Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole

Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study

The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of hallux valgus treated with total contact insole. The outcome measurement may shed light in treating patient with painful hallux valgus and document evidence for plantar pressure changes in acute, sub-acute and chronic stage.

Study Overview

• Status: Completed
• Conditions: Hallux Valgus
• Intervention / Treatment: Drug: BOTOX; Drug: Normal Saline (0.9% NaCl)

Detailed Description

This is a randomized, double-blind, placebo-controlled prospective study to assess the influence and efficacy of intramuscular (IM) Botulinum Toxin Type A (BTA) injection in patients with painful hallux valgus with the use of total contact insole.

Fifty feet with painful hallux valgus will be collected. Informed consent is obtained according to the hospital's medical ethics and the human clinical trial committee. The feet will be randomized into 2 groups: Group A (n=25, treatment group) and Group B (n=25, control group). Clinical diagnosis of hallux valgus is made based on observation of great toe lateral deviation. Inclusion criteria were hallux valgus with angle of at least 20°, single or bilateral hallux valgus. To obtain the hallux valgus angle, foot roentgenography in AP and sesamoid views under the weight bearing condition will be obtained. The angle formed by lines drawn to bisect the first metatarsal bone and the proximal phalanx of the great toe will be measured. The exclusion criteria include history of foot operations, rheumatoid and gouty arthritis, and any contraindication to BTA administration. Subjective data such as the Foot Function Index will be collected.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Gueishan, Taoyuan, Taiwan, 333
      • Chang Gung MH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• hallux valgus with angle of at least 20°,
• single or bilateral hallux valgus.

Exclusion Criteria:

• history of foot operations,
• rheumatoid arthritis and gouty arthritis.
• Any contraindication on BTA administration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: botulinum toxin type A. HV angle; intramuscular injection of BTA into target muscle	Drug: BOTOX; once injection of BTA 3oU into hallux oblique and transverse heads each; Other Names: BOTOX (Allergan, Irvine, CA)
Placebo Comparator: Normal saline, HV angle; intramuscular injection of normal saline into target muscle	Drug: Normal Saline (0.9% NaCl); Normal saline 0.3ml to oblique and transverse heads each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hallux valgus angle	radiological assessment before and after the intervention	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
foot function index for quality of life	Foot Function Index before and after the intervention	up to 18 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: National Science Council, Taiwan

Publications and helpful links

General Publications

• Wu KP, Chen CK, Lin SC, Pei YC, Lin RH, Tsai WC, Fuk-Tan Tang S. Botulinum Toxin type A injections for patients with painful hallux valgus: a double-blind, randomized controlled study. Clin Neurol Neurosurg. 2015 Feb;129 Suppl 1:S58-62. doi: 10.1016/S0303-8467(15)30014-7.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: December 21, 2011
• First Submitted That Met QC Criteria: December 28, 2011
• First Posted (Estimate): December 29, 2011

Study Record Updates

• Last Update Posted (Estimate): September 6, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: botulinum toxin type A; hallux valgus angle; foot function index; VAS pain scale
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Hallux Valgus; Bunion; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A
• Other Study ID Numbers: NSC 99-2314-B-182A-020