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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hallux Valgus	Drug: BOTOX; Drug: Normal Saline (0.9% NaCl)	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study
Study Start Date :	August 2010
Actual Primary Completion Date :	August 2013
Actual Study Completion Date :	August 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. hallux valgus angle [ Time Frame: up to 18 months ]
   radiological assessment before and after the intervention

Secondary Outcome Measures :

1. foot function index for quality of life [ Time Frame: up to 18 months ]
   Foot Function Index before and after the intervention

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Taiwan
Chang Gung MH
Gueishan, Taoyuan, Taiwan, 333

Sponsors and Collaborators

Chang Gung Memorial Hospital

National Science Council, Taiwan

Investigators

Principal Investigator:	Katie P Wu, MD	Chang Gung Memorial Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01501500 History of Changes
Other Study ID Numbers:	NSC 99-2314-B-182A-020
First Posted:	December 29, 2011
Last Update Posted:	September 6, 2013
Last Verified:	March 2010

Keywords provided by Chang Gung Memorial Hospital:

botulinum toxin type A; hallux valgus angle; foot function index; VAS pain scale

Additional relevant MeSH terms:

Hallux Valgus; Bunion; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Botulinum Toxins; onabotulinumtoxinA; Botulinum Toxins, Type A; abobotulinumtoxinA	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