Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole - Full Text View

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

Drug Information available for: OnabotulinumtoxinA

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


Enrollment:	25
Study Start Date:	August 2010
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501500

Locations


Taiwan
Chang Gung MH
Gueishan, Taoyuan, Taiwan, 333

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:	September 5, 2013
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 Botulinum Toxins, Type A Anti-Dyskinesia Agents	Central Nervous System Agents Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015