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

ConditionsMuscle Spasticity Spinal Cord Injury Stroke Traumatic Brain Injuries

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVastra Gotaland Region

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

18 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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

Tendon lengthening surgery
Procedure/Surgery
The participants will first receive BoNT injections, earliest three months after they will undergo tendon lengthening surgery
BoNT Injections
Drug
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: BoNT injectionExperimental treatment 1 intervention

Group B: SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Modified Ashworth Scale (MAS).

The single-item Modified Ashworth Scale is a six-point scale from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), with an additional point allocated at 1+ (slight increase in muscle tone). As such, the Modified Ashworth Scale provides a single score to represent spasticity in a specific movement. Higher scores mean a worse outcome.

Time frame