Groin PainNCT06831630
Comparing the Effects of Holmich Protocol Exercise Therapy and Joint Mobilization Training on Pain, Balance, Function of the Lower Limb, and Muscle Activity in Soccer Players with Athletic Groin Pain.
A study testing Holmich protocol exercise and Joint Mobilization in people with Groin Pain, run by Yeditepe University.
Trial summary
The goal of this clinical trial is comparison the Holmich protocol exercise therapy and joint mobilization training, investigating their respective effects on muscle activity in soccer players with athletic groin pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Groin Pain
- What is being tested?
- Holmich protocol exercise and Joint Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 20 Nov 2025
- 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 18 to 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- between 18-35 years old
- Have a normal body mass index (BMI)
- Desire to return to the former level of sports activity
- groin pain for at least 2 months
- Pain at palpation of the adductor tendons or the insertion of the pubic bone or both; Groin pain during active adduction against resistance (squeeze test); Pain during adduction against resistance had to be less than six*, based on the visual analogue scale (VAS).
- In addition, at least two of the following criteria had to be present: a clear history of groin pain and stiffness in the morning, cough induced or sneeze-induced groin pain, nocturnal groin pain or radiological evidence demonstrating osteitis pubis or pain at the symphysis pubis due to palpation.
Who cannot join
- Receiving physical therapy or other conventional therapy in the past 6 months.
- Absence in one of the pre- or post-test sessions.
- Absence of more than two sessions in practice sessions.
About this study
The goal of this clinical trial is comparison the Holmich protocol exercise therapy and joint mobilization training, investigating their respective effects on muscle activity in soccer players with athletic groin pain.
The main questions it aims to answer are:
Read more
Is there a difference between Holmich protocol exercise therapy and joint mobilization training on pain, balance, function of the lower limb, and Muscle activity in Soccer Players with athletic Groin Pain ?
Researchers will compare Holmich protocol exercise therapy (HT)with joint mobilization training (JMT) to see if the exercises are effective on pain, balance, lower limb function, and muscle activity.
Participants will:
Practice Holmich protocol exercise therapy (HT) three times a week, 90 minutes per session, for 12 weeks.
Practice joint mobilization training (JMT) for 12 weeks.
- Conditions
- Groin Pain
- Being tested
- Holmich protocol exercise, Joint Mobilization
- Keywords
- Holmich protocol, Groin Pain, joint mobilization training, Electromyography, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmich protocol exerciseOther
The treatment consisted of exercise therapy (ET) protocol suggested by Holmich et al and was started under the supervision of a trained sport physiotherapist who ensured that the exercise was carried out correctly and adhered to the original protocol. No treatment other than ET was applied. Although the ET protocol exactly mirrored the randomised clinical trial of Holmich et al, details such as the perceived resistance or weights (in exercise 3 in module 2) and the rest period between the exercise sets and repetitions, which were not defined in the Holmich study, were explained here for the athletes' benefit (tables 1 and 2). Treatment was administered three times a week (on even or odd days). The duration of each session was about 90 min for module 1 (first two weeks) and 120 min for module 2 (from the third week). From the third week, the athletes were asked to perform exercises from module 1 every other day, between the treatment sessions. Although adductor muscle stretching was for
Joint MobilizationOther
Focus of treatment was on reducing hip joint pain using joint mobilization techniques provided by the physical therapist and exercises performed in the HEP. Based on published literature, we developed a standard set of mobilizations to target hip joint motion limitations, defined as stiffness or pain that limited joint range of motion. Joint mobilization techniques were prioritized based on patient-specific tasks and the motion used during those tasks, followed by the hip motion limitations. The choice of joint mobilization techniques and grade used was based on direction of hip motion limitation and the relationship of pain and stiffness during hip motion assessment. The HEP included commonly used joint motion and stretching exercises to complement techniques performed during supervised sessions.
The exercises will be conducted over a period of 12 weeks, which is explained below Techniques will be prioritized based on restrictions noted on baseline examination.
- Caudal glide
- Lat
| Study group | Role | What they receive |
|---|---|---|
| Holmich protocol exercise | Experimental | Not described Receives: Other: Holmich protocol exercise |
| Joint Mobilization | Experimental | Not described Receives: Other: Joint Mobilization |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG
To record electromyographic activity of selected lumbo-pelvic muscles, the skin surface of the participants will be cleansed with alcohol pads and shaved to remove any hair in the designated area. Subsequently, to reduce skin electrical resistance, the skin will be lightly abraded with a soft sandpaper until its color visibly lightens. Surface electrodes, spaced 2 centimeters center-to-center along the muscle fibers, will then be affixed in the direction of the muscle fibers. The selected muscles for the lumbar region include the right rectus abdominis, internal oblique, and multifidus, while for the pelvic region, the iliocostalis lumborum and gluteus medius will be considered. Electrodes will be positioned according to SENIAM protocols for the respective muscles of interest. Proper electrode placement will be verified through manual assessment techniques, and electromyographic signals will be assessed and analyzed.
Measured: From enrollment to the end of treatment at 12 weeks
ESST
The ESST was administered using a version standardized from previous literature. The units of measurement were changed from feet to meters, resulting in a slightly longer course of 4 m in length with four 1 m (3.28 ft) increments. The starting position was changed from the center cone to the far left cone in order to standardize the starting position, and each 1 m increment was marked with a strip of tape and a cone, which allowed for easier scoring of the test. The raters were positioned in front of and behind the participant. The participant began in a standing position behind the far left cone and was instructed not to cross his feet while sidestep ping. On the "go" command, the participant sidestepped to the right until his right foot had touched or crossed the outside cone or tape mark. The participant then side-stepped to the left until his left foot had touched or crossed the left outside cone or tape mark. The participant sidestepped back and forth to the outside cones as rapi
Measured: From enrollment to the end of treatment at 12 weeks
T-TEST
The T-test was set up and administered using the protocol outlined by Semenick (1984). Upon the "Go" command, the sub- jects were instructed to sprint forward 9.10 m (10 yd), touch the cone with their right hand and without crossing their feet, side shuffle 4.55 m (5 yd) to the left, and touch the cone with their left hand. The subject then shuffles to the right 9.10 m (10 yd), touches the cone with their right hand, and returns to the center cone by side shuffling 4.55 m (5 yd). The subject then touches the center cone with their left hand and back pedals 9.10 m (10 yd) through the finish line, ensuring that balance is maintained. The intraclass reliability of the T-test was 0.98 across 3 trials in Pauole study (2000)(110) and 0.88 - 0.95 in Stewart study (2014)(111).
Measured: From enrollment to the end of treatment at 12 weeks
Y balance test
YBT test performance was assessed with a Y Balance Test Kit. Before assessment, participants were acquainted with the Y-Balance Test (YBT) by practicing on their injured limb. The YBT was performed on a platform. Throughout the task, the standing leg remained on the platform, while the other leg executed error-free maximum reach in three directions: anterior, posteromedial, and posterolateral. Maximum distances in each direction, relative to the stance leg, were measured. During the test, participants kept their hands on their waists, and each direction was repeated three times with a 10-second rest between trials.
Measured: From enrollment to the end of treatment at 8 weeks
Groin Pain
Pain was assessed and recorded based on the visual analogue scale (VAS) in the following two situations: (i) pain during the hip adduction against resistance (squeeze test) and (ii) pain during functional tests (the average earned from the two functional tests)(54).
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start20 Apr 2025 (estimated)
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Groin PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831630
- Sponsor's protocol ID
- Farzadyeditepe
- Status last verified
- Jan 2025
- First submitted
- 12 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Publications
Yousefzadeh A, Shadmehr A, Olyaei GR, Naseri N, Khazaeipour Z. Effect of Holmich protocol exercise therapy on long-standing adductor-related groin pain in athletes: an objective evaluation. BMJ Open Sport Exerc Med. 2018 Jun 26;4(1):e000343. doi: 10.1136/bmjsem-2018-000343. eCollection 2018.
PubMed 30018787Tak I PhD, MScPT, Langhout R MMT PT, Bertrand B MScPT, Barendrecht M MPTS, Stubbe J PhD, Kerkhoffs G PhD, MD, Weir A PhD, MBBS. Manual therapy and early return to sport in football players with adductor-related groin pain: A prospective case series. Physiother Theory Pract. 2020 Sep;36(9):1009-1018. doi: 10.1080/09593985.2018.1531096. Epub 2018 Oct 11.
PubMed 30307775Jha S, Bajpai S, Mishra R. The Comparative Study between Active Physical Training versus Active Resistance Training in Groin Pain among Young Gymnasts. Central India Journal of Medical Research. 2023;2(01):8-12.
Harris-Hayes M, Zorn P, Steger-May K, Buss J, Burgess MM, DeMargel RD, et al. Comparison of Joint Mobilization and Movement Pattern Training for Hip-related Groin Pain: Ancillary Analysis to Assess 12 Month Outcomes of a Pilot Randomized Clinical Trial. JOSPT Open. 2024;2(1):1-26.
Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.
PubMed 26031644Verrall GM, Slavotinek JP, Fon GT, Barnes PG. Outcome of conservative management of athletic chronic groin injury diagnosed as pubic bone stress injury. Am J Sports Med. 2007 Mar;35(3):467-74. doi: 10.1177/0363546506295180. Epub 2007 Jan 31.
PubMed 17267768Zeppieri G, Smith MS, Roach RP. Nonsurgical Management of Adductor-related groin pain with Ultrasound-Guided Platelet-Rich Plasma Injection and Physical Therapy in a Competitive Soccer Player: A Case Report. Int J Sports Phys Ther. 2024 Jul 1;19(7):898-909. doi: 10.26603/001c.120209. eCollection 2024.
PubMed 38966832Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.
PubMed 9989713Holmich P. Long-standing groin pain in sportspeople falls into three primary patterns, a "clinical entity" approach: a prospective study of 207 patients. Br J Sports Med. 2007 Apr;41(4):247-52; discussion 252. doi: 10.1136/bjsm.2006.033373. Epub 2007 Jan 29.
PubMed 17261557
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Holmich Protocol Exercise Therapy and Joint Mobilization Training on Pain, Balance, Function of the Lower Limb, and Muscle Activity in Soccer Players with Athletic Groin Pain.
- ClinicalTrials.gov ID
- NCT06831630
- Acronym / sponsor ID
- Farzadyeditepe
- Conditions
- Groin Pain
- Keywords
- Holmich protocol, Groin Pain, joint mobilization training, Electromyography, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
The goal of this clinical trial is comparison the Holmich protocol exercise therapy and joint mobilization training, investigating their respective effects on muscle activity in soccer players with athletic groin pain.
The main questions it aims to answer are:
Is there a difference between Holmich protocol exercise therapy and joint mobilization training on pain, balance, function of the lower limb, and Muscle activity in Soccer Players with athletic Groin Pain ?
Researchers will compare Holmich protocol exercise therapy (HT)with joint mobilization training (JMT) to see if the exercises are effective on pain, balance, lower limb function, and muscle activity.
Participants will:
Practice Holmich protocol exercise therapy (HT) three times a week, 90 minutes per session, for 12 weeks.
Practice joint mobilization training (JMT) for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Holmich protocol exercise | Experimental | Other: Holmich protocol exercise |
| Joint Mobilization | Experimental | Other: Joint Mobilization |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- between 18-35 years old
- Have a normal body mass index (BMI)
- Desire to return to the former level of sports activity
- groin pain for at least 2 months
Key exclusion criteria (3 listed)
- Receiving physical therapy or other conventional therapy in the past 6 months.
- Absence in one of the pre- or post-test sessions.
- Absence of more than two sessions in practice sessions.
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 |
|---|---|---|
| Holmich protocol exerciseThe treatment consisted of exercise therapy (ET) protocol suggested by Holmich et al and was started under the supervision of a trained sport physiotherapist who ensured that the exercise was carried out correctly and adhered to the original protocol. No treatment other than ET was applied. Although the ET protocol exactly mirrored the randomised clinical trial of Holmich et al, details such as the perceived resistance or weights (in exercise 3 in module 2) and the rest period between the exercise sets and repetitions, which were not defined in the Holmich study, were explained here for the athletes' benefit (tables 1 and 2). Treatment was administered three times a week (on even or odd days). The duration of each session was about 90 min for module 1 (first two weeks) and 120 min for module 2 (from the third week). From the third week, the athletes were asked to perform exercises from module 1 every other day, between the treatment sessions. Although adductor muscle stretching was for | Other | Holmich protocol exercise |
| Joint MobilizationFocus of treatment was on reducing hip joint pain using joint mobilization techniques provided by the physical therapist and exercises performed in the HEP. Based on published literature, we developed a standard set of mobilizations to target hip joint motion limitations, defined as stiffness or pain that limited joint range of motion. Joint mobilization techniques were prioritized based on patient-specific tasks and the motion used during those tasks, followed by the hip motion limitations. The choice of joint mobilization techniques and grade used was based on direction of hip motion limitation and the relationship of pain and stiffness during hip motion assessment. The HEP included commonly used joint motion and stretching exercises to complement techniques performed during supervised sessions. The exercises will be conducted over a period of 12 weeks, which is explained below Techniques will be prioritized based on restrictions noted on baseline examination. 1. Caudal glide 2. Lat | Other | Joint Mobilization |
Primary outcome
EMG
Time frame: From enrollment to the end of treatment at 12 weeks
To record electromyographic activity of selected lumbo-pelvic muscles, the skin surface of the participants will be cleansed with alcohol pads and shaved to remove any hair in the designated area. Subsequently, to reduce skin electrical resistance, the skin will be lightly abraded with a soft sandpaper until its color visibly lightens. Surface electrodes, spaced 2 centimeters center-to-center along the muscle fibers, will then be affixed in the direction of the muscle fibers. The selected muscles for the lumbar region include the right rectus abdominis, internal oblique, and multifidus, while for the pelvic region, the iliocostalis lumborum and gluteus medius will be considered. Electrodes will be positioned according to SENIAM protocols for the respective muscles of interest. Proper electrode placement will be verified through manual assessment techniques, and electromyographic signals will be assessed and analyzed.
ESST
Time frame: From enrollment to the end of treatment at 12 weeks
The ESST was administered using a version standardized from previous literature. The units of measurement were changed from feet to meters, resulting in a slightly longer course of 4 m in length with four 1 m (3.28 ft) increments. The starting position was changed from the center cone to the far left cone in order to standardize the starting position, and each 1 m increment was marked with a strip of tape and a cone, which allowed for easier scoring of the test. The raters were positioned in front of and behind the participant. The participant began in a standing position behind the far left cone and was instructed not to cross his feet while sidestep ping. On the "go" command, the participant sidestepped to the right until his right foot had touched or crossed the outside cone or tape mark. The participant then side-stepped to the left until his left foot had touched or crossed the left outside cone or tape mark. The participant sidestepped back and forth to the outside cones as rapi
T-TEST
Time frame: From enrollment to the end of treatment at 12 weeks
The T-test was set up and administered using the protocol outlined by Semenick (1984). Upon the "Go" command, the sub- jects were instructed to sprint forward 9.10 m (10 yd), touch the cone with their right hand and without crossing their feet, side shuffle 4.55 m (5 yd) to the left, and touch the cone with their left hand. The subject then shuffles to the right 9.10 m (10 yd), touches the cone with their right hand, and returns to the center cone by side shuffling 4.55 m (5 yd). The subject then touches the center cone with their left hand and back pedals 9.10 m (10 yd) through the finish line, ensuring that balance is maintained. The intraclass reliability of the T-test was 0.98 across 3 trials in Pauole study (2000)(110) and 0.88 - 0.95 in Stewart study (2014)(111).
Y balance test
Time frame: From enrollment to the end of treatment at 8 weeks
YBT test performance was assessed with a Y Balance Test Kit. Before assessment, participants were acquainted with the Y-Balance Test (YBT) by practicing on their injured limb. The YBT was performed on a platform. Throughout the task, the standing leg remained on the platform, while the other leg executed error-free maximum reach in three directions: anterior, posteromedial, and posterolateral. Maximum distances in each direction, relative to the stance leg, were measured. During the test, participants kept their hands on their waists, and each direction was repeated three times with a 10-second rest between trials.
Groin Pain
Time frame: From enrollment to the end of treatment at 12 weeks
Pain was assessed and recorded based on the visual analogue scale (VAS) in the following two situations: (i) pain during the hip adduction against resistance (squeeze test) and (ii) pain during functional tests (the average earned from the two functional tests)(54).
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 18 Feb 2025.
- Background: PubMed 30018787Yousefzadeh A, Shadmehr A, Olyaei GR, Naseri N, Khazaeipour Z. Effect of Holmich protocol exercise therapy on long-standing adductor-related groin pain in athletes: an objective evaluation. BMJ Open Sport Exerc Med. 2018 Jun 26;4(1):e000343. doi: 10.1136/bmjsem-2018-000343. eCollection 2018.
- Background: PubMed 30307775Tak I PhD, MScPT, Langhout R MMT PT, Bertrand B MScPT, Barendrecht M MPTS, Stubbe J PhD, Kerkhoffs G PhD, MD, Weir A PhD, MBBS. Manual therapy and early return to sport in football players with adductor-related groin pain: A prospective case series. Physiother Theory Pract. 2020 Sep;36(9):1009-1018. doi: 10.1080/09593985.2018.1531096. Epub 2018 Oct 11.
- BackgroundJha S, Bajpai S, Mishra R. The Comparative Study between Active Physical Training versus Active Resistance Training in Groin Pain among Young Gymnasts. Central India Journal of Medical Research. 2023;2(01):8-12.
- BackgroundHarris-Hayes M, Zorn P, Steger-May K, Buss J, Burgess MM, DeMargel RD, et al. Comparison of Joint Mobilization and Movement Pattern Training for Hip-related Groin Pain: Ancillary Analysis to Assess 12 Month Outcomes of a Pilot Randomized Clinical Trial. JOSPT Open. 2024;2(1):1-26.
- Background: PubMed 26031644Delahunt E, Thorborg K, Khan KM, Robinson P, Holmich P, Weir A. Minimum reporting standards for clinical research on groin pain in athletes. Br J Sports Med. 2015 Jun;49(12):775-81. doi: 10.1136/bjsports-2015-094839.
- Background: PubMed 17267768Verrall GM, Slavotinek JP, Fon GT, Barnes PG. Outcome of conservative management of athletic chronic groin injury diagnosed as pubic bone stress injury. Am J Sports Med. 2007 Mar;35(3):467-74. doi: 10.1177/0363546506295180. Epub 2007 Jan 31.
- Background: PubMed 38966832Zeppieri G, Smith MS, Roach RP. Nonsurgical Management of Adductor-related groin pain with Ultrasound-Guided Platelet-Rich Plasma Injection and Physical Therapy in a Competitive Soccer Player: A Case Report. Int J Sports Phys Ther. 2024 Jul 1;19(7):898-909. doi: 10.26603/001c.120209. eCollection 2024.
- Background: PubMed 9989713Holmich P, Uhrskou P, Ulnits L, Kanstrup IL, Nielsen MB, Bjerg AM, Krogsgaard K. Effectiveness of active physical training as treatment for long-standing adductor-related groin pain in athletes: randomised trial. Lancet. 1999 Feb 6;353(9151):439-43. doi: 10.1016/S0140-6736(98)03340-6.
- Background: PubMed 17261557Holmich P. Long-standing groin pain in sportspeople falls into three primary patterns, a "clinical entity" approach: a prospective study of 207 patients. Br J Sports Med. 2007 Apr;41(4):247-52; discussion 252. doi: 10.1136/bjsm.2006.033373. Epub 2007 Jan 29.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Holmich protocol exercise and Joint Mobilization in people with Groin Pain, run by Yeditepe University.
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 3 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 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
EMG (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 5 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 NCT06831630, which also lists 9 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 18 Feb 2025.