Comparative Study of Two Ultrasound-guided Percutaneous Neuromodulation Protocols on Maximal Handgrip Strength: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Maximum Handgrip Strength
研究概览
简要总结
Purpose of the Study:
This study aims to compare the effects of two different ultrasound-guided percutaneous neuromodulation (PNM) protocols targeting the median nerve on maximal handgrip strength in healthy individuals. The study seeks to enhance scientific understanding of the clinical applications of PNM in improving neuromuscular performance and functional capacity.
Benefits of the Study:
Contribute to the evidence base supporting the use of PNM in physiotherapy and rehabilitation.
Inform future therapeutic protocols aiming to optimize muscle strength and functional recovery.
Provide participants with access to a professional evaluation of physical performance and exposure to advanced rehabilitative techniques in a safe and monitored environment.
Interventions:
Participants will undergo a single session of ultrasound-guided PNM to the median nerve using one of two protocols:
Protocol 1 (100 Hz): 5 cycles of 5 seconds stimulation (350 µs pulse width), followed by 55 seconds rest.
Protocol 2 (10 Hz): 10 cycles of 10 seconds stimulation (250 µs pulse width), followed by 10 seconds rest.
In both protocols, stimulation intensity will be set to the maximum tolerable level that elicits a strong but non-painful muscular contraction. Total treatment duration will be approximately 10 minutes.
Measurements:
Primary Outcome: Maximal handgrip strength measured using a digital dynamometer before and after the intervention.
Secondary Outcomes: Perceived pain during the intervention, assessed with the Numerical Pain Rating Scale (0-10). Sociodemographic data (age, sex, weight, height, BMI).
Conclusion:
This clinical trial will provide valuable insights into the comparative effectiveness of two PNM protocols for improving muscular performance. By identifying the most effective parameters for PNM application, this research may help optimize rehabilitation strategies and contribute to enhancing patients' functional outcomes in clinical and athletic settings.
详细描述
Study Design:
This is a randomized, controlled, double-blinded clinical trial. Both the evaluator and the participants will be blinded to group allocation. A total of 86 volunteers (aged 18-40 years) will be randomly assigned to one of two intervention groups.
Eligibility Criteria:
Inclusion:
Healthy adults aged 18-40 years No musculoskeletal, neurological, or upper limb conditions Informed consent provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be unaware of the specific stimulation frequency applied. Since both protocols involve similar sensations and durations, distinguishing between them is unlikely. Evaluations will be performed by a separate physiotherapist who is not informed of the group assignments.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 18-40 years
- •No musculoskeletal, neurological, or upper limb conditions
- •Informed consent provided
排除标准
- •Recent physical activity (within 48 hours)
- •Electrotherapy contraindications (e.g., pregnancy, epilepsy, needle phobia)
- •Pain or functional limitations at the time of assessment
结局指标
主要结局
Maximum Handgrip Strength
时间窗: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.
This variable will be measured using a digital dynamometer
Maximum Handgrip Strength
时间窗: This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention.
This variable will be measured using a digital dynamometer
次要结局
- Pain during the intervention(This variable will be measured 2 times: immediately pre-intervention and immediately post-intervention)
研究者
Dr. Pablo Herrero Gallego
Principal Investigator
Universidad de Zaragoza