TendinopathyPhase 3PRP-GTPSNCT04231357
Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle Tenotomy.
A Phase 3 study testing platelet rich plasma in people with Tendinopathy, run by Isabel Andia at 1 site in Spain.
Trial summary
Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2019to 28 Apr 2023
- Phase
- Phase 3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes between the ages of 35 and 75 years.
- At the screening visit, they present hip pain at 3 points out of 10 in EVA.
- Body Mass Index values between 20 and 35 (both values included).
- Commitment to comply with all study procedures.
- Diagnoses of chronic GTPS according to the diagnostic criteria that have been previously described.
- The patient must give written informed consent.
- Women of child-bearing age must obtain a negative test result of pregnancy in blood or urine and accept the use of appropriate contraception while in the trial.
Who cannot join
- • Body Mass Index>35.
- Presence of full tendon tear.
- Systemic autoimmune rheumatologic disease (connective tissue diseases and systemic necrotizing vasculitis)
- Poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%)
- Blood disorders (thrombopathy, thrombocytopenia, anemia with Hb <9)
- Patients receiving immunosuppressive treatments
Show all 14Show fewer
- Treatment by intramuscular corticoid, during the 3 months prior to the first administration of the trial treatment.
- Treatment with non-steroidal anti-inflammatory drugs (more than 10 days consecutive to usual doses), opiates or oral steroids during the 15 days prior to treatment in the study.
- Severe heart disease
- Patients unable to comply with scheduled visits, for work or spend long periods away from their habitual residence.
- Patients with active cancer or cancer diagnosed in the last five years.
- Analytical Diagnosis Hepatitis B, C or HIV infection.
- Pregnant or lactating.
- People who are taking a drug in clinical investigation or participated in any investigational study clinic (with an authorized or not) within 30 days prior to randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Great Trochanteric Pain Syndrome: Parallel Group, Blind Randomised Clinical Trial to Assess the Efficacy and Safety of PRP Injection Versus Needle Tenotomy With Lidocaine
Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have an ultrasound (US)-guided injection of pure platelet-rich plasma (PRP) or needle tenotomy. Outcome data will be collected before the intervention, and at 3, 6, and 12 months after intervention. Main outcome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after the intervention. Secondary outcome measures include percent of responders at three and twelve months, and pain reduction (VAS) at 3, 6, and 12 months. Adverse reactions or events will be recorded.
Read the detailed description
Evaluation of gluteal tendon pathology, including superoposterior and lateral aspects of gluteus medius and gluteus minimus(changes in echotexture, partial tears, calcified deposits, thickness, and loss of fibrillar pattern were evaluated by ultrasound at baseline, six and 12 m post-treatment. Peritrochanteric pathology including tensor fascia lata, trochanteric bursa, and cortical irregularities were also recorded. To analyze the relationship between the possible predictor variables (including sociodemographic and clinical factors, and imaging biomarkers, such as tendon degeneration and abnormalities in the peritrochanteric space) and changes in pain (VAS score) and functionality (HOS score), multivariate analyses were performed using multiple linear regressions.
- Conditions
- Tendinopathy
- Being tested
- platelet rich plasma
- Keywords
- ultrasound;platelet-rich plasma;tendinopathy;pain;trochanter
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaDrug
Also called PRP
platelet rich plasma prepared from peripheral blood using single spin centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma (PRP) | Experimental | 3 mL of autologous platelet rich plasma with a moderate concentration of platelet (2x above peripheral blood) and no leukocytes will be injected under ultrasound guidance Receives: Drug: platelet rich plasma |
| control | Active comparator | needle tenotomy with lidocaine Receives: Drug: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants that showed a clinically minimal clinically important change in function as measured by HOS (Hip Outcome Score, Activity of Daily Living Scale)
Rate of participants that experience at least 25% change in Hip Outcome score (HOS) (comparing to baseline) (Hip Outcome Score, Activity of Daily Living Scale, 0 (worst) to 100 (level of activity prior to hip problem)
Measured: 6 months
Number of adverse events related to treatment
Differences in the patient self-reported adverse events related to treatment
Measured: 3 months
Secondary outcomes (2)
Rate of patients that experience a significant minimal clinically important change in HOS at 3 and 12 months
Rate of patients that experience at least 25% change in Hip Outcome score (HOS, Activity of Daily Living Scale, 0 to 100 (level of activity prior to hip problem)
Measured: 3 and 12 months
Pain changes (VAS) (0 to 10 maximum pain)
Pain changes assessed by visual analog scale (VAS)
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start4 Dec 2019
- Primary completion27 Jan 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, superiority type, double blinded, randomised controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabel Andia
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Isabel Andia, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231357
- Sponsor's protocol ID
- PRP-GTPS
- Other IDs
- 2019-000538-21, 2019
- Acronym
- PRP-GTPS
- Status last verified
- May 2024
- First submitted
- 14 Jan 2020
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atilano L, Martin N, Ignacio Martin J, Iglesias G, Mendiola J, Bully P, Aiyegbusi A, Manuel Rodriguez-Palomo J, Andia I. Ultrasound-Guided Subfascial Platelet-Rich Plasma Injections Versus Enthesis Needling for Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial. Orthop J Sports Med. 2024 May 14;12(5):23259671241249123. doi: 10.1177/23259671241249123. eCollection 2024 May.
PubMed 38751852
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Great Trochanteric Pain Syndrome: Parallel Group, Blind Randomised Clinical Trial to Assess the Efficacy and Safety of PRP Injection Versus Needle Tenotomy With Lidocaine
- ClinicalTrials.gov ID
- NCT04231357
- Acronym / sponsor ID
- PRP-GTPS / PRP-GTPS
- Conditions
- Tendinopathy
- Keywords
- ultrasound;platelet-rich plasma;tendinopathy;pain;trochanter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Isabel AndiaOther government
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 18 Jan 2020 (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.
Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have an ultrasound (US)-guided injection of pure platelet-rich plasma (PRP) or needle tenotomy. Outcome data will be collected before the intervention, and at 3, 6, and 12 months after intervention. Main outcome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after the intervention. Secondary outcome measures include percent of responders at three and twelve months, and pain reduction (VAS) at 3, 6, and 12 months. Adverse reactions or events will be recorded.
Detailed description
Evaluation of gluteal tendon pathology, including superoposterior and lateral aspects of gluteus medius and gluteus minimus(changes in echotexture, partial tears, calcified deposits, thickness, and loss of fibrillar pattern were evaluated by ultrasound at baseline, six and 12 m post-treatment. Peritrochanteric pathology including tensor fascia lata, trochanteric bursa, and cortical irregularities were also recorded. To analyze the relationship between the possible predictor variables (including sociodemographic and clinical factors, and imaging biomarkers, such as tendon degeneration and abnormalities in the peritrochanteric space) and changes in pain (VAS score) and functionality (HOS score), multivariate analyses were performed using multiple linear regressions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, superiority type, double blinded, randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma (PRP) | Experimental | Drug: platelet rich plasma3 mL of autologous platelet rich plasma with a moderate concentration of platelet (2x above peripheral blood) and no leukocytes will be injected under ultrasound guidance |
| control | Active comparator | Drug: platelet rich plasmaneedle tenotomy with lidocaine |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes between the ages of 35 and 75 years.
- At the screening visit, they present hip pain at 3 points out of 10 in EVA.
- Body Mass Index values between 20 and 35 (both values included).
- Commitment to comply with all study procedures.
- Diagnoses of chronic GTPS according to the diagnostic criteria that have been previously described.
Key exclusion criteria (14 listed)
- • Body Mass Index>35.
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 |
|---|---|---|
| platelet rich plasmaAlso: PRPplatelet rich plasma prepared from peripheral blood using single spin centrifugation | Drug | Platelet rich plasma (PRP), control |
Primary outcome
Rate of participants that showed a clinically minimal clinically important change in function as measured by HOS (Hip Outcome Score, Activity of Daily Living Scale)
Time frame: 6 months
Rate of participants that experience at least 25% change in Hip Outcome score (HOS) (comparing to baseline) (Hip Outcome Score, Activity of Daily Living Scale, 0 (worst) to 100 (level of activity prior to hip problem)
Number of adverse events related to treatment
Time frame: 3 months
Differences in the patient self-reported adverse events related to treatment
2 secondary outcomes
Rate of patients that experience a significant minimal clinically important change in HOS at 3 and 12 months
Time frame: 3 and 12 months
Pain changes (VAS) (0 to 10 maximum pain)
Time frame: 3, 6 and 12 months
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 31 May 2024.
- Results publication: PubMed 38751852Atilano L, Martin N, Ignacio Martin J, Iglesias G, Mendiola J, Bully P, Aiyegbusi A, Manuel Rodriguez-Palomo J, Andia I. Ultrasound-Guided Subfascial Platelet-Rich Plasma Injections Versus Enthesis Needling for Greater Trochanteric Pain Syndrome: A Randomized Controlled Trial. Orthop J Sports Med. 2024 May 14;12(5):23259671241249123. doi: 10.1177/23259671241249123. eCollection 2024 May.
- here is a link to the open access article containing the clinical trial resultsLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing platelet rich plasma in people with Tendinopathy, run by Isabel Andia 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 7 inclusion and 14 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 31 May 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rate of participants that showed a clinically minimal clinically important change in function as measured by HOS (Hip Outcome Score, Activity of Daily Living Scale) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231357, which also lists 1 linked publication.
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 31 May 2024.