The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.

Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial.

BACKGROUND: In this study, we aimed to compare the efficacy of corticosteroid trigger point injection (TPI) versus extracorporeal shock wave therapy (ESWT) on inferior trigger points in the quadratus lumborum (QL) muscle. METHODS: In this single-blind randomized clinical trial, 54 low back pain patients with myofascial trigger points on QL muscle were investigated. Participants were randomly allocated into two groups with A and B pockets. Patients in group A underwent radial ESWT and received 5 treatment sessions (1 per week) and actually were not followed-up. However, patients in group B received corticosteroid TPI and received one session of corticosteroid treatment and followed-up for 4 weeks after injection. Oswestry Disability Index (ODI), visual analogue scale (VAS), pain pressure threshold (PPT) and short form (36) health survey (SF-36) were measured in both groups before, two weeks after and four weeks after intervention. RESULTS: The between group comparison indicated that corticosteroid TPI leaded to significant higher improvements of ODI (P-value< 0.01), VAS (P value< 0.001), and PPT (P-value = 0.001) scores compared to the ESWT group at two-week follow-up time-point. ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation. At four-week follow-up time-point, the patients in the ESWT group were 1.46 times more likely to achieve 30% reduction in VAS, 2.67 times more likely to achieve 30% reduction in ODI, and 2.30 times more likely to achieve 20% improvement in SF-36 compared to the participants in corticosteroid TPI group. These results refer to large effect size for all study outcomes in ESWT group (d = 4.72, d = 1.58, d = 5.48, and d = 7.47 for ODI, PPT, SF-36, and VAS, respectively). CONCLUSION: Corticosteroid TPI was more effective compared to ESWT in short-term controlling of pain and disability caused by myofascial pain syndrome of QL muscle. However, after 4 weeks treatment, ESWT further improved the quality of life and disability and was related with more probability of achievement the minimal clinically important difference concerning pain, disability and quality of life and large effect size for all study outcomes in treated patients compared to corticosteroid TPI. TRIAL REGISTRATION: www.irct.ir , IRCT20100827004641N14 , retrospectively registered 2019-01-19.

Lower serum 25-hydroxyvitamin D3 concentration is associated with higher pain and disability in subjects with low back pain: a case-control study.

OBJECTIVES: Low back pain (LBP) is a common medical problem worldwide. The aim of this study is to evaluate the association between serum concentration of 25-hydroxivitamin D3 and functional disability in patients suffering from LBP in a sample of Azeri middle-aged subjects, North West of Iran. RESULTS: In this case-control study, 63 eligible patients with LBP and 55 healthy subjects enrolled in the study. Peripheral venous blood was taken for evaluating the serum concentration of 25-hydroxivitamin D3. We recognized factors related with LBP by multiple regression analyses. The average serum 25-hydroxivitamin D3 concentration in case group was significantly lower than that of the matched controlled group (26.25 ± 15.95 vs. 34.20 ± 14.92, p-value < 0.01 respectively). Subjects with vitamin D deficiency or insufficiency were more likely to exhibit LBP than subjects with normal serum 25-hydroxivitamin D3 concentration [(OR = 2.388, 95% CI (1.114 to 5.119)]. According to the partial correlation analysis, there was a reverse correlation between serum 25-hydroxivitamin D3 concentration with functional disability measured by Modified Oswestry Questionnaire (r = - 0.307, p = 0.017) and also with pain intensity according to Visual Analogue Scale (VAS) score (r = - 0.268, p = 0.040) whilst adjusting for age, sex and body mass index (BMI).

Effect of hippotherapy simulator on pain, disability and range of motion of the spinal column in subjects with mechanical low back pain: A randomized single-blind clinical trial.

BACKGROUND: Hippotherapy is a form of therapeutic exercise for conservative treatment of lumbar spine segmental instability and/or hypomobility in subjects with low back pain (LBP). OBJECTIVE: The current study evaluates the effects of a hippotherapy simulator on pain, disability, and range of motion (ROM) of the spinal column in subjects with mechanical LBP. METHODS: In a randomized clinical trial, 80 subjects were randomly assigned to either the control or intervention groups. All subjects underwent routine physiotherapy. In addition, the intervention group underwent hippotherapy with a hippotherapy simulator for 15 sessions, each lasting 15 minutes. Pain, disability, and ROM of the lumbar spinal column of the subjects were measured in the first and last physiotherapy sessions respectively. RESULTS: Improvement in pain intensity was higher in the hippotherapy simulator group over the first eight days of treatment (Hippotherapy vs. Control Point changes: Day 12: p= 0.010; after treatment: p= 0.005). The hippotherapy simulator group had significantly higher improvement in disability score in comparison to the control group (p< 0.001); mean changes in the modified Schober test were not significant (p= 0.423). CONCLUSION: The hippotherapy simulator decreased pain and disability in subjects with LBP; however, no additional improvement in lumbar spine ROM was observed.

Effect of probiotic supplements in women with gestational diabetes mellitus on inflammation and oxidative stress biomarkers: a randomized clinical trial.

BACKGROUND AND OBJECTIVES: Very little is known about the use of probiotics among pregnant women with gestational diabetes mellitus (GDM) especially its effect on oxidative stress and inflammatory indices. The aim of present study was to measure the effect of a probiotic supplement capsule on inflammation and oxidative stress biomarkers in women with newly-diagnosed GDM. METHODS AND STUDY DESIGN: 64 pregnant women with GDM were enrolled in a double-blind placebo controlled randomized clinical trial in the spring and summer of 2014. They were randomly assigned to receive either a probiotic containing four bacterial strains of Lactobacillus acidophilus LA-5, Bifidobacterium BB-12, Streptococcus Thermophilus STY-31 and Lactobacillus delbrueckii bulgaricus LBY-27 or placebo capsule for 8 consecutive weeks. Blood samples were taken pre- and post-treatment and serum indices of inflammation and oxidative stress were assayed. The measured mean response scales were then analyzed using mixed effects model. All statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (version 16). RESULTS: Serum high-sensitivity C-reactive protein and tumor necrosis factor-α levels improved in the probiotic group to a statistically significant level over the placebo group. Serum interleukin-6 levels decreased in both groups after intervention; however, neither within group nor between group differences interleukin-6 serum levels was statistically significant. Malondialdehyde, glutathione reductase and erythrocyte glutathione peroxidase levels improved significantly with the use of probiotics when compared with the placebo. CONCLUSIONS: The probiotic supplement containing L.acidophilus LA- 5, Bifidobacterium BB- 12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2 appears to improve several inflammation and oxidative stress biomarkers in women with GDM.