Botulinum Toxin A Adult Gastrocnemius Muscle Study "BTX-A"

Completed

Phase 4 Results N/A

Trial Description

The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.

Detailed Description

Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly.
40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group.
Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.

Conditions

Interventions

  • BOTOX-A® Drug
    Other Names: Generic Name: Botulinum toxin type A
    Intervention Desc: 200 units, single treatment only
    ARM 1: Kind: Experimental
    Label: Intramuscular ending Targeting
    Description: Botox 200 units placed at the upper 1/10 and 2/10 length of the GCM
    ARM 2: Kind: Experimental
    Label: Midbelly Targeting
    Description: A total of 200 units will be placed at the four quadrants of the midbelly portion of the GCM.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline for EMG (electromyogram) activity week 8 No
Secondary Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS) Change from baseline at 8 weeks No
Secondary Change from baseline of Ankle Range of motion Change from baseline at 8 weeks No
Secondary Change from baseline of gait speed with 10 meters walk test Change from baseline at 8 weeks No
Secondary Change from baseline of ABILOCO scale Change from baseline at 8 weeks No
Secondary Change from baseline of Disability Assessment Scale Change from baseline at 8 weeks No
Secondary Change from baseline of Functional Ambulation Category Scale Change from baseline at 8 weeks No
Secondary Change of baseline of Lindmark Modified Fugyl Meyer Scale Change from baseline at 8 weeks No
Secondary Change from baseline of Tardieu angle of ankle Change from baseline at 8 weeks No

Sponsors