Clinical trial NCT00822523
Conditions: Muscle Strength Botulinum Toxins, Type A
Sponsor: Loma Linda University
Start date: 2009-01-01; Completion date: 2015-07-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.

Detailed description:
Purpose/Hypothesis:

Verify the validity and reliability of strain gauge assessment of strength of extensor digitorum brevis (EDB) muscle compared to compound muscle action potential (CMAP) size from EDB and surface electromyography (SEMG) data from EDB after injection of botulinum toxin into EDB

1. Primary Outcome Measure:

   Change in measured strength (using strain gauges) of dorsiflexion of digits 3 and 4 ("strength of EDB") after vs. before botulinum toxin injection into EDB
2. Secondary Outcome Measures:

   1. Change in CMAP (with standard reference electrode location and with an "inactive" reference electrode location) from EDB after vs. before botulinum toxin injection into EDB;
   2. Change in SEMG parameters from EDB, tibialis anterior (TA), and extensor digitorum longus (EDL) after vs. before botulinum toxin injection into EDB

STUDY DESIGN:

1. Overview:

   Single intramuscular injection of botulinum toxin or placebo (placebo or BOTOX 2 units or BOTOX 20 units, each with a total volume of 0.1 ml) intramuscular into right EDB on Day 0. Strain gauge data and SEMG data from TA and EDL are obtained at each evaluation time: Baseline (3 separate times prior to Day 0 after at least 5 separate training sessions for the strain gauges); Day 1; Day 2; Day 4 (during anticipated rapid change); Day 14 (+/-1 day) (at clinical nadir); Day 21 (+/-1 day) (another day at clinical nadir); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred); CMAP \& SEMG data from EDB are obtained at Baseline; Day 4 (close to nadir of CAMP); Day 14 (at nadir of CAMP) and/or Day 21 (at nadir of CAMP); and Month 4 (when clinical recovery from the effect of BOTOX should have occurred but CMAP should not have recovered).
2. Protocol:

Single-center, Double-Blind, Randomized, Pilot Trial Total Sample Size: 12-15

Treatment Groups:

BOTOX Single Dose 20 units IM in EDB in 0.1 ml BOTOX Single Dose 2 units IM in EDB in 0.1 ml Placebo (Saline) Single Dose IM in EDB in 0.1 ml

Estimated Time to Enroll:

0-3 months

Estimated Study Duration:

4-6 months

Arms: arm 1: Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units arm 2: Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units arm 3: Saline, Single dose, Intramuscular injection into right EDB
Interventions: intervention 1: Botulinum Toxin, Type A intervention 2: Botulinum Toxin, Type A intervention 3: Saline
Intervention descriptions: intervention 1: 20 units, single dose, intramuscular in right EDB muscle intervention 2: 2 units, single dose, intramuscular to right EDB muscle intervention 3: Single Dose, Intramuscular into right EDB muscle

Protocol documents: