protocolSection identificationModule nctId: NCT06340035, orgStudyIdInfo id: 20230901, briefTitle: Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Pain, conditions: Chronic Knee Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: TENS, interventions name: Percutaneous Peripheral Nerve Stimulation, outcomesModule primaryOutcomes measure: Hip Extension Concentric Peak Power (Watts), primaryOutcomes measure: Hip Extension Concentric Peak Strength (Newtons), secondaryOutcomes measure: Concentric Phase Velocity (m/s), secondaryOutcomes measure: Maximum Strength (1RM in kgs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Barcelona, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False