跳至主要内容
临床试验/NCT06340035
NCT06340035进行中(未招募)不适用

Ultrasound Guided Peripheral Nerve Stimulation of Gluteal Nerves to Enhance Strength and Power in Individuals With Chronic Knee Pain: A Randomized Controlled Pilot Study

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
12
试验地点
2
主要终点
Hip Extension Concentric Peak Power (Watts)

研究概览

简要总结

The goal of this pilot clinical trial is to evaluate whether the ultrasound-guided percutaneous peripheral nerve stimulation through a needle results in greater gains in strength and power compared to the administration of current through surface electrodes in patients undergoing strength and power assessments. The main questions it aims to answer are:

Does percutaneous stimulation of the superior and inferior gluteal nerves using ultrasound-guided needles enhance strength and power more effectively than transcutaneous stimulation through electrodes?

Is the effectiveness of current delivery significantly different between percutaneous and transcutaneous methods when assessed with a linear encoder in a standarized hip extension exercise?

Participants will:

Be randomized into two groups: one undergoing ultrasound-guided percutaneous stimulation of the gluteal nerves (experimental group) and the other undergoing transcutaneous stimulation through electrodes (control group).

The same stimulation protocol at 10 Hz frequency with the maximum muscle contraction evoked without pain will be performed in both groups. Then, the participants will undergo strength and power assessment before and after therapy administration using a linear encoder in a hip extension exercise.

Researchers will compare the experimental group to the control group to see if the method of current delivery (percutaneous vs. transcutaneous) has a significant impact on the gains in strength and power. This comparison is based on the hypothesis that percutaneous delivery of current, guided by ultrasound, is more effective than simply positioning a surface electrode for transcutaneous stimulation. The evaluation of strength and power will be performed through a linear encoder that measures peak strength and concentric power in each repetition, conducted by a blind operator unaware of the patients' group allocations.

详细描述

This study delves into the comparative efficacy of two modalities of nerve stimulation for enhancing muscular strength and power: the percutaneous application of electrical current via acupuncture needles versus traditional transcutaneous electrical nerve stimulation (TENS). The overarching objective is to discern whether percutaneous peripheral nerve stimulation (pPNS), guided by ultrasound, facilitates superior gains in muscle strength and power in the gluteal muscles compared to conventional TENS.

Participants, suffering from chronic knee pain, were systematically randomized into two cohorts: the experimental group underwent ultrasound-guided pPNS targeting the superior and inferior gluteal nerves, whereas the control group received TENS. The experimental setup was meticulously designed to ensure the sole variable of distinction between groups was the method of electrical stimulation applied. pPNS was delivered using a biphasic asymmetric electric current, set to a frequency of 10 Hz, a pulse width of 240 microseconds, and an intensity tailored to achieve maximal muscle contraction without inducing pain, based on a protocol of ten 10-second stimulations interspersed with 10-second rest periods. This regimen was predicated on prior findings demonstrating its efficacy in augmenting isometric strength following femoral nerve stimulation. The control group was subjected to a parallel protocol, differing only in the application technique, wherein electrodes replaced needles, adhering to the same stimulation parameters.

The therapeutic efficacy of both interventions was assessed through a rigorous evaluation of strength and power before and after the administration of therapy. This assessment employed a linear encoder to measure peak strength and concentric power during the Hip Thrust exercise, a method chosen for its reliability in quantifying these parameters. The procedure entailed performing the exercise under three different loads (30%, 50%, and 70% of the participant's maximum capacity, 1RM), with the evaluation aimed at capturing the concentric peak power in each repetition until a noticeable decline in performance was observed.

The hypothesis posits that pPNS, by virtue of its targeted and invasive nature, will yield greater improvements in muscle strength and power than TENS, attributed to its more direct stimulation of the nerve fibers and the encompassing muscle groups. The underpinning rationale is that pPNS's ultrasound-guided approach allows for a more precise delivery of electrical current to the nerves, potentially overcoming limitations associated with the superficial and diffuse application of TENS.

For the analysis of the collected data, an initial evaluation of distribution characteristics will be performed utilizing visual tools such as Q-Q plots and density plots, complemented by statistical measures of kurtosis and skewness to understand the data's underlying structure. The Shapiro-Wilk test will be applied to assess the normality of residuals, ensuring the validity of subsequent statistical tests. Descriptive statistics, including the mean, median, mode, and standard deviation of the collected quantitative measures, will be thoroughly examined to summarize the data effectively. Additionally, the homogeneity of these variables across the dataset will be scrutinized.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

In the study, blinding will be implemented to minimize bias. The evaluating clinician will be blinded to participant group assignments, ensuring assessments are unbiased. Similarly, the data analyst will also be blinded, analyzing data without knowledge of group allocations to maintain impartiality. Data will be handled objectively, with statistical methods applied blindly to compare treatment groups. Despite challenges in completely blinding participants due to the distinct nature of interventions, every effort will be made to minimize potential bias.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hip Extension Concentric Peak Power (Watts)

时间窗: Through study completion, 1 day

This parameter quantifies the maximum power output a participant can generate during the concentric phase of a barbell hip thrust, performed at maximal velocity. The measurement is facilitated by a validated linear encoder system, ChronoJump, which captures motion data at a high sampling rate of 1000 Hz. This system translates the vertical displacement of the barbell and the execution time of the concentric phase into real-time power output. By integrating the bar's velocity with the mass being lifted.

Hip Extension Concentric Peak Strength (Newtons)

时间窗: Through study completion, 1 day

Real-time generated force, measured in newtons (N), is a pivotal outcome for assessing the impact of the interventions on the muscular strength during a hip extension exercise, specifically the barbell hip thrust performed at maximal velocity. This metric is derived using the ChronoJump linear encoder system, which accurately captures the motion and force exerted by the participant in real-time.

次要结局

  • Maximum Strength (1RM in kgs)(Through study completion, 1 day)
  • Concentric Phase Velocity (m/s)(Through study completion, 1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xavier Picañol Parraga

Principal Investigator

Hospital Clinic of Barcelona

研究点 (2)

Loading locations...

相似试验