Acupuncture for Knee Osteoarthritis – a Randomised Trial Using a Novel Sham

2006 ◽  
Vol 24 (1_suppl) ◽  
pp. 7-14 ◽  
Author(s):  
Eric Manheimer ◽  
Byungmook Lim ◽  
Lixing Lao ◽  
Brian Berman
Keyword(s):  
Pain Relief ◽  
Global Assessment ◽  
Sham Acupuncture ◽  
Mean Difference ◽  
Acupuncture Group ◽  
Patient Global Assessment ◽  
Osteoarthritis Of The Knee ◽  
Womac Pain ◽  
Womac Pain Score ◽  
Womac Function

Background Evidence on the efficacy of acupuncture for reducing the pain and dysfunction of osteoarthritis is equivocal. Objective To determine whether acupuncture provides greater pain relief and improved function compared with sham acupuncture or education in patients with osteoarthritis of the knee. Design Randomised, controlled trial. Setting Two outpatient clinics (an integrative medicine facility and a rheumatology facility) located in academic teaching hospitals and one clinical trials facility. Patients 570 patients with osteoarthritis of the knee (mean age [±SD], 65.5 ± 8.4 years). Intervention 23 true acupuncture sessions over 26 weeks. Controls received 6 two-hour sessions over 12 weeks or 23 sham acupuncture sessions over 26 weeks. Measurements Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scores at 8 and 26 weeks. Secondary outcomes were patient global assessment, 6-minute walk distance, and physical health scores of the 36-Item Short-Form Health Survey (SF-36). Results Participants in the true acupuncture group experienced greater improvement in WOMAC function scores than the sham acupuncture group at 8 weeks (mean difference, −2.9 [95% CI, −5.0 to −0.8]; P=0.01) but not in WOMAC pain score (mean difference, −0.5 [CI, −1.2 to 0.2]; P=0.18) or the patient global assessment (mean difference, 0.16 [CI, −0.02 to 0.34]; P> 0.2). At 26 weeks, the true acupuncture group experienced significantly greater improvement than the sham group in the WOMAC function score (mean difference, −2.5 [CI, −4.7 to −0.4]; P=0.01), WOMAC pain score (mean difference, −0.87 [CI, −1.58 to −0.16]; P=0.003), and patient global assessment (mean difference, 0.26 [CI, 0.07 to 0.45]; P=0.02). Limitations At 26 weeks, 43% of the participants in the education group and 25% in each of the true and sham acupuncture groups were not available for analysis. Conclusions Acupuncture seems to provide improvement in function and pain relief as an adjunctive therapy for osteoarthritis of the knee when compared with credible sham acupuncture and education control groups.

A Blinded Randomised Trial of Acupuncture (Manual and Electroacupuncture) Compared with a Non-Penetrating Sham for the Symptoms of Osteoarthritis of the Knee

2008 ◽  
Vol 26 (2) ◽  
pp. 69-78 ◽  
Author(s):  
Ronald W Jubb ◽  
Emad S Tukmachi ◽  
Peter W Jones ◽  
Emma Dempsey ◽  
Lynn Waterhouse ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Symptomatic Improvement ◽  
Sham Acupuncture ◽  
Mean Difference ◽  
Acupuncture Group ◽  
Control Group ◽  
Acupuncture Points ◽  
Osteoarthritis Of The Knee ◽  
Womac Pain ◽  
Treatment Comparison

Objectives To compare the effect of acupuncture (manual and electroacupuncture) with that of a non-penetrating sham (‘placebo’ needle) in patients with osteoarthritic knee pain and disability who are blind to the treatment allocation. Methods Acupuncture naive patients with symptomatic and radiological evidence of osteoarthritis of the knee were randomly allocated to a course of either acupuncture or non-penetrating sham acupuncture using a sheathed ‘placebo’ needle system. Acupuncture points for pain and stiffness were selected according to acupuncture theory for treating Bi syndrome. Both manual and electrical stimulation were used. Response was assessed using the WOMAC index for osteoarthritis of the knee, self reported pain scale, the EuroQol score and plasma β-endorphin. The effectiveness of blinding was assessed. Results There were 34 patients in each group. The primary end point was the change in WOMAC pain score after the course of treatment. Comparison between the two treatment groups found a significantly greater improvement with acupuncture (mean difference 60, 95% CI 5 to 116, P=0.035) than with sham. Within the acupuncture group there was a significant improvement in pain (baseline 294, mean change 95, 95% CI 60 to 130, P<0.001) which was not seen by those who had sham acupuncture (baseline 261, mean change 35, 95% CI-10 to 80, P=0.12). Similar effects within group, but not between groups, were seen with the secondary end points of WOMAC stiffness, WOMAC function, and self reported pain. One month after treatment the between group pain difference had been lost (mean difference 46; 95% CI −9 to 100, P=0.10) although the acupuncture group was still benefiting compared to baseline (mean difference 59; 95% CI 16 to 102, P=0.009). The EuroQol score, a generic measure of health related quality of life, was not altered by the treatments. A minority of patients correctly guessed their treatment group (41% in the acupuncture group and 44% in the control group). Plasma β-endorphin levels were not affected by either treatment. Conclusions Acupuncture gives symptomatic improvement for patients with osteoarthritis of the knee, and is significantly superior to non-penetrating sham acupuncture. The study did not confirm earlier reports of release of plasma β-endorphin during acupuncture.

scholarly journals Impact of Acupuncture on Antihistamine Use in Patients Suffering Seasonal Allergic Rhinitis: Secondary Analysis of Results from a Randomised Controlled Trial

2018 ◽  
Vol 36 (3) ◽  
pp. 139-145 ◽  
Author(s):  
Daniela Adam ◽  
Linus Grabenhenrich ◽  
Miriam Ortiz ◽  
Sylvia Binting ◽  
Thomas Reinhold ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Secondary Analysis ◽  
Sham Acupuncture ◽  
Mean Difference ◽  
Acupuncture Group ◽  
The Other ◽  
Common Disease ◽  
The Impact ◽  
Non Parametric

Background Seasonal allergic rhinitis (SAR) is a common disease that has detrimental effects on the quality of life (QoL) of affected individuals. Approximately 18% of patients try to alleviate their symptoms through acupuncture. The ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) study (ClinicalTrials.gov registration no. NCT00610584) assessed the impact of acupuncture on SAR, showing significant improvements in rhinitis-specific QoL (RQoL) and in rescue medication (RM) use. Objective A secondary analysis of SAR patients’ use of antihistamine. Methods Patients were randomised into three study groups: acupuncture plus RM, sham acupuncture plus RM, and RM alone. The patients documented their medication use before and during the intervention period (8 weeks). The main outcome was the number of days with antihistamine use. Statistical analyses were conducted using parametric and non-parametric tests. The robustness of the results was tested by sensitivity analyses using non-parametric bootstrapping. Results The data from 414 patients were analysed. The acupuncture group used antihistamines significantly less often compared with the other groups (acupuncture vs sham acupuncture: mean difference −4.49 days, p=0.01; acupuncture vs RM: mean difference −9.15 days, p<0.001). Approximately 38% of the acupuncture group did not use any antihistamine in contrast to only 16% in the RM group. The pre-post comparison suggested that the acupuncture patients did not need to increase the days of antihistamine use to alleviate their symptoms, unlike the other groups. Conclusions Acupuncture appeared to significantly reduce the number of days of antihistamine use while improving RQoL and SAR symptoms; it can therefore be considered a valuable, additional treatment option for patients with SAR. Trial Registration Number NCT00610584; Post-results.

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.

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 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 Comparison of the short-term results of single-dose intra-articular peptide with hyaluronic acid and platelet-rich plasma injections in knee osteoarthritis: a randomized study

2020 ◽  
Vol 39 (10) ◽  
pp. 3057-3064 ◽  
Author(s):  
Fatma Nur Kesiktas ◽  
Bahar Dernek ◽  
Ekin Ilke Sen ◽  
Havva Nur Albayrak ◽  
Tugba Aydin ◽  
...  
Keyword(s):  
Pain Relief ◽  
Knee Osteoarthritis ◽  
Platelet Rich Plasma ◽  
Randomized Study ◽  
Functional Improvement ◽  
Womac Pain ◽  
Peptide Group ◽  
Short Term ◽  
Womac Pain Score ◽  
The Third

Abstract Introduction/objectives Intra-articular injections may be useful in terms of pain and functional status, in knee osteoarthritis (OA). Besides hyaluronic acid (HA) and platelet-rich plasma (PRP), peptide molecules recently begin to be used. The aim of this study was to compare the efficacy of intra-articular peptide Prostrolane® (CAREGEN Co. Ltd.) injection with that of the HA and PRP in the persons with OA. Method Fifty-four patients with OA were included in this prospective, randomized study. Patients were randomized into three groups as intra-articular HA, peptide, and PRP groups. Paracetamol was permitted three times a day to all groups. All the patients were evaluated by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), Health Assessment Questionnaire (HAQ), and visual analogue scale (VAS) at rest and during movements. Measurements performed at the baseline, after the first week of injection, and at the first and third months of follow-up. Results Mean age was 55.8 ± 8.9 years. Forty-four (81.6%) were women. A week after the injections, rest and movement pain severity was measured by VAS decreased significantly in all the study groups (p < 0.05). There were no statistically significant differences between the groups in terms of first week pain relief (p > 0.05). WOMAC pain, stiffness, function, and total scores were improved significantly in all the groups a week after the injections (p < 0.05). Improvement continued at the third month control; however, the improvement in the WOMAC pain score was significantly better in the peptide group at the third month control (p < 0.05). The decrease in the rest and movement pain was continued for 3 months except the HA group’s rest pain. There were no differences among the groups for all measurements, except for the WOMAC pain score at 3 months after treatment, which was significantly lower in the peptide group. Conclusion As a result, pain relief and functional improvement were obtained after the intra-articular HA, peptide, and PRP injections in OA, and decrease in pain was better in the peptide group. Key Points• The short-term effects of intra-articular HA, peptide, and PRP injections were compared in knee osteoarthritis.• HA, peptide, and PRP injections may be useful in pain relief and functional improvement in knee osteoarthritis.

Efficacy and Safety of Hylan versus Hyaluronic Acid in the Treatment of Knee Osteoarthritis

2018 ◽  
Vol 32 (03) ◽  
pp. 259-268 ◽  
Author(s):  
Wen-Li Dai ◽  
Ze-Ming Lin ◽  
Dong-Hong Guo ◽  
Zhan-Jun Shi ◽  
Jian Wang
Keyword(s):  
Meta Analysis ◽  
Womac Pain ◽  
Efficacy And Safety ◽  
Function Score ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Womac Function ◽  
The Difference ◽  
Level I ◽  
And Function

AbstractThe purpose of this study was to use meta-analytic approach to compare the efficacy and safety of intraarticular hylan and hyaluronic acid (HA) for knee osteoarthritis (OA) treatment. We searched PubMed, Embase, and the Cochrane databases through July 2017 to identify Level I randomized controlled trials (RCTs) that evaluated clinical efficacy and safety of hylan compared with HA for knee OA. The primary outcomes were Visual Analogue Scale (VAS) for pain and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, and WOMAC function scores. In each study and for the outcome measures (VAS for pain, WOMAC pain, function and stiffness scores, and Lequesne score), we calculated the treatment effect from the difference between the preintervention and postintervention changes in the hylan and HA groups. Twenty-one RCTs involving 3,058 patients were included. Pooled analysis suggested that compared with HA, hylan was associated with similar pain relief and function improvement in patients with knee OA (VAS for pain: mean difference [MD], –3.04; 95% confidence interval [CI], –9.13 to 3.04; p = 0.33; I 2 = 76%. WOMAC pain score: MD, 0.23; 95% CI, –0.25 to 0.70; p = 0.35; I 2 = 0%. WOMAC function score: MD, –0.47; 95% CI, –6.81 to 5.88; p = 0.88; I 2 = 84%). No significant difference was found comparing the patients with treatment-related adverse events. The relationship was robust in sensitivity analysis and consistent in most of the subgroup analyses. As to the primary outcomes (WOMAC pain, function scores, VAS for pain), the difference between hylan and HA did not reach the previously reported minimum clinically important difference (MCID) values (–13.4 for VAS for pain, –2.0 for WOMAC pain score, –7.7 for WOMAC function score). Our meta-analysis showed that there were no statistically and clinically significant differences in pain relief and function improvement between hylan and HA injections for knee OA treatment. In view of its higher costs, we discourage the use of hylan in patients with knee OA in clinical practice. The level of evidence is I, meta-analysis of Level I studies.

scholarly journals OP0008 DEVELOPMENT AND VALIDATION OF AN ALTERNATIVE ANKYLOSING SPONDYLITIS DISEASE ACTIVITY SCORE WHEN PATIENT GLOBAL ASSESSMENT IS UNAVAILABLE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Psychometric Properties ◽  
Global Assessment ◽  
Disease Activity Score ◽  
Validation Cohort ◽  
Patient Global Assessment ◽  
Activity Score ◽  
Research Support ◽  
Low Disease Activity

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

Sign in / Sign up

Export Citation Format

Share Document