Ultrasound-Guided Percutaneous Neuromodulation on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome: A Pilot Study

Effectiveness of Ultrasound-Guided Percutaneous Neuromodulation (UG-PNM) on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome (GTPS): A Pilot Study

Greater Trochanteric Pain Syndrome (GTPS) predominantly affects women, with an annual incidence of 1.8 to 5.6 per 1000 individuals and a prevalence ratio of 4:1 compared to men. It is characterized by lateral pain in the greater trochanter region, particularly during palpation, prolonged sitting, and physical activity. Conservative treatments, such as radial shockwave therapy and therapeutic exercises, are effective but slow, and some patients eventually require surgery.

Ultrasound-guided percutaneous neuromodulation, targeting the superior gluteal nerve, has emerged as a promising alternative to improve GTPS outcomes. This technique aims to normalize motor response and reduce pain more rapidly than conventional therapies. Integrating neuromodulation could accelerate recovery, enhancing both pain relief and tendon functionality. This study aims to explore the effectiveness of this technique as an adjunct to conventional treatments, aiming for faster symptom improvement and better long-term adherence.

Study Overview

• Status: Recruiting
• Conditions: Greater Trochanteric Pain Syndrome
• Intervention / Treatment: Other: Shockwave Therapy; Other: Therapeutic Exercises; Other: Ultrasound-Guided Percutaneous Neuromodulation:

Detailed Description

Greater Trochanteric Pain Syndrome (GTPS) is a condition primarily affecting women, with an annual incidence ranging from 1.8 to 5.6 per 1000 individuals and a prevalence ratio of 4:1 compared to men. Formerly known as trochanteric bursitis, this syndrome is characterized by lateral pain in the region of the greater trochanter, particularly manifesting during palpation, prolonged sitting, and physical activity. The primary cause of GTPS is attributed to repetitive friction between the greater trochanter and the iliotibial band, resulting in gluteus medius or minimus tendinopathy, as well as other associated conditions such as trochanteric bursitis and iliotibial band syndrome.

Conservative treatment is the first-line approach for GTPS, with radial shockwave therapy and therapeutic exercises demonstrating long-term efficacy. However, a percentage of patients require surgical intervention due to a lack of response to conservative treatments.

Ultrasound-guided percutaneous neuromodulation, a technique utilizing electrical stimulation via a needle guided by ultrasound, has emerged as a potential alternative to improve therapeutic outcomes for GTPS. In this study, this technique targets the superior gluteal nerve, which innervates the gluteus medius, minimus, and tensor fasciae latae, with the aim of normalizing motor response and reducing pain. Neuromodulation could provide a faster improvement in symptoms and motor patterns compared to conventional therapies, which require prolonged periods to be effective.

Given that current treatments for GTPS, such as shockwave therapy and therapeutic exercises, are effective but slow in progress, the integration of percutaneous neuromodulation could accelerate patient recovery, improving both pain relief and mechanical functionality of the tendon. This combined approach has the potential not only to optimize clinical outcomes but also to reduce the need for surgical interventions in GTPS patients.

In summary, this study proposes to explore the effectiveness of superior gluteal nerve neuromodulation as an adjunct to conventional treatments for GTPS. The research aims to demonstrate whether this technique can significantly expedite pain reduction and motor pattern improvement, thereby enhancing long-term treatment adherence and tolerance.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Carcasona, Physiotherapist; Phone Number: 666387648; Email: acarcasona@unizar.es

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Recruiting
    • University of Zaragoza
    • Principal Investigator: Pablo Herrero, Physiotherapist
    • Contact: University of Zaragoza; Phone Number: +34976761749; Email: sfcs@unizar.es
    • Sub-Investigator: Alberto Carcasona, Physiotherapist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Suffering from Greater Trochanteric Pain Syndrome (GTPS).
• Experiencing local pain upon palpation of the greater trochanter area.
• Having pain in the greater trochanter region lasting more than three months, indicating chronicity.
• Being over 18 years of age.
• Experiencing pain when bearing weight on the affected trochanter.
• Having pain that impairs the functionality of resisted hip abduction.

Exclusion Criteria:

• Radiological evidence of pathology in the hip or knee joints.
• Blood coagulation disorders.
• Use of oral anticoagulants.
• Presence of infections.
• History of disc or hip surgery.
• Presence of dysplasia, deformities, or sciatica.
• History of vascular, neurological, or neoplastic diseases.
• Specific contraindications for ultrasound-guided percutaneous neuromodulation (UG-PNM): belenophobia, pregnancy, pacemakers, epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Shockwave Therapy + Therapeutic Exercises; Patients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises	Other: Shockwave Therapy; The proposed model for radial shockwave therapy at Clínica Osteopática Dr. David Ponce is the DolorClast® by EMS, made in Nyon, Switzerland. Treatment parameters include 2500 impulses, 0.2 mJ/mm² energy density, and 15 pulses per second, using a 15 mm diameter applicator with ultrasound gel applied to the treatment area. The patient will be positioned laterally on the table with specific leg positions to ensure comfort and effectiveness.; Other: Therapeutic Exercises; The exercise protocol was followed daily, with continuous physiotherapist supervision to ensure correct execution and avoid improper postures. The protocol includes four exercises: bilateral low-load supine abduction, unilateral isometric hip abduction in medial rotation, hip abduction with sliding, and bilateral supported glute bridge. A maximum of 4/10 on the VAS pain scale is allowed during exercise; exceeding this threshold means skipping exercises for that day.
Experimental: Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation; Patients on this group receive both interventions previously described and ultrasound-guided percuteneous neuromodulation is added.	Other: Shockwave Therapy; The proposed model for radial shockwave therapy at Clínica Osteopática Dr. David Ponce is the DolorClast® by EMS, made in Nyon, Switzerland. Treatment parameters include 2500 impulses, 0.2 mJ/mm² energy density, and 15 pulses per second, using a 15 mm diameter applicator with ultrasound gel applied to the treatment area. The patient will be positioned laterally on the table with specific leg positions to ensure comfort and effectiveness.; Other: Therapeutic Exercises; The exercise protocol was followed daily, with continuous physiotherapist supervision to ensure correct execution and avoid improper postures. The protocol includes four exercises: bilateral low-load supine abduction, unilateral isometric hip abduction in medial rotation, hip abduction with sliding, and bilateral supported glute bridge. A maximum of 4/10 on the VAS pain scale is allowed during exercise; exceeding this threshold means skipping exercises for that day.; Other: Ultrasound-Guided Percutaneous Neuromodulation: This technique was applied only to the experimental group before shockwave therapy. An ultrasound-guided approach to the superior gluteal nerve used a 7-12 MHz linear probe from Esaote MyLab™Alpha and Physio Invasiva® equipment. The needle length varied with patient anatomy, with a typical safety reference from 0.30 x 60 to 0.35 x 70 mm. A biphasic current with 10 Hz frequency and 240 μs pulse width was used, with intensity adjusted for a visible but non-painful motor response, following the 10-10-10 protocol. To locate the superior gluteal nerve, a longitudinal scan of the lateral iliac crest identified the nerve between the gluteus minimus and medius. The procedure used a short-axis approach at 80º to target the nerve's perineurium, with the area disinfected with chlorhexidine before needle insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	Functionality will be assessed using the Visa-G questionnaire, which consists of 8 questions divided into three main aspects: pain, function, and activity. The first 7 questions score up to 10 points each, while question 8 has a maximum score of 30. An asymptomatic person would score a total of 100 points; thus, a lower score indicates greater disability severity.	This variable is measured five times, corresponding with the five participant visits (day 1, week 4, week 8, week 16, and year 1).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on the Day Prior to the Visit	Pain is measured using the Visual Analog Scale (VAS).	This variable is collected on five occasions, coinciding with the five participant visits (day 1, week 4, week 8, week 16, and year 1)
Pain on Palpation of the Greater Trochanter	Pain on palpation, performed by the physiotherapist, is also measured using the VAS	day 1, week 4, week 8, week 16, and year 1
Hip Abductor Muscle Strength	Strength is measured using an Active Force 2 dynamometer	day 1, week 4, week 8, week 16, and year 1
Adverse Effects	Adverse effects for this study include pain during the treatment session, pain after the session, inflammation and/or redness in the treated area, bruising in the treated region, dizziness, muscle fatigue, numbness, and drowsiness. These are assessed through the participant's oral reports.	day 1, week 4, week 8, week 16, and year 1
Adherence to the Therapeutic Exercise Protocol	Adherence is assessed by asking the patient in each session if they are following the protocol correctly, with an emphasis on honesty to ensure accurate recording of adherence.	day 1, week 4, week 8, week 16, and year 1

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Study Director: Pablo Herrero, Physiotherapist, Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; Percutaneous; Neromodulation; superior gluteal nerve
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mental Disorders; Pathologic Processes; Joint Diseases; Disease; Somatoform Disorders; Syndrome; Bursitis
• Other Study ID Numbers: NMP-e.STM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data will be shared on a reasonable request contacting with the main author once data has been published.

Anyway, Individual participant data (IPD) will be shared with other researchers in accordance with data sharing protocols and participant consent, ensuring confidentiality and ethical considerations are maintained.

• IPD Sharing Time Frame: Once research has been published
• IPD Sharing Access Criteria: Study protocol will be publish in a scientific journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No