Ultrasound-Guided Percutaneous Neuromodulation on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome: A Pilot Study
- Conditions
- Greater Trochanteric Pain Syndrome
- Interventions
- Other: Shockwave TherapyOther: Therapeutic Exercises
- Registration Number
- NCT06529783
- Lead Sponsor
- Universidad de Zaragoza
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shockwave Therapy + Therapeutic Exercises Therapeutic Exercises Patients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation Shockwave Therapy Patients on this group receive both interventions previously described and ultrasound-guided percuteneous neuromodulation is added. Shockwave Therapy + Therapeutic Exercises Shockwave Therapy Patients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation Therapeutic Exercises Patients on this group receive both interventions previously described and ultrasound-guided percuteneous neuromodulation is added.
- Primary Outcome Measures
Name Time Method Functional capacity This variable is measured five times, corresponding with the five participant visits (day 1, week 4, week 8, week 16, and year 1). 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.
- Secondary Outcome Measures
Name Time Method Pain on Palpation of the Greater Trochanter day 1, week 4, week 8, week 16, and year 1 Pain on palpation, performed by the physiotherapist, is also measured using the VAS
Adverse Effects day 1, week 4, week 8, week 16, and year 1 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.
Adherence to the Therapeutic Exercise Protocol day 1, week 4, week 8, week 16, and year 1 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.
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 is measured using the Visual Analog Scale (VAS).
Hip Abductor Muscle Strength day 1, week 4, week 8, week 16, and year 1 Strength is measured using an Active Force 2 dynamometer
Trial Locations
- Locations (1)
University of Zaragoza
🇪🇸Zaragoza, Spain