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

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501500
• Other study ID #: NSC 99-2314-B-182A-020
• Status: Completed
• Phase: Phase 4
• First received: December 21, 2011
• Last updated: September 5, 2013
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: March 2010
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Drug:
• BOTOX
once injection of BTA 3oU into hallux oblique and transverse heads each
• Normal Saline (0.9% NaCl)
Normal saline 0.3ml to oblique and transverse heads each

Locations

Country	Name	City	State
Taiwan	Chang Gung MH	Gueishan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hallux valgus angle	radiological assessment before and after the intervention	up to 18 months	Yes
Secondary	foot function index for quality of life	Foot Function Index before and after the intervention	up to 18 months	Yes