RecruitingNot ApplicableNCT06733025

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

The Effectiveness of Spasticity-correcting Upper Limb Surgery Versus Botulinum Toxin Injections in Patients With Upper Limb Spasticity: an Experimental Study With Paired Design


Sponsor

Vastra Gotaland Region

Enrollment

30 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Spasticity is a common complication following central nervous system injuries. Left untreated, spasticity can lead to various complications, hindering activities of daily living and diminishing independence. Spasticity affecting the hand is particularly debilitating because it prevents prehension and grasp, which are critical factors for the ability to perform activities of daily living independently. Spasticity is described as one of the prominent secondary conditions in individuals with various disabilities. While Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes. Center for Advanced Reconstruction of Extremities(C.A.R.E), at the hand surgery department at Sahlgrenska University hospital in Gothenburg, Sweden is a multiprofessional team and advocates a stratified surgical algorithm based on residual motor function, aiming to optimize patient outcomes. This open-label, non-randomized, paired study aims to compare the efficacy of spasticity-correcting upper limb surgery with BoNT injections in improving body function, activity, and participation in patients with upper limb spasticity. A total of 30 patients will undergo both interventions sequentially, allowing for within-patient comparisons. The sample size calculation is based on prior studies. All patients with ongoing BoNT treatment who get referral to C.A.R.E and seem eligible for the study will be informed about the study and enrolment procedure. Eligible participants will undergo both treatments sequentially, with outcome assessments conducted before and after each intervention. The treatments will follow routine clinical care. The primary outcome measure, Modified Ashworth Scale, will assess spasticity severity. Secondary outcomes will include measures of functional and activity changes specific to each treatment regimen. This study aims to provide valuable insights into the comparative effectiveness of spasticity interventions, guiding treatment decisions for patients with upper limb spasticity.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • years or above
  • 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
  • Patients treated at least 6 months after the injury event
  • Ongoing BoNT treatment in the UL
  • A minimum of 3 months passed since the last BoNT injection
  • At least two muscles in the hand and wrist were considered for treatment
  • For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment
  • For the surgery group, medically stable to undergo surgery
  • No other severe UL injuries affecting the functional level

Exclusion Criteria1

  • \-

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Interventions

PROCEDURETendon lengthening surgery

The participants will first receive BoNT injections, earliest three months after they will undergo tendon lengthening surgery

DRUGBoNT Injections

The dosage and number of injected muscles will vary depending on the degree and extent of spasticity. All patients had previous BoNT injections, one injection circle will be followed in this study.


Locations(1)

Sahlgrenska University Hoispital

Mölndal, Sweden

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NCT06733025


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