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

NCT01501500 | Completed Phase 4 DMC

• 1 other identifier: NSC 99-2314-B-182A-020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hallux Valgus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• hallux valgus angle

  radiological assessment before and after the intervention

  up to 18 months

Secondary Outcomes (1)

• foot function index for quality of life

  up to 18 months

Study Arms (2)

botulinum toxin type A. HV angle

ACTIVE COMPARATOR

intramuscular injection of BTA into target muscle

Drug: BOTOX

Normal saline, HV angle

PLACEBO COMPARATOR

intramuscular injection of normal saline into target muscle

Drug: Normal Saline (0.9% NaCl)

Interventions

BOTOX DRUG

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

Also known as: BOTOX (Allergan, Irvine, CA)

botulinum toxin type A. HV angle

Normal Saline (0.9% NaCl) DRUG

Normal saline 0.3ml to oblique and transverse heads each

Normal saline, HV angle

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hallux valgus with angle of at least 20°,
• single or bilateral hallux valgus.

You may not qualify if:

• history of foot operations,
• rheumatoid arthritis and gouty arthritis.
• Any contraindication on BTA administration

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung MH

Guishan, Taoyuan, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 25683315 DERIVED

MeSH Terms

Conditions

Hallux Valgus

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Katie P Wu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 29, 2011
• Study Start: August 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2010-03

Locations

TW (1)