Studies

Peri-articular hyaluronic acid in acute ankle sprain


Peri-articular hyaluronic acid in acute ankle sprain

RJ Petrella, MJ Petrella, A Cogliano
Faculties of Medicine and Health Sciences
University of Western Ontario
London, Canada

Abstract Background: Ankle

Abstract

Background:
Ankle sprains account for almost 2 million sport medicine visits in the US every year. Many lead to impaired performance and chronic disability. Unfortunately, current therapies are of limited effectiveness in altering recovery or have associated adverse effects.

Objectives:
In this study we determined the efficacy and safety of peri-articular hyaluronic acid injections in acute lateral ankle sprain compared to standard or care treatment in a cohort of athletes presenting over 9 months to a sports injuries center.
Methods: One hundred and fifty-eight consecutive competitive athletes who suffered an acute Grade 1 or 2 lateral ankle sprain were randomized within 48 hours of injury (baseline) to peri-articular injection with hyaluronic acid (HA) + standard of care or placebo injection (PL) + standard of care treatment at baseline assessment and Day 4 post injury,. No other treatment modalities were delivered during the study but patients could adopt any alternate treatment after Day 9. Assessments at baseline and Days 4, 8, 30 and 90 included VAS (0-10 cm) pain on weight bearing and walking 20 m, patient global assessment of ankle injury (5-point categorical scale), patient satisfaction with treatment (5-point categorical scale), time to return to pain-free and disability-free sport and adverse events. Differences between groups were determined using an intent-to-treat ANOVA. Data are reported as mean (SD) and significance was accepted as p<0.05.
Results: About 30% of the ankle sprains were “first” events and no differences in clinical assessments with those presenting but not volunteering for the study (N=341) was observed. No serious adverse events were recorded during the 8-day treatment period. Sixteen subjects took oral NSAIDs after day 8 for 14 (±9) days. Physical therapy was utilized by 33 patients but for only 4 (±3) sessions for ankle indications over the 90 day followup. No difference in concomitant treatment or physical therapy was observed between groups.

A significant reduction in VAS pain on both weight bearing and walking was observed at Day 8 for HA compared to PL (p<0.05). Significantly greater patient satisfaction was observed for HA vs PL at Days 4 (p<0.05), 8 (p<0.001), 30 (p<0.001) and 90 (p<0.05). Patient global assessment of ankle injury was significantly better compared to baseline in the HA group at Day 8 but this was not different between groups. Time to pain-free and disability-free return to sport was 11 (±8) vs 17 (±8) days for HA and PL respectively (p<0.05).

Conclusion: HA treatment for acute ankle sprain was highly satisfactory in the short and long term versus PL. This was associated with reduced pain and more rapid return to sport with few associated adverse events.

Peri-articular hyaluronic acid in acute ankle sprain: 18 months follow-up


Peri-articular hyaluronic acid in acute ankle sprain

RJ Petrella, A Cogliano, J Decaria
Faculties of Medicine and Health Sciences
University of Western Ontario
London, Canada

Abstract

Background:
We previously have reported the efficacy and safety of peri-articular injection of Hyaluronic acid (HA) in acute ankle sprain to 90 days followup.
Objectives:
To determine the long-term efficacy and safety to 18 months of peri-articular hyaluronic acid injections in acute lateral ankle sprain.
Methods: One hundred and fifty-eight consecutive competitive athletes who suffered an acute Grade 1 or 2 lateral ankle sprain were randomized within 48 hours of injury.

Interventions:
Patients were randomized at baseline to peri-articular injection with hyaluronic acid (HA) + standard of care (RICE) or placebo injection (PL) + standard of care (RICE) treatment at baseline assessment and Day 4 post injury. This report describes the 18 month followup results of this cohort.

Outcomes measures: Assessments at baseline and Days 4, 8, 30, 90 and 18 months included VAS (0-10 cm) pain on weight bearing and walking 20 m, patient global assessment of ankle injury (5-point categorical scale), patient satisfaction with treatment (5-point categorical scale), time to return to pain-free and disability-free sport, adverse events, recurrent ankle sprain and total number of days missing primary sport activity. Differences between groups were determined using an intent-to-treat ANOVA.

Results:
About 30% of the ankle sprains were ’’first’’ events and no differences in clinical assessments with those presenting but not volunteering for the study (N=341) was observed. Time to intervention was 39±4 hours with no difference between groups. A significant reduction in VAS pain on both weight bearing and walking was observed at Day 8 for HA compared to PL (p<0.05). There was a significant difference in VAS pain on weight bearing at 18 months favoring the HA group (p<0.05). At 18 months, in the PL versus HA group, there were 2 versus 0 lower limb fractures, 16 versus 8 second ankle sprains (p<0.05), 3 versus 1 third ankle sprains, and a significantly greater number of days missing primary sport activity (43±4 versus 21±6, p<0.002). An increased number of concomitant treatment was observed in the PL vs the HA group at 18 months. This included greater external ankle bracing (61 versus 28, p<0.02) and orthotics (21 versus 11, p<0.05). Significantly greater patient satisfaction was observed for HA vs PL at Days 4 (p<0.05), 8 (p<0.001), 30 (p<0.001), 90 (p<0.05) and 18 months (p<0.05). Time to pain-free and disability-free return to sport was 11 (±8) vs 17 (±8) days for HA and PL respectively (p<0.05).

Conclusion:
Peri-articular HA treatment for acute ankle sprain was highly satisfactory in the short and long term versus PL. This was associated with reduced pain, more rapid return to sport, fewer recurrent ankle sprains, fewer missed days from sport with few associated adverse events.

Ann Rheum Dis 2008;67(Suppl II):392

Long-Term Efficacy and Safety of Periarticular Hyaluronic Acid in Acute Ankle Sprain


Long-Term Efficacy and Safety of Periarticular Hyaluronic Acid in Acute Ankle Sprain

Michael J. Petrella, PhD; Anthony Cogliano, MD; Robert J. Petrella, MD, PhD
Dept. of Family and Physical
Medicine & Rehabilitation, Schulich School of Medicine, Lawson Health Research Institute
University of Western Ontario
London, Canada


Abstract

Background:
We previously have reported the efficacy and safety of peri-articular injection of Hyaluronic acid (HA) in acute ankle sprain to 180 days followup. We are please to include now, the published followup of the initial study up to 24 months.

Objectives:
The objectives of this study were to determine the long-term efficacy and safety of periarticular hyaluronic acid injections in acute lateral ankle sprain.

Method:
A randomized controlled prospective trial in a primary sport medicine and emergency practice involved 158 competitive athletes who suffered an acute Grade 1 or 2 lateral ankle sprain, and who were randomized within 48 hours of injury.

Patients were randomized at baseline to periarticular injection with hyaluronic acid (HA) + standard of care (rest, ice, elevation, and compression [RICE]) or placebo injection (PL) + standard of care (RICE) treatment at baseline assessment and Day 4 post injury.

Follow-up was at 30, 90, and 712 days post treatment.

Assessments at baseline and Days 4, 8, 30, 90, and 712 included visual analog scale (VAS) (0–10 cm) pain on weight bearing and walking 20 m, patient global assessment of ankle injury (5-point categorical scale), patient satisfaction with treatment (5-point categorical scale), time to return to pain-free and disability-free sport, recurrent ankle sprain, total number of days missing from primary sport activity, and adverse events (AEs).

Results:
Time to intervention was 39 ± 4 hours with no difference between groups.

A significant reduction in VAS pain on both weight bearing and walking was observed at all follow-up assessments for HA compared with PL (P < 0.001).

Time to pain-free and disability-free return to sport was 11 (± 8) versus 17 (± 8) days for HA and PL, respectively (P < 0.05).

At 24 months, in the PL versus HA group, there were 2 versus 0 lower limb fractures, 16 versus 7 second ankle sprains (P < 0.05), 3 versus 1 third ankle sprains, and a significantly greater number of days missing primary sport activity (41 versus 21; P < 0.002).

Significantly greater patient satisfaction was also observed for HA versus PL at all follow-up assessments.

No serious AEs were recorded throughout follow-up.

Periarticular HA treatment for acute ankle sprain was highly satisfactory in the short and long term versus PL. This was associated with reduced pain, more rapid return to sport, fewer recurrent ankle sprains, fewer missed days from sport, with few associated AEs to 24 months.

Conclusion:
Our results showed superior short- and long-term therapeutic response of periarticular HA in patients with acute ankle sprain versus standard of care treatment.

Further, periarticular HA resulted in fewer recurrent ankle sprains, less use of concomitant treatments, and fewer days missing from sport 2 years after the initial injury.

Given that this treatment is easily performed in primary care sport medicine and has high patient satisfaction, these results suggest that periarticular HA in acute ankle should be considered an important alternative by physicians and their patients.

THE PHYSICIAN AND SPORTSMEDICINE 2009;36(2):1-8..

Management of Tennis Elbow with sodium hyaluronate periarticular injections


Management of Tennis Elbow with sodium hyaluronate periarticular injections

Robert J Petrella, Anthony Cogliano, Joseph Decaria, Naem Mohamed, Robert Lee
Dept Medicine, Canadian Centre for Activity and Aging, 801 Commissioners
Road, London, N6C5J1, Canada


Abstract

Background: Chronic tennis elbow or lateral epicondylosis produces symptoms of pain and functional disability. Typical treatments include RICE for acute exacerbations as well as oral or topical NSAIDs, bracing and physical therapy. However, there is no consensus on treatment while efficacy of existing treatments is poor.

Intra-articular hyaluronic acid (HA) has shown efficacy equivalent to
NSAID in the treatment of osteoarthritis while it’s periarticular efficacy and safety have recently been reported for soft tissue use in acute ankle sprain. Hence, many patients, particularly those who require more rapid improvement to return to sport or work activity, or those in whom previous therapies have not achieved expected results, would benefit from a more rapid alleviation of symptoms, while still achieving the longer term benefits of hyaluronic acid that have been reported in other soft tissue indications.

Previous studies regarding treatment of chronic tennis elbow have shown lack of consensus as well as variable efficacy and high incidence of adverse effects. Hyaluronic acid has been used in soft tissue application for acute ankle sprain with high degree of efficacy and very limited side effect. Hence, given the biocompatibility of HA in treatment of acute ankle sprain we may show efficacy in terms of pain and function with low incidence of side effect and treatment of chronic tennis elbow.

Objectives: To determine the efficacy and safety of peri-articular hyaluronic acid injections in chronic lateral epicondylosis (tennis elbow).

Design: Prospective randomized clinical trial in primary care sport medicine.

Patients: Three hundred and thirty one consecutive competitive racquette sport athletes with chronic (>3 months) lateral epicondylosis were administered 2 injections (first injection at baseline) into the subcutaneous tissue and muscle 1 cm. from the lateral epicondyle toward the primary point of pain using a two-dimensional fanning technique. A second injection was administered 1 week later.

Outcomes measures: Assessments were done at baseline, days 7, 14, 30, 90 and 356. Efficacy measures included patient’s visual analogue scale (VAS) of pain at rest (0-100 mm) and following assessment of grip strength (0-100 mm). Grip strength was determined using a jamar hydraulic hand dynamometer. Other assessments included patients’ global assessment of elbow injury (5 point categorical scale; 1 = no disability, 5 = maximal disability), patients’ assessment of normal function/activity (5 point categorical scale), patients/physician satisfaction assessment (10 point categorical scale), time to return to pain-free and disability-free sport and adverse events as per WHO definition. Differences between groups were determined using an intent-to-treat ANOVA.

Results: Average age of the study population was 49 years (± 12 years). One hundred and sixty-five patients were randomized to the HA and 166 were randomized to the control groups.
>The change in VAS pain was -6.7 (± 2.0) for HA vs -1.3 (± 1.5) for control (p < 0.001).
>The VAS post handgrip was -7.8 (± 1.3) vs +0.3 (± 2.0) (p < 0.001) which corresponded to a significant improvement in grip of 2.6 kg in the HA vs control groups (p < 0.01).
>Statistically significant improvement in patients’ global assessment of elbow injury (p < 0.02), patients’ assessment of normal function/activity (p < 0.05) and patients/physician satisfaction assessment (p < 0.05) were also observed favoring the HA group.
>Time to return to pain-free and disability-free sport was 18 (± 11) days in the HA group but was not achieved in the control group. VAS changes were maintained in the HA group at each followup while those in the control significantly declined from baseline.
>Assessment of patient and physician satisfaction continued to favor the HA group at subsequent followup.

Conclusion: Peri-articular HA treatment for tennis elbow was significantly better than control in improving pain at rest and after maximal grip testing. Further, HA treatment was highly satisfactory by patients and physicians and resulted in better return to pain free sport compared to control.

PAULHEN CORPORATION