Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340035
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-17
Brief Title:
Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Ultrasound Guided Peripheral Nerve Stimulation of Gluteal Nerves to Enhance Strength and Power in Individuals With Chronic Knee Pain A Randomized Controlled Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 participants 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 pPNSs 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 datas 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
Regarding inferential statistics an exploratory approach will be adopted to estimate confidence intervals and discern trends in the data particularly focusing on pre- and post-treatment differences both within individual subjects and between the groups Due to the anticipation of non-normal data distribution and the structure of the study design pretest-posttest control group non-parametric statistical tests will be employed for the analysis Specifically the Mann-Whitney U test will facilitate between-group comparisons while the Wilcoxon test will be used for related measurements to detect changes within groups over time
Data analysis and visualization efforts will be supported by SPSS 230 software SPSS Inc IBM Chicago IL USA andor GraphPad Software San Diego CA USA For the interpretation of results a 95 confidence interval and an alpha level of 005 will be established as thresholds for statistical significance The creation of figures and graphical representations of the findings will be executed using Adobe Illustrator San José CA USA ensuring that the visual presentation of data is both clear and informative This comprehensive approach to data analysis and visualization aims to elucidate the potential differences in efficacy between percutaneous peripheral nerve stimulation and transcutaneous electrical nerve stimulation in enhancing muscle strength and power guiding future research and clinical applications in the field
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 participants 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 pPNSs 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 datas 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
Regarding inferential statistics an exploratory approach will be adopted to estimate confidence intervals and discern trends in the data particularly focusing on pre- and post-treatment differences both within individual subjects and between the groups Due to the anticipation of non-normal data distribution and the structure of the study design pretest-posttest control group non-parametric statistical tests will be employed for the analysis Specifically the Mann-Whitney U test will facilitate between-group comparisons while the Wilcoxon test will be used for related measurements to detect changes within groups over time
Data analysis and visualization efforts will be supported by SPSS 230 software SPSS Inc IBM Chicago IL USA andor GraphPad Software San Diego CA USA For the interpretation of results a 95 confidence interval and an alpha level of 005 will be established as thresholds for statistical significance The creation of figures and graphical representations of the findings will be executed using Adobe Illustrator San José CA USA ensuring that the visual presentation of data is both clear and informative This comprehensive approach to data analysis and visualization aims to elucidate the potential differences in efficacy between percutaneous peripheral nerve stimulation and transcutaneous electrical nerve stimulation in enhancing muscle strength and power guiding future research and clinical applications in the field
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None