Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

NCT06296082 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 49317
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 3

Brief Summary

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

Conditions

Stroke

Keywords

Stroke [Mesh]; Dry Needling; Muscle Spasticity [Mesh]; Botulinum Toxins [Mesh]; Tonic Stretch Reflex Threshold; Ultrasound imaging; Gait analysis; Quality of Life [Mesh]

Outcome Measures

Primary Outcomes (1)

• Tonic Stretch Reflex Threshold (TSRT)

  TSRT is a novel measures of stretch reflex excitability that provide an indirect indicator of the excitability of α-motoneurons at the level of the spinal cord.

  Week 1 to 15 and 19.

Secondary Outcomes (11)

• Muscle thickness

  Week 1 to 15 and 19.

• Pennation angle

  Week 1 to 15 and 19.

• Concurrence matrices

  Week 1 to 15 and 19.

• Resistance to passive stretching

  Week 1 to 15 and 19.

• Gait analysis

  Week 1,2,9,15 and 19

Study Arms (2)

Botulinum Toxin type A

ACTIVE COMPARATOR

The BTX-A group will receive onabotulinumtoxinA (Botox®, Allergan) with mandatory muscles getting 300 units and optional muscles getting up to 100 additional units (maximum dose of 400 units) (14) delivered with a 27-gauge (0.45 mm) beveled needle. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.

Drug: Botulinum toxin type A

Dry Needling

ACTIVE COMPARATOR

For Dry Needling group solid, filiform non-beveled 0.30 mm caliber needles will be used. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.

Other: Dry Needling

Interventions

Botulinum toxin type A DRUG

Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.

Botulinum Toxin type A

Dry Needling OTHER

Dry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.

Dry Needling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75 years.
• post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
• first stroke.
• months evolution.
• no previous BTX-A or DN treatment for spasticity.
• ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
• independent ambulation with or without aids.

You may not qualify if:

• medical conditions interfering with data interpretation.
• contraindications for BTX-A or DN treatment.
• changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
• pregnant or breastfeeding.

Sponsors & Collaborators

• Instituto de Salud Carlos III: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Research Foundation Flanders: collaborator
• Universiteit Antwerpen: lead
• Instituto de Investigación Sanitaria Aragón: collaborator
• McGill University: collaborator

Study Sites (3)

Universiteit Antwerpen

Antwerp, Flanders, 2000, Belgium

RECRUITING

Jewish Rehabilitation Hospital

Montreal, Quebec, H7V 1R2, Canada

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Links

• Web site of the project.

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins, Type A; Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Pablo Herrero Gallego, PhD

  Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Herrero Gallego, PhD

CONTACT

+34646168248; pherrero@unizar.es

Clara Pujol Fuentes, Msc

CONTACT

+34661075990; clara.pujol.fisioterapeuta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be conducted by blinded assessors for treatment allocation. Participants and staff cannot be blinded due to the nature of the intervention, but are instructed not to disclose their treatment allocation. Data will be anonymized and an independent researcher will enter coded data into secure databases. Data will be analyzed by a blinded statistician. Code breaks will only be allowed in crucial cases for patient management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: A prospective randomized, controlled, multiple-baseline, and assessor blinded multicenter equivalence trial with two parallel groups.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 6, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 29, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for 15 years.
• Access Criteria: In relation to other academic institutions and in the possession of a Good Clinical Practice Certificate

Locations

ES (1); BE (1); CA (1)