Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Tonic Stretch Reflex Threshold (TSRT)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-75 years.
- •post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
- •first stroke.
- •0-12 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.
排除标准
- •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.
研究组 & 干预措施
Dry Needling
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.
干预措施: Dry Needling (Other)
Botulinum Toxin type A
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.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Tonic Stretch Reflex Threshold (TSRT)
时间窗: Week 1 to 15 and 19.
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.
次要结局
- Muscle thickness(Week 1 to 15 and 19.)
- Pennation angle(Week 1 to 15 and 19.)
- Concurrence matrices(Week 1 to 15 and 19.)
- Functional mobility(Week 1,2,9,15 and 19)
- Resistance to passive stretching(Week 1 to 15 and 19.)
- Gait analysis(Week 1,2,9,15 and 19)
- Muscle Strength(Week 1 to 15 and 19.)
- Quality of life analysis(Week 1, 15 and 19.)
- Cost-effectiveness(Week 19.)
- Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events(Week 3 to 14 and 19.)
研究者
Dr. Pablo Herrero Gallego
Prof. Dr.
Universiteit Antwerpen