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NCT Number: NCT01501500

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

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.

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Key information

Conditions

Hallux Valgus Foot Deformities Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung MH

Guishan, Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox

Drug

once injection of BTA 3oU into hallux oblique and transverse heads each

Other names: BOTOX (Allergan, Irvine, CA)

Normal Saline (0.9% NaCl)

Drug

Normal saline 0.3ml to oblique and transverse heads each

Primary outcomes

  1. hallux valgus angle

    Time frame: up to 18 months

    radiological assessment before and after the intervention

Secondary outcomes

  1. foot function index for quality of life

    Time frame: up to 18 months

    Foot Function Index before and after the intervention

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 29, 2011
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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