Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole
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ClinicalTrials.gov Identifier: NCT01501500 |
Recruitment Status
:
Completed
First Posted
: December 29, 2011
Last Update Posted
: September 6, 2013
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Condition or disease | Intervention/treatment | Phase |
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Hallux Valgus | Drug: BOTOX Drug: Normal Saline (0.9% NaCl) | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
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)
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Placebo Comparator: Normal saline, HV angle
intramuscular injection of normal saline into target muscle
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Drug: Normal Saline (0.9% NaCl)
Normal saline 0.3ml to oblique and transverse heads each
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- hallux valgus angle [ Time Frame: up to 18 months ]radiological assessment before and after the intervention
- foot function index for quality of life [ Time Frame: up to 18 months ]Foot Function Index before and after the intervention

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501500
Taiwan | |
Chang Gung MH | |
Gueishan, Taoyuan, Taiwan, 333 |
Principal Investigator: | Katie P Wu, MD | Chang Gung Memorial Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Chang Gung Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT01501500 History of Changes |
Other Study ID Numbers: |
NSC 99-2314-B-182A-020 |
First Posted: | December 29, 2011 Key Record Dates |
Last Update Posted: | September 6, 2013 |
Last Verified: | March 2010 |
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 Bunion Foot Deformities Musculoskeletal Diseases Foot Deformities, Acquired Botulinum Toxins onabotulinumtoxinA Botulinum Toxins, Type A abobotulinumtoxinA |
Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |