Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid® OAD)

2007 ◽  
Vol 3 (5) ◽  
pp. 273 ◽  
Author(s):  
Ritchard L. Fishman, MD ◽  
Charles James Kistler, DO ◽  
Michael T. Ellerbusch, MD ◽  
Raul Tomas Aparicio, MD ◽  
Sharad S. Swami, MD ◽  
...  
Keyword(s):  
Pain Relief ◽  
Pain Score ◽  
Severe Pain ◽  
Womac Pain ◽  
Global Rating ◽  
Efficacy And Safety ◽  
Once Daily ◽  
Womac Pain Score ◽  
Responder Analysis ◽  
Percent Improvement

This placebo-controlled study examined the analgesic efficacy, safety, and clinical benefit of Tramadol Contramid OAD, a once-daily formulation with both immediate- and extended-release components. Five hundred and fifty-two patients with moderate to severe pain due to osteoarthritis (OA) of the knee were randomized into this multicenter, double-blind, parallel arm study. After randomization to Tramadol Contramid OAD 100, 200, or 300 mg, or to placebo, patients’ dose was titrated to the fixed randomized dose and maintained for 12 weeks. Efficacy was evaluated with the Patients’ Global Rating of Pain Relief (median ratings at maintenance visits), and the Western Ontario and McMaster University (WOMAC) Pain and Physical Function subscales (percent difference, baseline to end of study) as coprimary endpoints. A responder analysis was conducted (percentage of patients who achieved a 30 percent improvement on their baseline WOMAC pain score). The difference from placebo on the median Patient Global Rating of Pain Relief at the four maintenance visits was statistically significant (200 and 300 mg: p ≤ 0.001). Treatment was rated effective or very effective by 75 percent and 80 percent of patients randomized to Tramadol Contramid OAD 200 mg and 300 mg, respectively. There was a 46 percent (300-mg dose; p = 0.016) and 43 percent (200-mg dose; p = 0.05) improvement on the WOMAC pain score (baseline to the end of the study) with Tramadol Contramid OAD compared with 32 percent for placebo. The responder analysis demonstrated a statistically significant difference in the percentage of patients who achieved a 30 percent improvement in their baseline WOMAC pain score for both Tramadol Contramid OAD 200 mg (65 percent; p = 0.0095) and 300 mg (65 percent; p = 0.0104) compared with placebo (50 percent). The type and incidence of adverse events were typical of tramadol (nausea, dizziness/vertigo, vomiting, somnolence, and constipation) and the intensity was mild to moderate in 87 percent of patients who experienced them regardless of dose. This study shows the efficacy and safety of Tramadol Contramid OAD 200 mg and 300 mg in patients with moderate or severe pain of the knee due to OA.

scholarly journals Pharmacological Use of Gamma-Aminobutyric Acid Derivatives in Osteoarthritis Pain Management: A Systematic Review

2021 ◽  
Author(s):  
Ze Du ◽  
Hanxiao Chen ◽  
Yongrui Cai ◽  
Zongke Zhou
Keyword(s):  
Pain Management ◽  
Pain Score ◽  
Aminobutyric Acid ◽  
Womac Pain ◽  
Gamma Aminobutyric Acid ◽  
Efficacy And Safety ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Vas Score ◽  
Gaba Derivatives

Abstract Background Pain is the major complication of osteoarthritis (OA) patients and is a decisive symptom for medical intervention. Gamma-aminobutyric acid (GABA) derivatives are optional painkillers but not widely used in pain management of OA patients. We synthesized the efficacy and safety of GABA derivatives for OA pain management. Methods We searched Medline, Cochrane CENTRAL, Embase, and ClinicalTrals.gov from inception to 13 October 2021 and included randomized controlled trials (RCTs) comparing the efficacy and safety of GABA derivatives with placebo or standard control in OA pain management. Two independent reviewers extracted data and assessed these studies for risk of bias using Cochrane Collaboration’s tool for RCT. Results In total, three eligible RCTs (n=3) meeting the eligibility criteria were included. Among these RCTs, one focused on hand OA pain management, while two RCTs focused on knee OA. In hand OA, pregabalin reduced numerical rating scale (NRS) score and the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score significantly compared with placebo, and caused 55 AEs. In knee OA, pregabalin reduced visual analogue scale (VAS) score and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score significantly with no recorded adverse event (AE). Meanwhile, in knee OA, gabapentin reduced both VAS score and WOMAC pain score compared with acetaminophen and caused 9 AEs. Conclusions GABA derivates are effective and safe in OA pain management. However, future researches with large sample size are needed to further prove the efficacy of GABA derivates in OA pain control. Trial registration: CRD42021240225.

scholarly journals An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (12) ◽  
pp. 3858-3868
Author(s):  
Jean-Pierre Pelletier ◽  
Jean-Pierre Raynauld ◽  
Marc Dorais ◽  
Louis Bessette ◽  
Eva Dokoupilova ◽  
...  
Keyword(s):  
Pain Score ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Womac Pain ◽  
Double Blind ◽  
Once Daily ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Symptomatic Knee ◽  
Significant Difference

Abstract Objective The objective of this study was to investigate whether diacerein has comparable efficacy with celecoxib in pain reduction for treatment in symptomatic knee OA patients. Methods This randomized double-blind multicentre non-inferiority trial evaluated diacerein vs celecoxib treatment in patients with Kellgren–Lawrence grade 2–3 and pain scoring ≥4 (10-cm VAS). Patients were randomized to 6 months of treatment with diacerein 50 mg (n = 187) once daily for 1 month and twice daily thereafter, or celecoxib 200 mg (n = 193) once daily. The primary outcome was the change in WOMAC pain score (0–50 cm) at 6 months, and the secondary outcomes were WOMAC sub-scores, VAS pain score, and the OMERACT–OARSI responder rate. Results In the per protocol population, the adjusted mean change from baseline in the WOMAC pain score was –11.1 ( 0.9) with diacerein (n = 140) and –11.8 (0.9) with celecoxib (n = 148). The intergroup difference was 0.7 (95% CI: −1.8, 3.2; P = 0.597), meeting the non-inferiority margin. Supportive analysis of the intention-to-treat population gave similar results. Other outcomes showed no significant difference between treatment groups. The incidence of treatment-related adverse events was low and balanced between groups, but a greater incidence of diarrhoea occurred with diacerein (10.2% vs 3.7%). Diarrhoea was considered mild-to-moderate in all but one case with complete resolution. Conclusions Diacerein was non-inferior to celecoxib in reducing knee OA pain and improving physical function. Diacerein also demonstrated a good safety profile. Trial registration A multicentre study on the effect of DIacerein on Structure and Symptoms vs Celecoxib in Osteoarthritis is a National Institutes of Health (NCT02688400) and European Clinical Trial Database (2015–002933-23) registered phase III (Canada) or IV (Europe) study.

scholarly journals Influence of Posterior Condylar Offset on Maximal Flexion and Outcome Scales Following TKA in Asian Patients

2015 ◽  
Vol 4 (4) ◽  
pp. 15-21
Author(s):  
Sae Kwang Kwon ◽  
Nimesh Prakash Jain ◽  
Jong Yeal Kang ◽  
Yeon Gwi Kang ◽  
Tae Kyun Kim
Keyword(s):  
Clinical Outcome ◽  
Pain Score ◽  
Functional Outcomes ◽  
Mobile Bearing ◽  
Womac Pain ◽  
Level Of Evidence ◽  
Womac Pain Score ◽  
Posterior Condylar Offset ◽  
Postoperative Flexion ◽  
Posterior Condylar

Background: Infection complicates traditional joint reconstruction prostheses in up to 7% of cases, witBackground: Alteration in femoral posterior condylar offset (PCO) after total knee arthroplasty (TKA) has been reported to influence maximal flexion angle after TKA. However, there are contradictory reports about its influence on clinical outcome, and the effects of PCO alterations may vary with implant type.Question / purposes: The purpose of this study was to determine whether PCO alterations affect maximal flexion after TKA and other functional outcomes, and whether the effects of PCO alterations differ by implant type.Patients and Methods: Fifty consecutive cases of TKAs in each of four implant types, namely, fixed bearing (FB) cruciate retaining (CR) or posterior stabilized (PS), mobile bearing (MB) CR or PS were included in the study. Patients were evaluated for maximal flexion and clinical outcome scales. The PCO alteration was measured using pre- and postoperative true lateral knee radiographs. Correlations between PCO alterations and functional outcomes including maximal flexion were compared among the four implant types. Results: No significant correlation was found between PCO alterations and maximal flexion achieved in any of the four implant groups (Correlation Coefficient [CC]=-0.03, 0.14, -0.14, 0.04; p> 0.05). The mean maximal postoperative flexion was greater in PS implants than in CR implants (p <0.05). In MB-CR implanted knees, a greater PCO alteration was correlated with worse anterior knee pain score as measured by the PF scoring system (CC=-0.44, p=0.003) and worse WOMAC pain score (CC=-0.41, p=0.007). Conclusions: Our findings indicate that PCO alterations have no effect on maximal postoperative flexion after TKA regardless of the implant type. Whether the implant is of PS or CR type is a better predictor of the final flexion achieved. However, increased PCO is correlated with worse pain score in MB-CR implants. Level of Evidence: Level III, Retrospective comparative study

scholarly journals T2 mapping evaluation of changes in cartilage matrix after PRP and HA injection therapy in knee osteoarthritis: a prospective, randomized, double blind, placebo controlled study

2020 ◽  
Author(s):  
Matjaz Vogrin ◽  
Jakob Naranda ◽  
Mario Gorenjak ◽  
Tomaz Bajec ◽  
Domen Mongus ◽  
...  
Keyword(s):  
Placebo Group ◽  
Knee Osteoarthritis ◽  
Pain Score ◽  
T2 Mapping ◽  
Womac Score ◽  
Controlled Study ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Knee Oa

Abstract BackgroundIn this study we focused on evaluating the effect of intra-articular platelet-rich plasma (PRP) and hyaluronic acid (HA) on the qualitative and quantitative properties of the articular cartilage in patients with knee osteoarthritis (OA).MethodsWe evaluated 264 patients undergoing treatment of moderate knee OA. Patients aged between 40 and 70 years were included with articular K-L stage ≤ 2. Patients were randomized into three groups and treated with three doses of intra-articular PRP, HA, or placebo injection. Patients were evaluated clinically and by using T2 mapping.ResultsBoth PRP (619.05 ± 243 ms; p = 2.7 × 10− 5) and HA (637.12 ± 273 ms; p = 1.×10− 4) group showed statistically significant lower post-application T2 relaxation times in comparison to the placebo group (859.80 ± 406 ms).Cartilage thickness increased significantly after PRP (2.41±0.87 vs. 2.58±0.97 mm, p=0.033) and HA (2.28±0.81 vs. 2.80±1.00 mm, p=1.8×10) applications. There was a significant decrease in WOMAC pain score by 30% (p=0,001) and the overall WOMAC score by 27 p=1.9×10-4%) in PRP group. The decrease in WOMAC pain score and the overall WOMAC score in the placebo group was similar to the results observed in the PRP group. In the HA group a significant decrease in WOMAC pain score by 14% (p=0,005) was observed only at the first follow-up, whereas no difference was observed at the second follow-up. ConclusionsT2 mapping of cartilage tissue may aid to monitor its properties after the intra-articular therapies in knee OA. However, there is a discrepancy between clinical findings and the results of T2 mapping, suggesting questionable grounds for applying intra-articular therapy.

scholarly journals Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Ye Zhao ◽  
Zhi Bi Shen ◽  
Ji Rong Ge ◽  
Wen Gang Liu ◽  
Jun Xing Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Knee Osteoarthritis ◽  
Physical Function ◽  
Pain Score ◽  
Adverse Reactions ◽  
Control Group ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Experimental Group

Objective. To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods. A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results. Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups (P<0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group (P<0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant (P<0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group (P<0.05). Safety Evaluation. A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion. These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.

scholarly journals Efficacy and safety of adalimumab by intra-articular injection for moderate to severe knee osteoarthritis: An open-label randomized controlled trial

2017 ◽  
Vol 46 (1) ◽  
pp. 326-334 ◽  
Author(s):  
Jianping Wang
Keyword(s):  
Knee Osteoarthritis ◽  
Global Assessment ◽  
Controlled Trial ◽  
Womac Pain ◽  
Physician Global Assessment ◽  
Efficacy And Safety ◽  
Open Label ◽  
Womac Pain Score ◽  
Physical Function Score ◽  
Pain Visual Analog Scale

Objective To evaluate the efficacy and safety of adalimumab (ADA) versus hyaluronic acid (HA) by intra-articular injection for moderate to severe knee osteoarthritis. Methods Fifty-six consecutive patients with moderate to severe knee osteoarthritis were randomly allocated to either the ADA group or HA group. On day 0, patients in the ADA group received 10 mg of ADA by intra-articular injection, while those in the HA group received 25 mg of HA. All patients received celecoxib at 200 mg/day for 4 weeks. The pain visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Patient Global Assessment (PGA), and Physician Global Assessment (PhGA) scores were assessed. Results At baseline, the pain VAS, WOMAC, PGA, and PhGA scores were similar between the two groups. The decrease in the pain VAS score, WOMAC pain score, WOMAC physical function score, and WOMAC total score from baseline to week 4 were greater in the ADA than HA group. A greater decrease in the PGA and PhGA scores from baseline to week 4 was noted in the ADA than HA group. No difference in adverse events was observed between the two groups. Conclusion ADA by intra-articular injection was effective and tolerated for moderate to severe knee osteoarthritis.

Three groups of dissatisfied patients exist after total knee arthroplasty: early, persistent, and late

2018 ◽  
Vol 100-B (2) ◽  
pp. 161-169 ◽  
Author(s):  
N. D. Clement ◽  
M. Bardgett ◽  
D. Weir ◽  
J. Holland ◽  
C. Gerrand ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Patient Satisfaction ◽  
Pain Score ◽  
Knee Arthroplasty ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Increased Risk ◽  
Total Knee ◽  
One Year

Aims The primary aim of this study was to assess whether patient satisfaction one year after total knee arthroplasty (TKA) changed with longer follow-up. The secondary aims were to identify predictors of satisfaction at one year, persistence of patient dissatisfaction, and late onset dissatisfaction in patients that were originally satisfied at one year. Patients and Methods A retrospective cohort consisting of 1369 patients undergoing a primary TKA for osteoarthritis that had not undergone revision were identified from an established arthroplasty database. Patient demographics, comorbidities, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, and Short Form 12 (SF-12) questionnaire scores were collected preoperatively, and one and five years postoperatively. In addition, patient satisfaction was assessed at one and five years postoperatively. Logistic regression analysis was used to identify independent predictors of satisfaction at one and five years. Results The overall rate of satisfaction did not change from one (91.7%, n = 1255) to five (90.1%, n = 1234) years (p = 0.16). Approximately half (n = 53/114) of the patients who were dissatisfied at one year became satisfied with their TKA at five years, whereas 6% (n = 74/1255) of those who were satisfied at one year became dissatisfied at five years. At one year, patients with lung disease (p = 0.04), with depression (p = 0.001), with back pain (p <  0.001), undergoing unilateral TKA (p = 0.001), or with a worse preoperative WOMAC pain score (p = 0.04) were more likely to be dissatisfied. Patients with gastric ulceration (p = 0.04) and a worse WOMAC stiffness score (p = 0.047) were at increased risk of persistent dissatisfaction at five years. In contrast, a worse WOMAC pain score (p = 0.01) at one year was a predictor of dissatisfaction in previously satisfied patients at five years. Conclusion Three groups of dissatisfied patients exist after TKA: ‘early’ dissatisfaction at one year, ‘persistent’ dissatisfaction with longer follow-up, and ‘late’ dissatisfaction developing in previously satisfied patients at one year. All three groups have different independent predictors of satisfaction, and potentially addressing risk factors specific to these groups may improve patient outcome and their satisfaction. Cite this article: Bone Joint J 2018;100-B:161–9.

scholarly journals Efficacy of Balneotherapy and Mud Therapy in Patients with Knee Osteoarthritis: A Systematic Literature Review

2020 ◽  
Author(s):  
Hafiz Muhammad Asim Raza ◽  
Grazina Krutulyte ◽  
Inesa Rimdeikiene ◽  
Raimondas Savickas
Keyword(s):  
Knee Osteoarthritis ◽  
Pain Score ◽  
Clinical Studies ◽  
Meta Analysis ◽  
Womac Pain ◽  
Function Score ◽  
Womac Pain Score ◽  
Womac Function ◽  
Significant Difference ◽  
Mud Therapy

Abstract Objectives To identify literature reporting on thermal mineral water and mud therapy effectiveness on pain, stiffness and knee function in patients with knee osteoarthritis. Design Systematic evidence scan of MEDLINE and PubMed was performed to identify the randomized controlled trial studies published from 2004 to December 2018. Study selection Papers reporting the effect of balneotherapy and mud therapy for treating knee OA, a duration of ≥2 weeks and in which Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were used as an outcome measure. Data extraction Not RCT, Studies not in English. Results A quantitative meta-analysis of ten studies (831 patients) was performed. Five clinical studies (407 patients) measured effectiveness of balneotherapy and there was significant difference between the groups in WOMAC pain score, WOMAC stiffness score and WOMAC function score, with the differences in favour of balneotherapy. Six clinical studies (500 patients) measured effectiveness of mud therapy and there was significant difference between the groups in WOMAC pain score, WOMAC stiffness score and WOMAC function score, with the differences in favour of mud therapy. Conclusion This meta-analysis indicates that balneotherapy and mud therapy were clinically effective in relieving pain, stiffness, and improving function, as assessed by WOMAC score.

scholarly journals Efficacy and safety of Sahastara remedy for pain relief: A systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 10 (4) ◽  
pp. 375-382
Author(s):  
Wiraphol Phimarn ◽  
Chatmanee Taengthonglang ◽  
Kritsanee Saramunee ◽  
Bunleu Sungthong
Keyword(s):  
Pain Relief ◽  
Adverse Events ◽  
Pain Score ◽  
Oswestry Disability Index ◽  
Global Assessment ◽  
Meta Analysis ◽  
Womac Score ◽  
Index Score ◽  
Efficacy And Safety ◽  
Oswestry Disability Index Score

The Sahastara (SHT) remedy is an herbal medicine that can be used as an alternative treatment for improving pain symptoms. The aim of this study was to evaluate the efficacy and safety of the SHT remedy for pain relief. PubMed, Scopus, ScienceDirect, TCI, and ThaiLis were systematically searched for relevant articles from inception to April 2021. We only included randomized clinical trials (RCTs) in which the efficacy and safety of the SHT remedy were compared with those of non-steroidal anti-inflammatory drugs (NSAIDs). Study selection, data extraction, and quality assessment were independently performed by two reviewers. The clinical therapeutic outcomes were the pain score, WOMAC score, Oswestry Disability Index score, 100 meters walk result, global assessment, and adverse events of the SHT remedy. The outcomes were assessed and pooled using a random-effects model. Heterogeneity was assessed using the I2 test. Four studies with 213 participants were included in the analysis. The efficacy of the SHT remedy was not different from that of NSAIDs in terms of the pain score (standardized mean difference [SMD] = -0.31; 95% CI = -1.26, 0.65; I2 = 91%), WOMAC score (SMD = 0.05; 95% CI = -0.30, 0.41; I2 = 0.0%), Oswestry Disability Index score (SMD = -0.41, 95% CI = -1.18, 0.35), 100 meters walk result (SMD = 0.31; 95% CI = -0.25, 0.87; I2 = 0.0%), and global assessment (relative risk = 0.85; 95% CI = 0.62, 1.16; I2 = 0.0%). Moreover, there were no statistically significant differences between the SHT remedy and NSAID treatment groups in terms of adverse events or liver function. This meta-analysis demonstrated that the SHT remedy is not different from NSAIDs in terms of clinical therapeutic efficacy and adverse events. However, larger and well-designed studies are needed to confirm this conclusion.

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