Greater Trochanteric Pain SyndromeNCT06529783
Ultrasound-Guided Percutaneous Neuromodulation on the Superior Gluteal Nerve in Patients With Greater Trochanteric Pain Syndrome: A Pilot Study
A study testing Shockwave Therapy, Therapeutic Exercises and Ultrasound-Guided Percutaneous Neuromodulation: in people with Greater Trochanteric Pain Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Greater Trochanteric Pain Syndrome
- What is being tested?
- Shockwave Therapy, Therapeutic Exercises and Ultrasound-Guided Percutaneous Neuromodulation:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2025to 20 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Greater Trochanteric Pain Syndrome
- Being tested
- Shockwave Therapy, Therapeutic Exercises, Ultrasound-Guided Percutaneous Neuromodulation:
- Keywords
- Neromodulation, Percutaneous, ultrasound, superior gluteal nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave TherapyOther
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.
Therapeutic ExercisesOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Shockwave Therapy + Therapeutic Exercises | Active comparator | Patients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises Receives: 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. Receives: Other: Shockwave Therapy; Other: Therapeutic Exercises; Other: Ultrasound-Guided Percutaneous Neuromodulation: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Secondary outcomes (5)
Pain on the Day Prior to the Visit
Pain is measured using the Visual Analog Scale (VAS).
Measured: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Pain on Palpation of the Greater Trochanter
Pain on palpation, performed by the physiotherapist, is also measured using the VAS
Measured: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Hip Abductor Muscle Strength
Strength is measured using an Active Force 2 dynamometer
Measured: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
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.
Measured: The occurrence of adverse events was recorded after each weekly intervention during the 4-week intervention period
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.
Measured: day 1, week 4, week 8, week 16, and year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start26 May 2025
- Primary completion20 Jul 2026
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
- Investigators
- Pablo Herrero, Physiotherapist, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529783
- Sponsor's protocol ID
- NMP-e.STM
- Status last verified
- Sep 2026
- First submitted
- 26 Jul 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06529783
- Acronym / sponsor ID
- NMP-e.STM
- Conditions
- Greater Trochanteric Pain Syndrome
- Keywords
- Neromodulation, Percutaneous, ultrasound, superior gluteal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 26 May 2025 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shockwave Therapy + Therapeutic Exercises | Active comparator | Other: Shockwave Therapy, Other: Therapeutic ExercisesPatients on this group receive two interventions based on Shockwave Therapy and Therapeutic Exercises |
| Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation | Experimental | Other: Shockwave Therapy, Other: Therapeutic Exercises, Other: Ultrasound-Guided Percutaneous Neuromodulation:Patients on this group receive both interventions previously described and ultrasound-guided percuteneous neuromodulation is added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave TherapyThe 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 | Shockwave Therapy + Therapeutic Exercises, Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation |
| Therapeutic ExercisesThe 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 | Shockwave Therapy + Therapeutic Exercises, Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation |
| 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. | Other | Shockwave Therapy + Therapeutic Exercises + US-Guided percutaneous neuromodulation |
Primary outcome
Functional capacity
Time frame: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
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.
5 secondary outcomes
Pain on the Day Prior to the Visit
Time frame: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Pain on Palpation of the Greater Trochanter
Time frame: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Hip Abductor Muscle Strength
Time frame: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).
Adverse Effects
Time frame: The occurrence of adverse events was recorded after each weekly intervention during the 4-week intervention period
Adherence to the Therapeutic Exercise Protocol
Time frame: day 1, week 4, week 8, week 16, and year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Herrero, Physiotherapist study director
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Therapy, Therapeutic Exercises and Ultrasound-Guided Percutaneous Neuromodulation: in people with Greater Trochanteric Pain Syndrome, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: This variable is measured at two time points: baseline (before the first treatment session) and post-treatment (immediately after completion of the four-week intervention period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.