This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by University of British Columbia.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University of British Columbia Identifier:
First received: September 7, 2005
Last updated: July 30, 2015
Last verified: July 2015

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.

Condition Intervention
Idiopathic Clubfoot (Talipes Equinovarus) Drug: Botox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot

Resource links provided by NLM:

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Primary Outcome: Response to study treatment (as indicated by ankle dorsiflexion with knee in flexion of 15 degrees or greater) [ Time Frame: Unspecified ]

Secondary Outcome Measures:
  • Patient outcomes collected at every patient visit including: [ Time Frame: Unspecified ]
  • 1. Ankle dorsiflexion with knee in extension [ Time Frame: Unspecified ]
  • 2. Plantarflexion [ Time Frame: Unspecified ]
  • 3. Heel bisector scores [ Time Frame: Unspecified ]
  • 4. Occurrence of recurrence [ Time Frame: Unspecified ]

Enrollment: 36
Study Start Date: September 2005
Estimated Study Completion Date: June 2016
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botox
    See Detailed Description
Detailed Description:

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).


Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. children presenting with idiopathic clubfoot at BC Children's Hospital and Hospital for Sick Children
  2. children ranging in age from 1 day to 2 months old
  3. children who have reached hindfoot stall
  4. children with complete pre-study data *From protocol, hindfoot stall is defined: "following initial manipulation and casting of clubfoot, when the forefoot can be abducted beyond 60 degrees but hindfoot equinus persists, requiring need for further intervention to correct the clubfoot deformity"

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00152347

Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Christine Alvarez, PhD University of British Columbia
  More Information

Responsible Party: University of British Columbia Identifier: NCT00152347     History of Changes
Other Study ID Numbers: H05-70384
Study First Received: September 7, 2005
Last Updated: July 30, 2015

Additional relevant MeSH terms:
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on September 21, 2017