Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study

Launched by VASTRA GOTALAND REGION · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for muscle spasticity in the arms, which can happen after injuries to the brain or spinal cord, like strokes or traumatic brain injuries. Spasticity can make it difficult to move the hand and perform everyday activities, leading to a loss of independence. The trial will compare the effectiveness of upper limb surgery and Botulinum toxin (BoNT) injections, which are commonly used to treat spasticity. A total of 30 patients with ongoing BoNT treatment will participate by undergoing both treatments one after the other. This will help researchers understand which option works better for improving arm function and daily activities.

To be eligible for the trial, participants must be 18 years or older, have significant spasticity in their arms that has been problematic for at least six months, and be currently receiving BoNT treatment. They should also have had at least three months since their last BoNT injection and need to be medically stable enough for surgery if they are selected for that treatment. Throughout the study, participants will be assessed before and after each treatment to measure any improvements in their condition. This research aims to provide new insights that could help guide treatment decisions for people dealing with upper limb spasticity.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or above
• • 2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI
• • 3. Patients treated at least 6 months after the injury event
• • 4. Ongoing BoNT treatment in the UL
• • 5. A minimum of 3 months passed since the last BoNT injection
• • 6. At least two muscles in the hand and wrist were considered for treatment
• • 7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment
• • 8. For the surgery group, medically stable to undergo surgery
• • 9. No other severe UL injuries affecting the functional level
• Exclusion Criteria:
• • -