Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type a As a Treatment for Lower Limb Post-stroke Spasticity (STROKEPOC)

Universiteit Antwerpen

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Stroke

Treatments: Other: Dry Needling; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT06296082

49317

Details and patient eligibility

About

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.

Full description

The primary hypothesis is that the effects of DN on post-stroke spasticity in the lower limbs at the spinal level is comparable to BTX-A in reducing spasticity by decreasing stretch reflex excitability.

Sample size: Spain, Canada and Belgium will recruit 90 participants (30 per country)

The platform used for randomization and electronic data collection will be Research Electronic Data Capture (REDcap): https://www.project-redcap.org/. A shared license will be used among the countries involved in the study.

Data dictionary:

• DN: Dry Needling
• BTX-A: Botulinum toxin type A
• TSRT: Tonic Stretch Reflex Threshold
• MAS: Modified Ashworth Scale
• 10MWT: 10 Metre Walk Test
• TUG: Timed Up & Go
• PPI: Public and Patient Involvement
• SOP: Standard Operating Procedure

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion ~30°.
7. independent ambulation with or without aids.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Botulinum Toxin type A

Active Comparator group

Description:

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.

Treatment:

Drug: Botulinum toxin type A

Dry Needling

Active Comparator group

Description:

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.

Treatment:

Other: Dry Needling