Elsevier

Archives of Gerontology and Geriatrics

Volume 55, Issue 2, September–October 2012, Pages 310-315
Archives of Gerontology and Geriatrics

The effect of intra-articular hyaluronic acid treatment on gait velocity in older knee osteoarthritis patients: A randomized, controlled study

https://doi.org/10.1016/j.archger.2011.11.007Get rights and content

Abstract

Purpose: To determine the effect of intra-articular hyaluronic acid (HA) on gait velocity, pain, and function, in older knee osteoarthritis (OA) patients. Materials and methods: Thirty knee OA patients (Kellgren–Lawrence II–III) [72.44 (±6.11) years old] were randomized, using the ‘RANDBETWEEN’ function in Microsoft Excel, to receive three weekly injections of HA (2 ml of 20 mg/ml HA), or placebo (P) (1.2 ml of 0.001 mg/ml HA), with fifteen participants per group. Patients and assessors were blind to treatment. Self-selected and fast gait velocities were measured with the GAITRite® system. Knee pain, stiffness, and physical function were measured with the Western Ontario McMaster Osteoarthritis OA index (WOMAC OA index). Data from 1 week, 3 and 6 months post-treatment were analyzed using repeated measures ANOVA. Results: The HA group significantly improved self-selected and fast gait velocity, while the P group only significantly improved self-selected gait velocity. Mean improvements in self-selected gait velocity [Mean (SD); 95% CI] [1.25 (52.4) cm/s; −18.38; 20.88] and fast gait velocity [7.16 (71.75) cm/s; −19.72; 34.04] were not significantly different between groups. Improvements in WOMAC pain scores were significantly greater in the HA group than the P group [−2.47 (6.39); −4.86; −0.08], while improvements in stiffness [−0.87 (2.42); −1.77; 0.04] and physical function [−7.23 (19.77); −14.63; 0.16] scores were not. Conclusions: The overall effect of HA on gait velocity in older knee OA patients was not significant compared to placebo. The preliminary results of improved fast gait velocity following HA treatment should be investigated further, along with the incidence of falls, in a larger sample of older knee OA patients.ClinicalTrials.gov ID: NCT00778076.

Introduction

Knee OA is characterized by joint damage, pain, and stiffness and approximately 12% of adults older than 60 years of age in the United States suffer from this musculoskeletal disease (Dillon et al., 2006). Knee pain and dysfunction, as a result of knee OA, alter gait characteristics in older adults, and increases dependency in lower extremity tasks, such as walking and stair climbing (Guccione et al., 1994). Knee OA has been associated with difficulty performing daily activities (Davis et al., 1991) as well as an increased risk for falls in older adults (Sturnieks et al., 2004). As a result, older knee OA patients require treatments which will not only reduce knee pain, but also improve their level of physical function.

Viscosupplementation with HA is recommended by the Osteoarthritis Research Society International (OARSI) as an acceptable therapeutic modality to treat the symptoms of knee OA patients (Zhang et al., 2008). HA is a glycosaminoglycan which theoretically provides the viscoelastic properties of synovial fluid (Balazs et al., 1967), contributing to joint lubrication and cartilage shock dissipation; important features for proper knee function. Knee OA patients have demonstrated improvements after treatment with HA on subjective functional measures such as the Western Ontario and McMaster Universities (WOMAC) OA index (Brandt et al., 2001, Altman et al., 2004), and on isolated knee strength (Tang et al., 2005), and range of motion (Briem et al., 2009) tests. In addition, previous reports suggest that significant improvements in balance sway (Sun et al., 2006) and the distinctive 2-peak ground reaction force curve during gait (Tang et al., 2004) have been observed in knee OA patients, beginning 1 week following treatment with HA and lasting for 6 months.

Gait velocity is an objective measure of physical function in clinical populations of older adults (Studenski et al., 2003) which is both clinically practical, and directly relevant to the daily activities of older adults. Knee OA patients have a reduced gait velocity (Chen et al., 2003), which has been associated with an increased risk for mobility impairment and falls in older adults (Montero-Odasso et al., 2004). To our knowledge, the effect of HA on gait velocity in elderly knee OA patients has not yet been established. A recent study by Lester and Zhang (2010) found no difference in the self-selected gait velocity in knee OA patients 3 weeks following treatment with intra-articular HA. However, this study did not include a control group or any additional follow-up beyond 3 weeks post-treatment. Furthermore, Landry et al. (2007) found that increasing gait speed was associated with an increase in the magnitude of all joint moments in knee OA patients. Increasing knee joint moments in knee OA patients increases the stress on the diseased joint, exaggerating gait dysfunction (McGibbon and Krebs, 2002). Therefore, changes observed in fast gait velocity may provide further objective evidence of the effect of HA on the physical function of older knee OA patients.

The purpose of this pilot study was to determine if older mild-moderate knee OA patients experienced improvements in self-selected and fast gait velocities, following treatment with intra-articular HA injections, to provide rationale for a larger trial. Secondary measures included clinical outcomes related to OA, such as pain, stiffness, and physical function. We compared older knee OA patients treated with HA to those treated with placebo (P) injections. We hypothesized that older knee OA patients treated with HA injections would experience greater improvements in self-selected and fast gait velocity, knee pain, stiffness, and self-reported physical function, when compared to those knee OA patients receiving P injections.

Section snippets

Design

We received approval from the Health Sciences Research Ethics Board of the University of Western Ontario to conduct a randomized, double-blind, placebo controlled trial to evaluate the effect of intra-articular HA on gait function and clinical outcomes in radiographically diagnosed mild-moderate knee OA patients. For this pilot study, we selected a sample of thirty patients to determine the feasibility of the trial design, including efficiency of recruitment strategy, retention of participants,

Patient population

A total of 38 potential participants were screened for inclusion, and 30 participants were eligible. Eight potential participants were excluded; two who did not think they would be able to follow the study visit schedule, as outlined in the protocol; two who did not have significant signs of knee OA, based on radiographic criteria; two who did not agree to discontinue NSAID treatment; one who opted for surgical knee repair; and one who presented with a torn anterior cruciate ligament (based

Discussion

Our results demonstrate that following treatment with intra-articular HA, older mild-moderate knee OA patient's experienced significantly improved gait velocity and clinical outcomes associated with OA, including WOMAC pain, stiffness, and physical function scores. The improvements in WOMAC pain scores were significantly greater in patients treated with HA when compared to age and diseased matched control patients receiving intra-articular P. However, the improvements in gait velocity, and

Conclusions

In conclusion, this study demonstrates the effect of intra-articular HA is not different from P on self-selected gait velocity of older knee OA patients, but provides preliminary evidence suggesting that the effect of HA is different from P on the fast gait velocity of older knee OA patients. This study also demonstrates the effect of HA on pain reduction in older knee OA patients is significantly greater than P, and provides clinically important improvements in self-reported physical function

Conflict of interest statement

The authors have no financial or any other kind of personal conflicts with this manuscript.

Role of funding source

The funding sources had no role in the design, methodology, data analysis, or preparation of this manuscript.

Acknowledgments

We are grateful for Sheree Shapiro's assistance with the randomization process. This study was supported, in part, by grants from the Physicians’ Services Incorporated Foundation (PSI), and by the Canadian Institutes of Health Research (CIHR). Dr. Montero Odasso is the first recipient of the Schulich Clinician-Scientist Award and recipient of the CIHR New Investigator Award (2011–2016).

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