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01-12-2014 | Research | Uitgave 1/2014 Open Access

Journal of Foot and Ankle Research 1/2014

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

Journal of Foot and Ankle Research > Uitgave 1/2014
Shu-Fen Sun, Chien-Wei Hsu, Huey-Shyan Lin, Yi-Jiun Chou, Jun-Yang Chen, Jue-Long Wang
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (doi:10.​1186/​1757-1146-7-9) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests. The study was supported by a grant of VGHKS100-061 (an academic research fund from the hospital’s medical research council).

Authors’ contributions

All authors contributed to the conception and design of this research. SS, YC, JC and JW performed the experiments. YC provided participants, JC and JW performed patient follow-up. HL and CH performed the statistical analysis. SS and CH interpreted data and drafted the manuscript. All authors read and approved the final manuscript.



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.

Trial registration

The trial was registered at clinical (Registry number NCT01760577).

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Reviewer acknowledgement

Reviewer acknowledgement 2013