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

NCT06733025 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Muscle Spasticity
  • Spinal Cord Injury
  • Stroke
  • Traumatic Brain Injuries

Interventions

PROCEDURE

Tendon lengthening surgery

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

DRUG

BoNT 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.

Sponsors & Collaborators

  • Promobilia Foundation

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2029-01-29
Completion
2029-06-29

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06733025 on ClinicalTrials.gov