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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01501500
First received: December 21, 2011
Last updated: December 28, 2011
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hallux Valgus
 Drug: BOTOX
Drug: Normal Saline (0.9% NaCl)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Botulinum Toxin Type A in Addition to Total Contact Insole in Treating Painful Hallux valgus-a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Foot Health
U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • hallux valgus angle [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
    radiological assessment before and after the intervention


Secondary Outcome Measures:
  • foot function index for quality of life [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
    Foot Function Index before and after the intervention


Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: botulinum toxin type A. HV angle
intramuscular injection of BTA into target muscle
 Drug: BOTOX
once injection of BTA 3oU into hallux oblique and transverse heads each
Other Name: BOTOX (Allergan, Irvine, CA)
Placebo Comparator: Normal saline, HV angle
intramuscular injection of normal saline into target muscle
 Drug: Normal Saline (0.9% NaCl)
Normal saline 0.3ml to oblique and transverse heads each
Other Name: Normal Saline (0.9% NaCl)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501500

Contacts
Contact: Katie P Wu, MD +886-3-3281200 ext 3846 katiewu1110@gmail.com

Locations
Taiwan
Chang Gung MH Recruiting
Gueishan, Taoyuan, Taiwan, 333
Contact: Katie P Wu, MD     +886-3-3281200 ext 3846     katiewu1110@gmail.com    
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Katie P Wu, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01501500     History of Changes
Other Study ID Numbers: NSC 99-2314-B-182A-020
Study First Received: December 21, 2011
Last Updated: December 28, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
botulinum toxin type A
hallux valgus angle
foot function index
VAS pain scale

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013