Related Experiment Video
Updated: Feb 5, 2026
Ultrasound-guided Botulinum Toxin-A Injections: A Method of Treating Sialorrhea
Published on: November 9, 2016
Botulinum Toxin Type A Versus Placebo for Idiopathic Clubfoot: A Two-Center, Double-Blind, Randomized Controlled
Christine M Alvarez1,2, James G Wright3,4, Harpreet Chhina2
1Department of Orthopaedics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Insights
Onabotulinum toxin A (BTX-A) injections did not improve outcomes for idiopathic clubfoot treated with the Ponseti method. Most infants achieved correction with casting alone, with minimal need for tenotomy.
Area of Science:
- Orthopedics
- Pediatric Orthopedics
- Sports Medicine
Background:
- Congenital idiopathic clubfoot affects approximately 1 in 1,000 infants.
- The Ponseti method, involving manipulation and casting, is a standard treatment.
- Percutaneous Achilles tenotomy is performed for persistent hindfoot stiffness.
Purpose of the Study:
- To compare clinical outcomes of onabotulinum toxin A (BTX-A) versus placebo injections.
- To evaluate BTX-A efficacy when administered at hindfoot stall during Ponseti treatment.
- To assess the impact of BTX-A on the need for tenotomy in idiopathic clubfoot.
Main Methods:
- Double-blind, placebo-controlled, parallel-group study with balanced randomization.
- Infants with idiopathic clubfoot received either BTX-A or placebo injection at hindfoot stall.
- Treatment involved Ponseti manipulation and serial casting.
Main Results:
- At 6 weeks, 66% (BTX-A) and 63% (placebo) achieved ≥15° dorsiflexion.
- At 12 weeks, combined response rates were 88% (BTX-A) and 100% (placebo).
- By 2 years, 89% maintained response, with an 8% surgical rate.
Conclusions:
- No significant difference in outcomes between BTX-A and placebo groups.
- 92% of clubfeet responded to casting alone or with BTX-A by 12 weeks.
- Tenotomy is reserved for non-responders; surgery is for refractory cases.
Background:
Congenital idiopathic clubfoot is a condition that affects, on average, approximately 1 in 1,000 infants. One broadly adopted method of management, described by Ponseti, is the performance of a percutaneous complete tenotomy when hindfoot stall occurs. The use of onabotulinum toxin A (BTX-A) along with the manipulation and cast protocol described by Ponseti has been previously reported. Our goal was to compare the clinical outcomes between BTX-A and placebo injections into the gastrocnemius-soleus muscle at the time of hindfoot stall in infants with idiopathic clubfoot treated with the Ponseti method of manipulation and cast changes.
Methods:
This was a double-blind, placebo-controlled, parallel-group study with balanced randomization.
Results:
At 6 weeks after the study injection (T1), 66% of the 32 feet in the BTX-A arm and 63% of the 30 in the placebo arm responded to the treatment (i.e., obtained ≥15° of dorsiflexion). Seven of the 11 patients in the BTX-A arm and all of the 11 in the placebo arm who had not responded at T1 responded to a rescue BTX-A injection at 12 weeks after the first injection (T2). The combined response rate at T2, which included the first-time responders as well as the patients who did not respond at T1 but did at T2, was 88% in the BTX-A arm and 100% in the placebo arm, culminating in a 94% response rate at T2. At T3 (2 years of age), 89% of the feet continued to respond and there was an 8% surgical rate.
Conclusions:
There was no difference in outcomes between the BTX-A and placebo groups when the injection was performed at the time of hindfoot stall. Overall, 92% of the clubfeet in this study responded to a manipulation and cast protocol alone, with or without BTX-A injection, by 12 weeks after hindfoot stall, or we can say that 92% of the clubfeet did not require percutaneous Achilles tendon lengthening by 2 years of age. The need for tenotomy is limited to those who have not responded to treatment at this point, and the need for surgery is limited to those for whom all attempts at treatment with sequential casts, BTX-A, and percutaneous Achilles tendon lengthening have failed.
Level Of Evidence:
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
More Related Videos
08:53Randomized, Triple-Blind, and Parallel-Controlled Trial of Transcranial Direct Current Stimulation for Cognitive Rehabilitation after Stroke
Published on: June 6, 2025
08:36Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
Related Concept Videos
02:07Blind Procedures
01:54The Placebo Effect
01:36Types of Toxins
Air pollutants, primarily gases, pose significant threats to respiratory health, leading to conditions like hypoxia, lung cancer, and in extreme cases, death.
Environmental pollutants like...
01:26Directly Acting Muscle Relaxants: Dantrolene and Botulinum Toxin
The binding of dantrolene to the RYR1...
01:21Brainstem: Control Centers of Medulla
Olivary Nucleus
The olivary nucleus, or inferior olivary nucleus, is located within the ventrolateral part of the medulla oblongata. It is primarily involved in motor coordination and motor learning. The olivary nucleus receives input from the spinal cord, cerebellum, and motor...
01:11Blinding