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

NCT06529783 | Recruiting DMC

• 1 other identifier: NMP-e.STM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Greater Trochanteric Pain Syndrome

Keywords

Neromodulation; Percutaneous; ultrasound; superior gluteal nerve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain on the Day Prior to the Visit

  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

  day 1, week 4, week 8, week 16, and year 1

• Hip Abductor Muscle Strength

  day 1, week 4, week 8, week 16, and year 1

• Adverse Effects

  day 1, week 4, week 8, week 16, and year 1

• Adherence to the Therapeutic Exercise Protocol

  day 1, week 4, week 8, week 16, and year 1

Study Arms (2)

Shockwave Therapy + Therapeutic Exercises

ACTIVE COMPARATOR

Patients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises

Other: Shockwave Therapy; Other: Therapeutic Exercises

Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation

EXPERIMENTAL

Patients on this group receive both interventions previously described and ultrasound-guided percuteneous neuromodulation is added.

Other: Shockwave Therapy; Other: Therapeutic Exercises; Other: Ultrasound-Guided Percutaneous Neuromodulation:

Interventions

Shockwave Therapy OTHER

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.

Shockwave Therapy + Therapeutic Exercises; Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation

Therapeutic Exercises OTHER

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.

Shockwave Therapy + Therapeutic Exercises; Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation

Ultrasound-Guided Percutaneous Neuromodulation: OTHER

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.

Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Exercise Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Pablo Herrero, Physiotherapist

  Universidad de Zaragoza

  STUDY DIRECTOR

Central Study Contacts

Alberto Carcasona, Physiotherapist

CONTACT

666387648; acarcasona@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: May 26, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once research has been published
• Access Criteria: Study protocol will be publish in a scientific journal

Locations

ES (1)