Dataset Information

Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial.

ABSTRACT:

Objectives

Viscosupplementation with new-generation, polyol-containing, cross-linked hyaluronic acid (HA) gels reduces joint inflammation in patients with knee osteoarthritis. Gait analysis is a complementary outcome measure to standard patient-reported scores and physical measures for testing the effect of HA injection. This three-arm, prospective, randomized, controlled, double-blind, feasibility pilot study investigated which gait parameters are more sensitive following a single bolus injection of polyol-containing HA for knee osteoarthritis.

Methods

Twenty-two patients with Ahlbäck grade II-III knee osteoarthritis were randomly allocated into three groups: (1) HA + mannitol (n = 9), (2) HA + sorbitol (n = 5), and (3) saline placebo (n = 8). Patients were assessed by blinded observers prior to injection and at 4 weeks post-injection (4W). Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Society score (KSS), EuroQol in five-dimensions (EQ-5D), VAS pain, and VAS stiffness. Gait was assessed over 30 m using a portable inertial-based data logger (Physilog®).

Results

Differences between 4W and baseline were statistically significant for the mannitol-containing viscosupplement, with a median increase of 0.076 m/s on gait speed (p = 0.039), 0.055 m on stride length (p = 0.027), and 15 points on the KSS (p = 0.047). In contrast, the HA + sorbitol and saline groups demonstrated no significant changes from baseline to 4W in any gait parameters or self-reported outcome measures (all p > 0.3). The observed increase in gait speed is approximately 13% greater than the mean difference between healthy subjects and those with knee osteoarthritis, is clinically important, and thus is a sensitive gait parameter.

Conclusions

This study demonstrated gait speed and stride length are the most relevant gait parameters to investigate when assessing the effect of polyol-containing HA viscosupplementation. This study supports the need for a larger, randomized, controlled, clinical trial to assess the effect of a single-bolus HA injection versus multiple injections in people with knee osteoarthritis using both gait performance and self-reported parameters of knee function.

Trial registration

This study was retrospectively registered at clinicaltrials.gov on August 20, 2018, and assigned #NCT03636971.

Level of evidence

SUBMITTER: Pereira LC

PROVIDER: S-EPMC6475965 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial.

Pereira Luis Carlos LC Schweizer Claude C Moufarrij Sara S Krähenbühl Swenn M SM Favre Julien J Gremion Gerald G Applegate Lee Ann LA Jolles Brigitte M BM

Pilot and feasibility studies 20190422

<h4>Objectives</h4>Viscosupplementation with new-generation, polyol-containing, cross-linked hyaluronic acid (HA) gels reduces joint inflammation in patients with knee osteoarthritis. Gait analysis is a complementary outcome measure to standard patient-reported scores and physical measures for testing the effect of HA injection. This three-arm, prospective, randomized, controlled, double-blind, feasibility pilot study investigated which gait parameters are more sensitive following a single bolus ...[more]

PMID: 31024734

Similar Datasets

Project description:BackgroundThe performance of an attention-demanding task while walking, i.e., dual-tasking, leads to dual-task costs (e.g., reduced gait speed) in older adults. Previous studies have shown that dual-task costs in gait are associated with future falls and cognitive decline. According to the communication through coherence hypothesis, transcranial alternating current stimulation (tACS) might help alleviate this problem.ObjectiveThe aim of this study was to examine the effects of a single session of theta-tACS targeting the left fronto-parietal network (L-FPN) on dual-task walking and cognitive function compared to sham stimulation and transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex, a node within the L-FPN.MethodsTwenty older adults completed a four-visit, double-blinded, within-subject, cross-over study in which usual-walking, dual-task walking, and cognitive function were evaluated before and immediately after 20 min of tACS, tDCS, or sham (order randomized) stimulation. Dual-task costs to gait speed (primary outcome) and other measures were analyzed.ResultsThe dual-task cost to gait speed tended to be lower (i.e., better) after tACS (p = 0.067, Cohen's d = 0.433∼small); tDCS significantly reduced this dual-task cost (p = 0.012, Cohen's d = 0.618∼medium), and sham stimulation had no effect (p = 0.467). tACS significantly reduced the dual-task cost to step length (p = 0.037, Cohen's d = 0.502∼medium); a trend was seen after tDCS (p = 0.069, Cohen's d = 0.443∼small). No statistical differences were found for other measures of gait or cognitive function.ConclusionsThe positive effects of tACS on dual-task gait speed and step length were roughly similar to those seen with tDCS. These results suggest that tACS affects the fronto-parietal network and, similar to tDCS, tACS may improve dual-tasking. Nonetheless, to achieve larger benefits and differentiate the effects of tACS and tDCS on brain function and dual-task walking in older adults, other stimulation montages and protocols should be tested.

Project description:AimTo evaluate the clinical outcomes of moderate intrabony defects treated with minimally invasive non-surgical technique (MINST) with or without adjunctive delivery of cross-linked hyaluronic acid (xHyA) gel.Materials and methodsForty-two patients with 42 interdental intrabony defects were randomly assigned to test (MINST + xHyA) or control procedures (MINST alone). Probing depth (PD), clinical attachment level (CAL), gingival recession (GR) and bleeding on probing (BOP) at the treated sites were assessed at baseline and at 3 and 6 months. Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) were recorded at baseline and after 6 months. Radiographic evaluation was performed at baseline and after 6 months, assessing the defect fill (DF) and radiographic defect angle (RDA). The primary outcome variable was PD change.ResultsThirty-eight patients completed the trial without any adverse events. At 6 months, a statistically significant improvement (p < 0.05) was measured in all clinical parameters except GR (p > 0.05). However, no statistically significant differences were found between the experimental and control procedures (p > 0.05). Statistically significant differences between the test and control sites were observed at 3 months for PD and CAL changes (p < 0.05). The DF change was statistically significant when comparing experimental and control procedures at 6 months (p < 0.05). Both procedures failed to show statistically significant differences in terms of RDA changes at 6 months (p > 0.05).ConclusionWithin their limitations, the present results indicate that (a) treatment of intrabony defects with MINST, with or without application of xHyA gel, resulted in statistically significant improvements in the investigated clinical parameters at 3 and 6 months after therapy, and (b) although the adjunctive use of xHyA gel to MINST improved the clinical outcomes compared with MINST alone up to 3 months, statistically significant differences were not observed at 6 months. The study protocol was registered in ClinicalTrial.gov (NCT05188898).

Project description:BackgroundInorganic arsenic is metabolized to monomethyl- (MMAs) and dimethyl- (DMAs) species via one-carbon metabolism (OCM); this facilitates urinary arsenic elimination. OCM is influenced by folate and vitamin B12 and previous randomized control trials (RCTs) showed that folic acid (FA) supplementation increases arsenic methylation in adults. This RCT investigated the effects of FA + B12 supplementation on arsenic methylation in children, a key developmental stage where OCM supports growth.MethodsA total of 240 participants (8-11 years, 53 % female) drinking from wells with arsenic concentrations > 50 μg/L, were encouraged to switch to low arsenic wells and were randomized to receive 400 μg FA + 5 μg B12 or placebo daily for 12-weeks. Urine and blood samples were collected at baseline, week 1 (only urine) and week 12. Generalized estimated equation (GEE) models were used to assess treatment effects on arsenic species in blood and urine.ResultsAt baseline, the mean ± SD total blood and urinary arsenic were 5.3 ± 2.9 μg/L and 91.2 ± 89.5 μg/L. Overall, total blood and urine arsenic decreased by 11.7% and 17.6%, respectively, at the end of follow up. Compared to placebo, the supplementation group experienced a significant increase in the concentration of blood DMAs by 14.0% (95% CI 5.0, 25.0) and blood secondary methylation index (DMAs/MMAs) by 0.19 (95% CI: 0.09, 0.35) at 12 weeks. Similarly, there was a 1.62% (95% CI: 0.43, 20.83) significantly higher urinary %DMAs and -1.10% (95% CI: -1.73, -0.48) significantly lower urinary %MMAs in the supplementatio group compared to the placebo group after 1 week. The direction of the changes in the urinary %iAs, %MMAs, and %DMAs at week 12 were consistent with those at week 1, though estimates were not significant. Treatment effects were stronger among participants with higher baseline blood arsenic concentrations. Results were consistent across males and females, and participants with higher and lower folate and B12 status at baseline.ConclusionThis RCT confirms that FA + B12 supplementation increases arsenic methylation in children as reflected by decreased MMAs and increased DMAs in blood and urine. Nutritional interventions may improve arsenic methylation and elimination in children, potentially reducing arsenic toxicity while also improving nutritional status.

Dataset Information

Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial.

Objectives

Methods

Results

Conclusions

Trial registration

Level of evidence

Publications

Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets