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NCT Number: NCT07803276

Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia

Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Ultrasound guidance enhances injection precision, potentially improving clinical outcomes. This prospective, single-group, fixed-sequence crossover study ($N = 40$) aims to compare the response to BoNT-A in patients with spastic paraplegia (all etiologies included). Participants will receive treatment in two distinct phases separated by a 16-week washout period: first with conventional anatomical landmark-guided injections, followed by ultrasound-guided injections. A fixed sequence (anatomical first, ultrasound second) is used to prevent observer bias, ensuring the injector remains blinded to muscle ultrasound features (e.g., fatty infiltration or fibrosis) during the landmark-guided phase. Both the participants and the outcome assessor are blinded to the application sequence. Assessments will occur before and 4 weeks after each intervention using validated tools, including the Modified Ashworth Scale, Goal Attainment Scaling (GAS), Timed Up and Go (TUG), Visual Analog Scale (VAS) for pain, modified Barthel Index, SF-36 questionnaire, and the Heckmatt scale. The hypothesis is that ultrasound-guided injections will achieve greater spasticity reduction and functional recovery.

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Key information

Conditions

Spastic Paraplegia Nervous System Diseases Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Neurologia Deolindo Couto

Rio de Janeiro, 22290-140, Brazil

Location status: Recruiting

Location contact

Bruna de Oliveira

CONTACT

[email protected]

5521999200801

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Clinical diagnosis of spastic paraplegia
  • Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
  • Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
  • Enrollment in a rehabilitation program
  • For women of childbearing potential, a negative beta-hCG test at the time of injection

Exclusion criteria

  • Concomitant neuromuscular disorders
  • History of hypersensitivity to botulinum toxin
  • Active infection at the injection site
  • Ashworth Scale score of 4
  • Pregnancy or breastfeeding

Treatment and study plan

AbobotulinumtoxinA - Ultrasound-Guided Technique

Drug

Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization. Performed 16 weeks after the first intervention. Assessments are performed pre-injection and 4 weeks post-injection

AbobotulinumtoxinA - Conventional Technique

Drug

Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation. Assessments are performed at baseline and 4 weeks post-injection.

Primary outcomes

  1. Change in spasticity after BoNT-A injection techniques

    Time frame: Baseline and 4 weeks after each injection session

    Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia. The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)

  2. Functional improvement assessed by Goal Attainment Scaling

    Time frame: Baseline and 4 weeks after each intervention

    Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome)

  3. Functional mobility assessed by the Timed Up and Go Test

    Time frame: Baseline and 4 weeks after each intervention

    Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome)

  4. Change in functional independence assessed by the Modified Barthel Index

    Time frame: Baseline and 4 weeks after each intervention

    Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome).

Secondary outcomes

  1. Pain intensity after BoNT-A injection techniques

    Time frame: Baseline and 4 weeks after each intervention

    Change in pain intensity measured by the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcome)

  2. Quality of life after BoNT-A injection techniques

    Time frame: Baseline and 4 weeks after each intervention

    Change in quality of life assessed by the 36-Item Short Form Health Survey (SF-36).

    The SF-36 assesses eight health domains, with scores ranging from 0 to 100 for each domain. Higher scores indicate better health status (better outcome)

  3. Adverse events related to BoNT-A injection techniques

    Time frame: Up to 16 weeks after each injection

    Incidence and severity of adverse events associated with conventional landmark-guided and ultrasound-guided botulinum toxin type A injections

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna de Oliveira, MD

CONTACT

[email protected]

5521999200801

Sponsors and collaborators

Lead sponsor

Universidade Federal Fluminense

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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