Trochanteric SyndromePhase 2HIPENCT07396246
Comparison Between Transarterial Musculoskeletal Embolization and Platelet-Rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome
A Phase 2 study testing Transarterial Musculoskeletal Embolization and Platelet-Rich Plasma Injection in people with Trochanteric Syndrome, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
Trial summary
Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly affect daily activities and quality of life. Standard treatments include physical therapy, anti-inflammatory medications, and local injections, but many patients continue to experience persistent symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trochanteric Syndrome
- What is being tested?
- Transarterial Musculoskeletal Embolization and Platelet-Rich Plasma Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 5 Jan 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of GTPS confirmed by clinical and imaging assessments
- Persistent symptoms despite at least 3 months of conservative treatment (e.g., physical therapy, NSAIDs)
- Willingness to participate and provide informed consent
- Availability for follow-up assessments at 1, 3, 6, and 12 months post-treatment
Who cannot join
- Prior hip surgery or other interventions (e.g., joint replacement, prior PRP injections or embolization)
- Severe osteoarthritis (Tonnis III)
- Active lumbar radiculopathy with pain, numbness, or weakness in a dermatomal distribution
- Contraindications for PRP injections (e.g., active infection, coagulopathy, antiplatelet or anticoagulation therapy,
- Pregnancy or breastfeeding
- Severe comorbidities that would interfere with participation
- Active cancer or other malignancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde do Alto Ave
Guimarães
Sofia Costa, +351253540330, centroacademico@ulsaave.min-saude.pt
About this study
Official title: The HIPE RCT - Comparison Between Transarterial Musculoskeletal Embolization (TAME) and Platelet-Rich Plasma (PRP) Injection for the Treatment of Greater Trochanteric Pain Syndrome - A Randomized Controlled Trial
Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly affect daily activities and quality of life. Standard treatments include physical therapy, anti-inflammatory medications, and local injections, but many patients continue to experience persistent symptoms.
This randomized controlled trial aims to compare two minimally invasive treatment options for GTPS: transarterial musculoskeletal embolization (TAME) and platelet-rich plasma (PRP) injection. Participants will be randomly assigned to receive either TAME or PRP.
Read more
The main goal of the study is to evaluate which treatment is more effective in reducing pain. Secondary goals include comparing functional improvement, quality of life, and safety between the two treatments. Pain and functional outcomes will be assessed at baseline and during follow-up at 1, 3, 6, and 12 months after treatment.
This study seeks to provide evidence on the effectiveness and safety of TAME compared with PRP injection for patients with Greater Trochanteric Pain Syndrome.
Read the detailed description
This is a prospective, single-center, parallel-group randomized controlled trial designed to compare the efficacy and safety of transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection in patients with Greater Trochanteric Pain Syndrome (GTPS).
Eligible adult patients with clinically and radiologically confirmed GTPS and persistent symptoms despite at least three months of conservative treatment will be enrolled. Participants will be randomized in a 1:1 ratio to receive either TAME or PRP injection.
TAME will be performed under local anesthesia by an experienced interventional radiologist, using selective catheterization and embolization of pathological vessels supplying the affected peri-trochanteric structures. A temporary, reabsorbable embolic agent (Nexsphere-F®, CE approved) will be used to achieve a transient embolization effect aimed at reducing pathological neovascularization and inflammation.
PRP treatment will consist of a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma into the affected gluteal tendon, performed by an orthopedic hip specialist under sterile conditions.
This is a single-blind study. A trained nurse from the radiology department, blinded to treatment allocation, will conduct all follow-up assessments and collect outcome data to minimize assessment bias.
The primary outcome measure is pain reduction assessed using the Visual Analog Scale (VAS) at baseline and at 1, 3, 6, and 12 months after treatment. Secondary outcome measures include functional improvement assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life evaluated with the EQ-5D-5L questionnaire, and the incidence of adverse events graded according to the CIRSE adverse event classification system.
A total of 30 participants (15 per group) will be included. Patients who do not achieve at least a 50% reduction in pain at 12 months will be eligible to cross over to the alternative treatment arm.
Statistical analysis will include descriptive statistics for baseline characteristics and outcomes. Group comparisons will be performed using independent t-tests or chi-square tests as appropriate. Longitudinal changes will be analyzed using repeated measures analysis of variance or mixed-effects models. Statistical significance will be set at p < 0.05.
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethics approval has been obtained from the Unidade Local de Saúde do Alto Ave ethics committee. Written informed consent will be obtained from all participants prior to enrollment.
- Conditions
- Trochanteric Syndrome
- Being tested
- Transarterial Musculoskeletal Embolization, Platelet-Rich Plasma Injection
- Keywords
- Embolization, Musculoskeletal, Hip, Greater Trochanter Pain Syndrome, Pain management, PRP
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial Musculoskeletal EmbolizationProcedure or surgery
Also called TAME
Transarterial musculoskeletal embolization (TAME) is performed under local anesthesia by an experienced interventional radiologist. The procedure consists of selective catheterization and embolization of pathological peri-trochanteric vessels supplying the affected hip structures. A temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) is used to achieve transient vessel occlusion, with the objective of reducing pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome.
Platelet-Rich Plasma InjectionBiological
Also called PRP injection
Platelet-rich plasma (PRP) injection consists of a single ultrasound-guided intratendinous administration of autologous PRP into the affected gluteal tendon. PRP is prepared from the participant's own blood using a standardized centrifugation protocol and injected under sterile conditions by an orthopedic hip specialist. The intervention aims to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Transarterial Musculoskeletal Embolization | Active comparator | Participants assigned to this arm will undergo transarterial musculoskeletal embolization (TAME) under local anesthesia. The procedure will be performed by an experienced interventional radiologist using selective catheterization of pathological peri-trochanteric vessels supplying the affected hip structures. Embolization will be carried out using a temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) to achieve transient vessel occlusion. The aim of the procedure is to reduce pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome. Receives: Procedure: Transarterial Musculoskeletal Embolization |
| Platelet-Rich Plasma Injection | Active comparator | Participants assigned to this arm will receive a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma (PRP) into the affected gluteal tendon. The procedure will be performed by an orthopedic hip specialist under sterile conditions. PRP will be prepared from the participant's own blood using a standardized centrifugation protocol. The objective of this intervention is to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome. Receives: Biological: Platelet-Rich Plasma Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction assessed by Visual Analog Scale (VAS)
Change in pain intensity from baseline measured using the Visual Analog Scale (VAS), comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Secondary outcomes (3)
Functional improvement assessed by WOMAC score
Change in functional status from baseline measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Quality of life assessed by EQ-5D-5L questionnaire
Change in health-related quality of life from baseline measured using the EQ-5D-5L questionnaire, comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Incidence of adverse events related to TAME or PRP
Number and severity of procedure-related adverse events associated with transarterial musculoskeletal embolization (TAME) or platelet-rich plasma (PRP) injection, graded according to the CIRSE adverse event classification system.
Measured: From treatment to 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start5 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trochanteric 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPE
- Sponsor type
- University, hospital or other
- Collaborators
- Serviço de Ortopedia da ULS Alto Ave, Serviço de Imagiologia da ULS Alto Ave
- Responsible party
- Principal investigator, Pedro Lopes, Unidade Local de Saúde do Alto Ave, EPE
- Investigators
- Pedro M M Lopes, MD, Principal investigator, Unidade Local de Saúde do Alto Ave
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396246
- Sponsor's protocol ID
- 114-2025 CAF
- Acronym
- HIPE
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results of this study, including baseline characteristics and outcome measures (VAS, WOMAC, EQ-5D-5L, and adverse events), will be made available for secondary research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIPE RCT - Comparison Between Transarterial Musculoskeletal Embolization (TAME) and Platelet-Rich Plasma (PRP) Injection for the Treatment of Greater Trochanteric Pain Syndrome - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07396246
- Acronym / sponsor ID
- HIPE / 114-2025 CAF
- Conditions
- Trochanteric Syndrome
- Keywords
- Embolization, Musculoskeletal, Hip, Greater Trochanter Pain Syndrome, Pain management, PRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde do Alto Ave, EPEUniversity, hospital or other
- Collaborators
- Serviço de Ortopedia da ULS Alto Ave, Serviço de Imagiologia da ULS Alto Ave
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (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) is a common cause of lateral hip pain that can significantly affect daily activities and quality of life. Standard treatments include physical therapy, anti-inflammatory medications, and local injections, but many patients continue to experience persistent symptoms.
This randomized controlled trial aims to compare two minimally invasive treatment options for GTPS: transarterial musculoskeletal embolization (TAME) and platelet-rich plasma (PRP) injection. Participants will be randomly assigned to receive either TAME or PRP.
The main goal of the study is to evaluate which treatment is more effective in reducing pain. Secondary goals include comparing functional improvement, quality of life, and safety between the two treatments. Pain and functional outcomes will be assessed at baseline and during follow-up at 1, 3, 6, and 12 months after treatment.
This study seeks to provide evidence on the effectiveness and safety of TAME compared with PRP injection for patients with Greater Trochanteric Pain Syndrome.
Detailed description
This is a prospective, single-center, parallel-group randomized controlled trial designed to compare the efficacy and safety of transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection in patients with Greater Trochanteric Pain Syndrome (GTPS).
Eligible adult patients with clinically and radiologically confirmed GTPS and persistent symptoms despite at least three months of conservative treatment will be enrolled. Participants will be randomized in a 1:1 ratio to receive either TAME or PRP injection.
TAME will be performed under local anesthesia by an experienced interventional radiologist, using selective catheterization and embolization of pathological vessels supplying the affected peri-trochanteric structures. A temporary, reabsorbable embolic agent (Nexsphere-F®, CE approved) will be used to achieve a transient embolization effect aimed at reducing pathological neovascularization and inflammation.
PRP treatment will consist of a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma into the affected gluteal tendon, performed by an orthopedic hip specialist under sterile conditions.
This is a single-blind study. A trained nurse from the radiology department, blinded to treatment allocation, will conduct all follow-up assessments and collect outcome data to minimize assessment bias.
The primary outcome measure is pain reduction assessed using the Visual Analog Scale (VAS) at baseline and at 1, 3, 6, and 12 months after treatment. Secondary outcome measures include functional improvement assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life evaluated with the EQ-5D-5L questionnaire, and the incidence of adverse events graded according to the CIRSE adverse event classification system.
A total of 30 participants (15 per group) will be included. Patients who do not achieve at least a 50% reduction in pain at 12 months will be eligible to cross over to the alternative treatment arm.
Statistical analysis will include descriptive statistics for baseline characteristics and outcomes. Group comparisons will be performed using independent t-tests or chi-square tests as appropriate. Longitudinal changes will be analyzed using repeated measures analysis of variance or mixed-effects models. Statistical significance will be set at p < 0.05.
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethics approval has been obtained from the Unidade Local de Saúde do Alto Ave ethics committee. Written informed consent will be obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarterial Musculoskeletal Embolization | Active comparator | Procedure: Transarterial Musculoskeletal EmbolizationParticipants assigned to this arm will undergo transarterial musculoskeletal embolization (TAME) under local anesthesia. The procedure will be performed by an experienced interventional radiologist using selective catheterization of pathological peri-trochanteric vessels supplying the affected hip structures. Embolization will be carried out using a temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) to achieve transient vessel occlusion. The aim of the procedure is to reduce pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome. |
| Platelet-Rich Plasma Injection | Active comparator | Biological: Platelet-Rich Plasma InjectionParticipants assigned to this arm will receive a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma (PRP) into the affected gluteal tendon. The procedure will be performed by an orthopedic hip specialist under sterile conditions. PRP will be prepared from the participant's own blood using a standardized centrifugation protocol. The objective of this intervention is to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of GTPS confirmed by clinical and imaging assessments
- Persistent symptoms despite at least 3 months of conservative treatment (e.g., physical therapy, NSAIDs)
- Willingness to participate and provide informed consent
- Availability for follow-up assessments at 1, 3, 6, and 12 months post-treatment
Key exclusion criteria (7 listed)
- Prior hip surgery or other interventions (e.g., joint replacement, prior PRP injections or embolization)
- Severe osteoarthritis (Tonnis III)
- Active lumbar radiculopathy with pain, numbness, or weakness in a dermatomal distribution
- Contraindications for PRP injections (e.g., active infection, coagulopathy, antiplatelet or anticoagulation therapy,
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Transarterial Musculoskeletal EmbolizationAlso: TAMETransarterial musculoskeletal embolization (TAME) is performed under local anesthesia by an experienced interventional radiologist. The procedure consists of selective catheterization and embolization of pathological peri-trochanteric vessels supplying the affected hip structures. A temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) is used to achieve transient vessel occlusion, with the objective of reducing pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome. | Procedure or surgery | Transarterial Musculoskeletal Embolization |
| Platelet-Rich Plasma InjectionAlso: PRP injectionPlatelet-rich plasma (PRP) injection consists of a single ultrasound-guided intratendinous administration of autologous PRP into the affected gluteal tendon. PRP is prepared from the participant's own blood using a standardized centrifugation protocol and injected under sterile conditions by an orthopedic hip specialist. The intervention aims to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome. | Biological | Platelet-Rich Plasma Injection |
Primary outcome
Pain reduction assessed by Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Change in pain intensity from baseline measured using the Visual Analog Scale (VAS), comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
3 secondary outcomes
Functional improvement assessed by WOMAC score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Quality of life assessed by EQ-5D-5L questionnaire
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
Incidence of adverse events related to TAME or PRP
Time frame: From treatment to 12 months after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results of this study, including baseline characteristics and outcome measures (VAS, WOMAC, EQ-5D-5L, and adverse events), will be made available for secondary research purposes.
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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.
Pedro M M Lopes, MD principal investigator
Unidade Local de Saúde do Alto Ave
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transarterial Musculoskeletal Embolization and Platelet-Rich Plasma Injection in people with Trochanteric Syndrome, run by Unidade Local de Saúde do Alto Ave, EPE at 1 site in Portugal.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 9 Feb 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 Portugal. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro M M Lopes, MD (+351965676431, mail@pedromarinholopes.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction assessed by Visual Analog Scale (VAS) (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment). 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 9 Feb 2026.