scholarly journals Randomized Clinical Trial Evaluating Transdermal Ibuprofen for Moderate to Severe Knee Osteoarthritis

2013 ◽  
Vol 6;16 (6;11) ◽  
pp. E749-E762
Author(s):  
Dr. Gyula Varadi
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Visual Analog Scale ◽  
Statistical Significance ◽  
Academic Medical Center ◽  
Osteoarthritis Of The Knee ◽  
Clinical Effects ◽  
Phase 2 ◽  
Analog Scale ◽  
Clinical Endpoints

Background: Osteoarthritis is a common condition, typically treated with orally administered analgesics and non-steroidal anti-inflammatory drugs (NSAIDs). Chronic administration of NSAIDs, serotoninnorepinephrine reuptake inhibitors (SNRIs, i.e., duloxetine), and opioid medications (i.e., tramadole) is regularly associated with multiple, serious side effects, in part due to the route of administration. Transdermal delivery of NSAIDs, such as ibuprofen, represents a potentially alternative treatment for this inflammatory pain condition with a better therapeutic profile. Objective: Investigate the safety and efficacy of a novel transdermal ibuprofen formulation (VALE®- ibuprofen) containing 10% ibuprofen, compared to a placebo in a randomized, double-blinded clinical trial, for clinical improvement in patients with moderate to severe painful osteoarthritis of the knee. Study Design: A randomized, placebo-controlled, double blind, multi-center Phase 2 clinical trial. Setting: An academic medical center, and private rheumatology and interventional pain management practices in Massachusetts and in Switzerland. Methods: The Phase 2 clinical study included patients with primary osteoarthritis in a single knee joint with a progression level of moderate to severe based in part on a grade II or III designation according to the Kellgren and Lawrence classification system. Patients received the corresponding, randomly assigned study formulation (VALE-ibuprofen or placebo) for application to the target knee at a dose of 2.0 grams of drug product (200 mg ibuprofen) twice daily for 14 days. The evaluation of the efficacy of the treatments utilized the widely accepted methods of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index and the Visual Analog Scale (VAS) scores for the patients. Results: The results indicate that the transdermal VALE-ibuprofen formulation was very well tolerated from a safety perspective during the 2-week trial and also produced significant, positive clinical improvements superior to the placebo in all clinical endpoints tested. In particular, the WOMACTotal and WOMACPhysical Functioning, for the VALE-ibuprofen, were superior compared to the placebo (P = 0.0283 and P = 0.0201, respectively). Other clinical endpoints including the WOMACPain, WOMACStiffness, and VASResting scores were superior to those obtained from the placebo group, trending towards statistical significance compared to placebo (P = 0.0811, 0.1103, and 0.0785, respectively). Based on the Patient and Physician Global Impression of Change survey, patient satisfaction slightly improved across both groups; however, no statistical significance was detectable as compared to the baseline. Limitations: The sample size of 64 subjects in the final data analysis and the lack of including an orally administered drug group are limitations of this study. Conclusions: The use of transdermal VALE-ibuprofen has beneficial clinical effects on the pain levels experienced in some patients with moderate to severe osteoarthritis of the knee as measured by the WOMAC Osteoarthritis Indices for stiffness, pain, physical function, and total. Visual Analog Scales (VAS) tests, VASMotion and VASWeight-bearing, again while appeared superior to placebo, were not statistically different from placebo. Clinical Trial Registration: NCT01496326 Key words: Ibuprofen, transdermal treatment, VALE-ibuprofen, knee osteoarthritis, Visual Analog Scale, WOMAC score

scholarly journals Efficacy of Genicular Nerve Radiofrequency Ablation Versus Intra-Articular Platelet Rich Plasma in Chronic Knee Osteoarthritis: A Single-Blind Randomized Clinical Trial

2021 ◽  
pp. 127-134
Keyword(s):  
Clinical Trial ◽  
Knee Osteoarthritis ◽  
Visual Analog Scale ◽  
Platelet Rich Plasma ◽  
Pulsed Radiofrequency ◽  
Analog Scale ◽  
P Values ◽  
Plasma Injection ◽  
Index Of Severity ◽  
Single Blind

BACKGROUND: Chronic knee osteoarthritis is a common problem with increasing of the aging population. Pulsed radiofrequency and intraarticular platelet rich plasma injection are well evidenced beneficial modalities for pain alleviation in such groups of patients. OBJECTIVE: The primary goal in this study was to compare the 2 modalities regarding pain alleviation evaluated by visual analog scale. The secondary goal focused upon the change of the Index of Severity for Osteoarthritis of the Knee by Lequesne. STUDY DESIGN: Single-blind randomized interventional clinical trial. SETTING: University hospitals. METHODS: Two hundred patients with chronic knee osteoarthritis were equally and randomly distributed into 2 groups. Group PRF received pulsed radiofrequency, whereas the group PRP received intraarticular platelet-rich plasma. The visual analog scale and index of severity of osteoarthritis were evaluated before intervention, after one week (for visual analog scale only), then after 3, 6, and 12 months. RESULTS: Visual analog scale was significantly lower in the PRF group compared to the PRP group at 6 and 12 months with P-values of 0.01 and 0.04, respectively. Regarding to the postinterventional index of severity of osteoarthritis, it was significantly lower in the PRF group than the PRP group with P-values of 0.001 at 3, 6, and 12 months follow-up. LIMITATIONS: Physical and analgesic therapy were not included in data collection, and there was no control group. CONCLUSION: Pulsed radiofrequency of the genicular nerves can be considered superior to knee intraarticular platelet-rich plasma injection for sustained pain relief and the lower severity index in patients with chronic knee osteoarthritis. KEY WORDS: Pulsed radio frequency, platelet-rich plasma, chronic knee osteoarthritis, chronic pain

Customized Foot Insoles Have a Positive Effect on Pain, Function, and Quality of Life in Patients with Medial Knee Osteoarthritis

2013 ◽  
Vol 103 (1) ◽  
pp. 50-55 ◽  
Author(s):  
Søren Thorgaard Skou ◽  
Lea Hojgaard ◽  
Ole H. Simonsen
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Older Adults ◽  
Knee Osteoarthritis ◽  
Visual Analog Scale ◽  
Oxford Knee Score ◽  
Analog Scale ◽  
Custom Made ◽  
Arch Support

Background: Knee osteoarthritis (KOA) is a prevalent degenerative disease in older adults. Treatment strategies, including insoles, focus on reducing pain and physical disability. In medial KOA, insoles have been studied extensively with conflicting results, possibly due to heterogeneity in outcome measures and the intervention. We sought to investigate the effect of custom-made laterally wedged insoles on pain, function, and quality of life in patients with medial KOA. Methods: Fifty-one consecutive patients with medial KOA were prescribed custom-made insoles with arch support and a 5.0° to 8.7° lateral wedge. At follow-up, 42 of the 51 participants (22 men; mean age, 63 years; mean Kellgren-Lawrence, 3.4) participated. Retrospectively, participants were asked to rate the pain intensity in their affected knee before and after the intervention measured on a visual analog scale after 30 min of physical activity (primary outcome), at rest, at night, and after 50 m of walking. Additionally, they completed the Oxford Knee Score and the EQ-5D. The paired-samples t test was applied in the statistics. Results: The visual analog scale score after 30 min of physical activity was significantly reduced after the intervention (mean, 3.3 cm; 95% confidence interval, 2.1–4.5 cm; P < .001). The same significant changes were found in all of the secondary outcomes. Conclusions: There was a significant reduction in pain and improvements in function and quality of life with custom-made laterally wedged insoles with arch support in older adults with mild-to-severe medial KOA. The customization of laterally wedged insoles may be essential for the effect in medial KOA. (J Am Podiatr Med Assoc 103(1): 50–55, 2013)

scholarly journals A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee

2017 ◽  
Vol 10 ◽  
pp. 117954411668889 ◽  
Author(s):  
María del Carmen Caamaño ◽  
Sandra García-Padilla ◽  
Miguel Ángel Duarte-Vázquez ◽  
Karla Elena González-Romero ◽  
Jorge L Rosado
Keyword(s):  
Clinical Trial ◽  
Sodium Bicarbonate ◽  
Knee Osteoarthritis ◽  
Calcium Gluconate ◽  
Controlled Clinical Trial ◽  
Osteoarthritis Of The Knee ◽  
Short Term ◽  
Double Blind ◽  
Knee Oa ◽  
Double Blind Clinical Trial

Objective: To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis. Methods: A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index. Results: After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (−12.5 [−14.3, −10.7]; −9.0 [−11.4, −6.7]) and SBCG2 (−12.3 [−14.3, −10.4]; −8.9 [−10.4, −7.4]) were significantly greater than for MP (−5.0 [−7.2, −2.8]; −3.2 [−4.9, −1.5]) ( P < .001). Conclusions: Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms. Trial Registration: Clinicaltrials.gov NCT00977444

scholarly journals CT-guided Chemical Lumbar Sympathectomy in the Treatment of Cold Hypersensitivity in the Hands and Feet

2021 ◽  
pp. E459-E466
Keyword(s):  
Therapeutic Effect ◽  
Visual Analog Scale ◽  
Statistical Significance ◽  
Perfusion Index ◽  
Analog Scale ◽  
Invasive Blood Pressure ◽  
Lumbar Sympathectomy ◽  
Non Invasive ◽  
Hands And Feet ◽  
Cold Hypersensitivity

BACKGROUND: Cold hypersensitivity in the hands and feet is a common clinical symptom in Asian women. Currently, treatment of cold hypersensitivity in the hands and feet is still limited to traditional Chinese medicine, mainly herbal medicine. However, many patients with cold hypersensitivity in the hands and feet in China are not satisfied with the therapeutic effect of herbal medicine, and took medication for a longer time. Chemical lumbar sympathectomy is widely used in the treatment of plantar hyperhidrosis, diabetic foot, recalcitrant erythromelalgia, and other diseases. OBJECTIVES: This study was conducted to evaluate the short-term as well as long-term efficacy, complications, and patient satisfaction of chemical lumbar sympathectomy during treatment cold hypersensitivity in the hands and feet. STUDY DESIGN: A retrospective, observational study. SETTING: Department of Anesthesiology and Pain Medicine, Jiaxing, China. METHODS: A retrospective study of 72 patients with cold hypersensitivity in the hands and feet who received chemical lumbar sympathectomy treatment in our hospital from January 2015 to October 2018 was conducted. The heart rate, non-invasive blood pressure, oxygen saturation, visual analog scale, perfusion index, and plantar temperature were monitored and recorded in before treatment (T1) and after treatment (T2) groups. The patients were followed up on day 1, at week 1, 1 month, 3 months, 6 months, one year, and 2 years after operation for satisfaction, complications, and recurrence. RESULTS: There were no significant differences in heart rate, non-invasive blood pressure, and oxygen saturation between T1 and T2 groups (P > 0.05). Perfusion index and plantar temperature in T2 group were remarkably higher than T1 group, and the difference was statistically significant (P < 0.01). The visual analog scale score of the T2 group was significantly reduced (P < 0.01). Of all the patients who underwent chemical lumbar sympathectomy, the postoperative therapeutic effect was effective in 63 cases (87.5%) and ineffective in 9 cases (12.5%). Among the effective patients, the postoperative curative effect was shown to be excellent in 47 cases and improved in 16 cases. According to the follow-up results at day 1, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after operation, the satisfaction rate was 87.5%, 87.5%, 81.9%, 61.1%, 52.7%, 41.6%, and 34.7%, respectively. There were no serious complications observed and 23 patients relapsed after two years. Multivariate logistic regression analysis results showed that the effect of visual analog scale (OR = 7.312, 95% CI: 1.598 – 33.646, P = 0.011) and plantar temperature (OR = 0.470, 95% CI: 0.288 – 0.766, P = 0.002) on therapeutic effect showed has statistical significance; the effect of gender (OR = 0.654, 95% CI: 0.134 – 3.181, P = 0.599), age (OR = 0.975, 95% CI: 0.916 – 1.039, P = 0.441), perfusion index (OR = 0.710, 95% CI: 0.367 – 1.375, P = 0.310), and disease course (OR = 1.019, 95% CI: 0.997 – 1.042, P = 0.088) on therapeutic effect showed no statistical significance. The effect of gender (OR = 0.451, 95% CI 0.131 – 1.554, P = 0.207), age (OR = 0.961, 95% CI 0.912 – 1.013, P = 0.141), and course of disease (OR = 1.006, 95% CI 0.997 – 1.015, P = 0.203) on postoperative recurrence showed no statistical significance. LIMITATIONS: The nonrandomized, single-center, small sample size, retrospective design is a major limitation of this study. CONCLUSIONS: Chemical lumbar sympathectomy is a valid treatment option for cold hypersensitivity in hands and feet, and computed tomography-guided percutaneous puncture chemical lumbar sympathectomy has the advantages of high success rate, less invasion, less complications, and repeatablity. KEY WORDS: Cold hypersensitivity in hands and feet, chemical lumbar sympathectomy, computed tomography-guided

scholarly journals GAMBARAN KEJADIAN NYERI LUTUT DENGAN KECURIGAAN OSTEOARTRITIS LUTUT PADA PERAWAT DI POLIKLINIK RAWAT JALAN BLU RSUP PROF. DR. R. D. KANDOU MANADO

e-CliniC ◽  
2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Rita Purnama Deu
Keyword(s):  
Body Mass Index ◽  
Knee Osteoarthritis ◽  
Knee Pain ◽  
Visual Analog Scale ◽  
Outpatient Treatment ◽  
Analog Scale ◽  
High Heel ◽  
Knee Oa ◽  
Lequesne Index ◽  
Female Nurses

Abstract: Osteoarthritis (OA) is a degenerative joint disease associated with destruction of joint cartilages. OA can occur in all joints of the cervical, thoracal, and lumbar vertebrae, pelvis, knees, ankles, hands, and fingers. However, it is most commonly found in the knee joints because these joints bear heavier burden than the other joints. OA patients usually complain pain at the time of doing activities or if there is some load on the affected joint. On a more serious degree, there is continuous pain which disturbs the patient’s mobility. This study aimed to find the incidence knee osteoarthritis among nurses at outpatient treatment of Prof. Dr. R.D. Kandou Hospital. This was a descriptive quantitative study. Sample consisted of 25 nurses. Data were obtained through interviews and questionnaires and then were analyzed by using SPSS. The results showed that the highest numbers of nurses (14 nurses, 56.0%) with suspected knee OA were in the age group of 51-60 years. There were as many as 23 female nurses (92.0%) with suspected knee OA. Based on BMI (Body Mass Index) most of the nurses (13 nurses, 52.0%) were obese I, meanwhile based on the degrees of knee pain most of the nurses (19 nurses, 76.0%) experienced mild pain. Based on the Lequesne index functions most samples (13 nurses, 52.0%) showed mild functional. Based on the usage of high heel shoes most of the female nurses (19 nurses, 76.0%) used high heel shoes. Conclusion: Most of the nurses at outpatient treatment of Prof. Dr. R.D.Kandou Hospital that were suspected of knee osteoarthritis were obese I, had associated mild pain, and showed mild functional tested with Lequesne index funtion. Moreover, most of the female nurses wore high heel shoes.Keywords: knee osteoarthritis , knee pain, Lequesne index parameters, BMT (Body Mass Index), VAS (Visual Analog Scale)Abstrak: Osteoartritis (OA) merupakan penyakit degenerative sendi yang berkaitan dengan kerusakan kartilago sendi. OA dapat mengenai semua persendian dari servikal, thorakal, dan lumbal, panggul, lutut, pergelangan kaki, tangan sampai ke jari-jari, tetapi paling sering ditemukan pada sendi lutut karena pada sendi ini terdapat pembebanan yang lebih besar. Pasien OA biasanya mengeluh nyeri pada waktu melakukan aktivitas atau jika ada pembebanan pada sendi yang terkena. Pada derajat yang lebih berat, nyeri dapat dirasakan terus menerus sehingga sangat mengganggu mobilitas pasien. Penelitian ini bertujuan untuk mengetahui angka kejadian nyeri lutut dengan kecurigaan OA lutut pada perawat di Poliklinik Rawat Jalan BLU RSUP Prof. Dr. R. D Kandou Manado. Penelitian ini menggunakanpendekatan deskriptif kuantitatif. Sampel berjumlah 25 perawat. Data diperoleh melalui kuesioner dan wawancara yang kemudian dianalisis menggunakan SPSS. Hasil penelitian memperlihatkan bahwa perawat yang dicurigai OA lutut terbanyak pada kelompok umur 51-60 tahun sebanyak 14 perawat (56,0 %). Berdasarkan jenis kelamin perawat yang di curigai OA lutut terbanyak pada perempuan yaitu sebanyak 23 perawat (92,0 %). Berdasarkan IMT (Indeks Massa Tubuh) sebagian besar perawat ialah obes I yaitu 13 perawat (52,0 %). Berdasarkan derajat nyeri lutut sebagian besar mengalami nyeri ringan yaitu sebanyak 19 perawat (76,0 %). Berdasarkan indeks Lequesne sebagian besar fungsi fungsional ringan yaitu 13 perawat (52,0 %). Berdasarkan pemakaian sepatu tumit tinggi sebagian besar perawat perempuan menggunakan sepatu tumit tinggi yaitu sebanyak 19 perawat (76,0 %). Simpulan: Sebagian besar perawat di Poliklinik Rawat Jalan BLU RSUP Prof. Dr. R.D. Kandou Manado yang dicurigai osteoartritis lutut termasuk obes I, disertai nyeri ringan, dan indeks Lequesne fungsional ringan. Sebagian besar perawat perempuan menggunakan sepatu tumit tinggi.Kata kunci : osteoartritis lutut, nyeri lutut, parameter indeks Lequesne, VAS (Visual Analog Scale)

scholarly journals Comparative Observational Study on the Effects of Intra-articular Hominis Placenta Pharmacopuncture and Acupoint Hominis Placenta Pharmacopuncture for Knee Osteoarthritis Patients

2021 ◽  
Vol 38 (1) ◽  
pp. 60-65
Author(s):  
Yeo-bin Park ◽  
Chang Beohm Ahn ◽  
Yun-Leong Park ◽  
Ji-Won Baek ◽  
Won-Ho Kong ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Medical Records ◽  
Joint Space ◽  
Osteoarthritis Of The Knee ◽  
Analog Scale ◽  
Degenerative Osteoarthritis ◽  
Significant Difference ◽  
Group A ◽  
Vas Scores ◽  
Group B

The aim of this case report was to observe the effects of intra-articular hominis placenta pharmacopuncture (HPP). Based on the medical records patients who received intra-articular treatment or received acupoint pharmacopuncture treatment, a comparison was made. There were 35 patients who were hospitalized for degenerative osteoarthritis of the knee joint from the 1<sup>st</sup> October 2019 to 26<sup>th</sup> September 2020. There were 14 patients who were treated with HPP in the intra-articular joint space (Group A), and 14 patients who were treated with HPP at specific acupoints (Group B). The outcome effects were measured using the Korean Western Ontario and Mc (KWOMAC) the visual analog scale (VAS) before the first treatment, and after the fifth treatment. The KWOMAC (<i>p</i> < 0.001) and the VAS scores (<i>p</i> < 0.001) in Groups A and B significantly improved after treatment compared with before treatment. When comparing Group A improvement with Group B improvement using the KWOMAC there was no statistically significant difference however, when using the VAS scores, Group A treatment was statistically more effective compared with Group B (<i>p</i> = 0.002). This study indicated that HPP may be an effective treatment for knee osteoarthritis. Moreover, intra-articular HPP may be more effective than acupoint HPP for knee osteoarthritis.

Correlation between three assessment pain tools in subacromial pain syndrome

2020 ◽  
pp. 026921552094759
Author(s):  
Javier Aceituno-Gómez ◽  
Juan Avendaño-Coy ◽  
Juan José Criado-Álvarez ◽  
Gerardo Ávila-Martín ◽  
Ana Cecilia Marín-Guerrero ◽  
...  
Keyword(s):  
Shoulder Pain ◽  
Visual Analog Scale ◽  
Pearson Correlation ◽  
Statistical Significance ◽  
Pain Syndrome ◽  
Assessment Tools ◽  
Linear Regression Models ◽  
Analog Scale ◽  
Subacromial Pain Syndrome ◽  
Constant Murley Score

Objective: To compare the correlation of Visual Analog Scale with pain subsections of Shoulder Pain and Disability Index and Constant-Murley Score in subacromial pain syndrome patients. Design: Single cross-sectional analysis. Setting: Hospital Rehabilitation Department. Methods: The assessment tools were applied at baseline. Correlations between Visual Analog Scale, Shoulder Pain and Disability Index and Constant-Murley Score pain subsections were assessed by Pearson correlation coefficient. Linear regression models were calculated between scales. Statistical significance was set at two-sided p < 0.05. Results: Forty-three patients were included. Pearson’s correlation between assessments was for Visual Analog Scale-Shoulder Pain Disability Index-pain ( r = 0.61, p < 0.001) and for Visual Analog Scale-Constant Murley Score-pain were ( r = −0.74, p < 0.001). Visual Analog Scale-Shoulder Pain and Disability Index-pain determination coefficient was r2 = 0.37 and r2 = 0.54 for Visual Analog Scale-Constant-Murley Score-pain. Conclusions: Visual Analog Scale showed better correlation with Constant Murley Score-pain than with Shoulder Pain and Disability Index-pain in subacromial pain syndrome patients.

Sign in / Sign up

Export Citation Format

Share Document