Spondylolysis LumbarActiveBackNCT07430072
A Pilot Study on the Safety of Active Conservative Management of Low Grade Lumbar Stress Reactions in Adolescent Soccer Players
A study testing Active rehabilitation protocol in people with Spondylolysis Lumbar, run by Western Norway University of Applied Sciences at 3 sites in Norway.
Trial summary
Introduction: The Background Prevalence: Low back pain (LBP) is very common in young athletes, and lumbar spondylolysis (an overuse injury of bones in the low back) is the leading cause. In adolescent male soccer players with LBP, almost half (up to 48%) have this specific injury. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Spondylolysis Lumbar
- What is being tested?
- Active rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesNorway
- Study dates
- May 2026to Feb 2027
- Phase
- Interventional
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 14-19.
- Soccer players
- Low grade (1-2) lumbar stress reaction in L4 or L5.
- Pain in the area of the affected vertebrae with sports activity and/or ADL.
Who cannot join
- Not able to get MRI,
- Other conditions/injuries that potentially could affect the result (at baseline and during follow up), i.e. lumbar disc prolapse, scheurmans disease, ankylosing spondylitis,
- Disorders influencing growth.
- Previously unsuccessful treatment of lumbar stress reaction.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites
Idrettsmedisinsk Klinikk, Brann Stadion
Bergen, 5052
David Tovi, Physiotherapist MSc, +4741247339, david.tovi@hotmail.com
Western Norway Center for Sports Medicine
Bergen, 5058
Nicolay Morland, Physiotherapist MSc, +4798654380, nicolay.morland@gmail.com
The Norwegian FA Sports Medicine Clinic
Oslo, 1177
Jan Henning Løken, Physiotherapist MSc, +4791601122, jan.loken@ihs.no
About this study
Introduction: The Background
- Prevalence: Low back pain (LBP) is very common in young athletes, and lumbar spondylolysis (an overuse injury of bones in the low back) is the leading cause. In adolescent male soccer players with LBP, almost half (up to 48%) have this specific injury.
- The Current Standard: Existing Norwegian guidelines mandate a break from all sports for a minimum of 3 months when rehabilitating spondylolysis
- The Challenge: These strict guidelines lack strong evidence from clinical trials and can lead to negative social and physical consequences for the athlete, including exclusion from team activities and reduced general physical activity.
Read more
AIM: The Goal of the Study To determine the safety and effectiveness of a newly developed, 4-phased, pain-controlled rehabilitation protocol that uses early, criteria-based activity progression (based on functional capacity and pain levels) for youth football players diagnosed with spondylolysis.
Method: Study Design and Measurements
- Design: This is a pilot study (prospective cohort study) involving 30-40 youth football players with a first-time diagnosis of low grade (1-2) spondylolysis.
- Diagnosis: The injury is confirmed using an MRI scan (specifically the VIBE sequence).
- Data Collection: We will gather data through:
- MRIs: Comparing images at baseline (start) and after 3 months.
- Standardized Clinical Examinations.
- PROMs (Patient-Reported Outcome Measures - standardized questionnaires about function and pain).
- Weekly reporting on pain intensity and training volume.
- Outcome: We will compare the changes in the bone healing seen on the MRI findings between the start and end of the 3-month period, and at six months if applicable.
- Conditions
- Spondylolysis Lumbar
- Being tested
- Active rehabilitation protocol
- Keywords
- Spondylolysis, adolescent, MRI, football
- Medical subject headings
- Spondylolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rehabilitation protocolOther
Also called ActiveBack, AktivRygg
Current Norwegian guidelines recommend that everyone with this injury stop participating in sports for a minimum of 3 months. There is very little research supporting these, and other international, guidelines. Considering the negative consequences of the current regime, we wish to conduct a pilot project with 30-40 football (soccer) players aged 13-19 with the mildest, and most common, MRI grading of this injury (Grade 1). Here, we aim to test a rehabilitation protocol that is more pain-controlled and individually adapted to each athlete. The training protocol is based on other so-called low-risk stress fractures, where the probability of healing is considered good, and is divided into four phases. The time it takes to complete the rehabilitation protocol will be quite similar to the expected healing time and current protocols. The actual rehabilitation time may ultimately end up being both shorter and longer than current protocols, but with a higher degree of meaningful activity.
| Study group | Role | What they receive |
|---|---|---|
| Active rehabilitation of low grade lumbar spondylolysis | Experimental | Not described Receives: Other: Active rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in edema on MRI
Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis. An addiotonal MR will be performed at 6 months for patients with the same or higher classification on the Hollenberg Critera at the 3 month follow-up
Measured: Baseline, 3 months and potentially at 6 months.
Secondary outcomes (2)
Changes in Youth Back Activity Questionnaire - norwegian version
The Youth Back Activity Questionnaire (YouthBAQ) is a 14-item validated tool designed specifically to measure functional limitations in adolescents (12-18) with low back pain. YouthBAQ is scored on 0-100 scale with 100 representing no disability and 0 representing maximum disability.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
Changes in Oswestry Disability Index
The Oswestry Disability Index (ODI) a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. It is considered one of the best accepted tools for assessment of low back pain, but it is not designed for adolescents.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Spondylolysis LumbarStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Nottingham Trent University, Federation Internationale de Football Association
- Responsible party
- Principal investigator, Bård Bogen, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430072
- Sponsor's protocol ID
- 821259
- Acronym
- ActiveBack
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized raw data sheet will be shared upon request or added to submission if required
Publications
Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5.
PubMed 27707738Dalen-Lorentsen T, Ranvik A, Bjorneboe J, Clarsen B, Andersen TE. Facilitators and barriers for implementation of a load management intervention in football. BMJ Open Sport Exerc Med. 2021 Jun 22;7(2):e001046. doi: 10.1136/bmjsem-2021-001046. eCollection 2021.
PubMed 34249374Grotle M, Brox JI, Vollestad NK. Cross-cultural adaptation of the Norwegian versions of the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. J Rehabil Med. 2003 Sep;35(5):241-7. doi: 10.1080/16501970306094.
PubMed 14582557Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
PubMed 15928561Koh E, Walton ER, Watson P. VIBE MRI: an alternative to CT in the imaging of sports-related osseous pathology? Br J Radiol. 2018 Jul;91(1088):20170815. doi: 10.1259/bjr.20170815. Epub 2018 Mar 15.
PubMed 29474097Dhouib A, Tabard-Fougere A, Hanquinet S, Dayer R. Diagnostic accuracy of MR imaging for direct visualization of lumbar pars defect in children and young adults: a systematic review and meta-analysis. Eur Spine J. 2018 May;27(5):1058-1066. doi: 10.1007/s00586-017-5305-2. Epub 2017 Sep 23.
PubMed 28942567Takei S, Torii S, Taketomi S, Iwanuma S, Tojima M, Otomo M, Iizuka S, Tanaka S. Is Increased Kicking Leg Iliopsoas Muscle Tightness a Predictive Factor for Developing Spondylolysis in Adolescent Male Soccer Players? Clin J Sport Med. 2022 Mar 1;32(2):e165-e171. doi: 10.1097/JSM.0000000000000920.
PubMed 33844489Tsutsui T, Iizuka S, Takei S, Maemichi T, Torii S. Risk Factors for Symptomatic Bilateral Lumbar Bone Stress Injury in Adolescent Soccer Players: A Prospective Cohort Study. Am J Sports Med. 2023 Mar;51(3):707-714. doi: 10.1177/03635465221146289. Epub 2023 Jan 20.
PubMed 36661480Yokoe T, Tajima T, Sugimura H, Kubo S, Nozaki S, Yamaguchi N, Morita Y, Chosa E. Comparison of symptomatic spondylolysis in young soccer and baseball players. J Orthop Surg Res. 2020 Sep 3;15(1):378. doi: 10.1186/s13018-020-01910-4.
PubMed 32883336El Rassi G, Takemitsu M, Woratanarat P, Shah SA. Lumbar spondylolysis in pediatric and adolescent soccer players. Am J Sports Med. 2005 Nov;33(11):1688-93. doi: 10.1177/0363546505275645. Epub 2005 Aug 10.
PubMed 16093537Selhorst M, Fischer A, MacDonald J. Prevalence of Spondylolysis in Symptomatic Adolescent Athletes: An Assessment of Sport Risk in Nonelite Athletes. Clin J Sport Med. 2019 Sep;29(5):421-425. doi: 10.1097/JSM.0000000000000546.
PubMed 31460956Wall J, Meehan WP 3rd, Trompeter K, Gissane C, Mockler D, van Dyk N, Wilson F. Incidence, prevalence and risk factors for low back pain in adolescent athletes: a systematic review and meta-analysis. Br J Sports Med. 2022 Nov;56(22):1299-1306. doi: 10.1136/bjsports-2021-104749. Epub 2022 Sep 23.
PubMed 36150752Cugusi L, Manca A, Fischbach E, Secci C, Bergamin M, Gobbo S, DI Blasio A, Montella A, Bandiera P, Deriu F. Low back pain prevalence and risk factors in Italian adolescent male soccer players: results from an online survey. J Sports Med Phys Fitness. 2022 Aug;62(8):1088-1094. doi: 10.23736/S0022-4707.21.12696-9. Epub 2021 Sep 9.
PubMed 34498823Tunas P, Nilstad A, Myklebust G. Low back pain in female elite football and handball players compared with an active control group. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2540-7. doi: 10.1007/s00167-014-3069-3. Epub 2014 May 18.
PubMed 24839041van Hilst J, Hilgersom NF, Kuilman MC, Kuijer PP, Frings-Dresen MH. Low back pain in young elite field hockey players, football players and speed skaters: Prevalence and risk factors. J Back Musculoskelet Rehabil. 2015;28(1):67-73. doi: 10.3233/BMR-140491.
PubMed 24968798
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Safety of Active Conservative Management of Low Grade Lumbar Stress Reactions in Adolescent Soccer Players
- ClinicalTrials.gov ID
- NCT07430072
- Acronym / sponsor ID
- ActiveBack / 821259
- Conditions
- Spondylolysis Lumbar
- Keywords
- Spondylolysis, adolescent, MRI, football
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Nottingham Trent University, Federation Internationale de Football Association
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 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.
Introduction: The Background
- Prevalence: Low back pain (LBP) is very common in young athletes, and lumbar spondylolysis (an overuse injury of bones in the low back) is the leading cause. In adolescent male soccer players with LBP, almost half (up to 48%) have this specific injury.
- The Current Standard: Existing Norwegian guidelines mandate a break from all sports for a minimum of 3 months when rehabilitating spondylolysis
- The Challenge: These strict guidelines lack strong evidence from clinical trials and can lead to negative social and physical consequences for the athlete, including exclusion from team activities and reduced general physical activity.
AIM: The Goal of the Study To determine the safety and effectiveness of a newly developed, 4-phased, pain-controlled rehabilitation protocol that uses early, criteria-based activity progression (based on functional capacity and pain levels) for youth football players diagnosed with spondylolysis.
Method: Study Design and Measurements
- Design: This is a pilot study (prospective cohort study) involving 30-40 youth football players with a first-time diagnosis of low grade (1-2) spondylolysis.
- Diagnosis: The injury is confirmed using an MRI scan (specifically the VIBE sequence).
- Data Collection: We will gather data through:
- MRIs: Comparing images at baseline (start) and after 3 months.
- Standardized Clinical Examinations.
- PROMs (Patient-Reported Outcome Measures - standardized questionnaires about function and pain).
- Weekly reporting on pain intensity and training volume.
- Outcome: We will compare the changes in the bone healing seen on the MRI findings between the start and end of the 3-month period, and at six months if applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active rehabilitation of low grade lumbar spondylolysis | Experimental | Other: Active rehabilitation protocol |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 14-19.
- Soccer players
- Low grade (1-2) lumbar stress reaction in L4 or L5.
- Pain in the area of the affected vertebrae with sports activity and/or ADL.
Key exclusion criteria (4 listed)
- Not able to get MRI,
- Other conditions/injuries that potentially could affect the result (at baseline and during follow up), i.e. lumbar disc prolapse, scheurmans disease, ankylosing spondylitis,
- Disorders influencing growth.
- Previously unsuccessful treatment of lumbar stress reaction.
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 |
|---|---|---|
| Active rehabilitation protocolAlso: ActiveBack, AktivRyggCurrent Norwegian guidelines recommend that everyone with this injury stop participating in sports for a minimum of 3 months. There is very little research supporting these, and other international, guidelines. Considering the negative consequences of the current regime, we wish to conduct a pilot project with 30-40 football (soccer) players aged 13-19 with the mildest, and most common, MRI grading of this injury (Grade 1). Here, we aim to test a rehabilitation protocol that is more pain-controlled and individually adapted to each athlete. The training protocol is based on other so-called low-risk stress fractures, where the probability of healing is considered good, and is divided into four phases. The time it takes to complete the rehabilitation protocol will be quite similar to the expected healing time and current protocols. The actual rehabilitation time may ultimately end up being both shorter and longer than current protocols, but with a higher degree of meaningful activity. | Other | Active rehabilitation of low grade lumbar spondylolysis |
Primary outcome
Change in edema on MRI
Time frame: Baseline, 3 months and potentially at 6 months.
Patients will have a repeat MRI performed at 3 months. A radiologist will assess for change in the spondylolytic lesion, edema and anterolisthesis. An addiotonal MR will be performed at 6 months for patients with the same or higher classification on the Hollenberg Critera at the 3 month follow-up
2 secondary outcomes
Changes in Youth Back Activity Questionnaire - norwegian version
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
Changes in Oswestry Disability Index
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 26 weeks
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 6 May 2026.
- Background: PubMed 27707738Slade SC, Dionne CE, Underwood M, Buchbinder R. Consensus on Exercise Reporting Template (CERT): Explanation and Elaboration Statement. Br J Sports Med. 2016 Dec;50(23):1428-1437. doi: 10.1136/bjsports-2016-096651. Epub 2016 Oct 5.
- Background: PubMed 34249374Dalen-Lorentsen T, Ranvik A, Bjorneboe J, Clarsen B, Andersen TE. Facilitators and barriers for implementation of a load management intervention in football. BMJ Open Sport Exerc Med. 2021 Jun 22;7(2):e001046. doi: 10.1136/bmjsem-2021-001046. eCollection 2021.
- Background: PubMed 14582557Grotle M, Brox JI, Vollestad NK. Cross-cultural adaptation of the Norwegian versions of the Roland-Morris Disability Questionnaire and the Oswestry Disability Index. J Rehabil Med. 2003 Sep;35(5):241-7. doi: 10.1080/16501970306094.
- Background: PubMed 15928561Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- Background: PubMed 29474097Koh E, Walton ER, Watson P. VIBE MRI: an alternative to CT in the imaging of sports-related osseous pathology? Br J Radiol. 2018 Jul;91(1088):20170815. doi: 10.1259/bjr.20170815. Epub 2018 Mar 15.
- Background: PubMed 28942567Dhouib A, Tabard-Fougere A, Hanquinet S, Dayer R. Diagnostic accuracy of MR imaging for direct visualization of lumbar pars defect in children and young adults: a systematic review and meta-analysis. Eur Spine J. 2018 May;27(5):1058-1066. doi: 10.1007/s00586-017-5305-2. Epub 2017 Sep 23.
- Background: PubMed 33844489Takei S, Torii S, Taketomi S, Iwanuma S, Tojima M, Otomo M, Iizuka S, Tanaka S. Is Increased Kicking Leg Iliopsoas Muscle Tightness a Predictive Factor for Developing Spondylolysis in Adolescent Male Soccer Players? Clin J Sport Med. 2022 Mar 1;32(2):e165-e171. doi: 10.1097/JSM.0000000000000920.
- Background: PubMed 36661480Tsutsui T, Iizuka S, Takei S, Maemichi T, Torii S. Risk Factors for Symptomatic Bilateral Lumbar Bone Stress Injury in Adolescent Soccer Players: A Prospective Cohort Study. Am J Sports Med. 2023 Mar;51(3):707-714. doi: 10.1177/03635465221146289. Epub 2023 Jan 20.
- Background: PubMed 32883336Yokoe T, Tajima T, Sugimura H, Kubo S, Nozaki S, Yamaguchi N, Morita Y, Chosa E. Comparison of symptomatic spondylolysis in young soccer and baseball players. J Orthop Surg Res. 2020 Sep 3;15(1):378. doi: 10.1186/s13018-020-01910-4.
- Background: PubMed 16093537El Rassi G, Takemitsu M, Woratanarat P, Shah SA. Lumbar spondylolysis in pediatric and adolescent soccer players. Am J Sports Med. 2005 Nov;33(11):1688-93. doi: 10.1177/0363546505275645. Epub 2005 Aug 10.
- Background: PubMed 31460956Selhorst M, Fischer A, MacDonald J. Prevalence of Spondylolysis in Symptomatic Adolescent Athletes: An Assessment of Sport Risk in Nonelite Athletes. Clin J Sport Med. 2019 Sep;29(5):421-425. doi: 10.1097/JSM.0000000000000546.
- Background: PubMed 36150752Wall J, Meehan WP 3rd, Trompeter K, Gissane C, Mockler D, van Dyk N, Wilson F. Incidence, prevalence and risk factors for low back pain in adolescent athletes: a systematic review and meta-analysis. Br J Sports Med. 2022 Nov;56(22):1299-1306. doi: 10.1136/bjsports-2021-104749. Epub 2022 Sep 23.
- Link to site with current and past reseach projectsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized raw data sheet will be shared upon request or added to submission if required
Related trials for Spondylolysis Lumbar
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rehabilitation protocol in people with Spondylolysis Lumbar, run by Western Norway University of Applied Sciences at 3 sites in Norway.
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 4 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
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 Bård E Bogen, Professor (+4791157142, bard.e.bogen@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in edema on MRI (time frame: Baseline, 3 months and potentially at 6 months.). 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 NCT07430072, which also lists 18 linked publications.
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 6 May 2026.