Greater Trochanteric Pain SyndromeMEDANTRONCT05486078
Evaluation of the Efficacy of the Use MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS)
A study testing MD Tissue Collagen Medical Device in people with Greater Trochanteric Pain Syndrome and GTPS - Greater Trochanteric Pain Syndrome, run by Guna S.p.a at 1 site in Italy.
Trial summary
Greater Trochanteric Pain Syndrome, also known as GTPS (Greater Trochanteric Pain Syndrome) is a complex clinical condition characterized by chronic and recurrent pain in the lateral region of the hip, near the greater trochanter of the femur. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome, GTPS - Greater Trochanteric Pain Syndrome, Tendon Disorder
- What is being tested?
- MD Tissue Collagen Medical Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2021to 31 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 70 years;
- subjects with lateral palpatory pain that has appeared for at least 1 month;
- subjects with hip pain symptomatology assessed by Numerical rating scale (NRS) ≥ to 5;
- Subjects able to cooperate for the assessments in the Survey plan;
- subjects able to understand and sign informed consent.
Who cannot join
- subjects with true coxalgia (with positive FADDIR);
- subjects with ESHS (external snap hip syndrome);
- subjects already undergoing candidate hip replacement surgery;
- subjects with radiologic and clinical evidence of small and/or middle gluteal tendon detachment with indication for surgical repair;
- subjects with evidence of radiographically documented tendon calcifications;
- subjects with a degree of coxarthrosis of the hip that is a candidate for treatment according to the classification of Tonnis>1
Show all 14Show fewer
- subjects who have taken fluoroquinolones within 30 days prior to enrollment
- subjects who have undergone treatment with hyaluronic acid or corticosteroids in the hip candidate for infiltrative treatment within 4 weeks before enrollment;
- subjects with local infections of the treatment candidate hip or systemic infections, osteomyelitis, or sepsis;
- subjects on chronic treatment with corticosteroids or immunosuppressants;
- subjects who are drug addicts, alcoholics, have psychiatric disorders, or have clinical conditions that may compromise the correct interpretation of PROMs or follow-up;
- subjects with coagulopathies, platelet aggregation disorders, or on treatment with oral anticoagulants or antiplatelets that cannot be discontinued during the study period;
- Pregnant and lactating subjects (female subjects of childbearing age should be tested for pregnancy before enrollment);
- subjects with allergy to porcine collagen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of the Use of a Type I Collagen-based MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS) "MEDANTRO PILOT STUDY"
Greater Trochanteric Pain Syndrome, also known as GTPS (Greater Trochanteric Pain Syndrome) is a complex clinical condition characterized by chronic and recurrent pain in the lateral region of the hip, near the greater trochanter of the femur.
Biomechanical and anatomic-histologic interactions of the structures of the peri trochanteric space, in which, given the close anatomic-functional relationships, the origin can be traced to three different pathologic entities that may influence each other and fuel the progressive exacerbation of symptomatology. These are: external snap hip, trochanteric bursitis, and tendinopathies of the tendons of the gluteus mediums and gluteus minimums muscles.
Read more
Recent studies regarding GTPS have shown that in most cases this condition is due to degenerative tendinopathy of the tendons of the gluteus minimums and gluteus mediums muscles. Tendinopathy is defined as a pathological condition associated with histological changes that may result in a change in the organization of collagen fibrils, relative increase in the percentage of proteoglycans, glycosaminoglycans, and no collagenous components of the ECM accompanied by neo-vascularization and inflammatory state.
Tendinopathies thus result in painful symptomatology that very often also results in biomechanical functional deficit.
Clinically, GTPS presents as pain that is often debilitating and exacerbated by activities such as walking, climbing stairs, and lying on the affected side at night, associated with a progressive loss of stenia in hip abduction movements. On objective examination, a point of tenderness (trigger point) is noted at the level of the region of the greater trochanter, which may radiate to the lumbar area and along the lateral aspect of the thigh to the ipsilateral knee and a difficulty on strength versus resistance tests in hip abduction movements.
Although it is a very common syndrome, the treatment of painful grand trochanter syndrome, as well as that of tendinopathies in general, is still a major hurdle because the specific cellular pathogenetic and biomechanical etiopathogenetic mechanisms are still partly unknown and many treatments are empirical. Traditionally, the treatment of GTPS is initially conservative and includes rest, ice, NSAIDs and physiotherapy with stretching exercises of the fascia late. The use of corticosteroids, with systemic or local infiltrative intake, for the treatment of tendinopathies is highly controversial and, in any case, does not seem to have long-term efficacy.
MD-Tissue Collagen Medical Device is an injectable medical device based on porcine collagen type I; the collagen content is 100µg/2mL. Porcine collagen is like human collagen and highly compatible; it has very low risks of inducing adverse effects and is therefore used in several clinical settings.
Read the detailed description
This is a pilot monocentric Clinical Investigation based on a One sample design.
In the ex vivo study, MD-Tissue Collagen Medical Device was used as a substrate for cell cultures of human gluteal tenocytes on culture plates. The results suggest how MD-Tissue can induce an anabolic phenotype in tenocytes by stimulating their proliferation and migration; it would also be able to promote the synthesis, maturation, and secretion of COL-I, thereby promoting tendon homeostasis and repair. Specifically, the modification of gene expression and proteins involved in collagen turnover pathways were analyzed by real-time PCR, Slot blot and SDS-zymography. Data from the study showed that tenocytes cultured with MD-Tissue compared with controls exhibited increased secretion and migration of COL-1 increased mRNA levels of the matrix metalloprotease inhibitor proteins MMP-1 and TIMP-1.
The tenocytes used for the cell cultures were gluteal tenocytes, derived from human gluteal tendon fragments (obtained from subjects without any tendon pathology who had undergone total hip replacement surgery); therefore, it is reasonable to think that the porcine type I collagen-based compound may be a viable treatment in GTPS.
The results of the preclinical study suggest how MD-Tissue Collagen Medical Device can induce an anabolic phenotype in tenocytes by stimulating tenocyte proliferation and COL-I synthesis, maturation, and secretion, thereby promoting tendon repair. As these effects have been evaluated ex vivo on tenocytes of gluteal muscle tendons, the purpose of this study is to evaluate its efficacy in local infiltrative treatment, in the pertechnetic region, of GTPS, in terms of resolution of pain symptoms and recovery of stenia in abduction.
Variables will be assessed at 6 different times; at baseline (day 0), after week 1, weeks 2, weeks 6, weeks 10 and after weeks 24.
- Conditions
- Greater Trochanteric Pain Syndrome, GTPS - Greater Trochanteric Pain Syndrome, Tendon Disorder, Pertrochanteric Fracture, Gluteal Tendinitis, Gluteal Muscles
- Being tested
- MD Tissue Collagen Medical Device
- Keywords
- MD-Tissue Collagen Medical, Ecoguide, Biomechanical, Modified Harris Hip Score, Numeric Rating Scale, Type I collagen
- Medical subject headings
- Tendinopathy, Osteogenesis Imperfecta, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD Tissue Collagen Medical DeviceDevice
The Experimental Group will be treated with 2-mL volume ultrasound-guided infiltration of: MD-Tissue (GUNA, Milan-Italy). Composition for 2 ml: collagen 100 micrograms Subjects will be treated with No.1 infiltration per week for 3 consecutive weeks. The infiltrations will be performed in an echoguided mode.
MD-Tissue Collagen Medical Device will be infiltrated into the trochanteric bursa and at the level of the tendons of the gluteus minimus and gluteus medius, particularly at the level of the most degenerated insertional areas.
| Study group | Role | What they receive |
|---|---|---|
| MD-Tissue Medical Device | Experimental | Not described Receives: Device: MD Tissue Collagen Medical Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10
Pain intensity was measured using the NRS (Numerical Rating Scale), a validated scale ranging from 0 (no pain) to 10 (worst possible pain).
Participants were asked to indicate their pain level at baseline (Week 0) and at Week 10.
A change of at least 3 points on the NRS is considered clinically significant. The primary outcome is the mean change in NRS score from baseline to Week 10.
Measured: weeks 10
Secondary outcomes (6)
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0)
Pain intensity was measured using the NRS (Numerical Rating Scale) at rest, ranging from 0 (no pain) to 10 (worst possible pain). Participants were asked to rate their pain at baseline (T0), week 6 (T6w/FU), and week 24 (T24w/FU). This outcome reports the mean NRS values at week 6 and 24. Higher scores indicate more intense pain.
Measured: weeks 6 and weeks 24
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24
The Modified Harris Hip Score (mHHS) is a validated tool for assessing hip function and pain. It ranges from 0 (worst functional outcome and highest pain) to 100 (best function and least pain). Participants were evaluated at Weeks 6, 10, and 24 compared to baseline. The change in total score is used to assess clinical improvement.
Unit of Measure:
Score from 0 to 100; higher scores indicate better outcome
Measured: Weeks 6, 10, and 24
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24
Hip abduction strength was assessed using a handheld dynamometer at Weeks 6, 10, and 24. The measurement was performed with the patient standing on the contralateral (healthy) limb, while abducting the hip affected by GTPS. For each assessment, three consecutive measurements were taken and averaged. Results were compared to baseline (Day 0) to evaluate functional improvement in muscular strength.
Measured: Weeks 6, 10, and 24
MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to Baseline
MRI evaluation focused on inflammatory and degenerative signs in the peritrochanteric region (gluteus medius/minimus tendons) was conducted at Week 24 and compared to baseline (Week 0). Two independent radiologists assessed peri-tendinous fluid and intra-tendinous edema on STIR-weighted images. Improvement was defined as visible reduction in peritendinous edema. The analysis was qualitative and dichotomous (Improved vs. Unchanged).
Measured: Week 24 compared to baseline (Week 0)
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24
Analgesic drug consumption (paracetamol and/or celecoxib) was recorded using a patient diary at time points T0 (baseline), T1w, T2w, T6w/FU, T10w/FU, and T24w/FU. Each patient logged the number of analgesic doses consumed per week. The total number of doses per timepoint was used to assess any significant change over time. The analysis aimed to evaluate whether the treatment reduced the need for pain medication, as an indirect marker of clinical efficacy.
Unit of measure: Number of analgesic doses consumed per week.
Measured: Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0)
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24
Adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs) were monitored at each study visit from baseline (Day 0) to Week 24. Data were collected via systematic interviews and clinical assessments. No adverse events of any type were reported during the study. AE definitions followed ICH-GCP and ClinicalTrials.gov guidance.
Measured: Day 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start13 Sep 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One sample study
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guna S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randelli RFMN Filippo Maria Nicola, Prof, Principal investigator, Gaetano Pini CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486078
- Sponsor's protocol ID
- MDG2020711
- Acronym
- MEDANTRO
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2022
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of the Use of a Type I Collagen-based MD Tissue Collagen Medical Device in the Infiltrative Treatment of Greater Trochanter Pain Syndrome (GTPS) "MEDANTRO PILOT STUDY"
- ClinicalTrials.gov ID
- NCT05486078
- Acronym / sponsor ID
- MEDANTRO / MDG2020711
- Conditions
- Greater Trochanteric Pain Syndrome, GTPS - Greater Trochanteric Pain Syndrome, Tendon Disorder, Pertrochanteric Fracture, Gluteal Tendinitis, Gluteal Muscles
- Keywords
- MD-Tissue Collagen Medical, Ecoguide, Biomechanical, Modified Harris Hip Score, Numeric Rating Scale, Type I collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Guna S.p.aIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Posted 14 Jul 2025
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, also known as GTPS (Greater Trochanteric Pain Syndrome) is a complex clinical condition characterized by chronic and recurrent pain in the lateral region of the hip, near the greater trochanter of the femur.
Biomechanical and anatomic-histologic interactions of the structures of the peri trochanteric space, in which, given the close anatomic-functional relationships, the origin can be traced to three different pathologic entities that may influence each other and fuel the progressive exacerbation of symptomatology. These are: external snap hip, trochanteric bursitis, and tendinopathies of the tendons of the gluteus mediums and gluteus minimums muscles.
Recent studies regarding GTPS have shown that in most cases this condition is due to degenerative tendinopathy of the tendons of the gluteus minimums and gluteus mediums muscles. Tendinopathy is defined as a pathological condition associated with histological changes that may result in a change in the organization of collagen fibrils, relative increase in the percentage of proteoglycans, glycosaminoglycans, and no collagenous components of the ECM accompanied by neo-vascularization and inflammatory state.
Tendinopathies thus result in painful symptomatology that very often also results in biomechanical functional deficit.
Clinically, GTPS presents as pain that is often debilitating and exacerbated by activities such as walking, climbing stairs, and lying on the affected side at night, associated with a progressive loss of stenia in hip abduction movements. On objective examination, a point of tenderness (trigger point) is noted at the level of the region of the greater trochanter, which may radiate to the lumbar area and along the lateral aspect of the thigh to the ipsilateral knee and a difficulty on strength versus resistance tests in hip abduction movements.
Although it is a very common syndrome, the treatment of painful grand trochanter syndrome, as well as that of tendinopathies in general, is still a major hurdle because the specific cellular pathogenetic and biomechanical etiopathogenetic mechanisms are still partly unknown and many treatments are empirical. Traditionally, the treatment of GTPS is initially conservative and includes rest, ice, NSAIDs and physiotherapy with stretching exercises of the fascia late. The use of corticosteroids, with systemic or local infiltrative intake, for the treatment of tendinopathies is highly controversial and, in any case, does not seem to have long-term efficacy.
MD-Tissue Collagen Medical Device is an injectable medical device based on porcine collagen type I; the collagen content is 100µg/2mL. Porcine collagen is like human collagen and highly compatible; it has very low risks of inducing adverse effects and is therefore used in several clinical settings.
Detailed description
This is a pilot monocentric Clinical Investigation based on a One sample design.
In the ex vivo study, MD-Tissue Collagen Medical Device was used as a substrate for cell cultures of human gluteal tenocytes on culture plates. The results suggest how MD-Tissue can induce an anabolic phenotype in tenocytes by stimulating their proliferation and migration; it would also be able to promote the synthesis, maturation, and secretion of COL-I, thereby promoting tendon homeostasis and repair. Specifically, the modification of gene expression and proteins involved in collagen turnover pathways were analyzed by real-time PCR, Slot blot and SDS-zymography. Data from the study showed that tenocytes cultured with MD-Tissue compared with controls exhibited increased secretion and migration of COL-1 increased mRNA levels of the matrix metalloprotease inhibitor proteins MMP-1 and TIMP-1.
The tenocytes used for the cell cultures were gluteal tenocytes, derived from human gluteal tendon fragments (obtained from subjects without any tendon pathology who had undergone total hip replacement surgery); therefore, it is reasonable to think that the porcine type I collagen-based compound may be a viable treatment in GTPS.
The results of the preclinical study suggest how MD-Tissue Collagen Medical Device can induce an anabolic phenotype in tenocytes by stimulating tenocyte proliferation and COL-I synthesis, maturation, and secretion, thereby promoting tendon repair. As these effects have been evaluated ex vivo on tenocytes of gluteal muscle tendons, the purpose of this study is to evaluate its efficacy in local infiltrative treatment, in the pertechnetic region, of GTPS, in terms of resolution of pain symptoms and recovery of stenia in abduction.
Variables will be assessed at 6 different times; at baseline (day 0), after week 1, weeks 2, weeks 6, weeks 10 and after weeks 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One sample study
| Arm | Type | Receives |
|---|---|---|
| MD-Tissue Medical Device | Experimental | Device: MD Tissue Collagen Medical Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 to 70 years;
- subjects with lateral palpatory pain that has appeared for at least 1 month;
- subjects with hip pain symptomatology assessed by Numerical rating scale (NRS) ≥ to 5;
- Subjects able to cooperate for the assessments in the Survey plan;
- subjects able to understand and sign informed consent.
Key exclusion criteria (14 listed)
- subjects with true coxalgia (with positive FADDIR);
- subjects with ESHS (external snap hip syndrome);
- subjects already undergoing candidate hip replacement surgery;
- subjects with radiologic and clinical evidence of small and/or middle gluteal tendon detachment with indication for surgical repair;
- subjects with evidence of radiographically documented tendon calcifications;
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 |
|---|---|---|
| MD Tissue Collagen Medical DeviceThe Experimental Group will be treated with 2-mL volume ultrasound-guided infiltration of: MD-Tissue (GUNA, Milan-Italy). Composition for 2 ml: collagen 100 micrograms Subjects will be treated with No.1 infiltration per week for 3 consecutive weeks. The infiltrations will be performed in an echoguided mode. MD-Tissue Collagen Medical Device will be infiltrated into the trochanteric bursa and at the level of the tendons of the gluteus minimus and gluteus medius, particularly at the level of the most degenerated insertional areas. | Device | MD-Tissue Medical Device |
Primary outcome
Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10
Time frame: weeks 10
Pain intensity was measured using the NRS (Numerical Rating Scale), a validated scale ranging from 0 (no pain) to 10 (worst possible pain). Participants were asked to indicate their pain level at baseline (Week 0) and at Week 10. A change of at least 3 points on the NRS is considered clinically significant. The primary outcome is the mean change in NRS score from baseline to Week 10.
6 secondary outcomes
Mean NRS (Numerical Rating Scale) Pain Score at Week 6 and Week 24 Compared to Baseline (T0)
Time frame: weeks 6 and weeks 24
Change in Modified Harris Hip Score (mHHS) From Baseline to Weeks 6, 10, and 24
Time frame: Weeks 6, 10, and 24
Change in Hip Abduction Strength From Baseline to Weeks 6, 10, and 24
Time frame: Weeks 6, 10, and 24
MRI Evaluation of Inflammatory and Degenerative Signs in the Peritrochanteric Region at Week 24 Compared to Baseline
Time frame: Week 24 compared to baseline (Week 0)
Change in Analgesic Drug Consumption (Paracetamol and/or Celecoxib) From Baseline to Week 24
Time frame: Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0) Week 1, Week 2, Week 6, Week 10, and Week 24 compared to baseline (Week 0)
Incidence of Adverse Events (AE, SAE, SUSAR) From Baseline to Week 24
Time frame: Day 0 to Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Randelli RFMN Filippo Maria Nicola, Prof principal investigator
Gaetano Pini CTO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD Tissue Collagen Medical Device in people with Greater Trochanteric Pain Syndrome and GTPS - Greater Trochanteric Pain Syndrome, run by Guna S.p.a at 1 site in Italy.
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 5 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 14 Jul 2025. 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 Italy. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in NRS (Numerical Rating Scale) Pain Score From Baseline (Week 0) to Week 10 (time frame: weeks 10). 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 Jul 2025.