Effect of laser moxibustion for knee osteoarthritis: a multi-site double-blind randomized controlled trial

Abstract Background A laser device that mimics traditional moxibustion without smoke may be effective and safe for treating patients with knee osteoarthritis.Methods A double-blind randomized clinical trial was conducted. A total of 392 patients with osteoarthritis of the knee were randomly assigned to receive laser treatment or sham control three times a week for 4 weeks with 20-week follow-up. Primary outcomes were changes in the WOMAC pain scores at week 4. Results Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score significantly decreased at week 4 in the active group than in the sham group (2.2; 95% CI, 1.7 to 2.8; P < .01). At week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.3; 95% CI, 2.7 to 3.9; P < 0.01, and 15.7; 95% CI, 12.8 to 18.8; P < .01, respectively). The physical component of the quality of life significantly improved in the active group than in the sham control at week 4 (3.0; 95% CI, 1.1 to 4.9; P = 0.002) up to week 24 (5.1; 95% CI, 3.2 to 7.0; P < .001). No serious adverse effects were reported. Conclusion Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis.

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Effect of laser moxibustion for knee osteoarthritis: a multi-site double-blind randomized controlled trial

The Journal of Rheumatology ◽

10.3899/jrheum.200217 ◽

2020 ◽

pp. jrheum.200217

Author(s):

Ling Zhao ◽

Ke Cheng ◽

Fan Wu ◽

Jiong Du ◽

Yue Chen ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Pain Score ◽

Laser Treatment ◽

Pain Reduction ◽

Active Group ◽

Womac Pain ◽

Double Blind ◽

Womac Pain Score ◽

Clinically Significant ◽

And Function

Objective To examine the effects of laser moxibustion on pain and function in patients with knee osteoarthritis. Methods A double-blind randomized clinical trial (4-week treatment, 20-week follow-up) was conducted. A total of 392 symptomatic knee osteoarthritis patients with moderate or greater clinically significant knee pain were randomly assigned to laser treatment or sham laser control group (1:1). Twelve sessions of laser moxibustion treatments or sham on the acupuncture points at the affected knee(s) were performed three times a week for 4 weeks. The primary outcome measurement was change in WOMAC pain score from baseline to week 4. Results Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score significantly decreased at week 4 in the active group than in the sham group (2.1; 95% CI, 1.6 to 2.6; P < .01). At week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.0; 95% CI, 2.5 to 3.6; P < 0.01, and 14.8; 95% CI, 11.9 to 17.6; P < .01, respectively). The physical component of the quality of life significantly improved in the active group than in the sham control at week 4 (3.2; 95% CI, 1.3 to 5.0; P = 0.001) up to week 24 (5.1; 95% CI, 3.3 to 7.0; P < .001). No serious adverse effects were reported. Conclusion Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis. Keywords: 10.6μm laser moxibustion, knee osteoarthritis, pain, traditional Chinese medicine, phototherapy

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Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial

Cartilage ◽

10.1177/1947603517703732 ◽

2017 ◽

Vol 9 (3) ◽

pp. 276-283 ◽

Cited By ~ 19

Author(s):

Laszlo Hangody ◽

Robert Szody ◽

Piotr Lukasik ◽

Wojciech Zgadzaj ◽

Endre Lénárt ◽

...

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Sodium Hyaluronate ◽

Intraarticular Injection ◽

Controlled Clinical Trial ◽

Osteoarthritis Of The Knee ◽

Womac Pain ◽

Double Blind ◽

Triamcinolone Hexacetonide ◽

And Function

Objective: To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis. Design: This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks. Results: A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported. Conclusions: Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

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Effectiveness and feasibility of acupuncture for knee osteoarthritis: a pilot randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518790632 ◽

2018 ◽

Vol 32 (12) ◽

pp. 1666-1675 ◽

Cited By ~ 10

Author(s):

Lu-Lu Lin ◽

Yong-Ting Li ◽

Jian-Feng Tu ◽

Jing-Wen Yang ◽

Ning Sun ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Response Rate ◽

Controlled Trial ◽

Womac Pain ◽

Chinese Acupuncture ◽

Randomized Controlled ◽

Acupuncture Intervention ◽

Significant Difference ◽

And Function ◽

Pilot Randomized Controlled Trial

Objective: To evaluate the effectiveness of acupuncture for pain relief and function improvement in patients with knee osteoarthritis and to determine the feasibility of an eight-week acupuncture intervention. Design: Pilot randomized controlled trial. Setting: Three teaching hospitals in China. Subjects: Patients with knee osteoarthritis (Kellgren grade II or III). Interventions: Patients were randomly assigned to an eight-week (three sessions per week) intervention of either traditional Chinese acupuncture or sham acupuncture. Main measures: The primary outcome was response rate—the proportion of patients achieving score ⩾36% decrease in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function at week 8 compared with baseline. Secondary outcomes included pain, function and quality of life. Results: Of 42 patients randomized, 36 (85.7%) completed the study. There was no significant difference in response rate between the traditional Chinese acupuncture and control groups: 61.9% (13 of 21) versus 42.9% (9 of 21) achieved score ⩾36% decrease in WOMAC pain and function at week 8 ( P = 0.217). The sum of WOMAC pain and function scores at week 8 was 11.6 (9.1) in the traditional Chinese acupuncture group compared with 16.3 (10.9) in the control group ( P = 0.183). There was no significant difference between groups. Three adverse events were recorded and were classified as mild. Conclusion: It showed that three sessions per week acupuncture intervention of knee osteoarthritis was feasible and safe. No difference was observed between groups due to small sample size. Larger (sample size ⩾ 296) randomized controlled trials of this intervention appear justified.

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Significant pain reduction with oral methotrexate in knee osteoarthritis; results from the promote randomised controlled phase iii trial of treatment effectiveness

Osteoarthritis and Cartilage ◽

10.1016/j.joca.2019.02.120 ◽

2019 ◽

Vol 27 ◽

pp. S84-S85

Author(s):

S.R. Kingsbury ◽

P. Tharmanathan ◽

A. Keding ◽

B. Corbacho ◽

F.E. Watt ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Treatment Effectiveness ◽

Pain Reduction ◽

Phase Iii ◽

Phase Iii Trial ◽

Oral Methotrexate ◽

Significant Pain ◽

Randomised Controlled

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

Clinical Medicine Insights Arthritis and Musculoskeletal Disorders ◽

10.1177/1179544116688899 ◽

2017 ◽

Vol 10 ◽

pp. 117954411668889 ◽

Cited By ~ 2

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

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Efficacy of Platelet-Rich Plasma and Plasma for Symptomatic Treatment of Knee Osteoarthritis: A Double-Blinded Placebo-Controlled Randomized Clinical Trial.

10.21203/rs.3.rs-514603/v1 ◽

2021 ◽

Author(s):

Murillo Dório ◽

Rosa Maria Rodrigues Pereira ◽

Alexandre Galeno Branco Luz ◽

Leticia Alle Deveza ◽

Ricardo Manoel Oliveira ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Primary Outcome ◽

Platelet Rich Plasma ◽

Controlled Trial ◽

Symptomatic Treatment ◽

Treatment Alternative ◽

Double Blind ◽

Secondary Outcomes ◽

Double Blinded ◽

And Function

Abstract Background: Platelet-rich plasma (PRP) has a still conflicting efficacy for knee osteoarthritis (KOA) and might be a minimally invasive and safe treatment alternative. The potential benefit of only plasma (non-enriched) has never been investigated. Our aim was to evaluate the efficacy of intra-articular platelet-rich plasma (PRP) and plasma to improve pain and function in participants with KOA over 24 weeks. Methods: Randomized, double-blind, placebo-controlled trial with 3 groups (n = 62): PRP (n = 20), plasma (n = 21) and saline (n = 21). Two ultrasound-guided knee injections were performed with a 2-week interval. The primary outcome was visual analog scale 0-10 cm (VAS) for overall pain at week 24, with intermediate assessments at weeks 6 and 12. Main secondary outcomes were: KOOS, OMERACT-OARSI criteria and TUGT. Results: At baseline, 92% of participants were female, with a mean age of 65 years, mean BMI of 28.0 Kg/m2and mean VAS pain of 6.2 cm. Change in pain from baseline at week 24 were -2.9 (SD 2.5), -2.4 (SD 2.5) and -3.5 cm (SD 3.3) for PRP, plasma and saline, respectively (p intergroup = 0.499). There were no differences between the three groups at weeks 6 and 12. Similarly, there were no differences between groups regarding secondary outcomes. The PRP group showed higher frequency of adverse events (65% versus 24% and 33% for plasma and saline, respectively, p = 0.02), mostly mild transitory increase in pain.Conclusions: PRP and plasma were not superior to placebo for pain and function improvement in KOA over 24 weeks. The PRP group had a higher frequency of mild transitory increase in pain.Trial registration: ClinicalTrials.gov, NCT03138317, 03/05/2017.

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Two-Year Results of the PHANTOM High Flex Trial: A Single-Arm Study on the Atlas Unicompartmental Knee System Load Absorber in Patients With Medial Compartment Osteoarthritis of the Knee

Clinical Medicine Insights Arthritis and Musculoskeletal Disorders ◽

10.1177/1179544119877170 ◽

2019 ◽

Vol 12 ◽

pp. 117954411987717

Author(s):

Konrad Slynarski ◽

Jacek Walawski ◽

Robert Smigielski ◽

Willem van der Merwe

Keyword(s):

Knee Osteoarthritis ◽

Invasive Surgery ◽

Young Patients ◽

Osteoarthritis Of The Knee ◽

Normal Range ◽

Medial Knee ◽

Medial Compartment Osteoarthritis ◽

Knee Oa ◽

And Function ◽

Post Implantation

The Atlas Knee System was designed to fill the gap between no longer effective conservative treatments and more invasive surgery for young patients with medial knee osteoarthritis (OA). This article reports on the 2-year results of a single-arm study of 26 subjects who previously reported favorable clinical outcomes 1 year post implantation. Western Ontario and McMaster Universities Osteoarthritis Index pain and function scores improved by a clinically meaningful amount relative to baseline, and subjects had a return to normal range of motion. This study confirmed that the benefit of a joint unloading device in the management of young patients with medial knee OA is maintained over 2 years. This trial was registered with ClinicalTrials.gov (NCT02711254).

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Electroacupuncture versus manual acupuncture for knee osteoarthritis: a randomized controlled pilot trial

Acupuncture in Medicine ◽

10.1177/0964528419900781 ◽

2020 ◽

Vol 38 (5) ◽

pp. 291-300 ◽

Cited By ~ 1

Author(s):

Tian-Qi Wang ◽

Yong-Ting Li ◽

Li-Qiong Wang ◽

Guang-Xia Shi ◽

Jian-Feng Tu ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Statistical Significance ◽

Pilot Trial ◽

Controlled Clinical Trial ◽

Acupuncture Points ◽

Womac Pain ◽

Manual Acupuncture ◽

Current Output ◽

Randomized Controlled ◽

And Function

Objective: We aimed to explore the feasibility of evaluating the comparative effectiveness and safety of electroacupuncture (EA) relative to manual acupuncture (MA) for the treatment of knee osteoarthritis (KOA). Methods: A multicenter randomized controlled clinical trial was conducted in Beijing from September 2017 to January 2018. A total of 60 participants with KOA were randomly allocated to either EA ( n = 30) or MA ( n = 30) groups. Participants in the EA group were treated with EA at six to seven local traditional acupuncture points or ah shi points, and two to three distal points. Participants in the MA group had the same schedule as the EA group except that the electrical apparatus featured a working power indicator without actual current output, constituting a sham EA procedure, in order to blind participants. Both groups received 24 sessions over 8 weeks. The primary outcome was response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after 8 weeks. Secondary outcomes included pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs) at 4 and 8 weeks. Results: Of 60 participants randomized, 53 (88%) completed the study. Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis. Although significant differences were observed in WOMAC pain, stiffness, and function scores within both groups, between-group differences at 8 weeks did not reach statistical significance (odds ratio = 1.75 (95% confidence interval = 0.593–5.162)). Rates of AEs were low and similarly distributed between groups. Conclusion: Both EA and MA interventions in KOA were feasible and appeared safe. Whether or not EA may have a stronger impact on pain and function requires further evaluation through larger, adequately powered, randomized controlled trials. Trial registration number: NCT03274713.

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