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Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial.

ABSTRACT: There was an increasing requirement for novel treatments of osteoarthritis (OA). The aim was to compare the efficacy of intraarticular Botulinum toxin type A (BoNT-A) and intraarticular hyaluronate plus rehabilitation exercise in patients with ankle OA.This was a prospective, randomized, assessor-blinded study with a 6-month follow-up period, conducted in the outpatient rehabilitation department at a university-affiliated tertiary care medical center. Seventy-five patients with symptomatic ankle OA (Kellgren-Lawrence grade 2) were randomized to receive either a single 100-unit BoNT-A injection into the target ankle (n?=?38) or a single hyaluronate injection plus 12 sessions of rehabilitation exercise (30 minutes/day, 3 times/week for 4 weeks) (n?=?37). The primary outcome measure was the Ankle Osteoarthritis Scale (AOS). Secondary outcome measures included American Orthopedic Foot and Ankle Society (AOFAS) Ankle/Hindfoot Score, visual analog scale (VAS) for ankle pain, single leg stance test (SLS), Timed "Up-and-Go" test (TUG), consumption of rescue analgesics and global patient satisfaction.There were no significant between-group differences in total AOS scores, pain subscale and disability subscale scores (adjusted mean difference AMD?=?-0.2, 95% CI?=?(-0.5, 0.2), p?=?0.39; AMD?=?-0.1, 95% CI?=?(-0.5, 0.3), p?=?0.57; AMD?=?-0.2, 95% CI?=?(-0.6, 0.2), p?=?0.36). The 2 groups showed no significant differences in AOFAS, VAS, SLS, TUG scores and consumption of rescue analgesics at each follow-up visit, except that the hyaluronate group improved more in SLS than the BoNT-A group at 1-month follow-up. Patients' satisfaction rate was high, with no serious adverse events. There was no difference in adverse events between the two groups (p?=?1.00).Treatment with intraarticular BoNT-A or hyaluronate injection plus rehabilitation exercise was associated with improvements in pain, physical function and balance in patients with ankle OA. These effects were rapid at 2 weeks and might last for at least 6 months. There was no difference in effectiveness between the two interventions.The trial was registered at clinical trials.gov (Registry number NCT01760577).

SUBMITTER: Sun SF

PROVIDER: S-EPMC3922455 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial.

Sun Shu-Fen SF Hsu Chien-Wei CW Lin Huey-Shyan HS Chou Yi-Jiun YJ Chen Jun-Yang JY Wang Jue-Long JL

Journal of foot and ankle research 20140206 1

<h4>Background</h4>There was an increasing requirement for novel treatments of osteoarthritis (OA). The aim was to compare the efficacy of intraarticular Botulinum toxin type A (BoNT-A) and intraarticular hyaluronate plus rehabilitation exercise in patients with ankle OA.<h4>Methods</h4>This was a prospective, randomized, assessor-blinded study with a 6-month follow-up period, conducted in the outpatient rehabilitation department at a university-affiliated tertiary care medical center. Seventy-f ...[more]

PMID: 24502534

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Project description:ObjectiveTo assess short-term efficacy of single intraarticular botulinum toxin (IA-BoNT/A) injection in patients with chronically painful total knee arthroplasty (TKA) in a randomized, placebo-controlled, triple-blind study.MethodsPatients with chronic TKA pain (pain > 6 on 0-10 scale and > 6 months post-TKA) evaluated in and referred from orthopedic surgery clinics were recruited. The primary outcome, proportion of patients with clinically meaningful decrease of at least 2 points on 0-10 visual analog scale (VAS) for pain, was compared between treatment groups at 2 months using comparison of proportions test and for all efficacy timepoints (2, 3, and 4 months) using generalized estimating equations (GEE). Secondary outcomes of global assessment, function, and quality of life were compared using GEE, duration of pain relief by t-test, and adverse events by chi-square test.ResultsIn total, 54 patients with 60 painful TKA were randomized, with main analyses restricted to one TKA per patient (49 TKA in 49 patients). Mean age was 67 years, 84% were men, and mean duration of TKA pain was 4.5 years. A significantly greater proportion of patients (71%) in the IA-BoNT/A group compared to IA-placebo (35%) achieved clinically meaningful reduction in VAS pain at 2 months (p = 0.028) and at all efficacy timepoints (p = 0.019). Duration of meaningful pain relief was significantly greater after IA-BoNT/A, 39.6 days (SD 50.4) compared to IA-placebo, 15.7 days (SD 22.6; p = 0.045). Statistically significantly better scores were seen in IA-BoNT/A vs IA-placebo for all efficacy timepoints for the following outcomes: "very much improved" on physician global assessment of change (p = 0.003); Western Ontario McMaster Osteoarthritis Index physical function (p = 0.026), stiffness (p = 0.004), and total scores (p = 0.024); and Short-Form 36 pain subscale score (p = 0.049). Number of total and serious adverse events was similar between groups, with no patients in either group with new objective motor or sensory deficits during followup.ConclusionIn this single-center randomized trial, single IA-BoNT/A injection provided clinically meaningful short-term improvements in pain, global assessment, and function in patients with chronic painful TKA. A multicenter trial is needed to confirm these findings.

Project description:Intraarticular hyaluronan or platelet-rich plasma (PRP) is widely used in the treatment of knee osteoarthritis (OA). The efficacy of combined hyaluronan with PRP remained inconclusive. This study aimed to investigate the efficacy of combined a single crosslinked hyaluronan (HYAJOINT Plus) and a single PRP versus a single PRP in patients with knee OA. In a prospective randomized-controlled trial, 85 patients with knee OA (Kellgren-Lawrence 2) were randomized to receive a single intraarticular injection of HYAJOINT Plus (3 ml, 20 mg/ml) followed by 3 ml PRP (the combined-injection group, N = 43) or a single injection of 3 ml PRP (the one-injection group, N = 42). The primary outcome was the change from baseline in the visual analog scale (VAS) pain (0-00 mm) at 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction at 1, 3 and 6 months. Seventy-eight patients were available for the intention-to-treat analysis at 6 months. Both groups improved significantly in VAS pain, WOMAC, Lequesne index and SLS at each follow-up visit (p < 0.001). Patients receiving a single PRP experienced significantly greater improvements in VAS pain than patients receiving combined injections at 1-month follow-up (adjusted mean difference: - 5.6; p = 0.017). There were no significant between-group differences in several of the second outcomes at each follow-up visit, except the WOMAC-pain and WOMAC-stiffness scores favoring the one-injection group at 1 month (p = 0.025 and p = 0.011). However, at 6-month follow-up, the combined-injection group achieved significantly better VAS pain reduction (p = 0.020). No serious adverse events occurred following injections. In conclusion, either combined injections of HYAJOINT Plus and PRP or a single PRP alone was safe and effective for 6 months in patients with Kellgren-Lawrence 2 knee OA. Combined injections of HYAJOINT Plus and PRP achieved better VAS pain reduction than a single PRP at 6 months. The results indicating a long term benefit effect of a combination of HYAJOINT Plus and PRP in a particular subset of patients with moderate knee OA need to be replicated in larger trials.ClinicalTrials.gov number NCT04315103.

Project description:INTRODUCTION:Recent studies have suggested that intra-articular injection of botulinum toxin A (BTA) may have analgesic effects in degenerative joint diseases. We aim to assess the efficacy of intra-articular injection of BTA associated with splinting in patients with trapeziometacarpal osteoarthritis (TMC OA). METHODS AND ANALYSIS:We will conduct a randomised double-blind controlled trial. Overall, 60 individuals with TMC OA fulfilling adapted 1990 American College of Rheumatology criteria for hand OA will be recruited in one tertiary care centre in France and randomised to receive splinting + a?single ultrasound-guided injection in the TMC joint of 50 Allergan Units of BTA resuspended in 1?mL saline or splinting +1?mL saline. Randomisation will be centralised. The allocation ratio will be 1:1. The primary outcome will be the mean change from baseline in base-of-thumb pain on a self-administered 11-point Numeric Rating Scale in 10-point increments at 3 months after injection. Secondary outcomes will be the mean change in base-of-thumb pain at 1 and 6 months, mean change in hand-specific activity limitations assessed by the self-administered Cochin Hand Function Scale, proportion of responders assessed by the Osteoarthritis Research Society International -Outcome Measures in Rheumatology (OMERACT) criteria and consumption of analgesics and non-steroidal anti-inflammatory drugs assessed by a self-administered 4-class scale at 3 and 6 months. Cointerventions will be allowed in both groups and will be self-reported. Adverse events will be recorded at 3 and 6 months. Participants, care providers and statisticians will be blinded to the allocated treatment. ETHICS AND DISSEMINATION:The RHIBOT trial has been authorised by the Agence Nationale de Sécurité du Médicament and approved by the Comité de Protection des Personnes de Tours Ouest-1. The findings of the study will be disseminated in peer-reviewed journals and at conferences. If the results are positive, intra-articular BTA could be an efficient and safe complementary therapeutic option for patients with TMC OA. DATE AND VERSION IDENTIFIER OF THE PROTOCOL:8 January 2018, V. 2.0. TRIAL REGISTRATION NUMBER:NCT03187626; Pre-results.

Dataset Information

Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial.

Publications

Efficacy of intraarticular botulinum toxin A and intraarticular hyaluronate plus rehabilitation exercise in patients with unilateral ankle osteoarthritis: a randomized controlled trial.

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