Adding Ozone to Dextrose and Somatropin for Intra-Articular Knee Prolotherapy: A Randomized Single-Blinded Controlled Trial

Background: Prolotherapy, as an alternative therapy, has emerged as an effective treatment for chronic musculoskeletal injury, including knee osteoarthritis (OA). Several studies have mention ozone as a potential treatment for these diseases, which is based on analgesic, anti-inflammatory, and anti-oxidant. Objectives: The current study aimed to investigate the effect of adding ozone gas to hypertonic dextrose and somatropin for knee prolotherapy in patients with knee OA. For this purpose, pain, knee stiffness, and physical activity are measured. Methods: Sixty patients with chronic knee OA were randomly assigned into two groups of DS and DSO. The DS group received intra-articular hypertonic dextrose (10 ml) plus 4 IU somatropin (4 IU), and the DSO group received 10 ml ozone 25 mcg plus intervention in the DS group. This procedure was performed three times (first, third, and fifth weeks). WOMAC score was examined during the third, fifth, and sixteenth weeks. Results: The mean WOMAC score of the DS group was decreased significantly (P < 0.001) sixteen weeks after providing the intervention (before 64.9 ± 10.6, vs. after 49.2 ± 9.0). A similar decrease (P < 0.001) was observed in the DSO group (before 64.1 ± 11.3, vs. after 41.3 ± 8.0). The decrease of the WOMAC score in the third and sixteenth weeks after providing the intervention was significant in the DSO group compared to the DS group (P < 0.005). Conclusions: For patients with knee OA, prolotherapy with ozone plus hypertonic dextrose and somatropin was more effective in sedating the pain and improving the stiffness and function of the knee than dextrose and somatropin alone.

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Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20180484 ◽

2018 ◽

Vol 7 (3) ◽

pp. 381

Author(s):

Tanmoy Kanti Goswami ◽

Pradip Kumar Ghoshal ◽

Avijit Hazra ◽

Asish Biswas

Keyword(s):

Randomized Controlled Trial ◽

Adverse Effects ◽

Controlled Trial ◽

Opioid Analgesics ◽

Womac Score ◽

Open Label ◽

Knee Oa ◽

Randomized Controlled ◽

Significant Difference ◽

Considerable Morbidity

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

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Effectiveness of collagen supplementation on pain scores in healthy individuals with self-reported knee pain: a randomized controlled trial

Applied Physiology Nutrition and Metabolism ◽

10.1139/apnm-2019-0654 ◽

2020 ◽

Vol 45 (7) ◽

pp. 793-800

Author(s):

Coen C.W.G. Bongers ◽

Dominique S.M. Ten Haaf ◽

Milène Catoire ◽

Bregina Kersten ◽

Jeroen A. Wouters ◽

...

Keyword(s):

Knee Pain ◽

Controlled Trial ◽

Middle Aged ◽

Physically Active ◽

P Values ◽

Elderly Individuals ◽

Collagen Peptide ◽

Pain Scores ◽

And Function ◽

Similar Decrease

The purpose of this study was to examine the effects of 12 weeks collagen peptide (CP) supplementation on knee pain and function in individuals with self-reported knee pain. Healthy physically active individuals (n = 167; aged 63 [interquartile range = 56–68] years) with self-reported knee pain received 10 g/day of CP or placebo for 12 weeks. Knee pain and function were measured with the Visual Analog Scale (VAS), the Lysholm questionnaire, and the Knee injury and Osteoarthritis Outcome Score (KOOS). Furthermore, we assessed changes in inflammatory, cartilage, and bone (bio)markers. Measurements were conducted at baseline and after 12 weeks of supplementation. Baseline VAS did not differ between CP and placebo (4.7 [2.5–6.1] vs. 4.7 [2.8–6.2], p = 0.50), whereas a similar decrease in VAS was observed after supplementation (−1.6 ± 2.4 vs. −1.9 ± 2.6, p = 0.42). The KOOS and Lysholm scores increased after supplementation in both groups (p values < 0.001), whereas the increase in the KOOS and Lysholm scores did not differ between groups (p = 0.28 and p = 0.76, respectively). Furthermore, CP did not impact inflammatory, cartilage, and bone (bio)markers (p values > 0.05). A reduced knee pain and improved knee function were observed following supplementation, but changes were similar between groups. This suggests that CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. Novelty CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. CP supplementation over a 12-week period does not impact on inflammatory, cartilage, and bone (bio)markers in healthy, active, middle-aged to elderly individuals.

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Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial

The American Journal of Sports Medicine ◽

10.1177/0363546519899923 ◽

2020 ◽

Vol 48 (3) ◽

pp. 588-598 ◽

Cited By ~ 12

Author(s):

Jaime R. Garza ◽

Richard E. Campbell ◽

Fotios P. Tjoumakaris ◽

Kevin B. Freedman ◽

Lawrence S. Miller ◽

...

Keyword(s):

Low Dose ◽

Controlled Trial ◽

Womac Score ◽

Percentage Change ◽

Controlled Clinical Trial ◽

High Dose ◽

Median Percentage ◽

Knee Oa ◽

Symptomatic Knee ◽

Double Blinded

Background: Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue. Hypothesis: Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority. Results: The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose, P = .04; low dose, P = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose, P = .006; low dose, P = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported. Conclusion: Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA. Registration: NCT02726945 (ClinicalTrials.gov identifier)

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Monitoring the Clinical Response to an Innovative Transdermal Delivery System for Ibuprofen

Pharmaceutics ◽

10.3390/pharmaceutics11120664 ◽

2019 ◽

Vol 11 (12) ◽

pp. 664 ◽

Cited By ~ 1

Author(s):

Anthony Wright ◽

Heather A. E. Benson ◽

Penny Moss ◽

Rob Will

Keyword(s):

Transdermal Delivery ◽

Controlled Trial ◽

Phase 1 ◽

Womac Pain ◽

Number Needed To Treat ◽

Womac Pain Score ◽

Patch Application ◽

Knee Oa ◽

Randomised Controlled ◽

And Function

We present a phase 1 study that utilizes a crossover design that provides a rapid and relatively inexpensive methodology for evaluating a new transdermal product. The treatment for osteoarthritis (OA) aims to reduce pain and improve function. An innovative magnetophoresis technology has been developed that facilitates transdermal delivery of ibuprofen. The study used measures that were taken over a relatively short time period to monitor the pharmacodynamic response to ibuprofen. Each participant received magnetophoresis-enhanced transdermal ibuprofen or placebo in randomised order, with a five-day washout period. The participants were 24 volunteers with medically diagnosed, painful knee OA. The primary outcome measures were VAS rating of pain on movement and Western Ontario and McMaster Universities (WOMAC) pain and function scores. VAS for pain on movement (p < 0.001), WOMAC pain score (p = 0.004), and WOMAC function score (p = 0.004) were all significantly improved. There was a significant reduction in movement-related pain (p < 0.05) during the first patch application and for the remainder of the study period. The number needed to treat for a 50% reduction in movement related pain was 2.2. The study showed a rapid and significant analgesic effect in response to transdermal ibuprofen. A short trial of this nature can be used for informing the parameters that are required for a major randomised controlled trial.

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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 ◽

10.1136/bmjopen-2017-017652 ◽

2017 ◽

Vol 7 (9) ◽

pp. e017652 ◽

Cited By ~ 4

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.

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PRENATAL YOGA TERHADAP TINGKAT KECEMASAN PRIMIGRAVIDA TRIMESTER III

Jurnal Sains Kebidanan ◽

10.31983/jsk.v2i1.5788 ◽

2020 ◽

Vol 2 (1) ◽

pp. 29-34

Author(s):

Riza Amalia ◽

Rusmini Rusmini ◽

Diki Retno Yuliani

Keyword(s):

Pregnant Women ◽

Alternative Therapy ◽

P Value ◽

Third Trimester ◽

The Third ◽

Before And After ◽

Change In The Mean ◽

Prolonged Labor ◽

The Mean ◽

Anxiety Levels

Anxiety in pregnant women often occurs in the third trimester. Anxiety results in prolonged labor, premature birth, LBW (Low Birth Weight). To prevent and reduce anxiety, prenatal yoga as an alternative therapy is given to primigravida pregnant women in the third trimester.The puropose of this study is to find out the influence of prenatal yoga toward anxiety level primigravida in the third trimester in Puskesmas I Kembaran, Banyumas District. This study used quasy experimental with pretest posttest design. The sample in this study are all of primigravida in third trimester, there are 24 pregnant woman in Puskesmas 1 Kembaran. The results showed there were differences in primigravida in third trimester anxiety levels before and after prenatal yoga with p value = 0,000 (p 0.05). There is an influence of prenatal yoga on the level of anxiety primigravida in third trimester. There is a change in the mean level of anxiety of 11,3.

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A single intraarticular platelet-rich plasma improves pain and function for patients with early knee osteoarthritis: Analyses by radiographic severity and age

Journal of Back and Musculoskeletal Rehabilitation ◽

10.3233/bmr-200193 ◽

2021 ◽

pp. 1-10

Author(s):

Shu-Fen Sun ◽

Chien-Wei Hsu ◽

Huey-Shyan Lin ◽

I-Hsiu Liou ◽

Yi-Chun Chou ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Platelet Rich Plasma ◽

Age Group ◽

Radiographic Severity ◽

Knee Oa ◽

Patients Satisfaction ◽

Younger Age ◽

Subgroup Analyses ◽

The Mean ◽

And Function

BACKGROUND: Most studies use platelet-rich plasma (PRP) requiring multiple intraarticular injections for knee osteoarthritis (OA). OBJECTIVE: To investigate the efficacy of a single intraarticular PRP injection for patients with early knee OA and consider subgroup analyses of radiographic severity and age, respectively. METHODS: Forty-one patients with knee OA (Kellgren-Lawrence grade 1–2) received a single PRP injection into the target knee and were assessed at baseline and 1, 3, and 6 months postinjection. The primary outcome was the mean change from baseline in the visual analog scale (VAS) pain (0–100 mm) at 6 months postinjection. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patients’ satisfaction. RESULTS: Thirty-eight patients completed the study. The mean pain VAS decreased significantly from 45.6 ± 13.0 mm at baseline to 16.9 ± 13.4 mm, 14.0 ± 13.1 mm and 15.5 ± 14.0 mm at 1, 3 and 6-month follow-ups (p< 0.001 for all). Significant improvements in WOMAC, Lequesne index, SLS and consumption of analgesics from baseline (p< 0.001 for all) were noted at each follow-up. Patients’ satisfaction was high. No serious adverse events occurred. Subgroup analyses revealed that patients with grade 1 OA showed significantly greater VAS pain reduction at 3 months (p= 0.006) and 6 months (p= 0.005) than patients with grade 2 OA. The older-age group (age > 60) showed significantly greater improvements in VAS pain, WOMAC function subscale scores and total scores at 6-month postinjection, compared with the younger age-group (age ≤ 60). The younger-age group reported better satisfaction at 1 and 3-month postinjection. CONCLUSIONS: One injection of PRP improved pain and function for 6 months for patients with early knee OA. This study supports putting the one-injection regimen into clinical practice. Further research is needed for more definite conclusions.

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Effectiveness of combined chain exercises on pain and function in patients with knee osteoarthritis

Bangladesh Journal of Medical Science ◽

10.3329/bjms.v15i2.24808 ◽

2016 ◽

Vol 15 (2) ◽

pp. 178-188 ◽

Cited By ~ 5

Author(s):

Oladapo Michael Olagbegi ◽

Babatunde Olusola Adeleke Adegoke ◽

Adesola C Odole

Keyword(s):

Controlled Trial ◽

Medical Science ◽

Hip Osteoarthritis ◽

Kinetic Chain ◽

Knee Oa ◽

Randomized Controlled ◽

Dependent Variables ◽

Before And After ◽

And Function ◽

Better Than

Objective: This randomized controlled trial was designed to investigate and compare the effectiveness of twelve-week open, closed and combined kinetic-chain exercises (OKCEs, CKCEs and CCEs) on pain and physical function (PF) in the management of knee osteoarthritis.Method: Ninety-six consecutive patients with knee OA were randomly assigned to one of OKCE, CKCE and CCE groups. Participants average daily pain (ADP), pain before and after walking (PBW and PAW), were evaluated using Visual Analogue Scale while PF was assessed using Ibadan Knee/Hip Osteoarthritis Outcome Measure.Results: Seventy-nine participants completed the study but data of another 4 participants who completed only 8-week treatment were included in data analysis (total=83; mean age = 61.10±13.75 years). The groups demographic and dependent variables were comparable at baseline but CCE group demonstrated significantly more reductions (p < 0.05) in ADP, PBW and PAW than OKCE and CKCE groups at weeks 4, 8 and 12 of the study. However, there were significant within group improvements (p < 0.05) in all four variables for the three groups. Conclusion: CCEs are better than OKCEs and CKCEs for pain reduction in though all three exercise regimens are singly effective. CCEs are recommended for improving treatment outcome for pain in patients with knee osteoarthritis.Bangladesh Journal of Medical Science Vol.15(2) 2016 p.178-188

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The Role of PRP and Its Platelet Concentration in Improving WOMAC Score on Early-Stage Knee Osteoarthritis (OA) Patients

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00108 ◽

2020 ◽

Vol 8 (5_suppl5) ◽

pp. 2325967120S0010

Author(s):

Basuki Supartono ◽

Salma Rahmadati ◽

Diana Agustini

Keyword(s):

Early Stage ◽

Platelet Rich Plasma ◽

Womac Score ◽

Bivariate Analysis ◽

Womac Pain ◽

Womac Pain Score ◽

Knee Oa ◽

Significant Difference ◽

Platelet Concentration ◽

And Function

Platelet concentration is one of the important factors in OA treatment with platelet-rich plasma (PRP). The purpose of this study was to determine the effect of PRP quality, which was determined by its platelet concentration, on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores in early-stage knee OA patients. This study involved 50 patients diagnosed with early-stage knee OA (stage I to III). Twenty-five patients received PRP with moderate platelet concentration (1× to 4×), another twenty-five patients received PRP with high platelet concentration (>4× to 6×). Patients were evaluated using WOMAC questionnaire before and three months after injection with PRP. Bivariate analysis showed that there was a significant improvement of three WOMAC score subscales (pain, stiffness, and function) in both group (p<0.05) and a significant difference in the differences between WOMAC pain scores between the two groups (p<0.05), meanwhile, significant differences in the differences between WOMAC stiffness and function scores between the two groups weren’t found (p>0.05). The conclusions of this study was, PRP with moderate and high platelet concentration had been shown to improve the three WOMAC score subscales of early-stage knee OA patients, but the effect of PRP’s platelet concentration was only significant in the improvement of WOMAC pain score.

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A 12-Words-for-Life-Nurturing Exercise Program as an Alternative Therapy for Cervical Spondylosis: A Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2014/961418 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7

Author(s):

Zhijun Hu ◽

Zhanying Tang ◽

Shiwei Wang ◽

Xiulan Ye ◽

Yongjun Wang ◽

...

Keyword(s):

Cervical Spondylosis ◽

Exercise Intervention ◽

Controlled Trial ◽

Alternative Therapy ◽

Exercise Program ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Sf 36 ◽

The Mean

In this paper, we carried out a randomized controlled clinical trial to explore the effect of 12-words-for-life-nurturing exercise on patients presenting with cervical spondylosis. After exercise intervention, the mean VAS and NDI scores of the patients decreased significantly and the scores of BP, VT, and MH in SF-36 Health Questionnaire were significantly higher. Exercise therapy showed significant effect on relieving pain and improving vitality and mental health. The 12-words-for-life-nurturing exercise may be a potential effective therapy for patients with cervical spondylosis.

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