scholarly journals Individual responses to topical ibuprofen gel or capsaicin cream for painful knee osteoarthritis: a series of n-of-1 trials

Rheumatology ◽  
2020 ◽  
Author(s):  
Monica S M Persson ◽  
Joanne Stocks ◽  
Aliya Sarmanova ◽  
Gwen Fernandes ◽  
David A Walsh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Random Sequence ◽  
The Other ◽  
Response To Treatment ◽  
Individual Response ◽  
Clinical Trial Registration ◽  
Knee Oa ◽  
Baseline Pain Intensity ◽  
Painful Knee ◽  
Equal Efficacy

Abstract Objectives To determine individual responses to ibuprofen gel or capsaicin cream for painful, radiographic knee OA using a series of n-of-1 trials. Methods Twenty-two participants were allocated 5% ibuprofen gel (A) and 0.025% capsaicin cream (B) in random sequence (AB or BA). Patients underwent up to 3 treatment cycles, each comprising one treatment for 4 weeks, an individualized washout period (maximum 4 weeks), then the other treatment for 4 weeks. Differential (ibuprofen or capsaicin) response was defined when change-from-baseline pain intensity scores (0–10 NRS) differed by ≥1 between treatments in ≥2 cycles within a participant. Results A total of 104 treatment periods were aggregated. Mean pain reduction was 1.2 (95% CI: 0.5, 1.8) on ibuprofen and 1.6 (95% CI: 0.9, 2.4) on capsaicin (P = 0.221). Of 22 participants, 4 (18%) had a greater response to ibuprofen, 9 (41%) to capsaicin, 4 (18%) had similar responses, and 5 (23%) were undetermined. Conclusion Irrespective of equal efficacy overall, 59% of people displayed a greater response to one treatment over the other. Patients who do not benefit from one type of topical treatment should be offered to try another, which may be more effective. N-of-1 trials are useful to identify individual response to treatment. Clinical trial registration https://clinicaltrials.gov, NCT03146689

scholarly journals Influence of serum inflammatory cytokines on cytochrome P450 drug metabolising activity during breast cancer chemotherapy: a patient feasibility study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Rebekah L. I. Crake ◽  
Matthew R. Strother ◽  
Elisabeth Phillips ◽  
Matthew P. Doogue ◽  
Mei Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Cytochrome P450 ◽  
Inflammatory Cytokines ◽  
Individual Response ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Response To Chemotherapy

AbstractIndividual response to chemotherapy in patients with breast cancer is variable. Obesity and exercise are associated with better and worse outcomes, respectively, and it is known that both impact the systemic cytokine milieu. Cytochrome P450 (CYP) enzymes are responsible for the metabolism of many chemotherapy agents, and CYP enzyme activity has been shown to be modified by inflammatory cytokines in vitro and in vivo. Cytokine-associated changes in CYP metabolism may alter chemotherapy exposure, potentially affecting treatment response and patient survival. Therefore, better understanding of these biological relationships is required. This exploratory single arm open label trial investigated changes in in vivo CYP activity in twelve women treated for stage II or III breast cancer, and demonstrated for the first time the feasibility and safety of utilising the Inje phenotyping cocktail to measure CYP activity in cancer patients receiving chemotherapy. Relative CYP activity varied between participants, particularly for CYP2C9 and CYP2D6, and changes in serum concentrations of the inflammatory cytokine monocyte chemoattractant protein 1 inversely correlated to CYP3A4 activity during chemotherapy. Future use of phenotyping cocktails in a clinical oncology setting may help guide drug dosing and improve chemotherapy outcomes.Clinical Trial Registration: Trial was retrospectively registered to the Australia New Zealand Clinical Trial Registry (ANZCTR). ACTRN12620000832976, 21 Aug 2020, https://www.anzctr.org.au/ACTRN12620000832976.aspx.

The effectiveness of waist-shaped and straight-shaped interdental brushes in cleaning implant overdenture attachments: a self-controlled clinical trial

2020 ◽  
Author(s):  
Qiuwen Chen ◽  
Yanjun Ge ◽  
Jinyou Chai ◽  
Hailan Feng ◽  
Jianzhang Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Oral Hygiene ◽  
Respiratory Diseases ◽  
The Other ◽  
Controlled Clinical Trial ◽  
Cleaning Procedure ◽  
Plaque Removal ◽  
Line Angle ◽  
Implant Overdenture ◽  
Interdental Brush

Elderly patients often find it challenging to remove plaque accumulated on the attachments of implant overdentures (IOD) using conventional cleaning instruments. Further, excessive plaque accumulation can lead to peri-implant diseases and occasionally to respiratory diseases. Therefore, here, we aimed to compare the effectiveness of waist-shaped interdental brushes (WIB) with that of straight-shaped ones (SIB) in plaque removal from the locator attachments of IOD. Twenty participants with two locator attachments retaining mandibular IOD participated in this study. After the baseline cleaning, the participants refrained from oral hygiene maintenance for 3 days. A dentist cleaned one of the attachments using the WIB and the other attachment using the SIB. The pre- and post-cleaning modified plaque index (mPLI) scores were recorded. Following another 3 days free from oral hygiene maintenance, the trained participants repeated the same cleaning procedure using the WIB and SIB. Pre- and post-cleaning mPLI scores were recorded. Regardless of the type of brush used, the post-cleaning mPLI scores were lower than the pre-cleaning ones. After the cleaning procedure, the overall mean mPLI score was lower in the WIB group than in the SIB group. The post-cleaning mPLI scores at the line-angles and on the axial surfaces of the attachments were also lower in the WIB group than in the SIB group. There was no difference in the cleaning effectiveness between the dentist and participants when they used the same type of interdental brush. The WIB was significantly more efficient in plaque removal than the SIB, especially at the line-angle sites.

THE EFFECT OF A TRIPOD CANE ON THE FUNCTIONAL MOBILITY OF PATIENTS WITH KNEE OSTEOARTHRITIS

2020 ◽  
Vol 5 (1) ◽  
pp. 29
Author(s):  
Nelson Sudiyono
Keyword(s):  
Knee Osteoarthritis ◽  
Cross Sectional Study ◽  
Functional Mobility ◽  
Cross Sectional ◽  
Knee Oa ◽  
Walking Aids ◽  
Symptomatic Knee Osteoarthritis ◽  
Symptomatic Knee ◽  
Contralateral Hand ◽  
Painful Knee

Background: Canes have been recommended as walking aids for knee osteoarthritis to reduce the loading on the affected knee. Patients are usually recommended to hold the cane in the contralateral hand to the affected knee. Nevertheless, some patients prefer to hold the cane ipsilateral to the affected knee. However, the effect of using ipsilateral or contralateral tripod cane on functional mobility in patients with knee osteoarthritis is still unknown Objective: To compare the immediate effect of ipsilateral and contralateral tripod cane usage on functional mobility in patients with symptomatic knee osteoarthritis Method: This cross-sectional study involved 30 overweight or obese patients with symptomatic unilateral or bilateral knee osteoarthritis (Kellgren Lawrence grade 2 and 3) who never use a cane. Functional mobility was evaluated with Time Up and Go test in three conditions; without walking aid, with tripod cane contralateral and ipsilateral to the more painful knee. Results: The TUG time of aid-free walking is 4.75 (p < 0.001, 95% CI 3.79 - 5.71) seconds faster than ipsilateral cane use and 6.69 (p < 0.001, 95%CI 5.35 - 8.03) seconds faster than contralateral cane use. The TUG time of ipsilateral cane use is 1,94 (95% CI, 1.13 - 2.79) seconds faster than contralateral. Conclusion: Patients with symptomatic knee OA who use tripod cane ipsilateral to the more painful knee have higher functional mobility than the contralateral.

scholarly journals Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Po-Yin Chen ◽  
Ying-Chun Jheng ◽  
Chien-Chih Wang ◽  
Shih-En Huang ◽  
Ting-Hua Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Light Exposure ◽  
Light Condition ◽  
Vestibular Stimulation ◽  
Galvanic Vestibular Stimulation ◽  
Lateral Deviation ◽  
Clinical Trial Registration ◽  
Vestibular Hypofunction ◽  
Dark Conditions ◽  
Bilateral Vestibular Hypofunction

AbstractA single-blind study to investigate the effects of noisy galvanic vestibular stimulation (nGVS) in straight walking and 2 Hz head yaw walking for healthy and bilateral vestibular hypofunction (BVH) participants in light and dark conditions. The optimal stimulation intensity for each participant was determined by calculating standing stability on a force plate while randomly applying six graded nGVS intensities (0–1000 µA). The chest–pelvic (C/P) ratio and lateral deviation of the center of mass (COM) were measured by motion capture during straight and 2 Hz head yaw walking in light and dark conditions. Participants were blinded to nGVS served randomly and imperceivably. Ten BVH patients and 16 healthy participants completed all trials. In the light condition, the COM lateral deviation significantly decreased only in straight walking (p = 0.037) with nGVS for the BVH. In the dark condition, both healthy (p = 0.026) and BVH (p = 0.017) exhibited decreased lateral deviation during nGVS. The C/P ratio decreased significantly in BVH for 2 Hz head yaw walking with nGVS (p = 0.005) in light conditions. This study demonstrated that nGVS effectively reduced walking deviations, especially in visual deprived condition for the BVH. Applying nGVS with different head rotation frequencies and light exposure levels may accelerate the rehabilitation process for patients with BVH.Clinical Trial Registration This clinical trial was prospectively registered at www.clinicaltrials.gov with the Unique identifier: NCT03554941. Date of registration: (13/06/2018).

scholarly journals Cross-cultural adaptation, reliability and validity of the Fremantle Knee Awareness Questionnaire in Italian subjects with painful knee osteoarthritis

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Marco Monticone ◽  
Cristiano Sconza ◽  
Igor Portoghese ◽  
Tomohiko Nishigami ◽  
Benedict M. Wand ◽  
...  
Keyword(s):  
Construct Validity ◽  
Knee Osteoarthritis ◽  
Pain Intensity ◽  
Internal Consistency ◽  
Structural Validity ◽  
Retest Reliability ◽  
Knee Oa ◽  
Pain Catastrophising ◽  
Test Retest Reliability ◽  
Painful Knee

Abstract Background and aim Growing attention is being given to utilising physical function measures to better understand and manage knee osteoarthritis (OA). The Fremantle Knee Awareness Questionnaire (FreKAQ), a self-reported measure of body-perception specific to the knee, has never been validated in Italian patients. The aims of this study were to culturally adapt and validate the Italian version of the FreKAQ (FreKAQ-I), to allow for its use with Italian-speaking patients with painful knee OA. Methods The FreKAQ-I was developed by means of forward–backward translation, a final review by an expert committee and a test of the pre-final version to evaluate its comprehensibility. The psychometric testing included: internal structural validity by Rasch analysis; construct validity by assessing hypotheses of FreKAQ correlations with the knee injury and osteoarthritis outcome score (KOOS), a pain intensity numerical rating scale (PI-NRS), the pain catastrophising scale (PCS), and the Hospital anxiety and depression score (HADS) (Pearson’s correlations); known-group validity by evaluating the ability of FreKAQ scores to discriminate between two groups of participants with different clinical profiles (Mann–Whitney U test); reliability by internal consistency (Cronbach’s alpha) and test–retest reliability (intraclass correlation coefficient, ICC2.1); and measurement error by calculating the minimum detectable change (MDC). Results It took one month to develop a consensus-based version of the FreKAQ-I. The questionnaire was administered to 102 subjects with painful knee OA and was well accepted. Internal structural validity confirmed the substantial unidimensionality of the FreKAQ-I: variance explained was 53.3%, the unexplained variance in the first contrast showed an eigenvalue of 1.8, and no local dependence was detected. Construct validity was good as all of the hypotheses were met; correlations: KOOS (rho = 0.38–0.51), PI-NRS (rho = 0.35–0.37), PCS (rho = 0.47) and HADS (Anxiety rho = 0.36; Depression rho = 0.43). Regarding known-groups validity, FreKAQ scores were significantly different between groups of participants demonstrating high and low levels of pain intensity, pain catastrophising, anxiety, depression and the four KOOS subscales (p ≤ 0.004). Internal consistency was acceptable (α = 0.74) and test–retest reliability was excellent (ICC = 0.92, CI 0.87–0.94). The MDC95 was 5.22 scale points. Conclusion The FreKAQ-I is unidimensional, reliable and valid in Italian patients with painful knee OA. Its use is recommended for clinical and research purposes.

scholarly journals MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohamad Hadi El Charif ◽  
Samer Doughan ◽  
Rawya Kredly ◽  
Sara Kassas ◽  
Rayan Azab ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Anal Fissure ◽  
Topical Therapy ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Anal Fissures ◽  
Link Type ◽  
Anorectal Region ◽  
Registration Date

Abstract Background Anal fissure is a common complication of the anorectal region and one of the most reported causes of anal pain. Acute anal fissure can be cured by surgery or medical treatment. There is an increase in the use of topical therapy for the treatment of anal fissures. A common topical drug used is Diltiazem (DTZ), a calcium-channel blocker, which relaxes the anal sphincter and thus promotes healing of the anal fissure. Moist exposed burn ointment (MEBO) is an ointment that is effective for the treatment of burns and wound healing and is becoming popular in the treatment of anal fissures. Methods This is a 1:1:1 randomized, controlled, parallel design, with endpoint measures of change in pain score, wound healing, defecation strain score and patient’s global impression of improvement. The study will be conducted at AUBMC over a 10-week period. Patients will be randomized to three treatment arms: MEBO, Diltiazem, and a combination of MEBO and Diltiazem ointments. Discussion The results of this study will allow physicians to assess the efficacy and safety of MEBO in the treatment of acute anal fissure, and also in comparison to Diltiazem. This trial will generate evidence-based conclusions regarding the use of a herbal/natural-based product (MEBO ointment) for the treatment of anal fissures. Trial registration ClinicalTrials.gov Identifier NCT04153032. Clinical Trial Registration Date: 06-NOVEMBER-2019.

scholarly journals Serum C-reactive protein metabolite (CRPM) is associated with incidence of contralateral knee osteoarthritis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anne-Christine Bay-Jensen ◽  
Asger Bihlet ◽  
Inger Byrjalsen ◽  
Jeppe Ragnar Andersen ◽  
Bente Juhl Riis ◽  
...  
Keyword(s):  
Phase Iii ◽  
Response To Treatment ◽  
C Reactive Protein ◽  
Two Phase ◽  
Knee Oa ◽  
Reactive Protein ◽  
Inflammatory Phenotype ◽  
The Mean ◽  
Using Data

AbstractThe heterogeneous nature of osteoarthritis (OA) and the need to subtype patients is widely accepted in the field. The biomarker CRPM, a metabolite of C-reactive protein (CRP), is released to the circulation during inflammation. Blood CRPM levels have shown to be associated with disease activity and response to treatment in rheumatoid arthritis (RA). We investigated the level of blood CRPM in OA compared to RA using data from two phase III knee OA and two RA studies (N = 1591). Moreover, the association between CRPM levels and radiographic progression was investigated. The mean CRPM levels were significantly lower in OA (8.5 [95% CI 8.3–8.8] ng/mL, n = 781) compared to the RA patients (12.8 [9.5–16.0] ng/mL, n = 60); however, a significant subset of OA patients (31%) had CRPM levels (≥ 9 ng/mL) comparable to RA. Furthermore, OA patients (n = 152) with CRPM levels ≥ 9 ng/mL were more likely to develop contra-lateral knee OA assessed by X-ray over a two-year follow-up period with an odds ratio of 2.2 [1.0–4.7]. These data suggest that CRPM is a blood-based biochemical marker for early identification OA patients with an inflammatory phenotype.

scholarly journals Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

2021 ◽  
Author(s):  
Mayte Buchbender ◽  
Jakob Fehlhofer ◽  
Peter Proff ◽  
Tobias Möst ◽  
Jutta Ries ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Oral Cavity ◽  
Bowel Disease ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
Expression Levels ◽  
Inflammatory Bowel ◽  
Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

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