Clinical trial NCT01501500: Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole
Official title: Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hallux Valgus
Keywords: botulinum toxin type A
hallux valgus angle
foot function index
VAS pain scale
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2011-12-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: hallux valgus angle
timeFrame: up to 18 months
Secondary outcomes:
measure: foot function index for quality of life
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Gueishan
country: Taiwan
facility: Chang Gung MH
state: Taoyuan
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Katie P Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.