Chronic PainNCT06340035
Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power
A study testing TENS and Percutaneous Peripheral Nerve Stimulation in people with Chronic Pain and Chronic Knee Pain, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Chronic Knee Pain
- What is being tested?
- TENS and Percutaneous Peripheral Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult athletes above the legal age threshold
- Amateur athletes
- Experiencing chronic knee pain
- Possessing a prior diagnosis related to their knee condition
- Competent in the execution of the hip thrust exercise
Who cannot join
- Underage or elderly
- Significant co-existing medical conditions and/or comorbidities
- Professional athletes
- Sedentary lifestyle
- Lack of familiarity with the hip thrust exercise
- Needle phobia or rejection to peripheral stimulation techniques
- Considerable contraindications such as a history of knee surgery, current pregnancy, or issues related to blood clotting.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read more
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.
Read the 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 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.
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 23.0 software (SPSS Inc., IBM Chicago, IL, USA) and/or GraphPad Software (San Diego, CA, USA). For the interpretation of results, a 95% confidence interval and an alpha level of 0.05 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.
- Conditions
- Chronic Pain, Chronic Knee Pain
- Being tested
- TENS, Percutaneous Peripheral Nerve Stimulation
- Keywords
- Peripheral Nerve Stimulation, TENS, Strength, Pain, Knee Pain, Rehabilitation, Neuromodulation
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSOther
The TENS group is subjected to transcutaneous current. Two surface electrodes are inserted at the level of the superior gluteal and inferior gluteal nerve tract. A protocol of 10 stimulations x 10 seconds of stimulations x 10 times is performed with a 10 second rest between each repetition. A maximum contraction evoked without pain is sought.
Percutaneous Peripheral Nerve StimulationOther
In the pPNS group, the superior gluteal nerve and inferior gluteal nerve are stimulated percutaneously. The nerves are localized at an ultrasound-guided level and with respect to the vascular-nervous package two acupuncture needles are inserted, one for each nerve. The stimulation is the same as the TENS group: 10 stimulations x 10 times x 10 seconds, evoking the maximum contraction without pain.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Peripheral Nerve Stimulation | Experimental | Nerves are localized at an ultrasound-guided level and with respect to the vascular-nervous package two acupuncture needles are inserted, one for each nerve. The stimulation is the same as the TENS group: 10 stimulations x 10 times x 10 seconds, evoking the maximum contraction without pain. Receives: Other: Percutaneous Peripheral Nerve Stimulation |
| Transcutaneous electrical nerve stimulation | Active comparator | Two surface electrodes are inserted at the level of the superior gluteal and inferior gluteal nerve tract. A protocol of 10 stimulations x 10 seconds of stimulations x 10 times is performed with a 10 second rest between each repetition. A maximum contraction evoked without pain is sought. Receives: Other: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Extension Concentric Peak Power (Watts)
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.
Measured: Through study completion, 1 day
Hip Extension Concentric Peak Strength (Newtons)
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.
Measured: Through study completion, 1 day
Secondary outcomes (2)
Concentric Phase Velocity (m/s)
The velocity of movement execution, quantified in meters per second (m/s), is a parameter for evaluating athletic performance during strength exercises. It measures the speed at which an individual can complete the concentric phase of a lift, such as a barbell hip thrust. This velocity is indicative of the athlete's power and explosiveness.
Measured: Through study completion, 1 day
Maximum Strength (1RM in kgs)
The one-repetition maximum (1RM) indirectly measured through the load-velocity profile incorporates three distinct points along the curve to estimate the maximum weight a participant can lift for a single repetition with maximal effort. This methodological approach leverages the relationship between the velocity of a lift and the load being moved, underpinning the premise that the speed at which a participant can perform an exercise decreases as the weight increases. By recording the velocity of the barbell at three different loads during the concentric phase of an exercise, such as the barbell hip thrust, and plotting these velocities against the respective weights, a linear or curvilinear relationship is established. This relationship is then extrapolated to determine the load corresponding to the theoretical velocity at which 1RM would occur.
Measured: Through study completion, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Sep 2023
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study utilizes a randomized parallel-group design, focusing on procedure feasibility for future clinical trials, in line with extended CONSORT guidelines for pilot studies. Participants, selected through a convenience sampling method due to their chronic knee pain, received pre- and post-treatment evaluations to assess the effect on gluteal muscle function. Post-informed consent, participants were allocated to either TENS or ultrasound-guided percutaneous nerve stimulation via a computer-generated randomization process executed with GraphPad Software (San Diego, CA, USA), ensuring a balanced 1:1 ratio.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Picañol Parraga, Hospital Clinic of Barcelona
- Investigators
- Javier Picañol Párraga, PhD(c), Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340035
- Sponsor's protocol ID
- 20230901
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In line with the commitment to share Individual Participant Data (IPD), the plan encompasses disseminating all collected IPD that underlie the results reported in a forthcoming scientific publication. This effort is designed to promote transparency and facilitate further research by providing comprehensive access to detailed datasets. To ensure adherence to ethical standards and protect participant privacy, all shared data will undergo an anonymization process.
Publications
Gallego-Sendarrubias GM, Arias-Buria JL, Ubeda-D'Ocasar E, Hervas-Perez JP, Rubio-Palomino MA, Fernandez-de-Las-Penas C, Valera-Calero JA. Effects of Percutaneous Electrical Nerve Stimulation on Countermovement Jump and Squat Performance Speed in Male Soccer Players: A Pilot Randomized Clinical Trial. J Clin Med. 2021 Feb 10;10(4):690. doi: 10.3390/jcm10040690.
PubMed 33578911Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.
PubMed 35191131de-la-Cruz-Torres B, Barrera-Garcia-Martin I, Romero-Morales C. Comparative Effects of One-Shot Electrical Stimulation on Performance of the Flexor Hallucis Longus Muscle in Professional Dancers: Percutaneous Versus Transcutaneous? Neuromodulation. 2020 Aug;23(6):865-870. doi: 10.1111/ner.13040. Epub 2019 Aug 25.
PubMed 31448488Requena Sanchez B, Padial Puche P, Gonzalez-Badillo JJ. Percutaneous electrical stimulation in strength training: an update. J Strength Cond Res. 2005 May;19(2):438-48. doi: 10.1519/13173.1.
PubMed 15903388Zhou S, Huang LP, Liu J, Yu JH, Tian Q, Cao LJ. Bilateral effects of 6 weeks' unilateral acupuncture and electroacupuncture on ankle dorsiflexors muscle strength: a pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):50-5. doi: 10.1016/j.apmr.2011.08.010. Epub 2011 Nov 8.
PubMed 22075372
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06340035
- Acronym / sponsor ID
- 20230901
- Conditions
- Chronic Pain, Chronic Knee Pain
- Keywords
- Peripheral Nerve Stimulation, TENS, Strength, Pain, Knee Pain, Rehabilitation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
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 23.0 software (SPSS Inc., IBM Chicago, IL, USA) and/or GraphPad Software (San Diego, CA, USA). For the interpretation of results, a 95% confidence interval and an alpha level of 0.05 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This pilot study utilizes a randomized parallel-group design, focusing on procedure feasibility for future clinical trials, in line with extended CONSORT guidelines for pilot studies. Participants, selected through a convenience sampling method due to their chronic knee pain, received pre- and post-treatment evaluations to assess the effect on gluteal muscle function. Post-informed consent, participants were allocated to either TENS or ultrasound-guided percutaneous nerve stimulation via a computer-generated randomization process executed with GraphPad Software (San Diego, CA, USA), ensuring a balanced 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Peripheral Nerve Stimulation | Experimental | Other: Percutaneous Peripheral Nerve StimulationNerves are localized at an ultrasound-guided level and with respect to the vascular-nervous package two acupuncture needles are inserted, one for each nerve. The stimulation is the same as the TENS group: 10 stimulations x 10 times x 10 seconds, evoking the maximum contraction without pain. |
| Transcutaneous electrical nerve stimulation | Active comparator | Other: TENSTwo surface electrodes are inserted at the level of the superior gluteal and inferior gluteal nerve tract. A protocol of 10 stimulations x 10 seconds of stimulations x 10 times is performed with a 10 second rest between each repetition. A maximum contraction evoked without pain is sought. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult athletes above the legal age threshold
- Amateur athletes
- Experiencing chronic knee pain
- Possessing a prior diagnosis related to their knee condition
- Competent in the execution of the hip thrust exercise
Key exclusion criteria (7 listed)
- Underage or elderly
- Significant co-existing medical conditions and/or comorbidities
- Professional athletes
- Sedentary lifestyle
- Lack of familiarity with the hip thrust exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSThe TENS group is subjected to transcutaneous current. Two surface electrodes are inserted at the level of the superior gluteal and inferior gluteal nerve tract. A protocol of 10 stimulations x 10 seconds of stimulations x 10 times is performed with a 10 second rest between each repetition. A maximum contraction evoked without pain is sought. | Other | Transcutaneous electrical nerve stimulation |
| Percutaneous Peripheral Nerve StimulationIn the pPNS group, the superior gluteal nerve and inferior gluteal nerve are stimulated percutaneously. The nerves are localized at an ultrasound-guided level and with respect to the vascular-nervous package two acupuncture needles are inserted, one for each nerve. The stimulation is the same as the TENS group: 10 stimulations x 10 times x 10 seconds, evoking the maximum contraction without pain. | Other | Percutaneous Peripheral Nerve Stimulation |
Primary outcome
Hip Extension Concentric Peak Power (Watts)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Concentric Phase Velocity (m/s)
Time frame: Through study completion, 1 day
Maximum Strength (1RM in kgs)
Time frame: Through study completion, 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 33578911Gallego-Sendarrubias GM, Arias-Buria JL, Ubeda-D'Ocasar E, Hervas-Perez JP, Rubio-Palomino MA, Fernandez-de-Las-Penas C, Valera-Calero JA. Effects of Percutaneous Electrical Nerve Stimulation on Countermovement Jump and Squat Performance Speed in Male Soccer Players: A Pilot Randomized Clinical Trial. J Clin Med. 2021 Feb 10;10(4):690. doi: 10.3390/jcm10040690.
- Background: PubMed 35191131Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.
- Background: PubMed 31448488de-la-Cruz-Torres B, Barrera-Garcia-Martin I, Romero-Morales C. Comparative Effects of One-Shot Electrical Stimulation on Performance of the Flexor Hallucis Longus Muscle in Professional Dancers: Percutaneous Versus Transcutaneous? Neuromodulation. 2020 Aug;23(6):865-870. doi: 10.1111/ner.13040. Epub 2019 Aug 25.
- Background: PubMed 15903388Requena Sanchez B, Padial Puche P, Gonzalez-Badillo JJ. Percutaneous electrical stimulation in strength training: an update. J Strength Cond Res. 2005 May;19(2):438-48. doi: 10.1519/13173.1.
- Background: PubMed 22075372Zhou S, Huang LP, Liu J, Yu JH, Tian Q, Cao LJ. Bilateral effects of 6 weeks' unilateral acupuncture and electroacupuncture on ankle dorsiflexors muscle strength: a pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):50-5. doi: 10.1016/j.apmr.2011.08.010. Epub 2011 Nov 8.
- Individual participant dataSharing planned: Yes. In line with the commitment to share Individual Participant Data (IPD), the plan encompasses disseminating all collected IPD that underlie the results reported in a forthcoming scientific publication. This effort is designed to promote transparency and facilitate further research by providing comprehensive access to detailed datasets. To ensure adherence to ethical standards and protect participant privacy, all shared data will undergo an anonymization process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Picañol Párraga, PhD(c) principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and Percutaneous Peripheral Nerve Stimulation in people with Chronic Pain and Chronic Knee Pain, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip Extension Concentric Peak Power (Watts) (time frame: Through study completion, 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.