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

NCT06733025 | Recruiting

• 1 other identifier: Etik_Dnr 2024-05157-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Muscle spasticity; spinal cord injury; stroke; traumatic brain injuries; tendon lengthening; Botulinum toxin injection

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

Secondary Outcomes (14)

• Visual Analogue Scale

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

• Visual Analogue Scale

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

• Active Range Of Motion

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

• Passive Range Of Motion

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

• The opening ability of the hand

  Baseline BoNT, 5weeks, 3months. Baseline surgery, 6 months

Study Arms (2)

BoNT injection

EXPERIMENTAL

The participants will first receive BoNT injection for their upper limb spasticity. Earliest three months after the injection they will undergo surgery.

Drug: BoNT Injections

Surgery

EXPERIMENTAL

Procedure: Tendon lengthening surgery

Interventions

Tendon lengthening surgery PROCEDURE

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

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.

BoNT injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Promobilia Foundation: collaborator

Study Sites (1)

Sahlgrenska University Hoispital

Mölndal, 43180, Sweden

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma

Central Study Contacts

Therese Ramström, PhD

CONTACT

+46(0)761357416; therese.ramstrom@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): January 29, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: September 17, 2025

Record last verified: 2024-12

Locations

SE (1)