was evaluated by the Impact of Event Scale – Revised (IES-R) and the Clinical Global Impression scale – Severity (CGI-S) and Improvement (CGI-I) ratings. Responder criteria were defined as a ⩾30% reduction in the IES-R total score plus a CGI-I rating of ‘much’ or ‘very much’ improved.ResultsOn both intention-to-treat (ITT) and per protocol (completer) methods of analysis, the mean reductions in the IES-R total and subscale (re-experiencing/intrusion, avoidance/numbing and hyperarousal) scores (p<0.001) and also in the CGI-S score (p<0.01) were significantly greater in the sertraline group than in the placebo group. For the CGI-I, the mean endpoint score was significantly lower in the sertraline group than in the placebo group (p⩽0.001). The number of responders in the sertraline group was significantly higher than in the placebo group (44% v. 3%, p⩽0.001). Sertraline was well tolerated, with a 6% discontinuation rate as a result of adverse reactions.ConclusionsThe results of this study suggest that sertraline can be an effective, safe and tolerable treatment for combat-related PTSD in Iranian veterans.

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.

scholarly journals Morinda citrifolia(Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
H. M. Fletcher ◽  
J. Dawkins ◽  
C. Rattray ◽  
G. Wharfe ◽  
M. Reid ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Morinda Citrifolia ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Menstrual Cycles ◽  
Primary Dysmenorrhoea ◽  
Before And After ◽  
Laboratory Variables ◽  
Anti Inflammatory ◽  
Bleeding Score

Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea.Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume.Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls.Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.

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