A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot

2014-07-23 21:48:52 | BioPortfolio


The purpose of this study is to continue the work from the previous review study and determine the effectiveness of Botox in treating patients with idiopathic clubfoot by comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment group) to those treated with manipulation and casting plus placebo (control group).

The null hypothesis is that manipulation and casting plus Botox is not an effective treatment for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting plus Botox is an effective treatment for idiopathic clubfoot.


The study timeline is divided into five phases which have been defined based on experiences with the previous review and with clubfoot treatment in general. These phases are as follows: 1) study treatment (Botox injection versus placebo); 2) post-treatment manipulation and casting; 3) bracing and full-time maintenance; 4) intent-to-treat intervention for management of first-time non-responders (NR1) and first-time recurrences (Rec1) post-study treatment; and 5) rescue intervention for management of second-time non-responders (NR2) and second-time recurrences (Rec2) post intent-to-treat intervention.

We will utilize a double-blind randomized control trial to assess the efficacy of Botox in the treatment of idiopathic clubfoot. Patients, parents, both participating surgeons, and members of their clinical and research teams (physiotherapist, occupational therapist, orthopaedic technologist, orthotist, research assistant) will be blinded to the study group (Botox group versus control group) each subject belongs in. The pharmacist preparing the syringes for injection will not be blinded.

Subjects will be randomly assigned to receive either Botox (Treatment group) or placebo injection (Control group). Subjects in the treatment group will receive Botox injections dosed at 10 IU/kg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline. If the child has bilateral clubfoot, the contents will be divided equally for injection into each gastrocnemius. Placebo injections for the control group will contain unpreserved saline at 0.1cc/kg (such that a 4.5 kg subject will receive 0.45cc).

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Idiopathic Clubfoot (Talipes Equinovarus)




BC Children's Hospital, Department of Orthopaedics
British Columbia
V6H 3V4




University of British Columbia

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:48:52-0400

Clinical Trials [705 Associated Clinical Trials listed on BioPortfolio]

Efficacy of Botox in Patients With Idiopathic Clubfoot

The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of ...

Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)

1. Purpose: The goal of this study is to identify and characterize the genetic loci causing idiopathic talipes equinovarus (clubfoot). 2. Hypothesis: The hypothesis is that a fe...

Using Botox to Treat Patients With Idiopathic Clubfoot

The purpose of this study is to determine the effectiveness of treatment of idiopathic clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study as we a...

Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results

There are many different treatments of congenital talipes equinovarus. At our institution, we use the Ponseti method with manipulation and immobilization of the foot. In our study we'd lik...

Customized Orthosis for Children With Clubfoot

This study will examine the use of a novel customized Ankle Foot Orthosis (AFO), created using 3D scanning, with children being treated for clubfoot. The AFO is inserted in the standard Mi...

PubMed Articles [790 Associated PubMed Articles listed on BioPortfolio]

The 5-Year Outcome of the Ponseti Method in Children With Idiopathic Clubfoot and Arthrogryposis.

The Ponseti method effectively treats idiopathic clubfoot, but its effectiveness in treating the stiffer clubfoot associated with arthrogryposis is less clear. The purpose of this study was to assess ...

Motor and cognitive functioning in children treated for idiopathic clubfoot at the age of 3 years.

Several studies have investigated motor and cognitive skills in infants as well as gross motor abilities in schoolchildren treated for congenital idiopathic clubfoot, mostly indicating specific impair...

Perfusion is Not Measurably Decreased in Idiopathic Clubfoot.

Vascular aberration has been accepted as a potential etiology of clubfoot, and abnormal vasculature has been observed in as high as 85% of children with severe clubfoot. The perfusion index (PI) corre...

A Long-term Follow-up of Young Adults With Idiopathic Clubfoot: Does Foot Morphology Relate to Pain?

Individuals with clubfoot, treated in infancy with either the Ponseti method or comprehensive clubfoot release, often encounter pain as adults. Multiple studies have characterized residual deformity a...

YouTube as an information source for clubfoot: a quality analysis of video content.

Idiopathic clubfoot is the most common congenital anomaly of the lower extremity. YouTube has emerged as an important source of health-related information for patients and families. Parents seek infor...

Medical and Biotech [MESH] Definitions

Deformity in which the foot is misaligned with respect to the TALUS in the ANKLE JOINT. While mostly congenital, as in CLUBFOOT, acquired deformities are included. Acquired talipedes are often associated with other foot deformities such as SYNDACTYLY and POLYDACTYLY.

A foot deformity in which the arch of the foot is high and often the heel adducted.

A deformed foot in which the foot is plantarflexed, inverted and adducted.

A group of interstitial lung diseases with no known etiology. There are several entities with varying patterns of inflammation and fibrosis. They are classified by their distinct clinical-radiological-pathological features and prognosis. They include IDIOPATHIC PULMONARY FIBROSIS; CRYPTOGENIC ORGANIZING PNEUMONIA; and others.

A disease of elderly men characterized by large osteophytes that bridge vertebrae and ossification of ligaments and tendon insertions.

More From BioPortfolio on "A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot"

Quick Search

Relevant Topic

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Searches Linking to this Trial