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

1. september 2026 oppdatert av: Universidade Federal Fluminense
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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Brasil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brasil, 22290-140
        • Rekruttering
        • Instituto de Neurologia Deolindo Couto
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)

Participants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period:

First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique.

Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique
Legemiddel: AbobotulinumtoxinA - Ultrasound-Guided Technique
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
Legemiddel: AbobotulinumtoxinA - Conventional Technique
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in spasticity after BoNT-A injection techniques
Tidsramme: 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)
Baseline and 4 weeks after each injection session
Functional improvement assessed by Goal Attainment Scaling
Tidsramme: 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)
Baseline and 4 weeks after each intervention
Functional mobility assessed by the Timed Up and Go Test
Tidsramme: 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)
Baseline and 4 weeks after each intervention
Change in functional independence assessed by the Modified Barthel Index
Tidsramme: 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).
Baseline and 4 weeks after each intervention

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity after BoNT-A injection techniques
Tidsramme: 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)
Baseline and 4 weeks after each intervention
Quality of life after BoNT-A injection techniques
Tidsramme: 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)
Baseline and 4 weeks after each intervention
Adverse events related to BoNT-A injection techniques
Tidsramme: 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
Up to 16 weeks after each injection

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universidade Federal Fluminense

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

22. april 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

24. august 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 90758725.3.0000.5243

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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