Percutaneous Peripheral Nerve Stimulation of Gluteus Nerves to Improve Hip Strength and Power

NCT06340035 | Active Not Recruiting

• 1 other identifier: 20230901
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Chronic Knee Pain

Keywords

Peripheral Nerve Stimulation; TENS; Strength; Pain; Knee Pain; Rehabilitation; Neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, 1 day

Secondary Outcomes (2)

• Concentric Phase Velocity (m/s)

  Through study completion, 1 day

• Maximum Strength (1RM in kgs)

  Through study completion, 1 day

Study Arms (2)

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.

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.

Other: TENS

Interventions

TENS OTHER

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.

Transcutaneous electrical nerve stimulation

Percutaneous Peripheral Nerve Stimulation OTHER

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.

Percutaneous Peripheral Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

University of Barcelona

Barcelona, 08036, Spain

Location

Related Publications (5)

• 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.

  PMID: 33578911 BACKGROUND

• Beltra 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.

  PMID: 35191131 BACKGROUND

• de-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.

  PMID: 31448488 BACKGROUND

• Requena 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.

  PMID: 15903388 BACKGROUND

• Zhou 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.

  PMID: 22075372 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Javier Picañol Párraga, PhD(c)

  Hospital Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after the publication of the main results, allowing sufficient time for the primary research team to complete additional analyses.
• Access Criteria: Access to the anonymized datasets will be granted upon request to researchers who provide a methodologically proposal.

Locations

ES (1)