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

2014-08-27 04:00:30 | BioPortfolio

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.

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hallux Valgus

Intervention

BOTOX, Normal Saline (0.9% NaCl)

Location

Chang Gung MH
Gueishan
Taoyuan
Taiwan
333

Status

Completed

Source

Chang Gung Memorial Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:30-0400

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Medical and Biotech [MESH] Definitions

Lateral displacement of the great toe (HALLUX), producing deformity of the first METATARSOPHALANGEAL JOINT with callous, bursa, or bunion formation over the bony prominence.

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

Displacement of the great toe (HALLUX) towards the midline or away from the other TOES. It can be congenital or acquired.

A genus of HALOBACTERIACEAE distinguished from other genera in the family by the presence of specific derivatives of TGD-2 polar lipids. Haloarcula are found in neutral saline environments such as salt lakes, marine salterns, and saline soils.

A family of gram-negative, moderately halophilic bacteria in the order Oceanospirillales. Members of the family have been isolated from temperate and Antarctic saline lakes, solar salt facilities, saline soils, and marine environments.

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