Clinical trial NCT06529783: Ultrasound-Guided Percutaneous Neuromodulation on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome: A Pilot Study
Official title: Effectiveness of Ultrasound-Guided Percutaneous Neuromodulation (UG-PNM) on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome (GTPS): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Greater Trochanteric Pain Syndrome
Keywords: Neromodulation
Percutaneous
ultrasound
superior gluteal nerve
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional capacity
timeFrame: 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:
measure: Pain on the Day Prior to the Visit
timeFrame: This variable is collected on five occasions, coinciding with the five participant visits (day 1, week 4, week 8, week 16, and year 1)
measure: Pain on Palpation of the Greater Trochanter
timeFrame: day 1, week 4, week 8, week 16, and year 1
measure: Hip Abductor Muscle Strength
timeFrame: day 1, week 4, week 8, week 16, and year 1
measure: Adverse Effects
timeFrame: day 1, week 4, week 8, week 16, and year 1
measure: Adherence to the Therapeutic Exercise Protocol
timeFrame: day 1, week 4, week 8, week 16, and year 1
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: University of Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: Pablo Herrero, Physiotherapist
role: STUDY_DIRECTOR
References: