Hamstring ContracturesNCT05931120
Comparison of Dry Needling and IASTM on Hamstring Tightness in Posterior Pelvic Tilt
A study testing Dry needling and IASTM in people with Hamstring Contractures, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on pain, range of motion, lower extremity functional status on hamstring tightness in patients with posterior pelvic tilt. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Dry needling and IASTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 8 May 2023to 8 Feb 2024
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lack of greater or equal to 20 degrees of supine active knee extension
- Passive SLR less or equal to 75 degrees
- Atraumatic back or knee pain greater or equal to 2 weeks
- Individuals willing to participate in the required treatment sessions and follow-up assessments
- Posterior pelvic tilt 8.9 standard deviation of 4.5 degree
Who cannot join
- History of herniated lumbar disc/radiculopathy
- Prior surgery in the hip, knee, or back
- Self-reported pregnancy
- History of blood borne pathogens/infectious disease/active infection
- Metal allergy
- Positive instability tests indicative of ligamentous tear
- Positive meniscal tests
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
DHQ Nankana sahib
Nankana Sahib, Punjab Province, 39100
Roman Aslam, 0322-6907144
Urooj Manzoor, MS(OMPT)
About this study
Official title: Comparative Effects of Dry Needling and Instrument Assisted Soft Tissue Mobilization on Hamstring Tightness in Patients With Posterior Pelvic Tilt.
The purpose of the study is to compare the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on pain, range of motion, lower extremity functional status on hamstring tightness in patients with posterior pelvic tilt.
Read the detailed description
A study conducted analyzed the effects of a 3-week combined treatment using transcutaneous electrical nerve stimulation (TENS) and instrument-assisted soft tissue mobilization (IASTM) on chronic back pain. The findings showed that this short-term combined treatment led to reduced pain levels and improved motor function in Chronic low back pain (CLBP) patients. These results suggest that TENS and IASTM could be beneficial as a complementary approach for managing chronic low back pain.
In a randomized trial which shows the results by comparing the efficacy of dry needling (DN) and Graston techniques (GR) in treating upper trapezius myofascial trigger points. Both interventions, were administered twice a week for 2 weeks and when combined with conventional treatment and home exercises, showed significant improvements. However, DN demonstrated superior outcomes in terms of the myofascial diagnostic scale, neck disability index, pain rating, and cervical range of motion. These findings highlight the effectiveness of DN in targeting trigger points and optimizing clinical outcomes.
A notable lacuna persists in the literature concerning the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on patients diagnosed with hamstring tightness and concurrent posterior pelvic tilt. The dearth of comparative research, inadequate incorporation of comprehensive outcome measures, and the paucity of studies targeting this specific patient cohort contribute to this research gap. Addressing this gap would yield valuable insights into the comparative efficacies and outcomes of DN and IASTM pertaining to pain modulation, range of motion enhancement and optimization of lower extremity functional status in this distinct population subset.
- Conditions
- Hamstring Contractures
- Being tested
- Dry needling, IASTM
- Keywords
- dry needling, Hamstring tightness, IASTM, Posterior pelvic tilt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
dry needling using 50mm or 60mm sized needles based on individual muscle bulk. Targeted dry needling will be performed on the muscles presenting with tight hamstrings. hurdler Hamstring stretch, extended triangular pose 10 repetitions, 3 sets per session and 2 sessions per week for 4weeks.
total 8 sessions , each consisting of 40mins
IASTMDevice
Instrument assisted soft tissue mobilization tools targeting tight hamstrings. hurdler Hamstring stretch, extended triangular pose 10 repetitions, 3 sets per session and 2 sessions per week for 4weeks.
total 8 sessions , each consisting of 40mins
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | dry needling with multimodal physical therapy approach containing hurdler stretch and extended triangular pose Receives: Device: Dry needling |
| IASTM | Experimental | IASTM with multimodal physical therapy approach containing hurdler stretch and extended triangular pose Receives: Device: IASTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROM( Posterior pelvic tilt)
The pelvic tilt is the angle between the horizontal plan and a line drawn from the anterior superior iliac spine (ASIS) to the posterior superior iliac spine (PSIS) in quiet standing. The average ranges of anterior and posterior pelvic tilting are 13.0 ± 4.9°, and 8.9 ± 4.5°,
Measured: 4th week
ROM(AKE)
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.The subject is positioned on the examination table in supine, the lower limb that is'nt examined is positioned in stabilised on the support surface. The opposite limb is elevated so that the hip is in 90degrees of flexion and the knees are extended to reach a position perpendicular to the ground. A lag of 20degrees is considered normal from full extension, anything less than 20degrees is considered as hamstrings tightness. This range needs to be measure using a digital inclinometer
Measured: 4th week
ROM(SLR)
The straight leg raise or straight leg lift is a hamstring muscle flexibility test. While the subject is lying on their back, the straight leg is raised as far as possible, and the angle of the leg from the horizontal is measured.
The straight leg raise test measures hamstring tightness. Restricted flexibility in the hamstrings will contribute to lower back, pelvis, hip, and knee malalignment. The straight leg raise test focuses on proximal hamstring tightness. The test is performed passively.
Measured: 4th week
Secondary outcomes (1)
Numeric pain rating scale
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start8 May 2023
- Primary completion8 Feb 2024 (estimated)
- Study completion8 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hamstring ContracturesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, phD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931120
- Sponsor's protocol ID
- REC/RCR & AHS/23/0149
- Status last verified
- Jan 2024
- First submitted
- 26 Jun 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allam NM, Eladl HM, Elruwaili LT, Elruwaili LF, Elbenya TJ, Elanzi EM, Elquobisi FF, Elgadoa HM, Elghaleb MA, Elsaeid MS, Elquarenes RA, Elrashed SM, Elmobarak SS, Elkholi SM, Eid MM, Alanazi AM, Nambi G, Abdelbasset WK. Correlation between hamstring muscle tightness and incidence of low back pain in female students at Jouf University, Saudi Arabia. Eur Rev Med Pharmacol Sci. 2022 Nov;26(21):7779-7787. doi: 10.26355/eurrev_202211_30127.
PubMed 36394725Dhingani M, Mody V. Short Term Effects of Remote Myofascial Release versus Mulligan's Bent Leg Raise on Hamstring and Lumbar Spine Flexibility in College Going Students: An Experimental Study. Indian Journal of Physiotherapy & Occupational Therapy Print-(ISSN 0973-5666) and Electronic-(ISSN 0973-5674). 2022;16(2):106-13.
Suhail M, Prakash A, Sonali D, Sangeeta M. Effectiveness of dynamic soft tissue mobilization vs passive stretching to improve hamstring flexibility in stroke patients-A comparative study. 2022.
Raza A, Haq K, Naveed J, Ali S, Rizwan I. Immediate effects of post facilitation stretch technique on straight leg raise with/without thoraco-lumber direct myofacial release in non-symptomatic adults. The Rehabilitation Journal. 2022;6(04):462-7.
Sathe SS, Rajandekar T, Thodge K, Gawande V. Comparison between immediate effects of MET and passive stretching techniques on hamstring flexibility in patients with hamstring tightness: An experimental study. Indian Journal of Forensic Medicine & Toxicology. 2020;14(4):6857-62.
Ansari NN, Alaei P, Naghdi S, Fakhari Z, Komesh S, Dommerholt J. Immediate Effects of Dry Needling as a Novel Strategy for Hamstring Flexibility: A Single-Blinded Clinical Pilot Study. J Sport Rehabil. 2020 Feb 1;29(2):156-161. doi: 10.1123/jsr.2018-0013.
PubMed 30526283Noreen A, Rashad A, Naeem F, Intikhab R, Angela C, Sonia A, et al. Comparative effect of graston technique and muscle energy technique on the flexibility of hamstring muscle. International Journal of Clinical Skills. 2022;16(8):255.
Clark NG. The Neurophysiological Effects of Dry Needling to the Thoracolumbar Junction Multifidi in Subjects with Low Back Pain and Decreased Hamstring Length: Nova Southeastern University; 2020.
Kim YK, Cho SY, Lee KH. Effects of transcutaneous electrical nerve stimulation and instrument-assisted soft tissue mobilization combined treatment on chronic low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(5):895-902. doi: 10.3233/BMR-200369.
PubMed 34092603Vicente-Mampel J, Bautista IJ, Lopez-Soler J, Torregrosa-Valls J, Falaguera-Vera F, Gargallo P, Baraja-Vegas L. Acute effects of self-myofascial release compared to dry needling on myofascial pain syndrome related outcomes: Range of motion, muscle soreness and performance. A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:632-639. doi: 10.1016/j.jbmt.2024.04.005. Epub 2024 Apr 10.
PubMed 39593656Osailan A, Jamaan A, Talha K, Alhndi M. Instrument assisted soft tissue mobilization (IASTM) versus stretching: A comparison in effectiveness on hip active range of motion, muscle torque and power in people with hamstring tightness. J Bodyw Mov Ther. 2021 Jul;27:200-206. doi: 10.1016/j.jbmt.2021.03.001. Epub 2021 Mar 11.
PubMed 34391234羅佳安. The Effects of Dry Needling on Gait Patterns in Subjects with Hamstring Muscle Fatigue 2021.
Sanchez-Infante J, Navarro-Santana MJ, Bravo-Sanchez A, Jimenez-Diaz F, Abian-Vicen J. Is Dry Needling Applied by Physical Therapists Effective for Pain in Musculoskeletal Conditions? A Systematic Review and Meta-Analysis. Phys Ther. 2021 Mar 3;101(3):pzab070. doi: 10.1093/ptj/pzab070.
PubMed 33609356Haq K, Riaz H. Comparison of dry needling and Graston technique on Active Myofascial trigger points in upper trapezius. Rawal Medical Journal. 2022;47(1):129-.
Chintamani R, Metgud S, Heggannavar A. Short term effects of instrument assisted soft tissuemobilisation technique versus Mulligan's bent leg raise technique in asymptomatic subjects with hamstring tightness-a randomised clinical trial. Int J Health Sci Res. 2019;9:50-64.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Dry Needling and Instrument Assisted Soft Tissue Mobilization on Hamstring Tightness in Patients With Posterior Pelvic Tilt.
- ClinicalTrials.gov ID
- NCT05931120
- Acronym / sponsor ID
- REC/RCR & AHS/23/0149
- Conditions
- Hamstring Contractures
- Keywords
- dry needling, Hamstring tightness, IASTM, Posterior pelvic tilt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 8 Feb 2024 (estimated)
- Study completion
- 8 Feb 2024 (estimated)
- First posted
- 5 Jul 2023 (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 purpose of the study is to compare the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on pain, range of motion, lower extremity functional status on hamstring tightness in patients with posterior pelvic tilt.
Detailed description
A study conducted analyzed the effects of a 3-week combined treatment using transcutaneous electrical nerve stimulation (TENS) and instrument-assisted soft tissue mobilization (IASTM) on chronic back pain. The findings showed that this short-term combined treatment led to reduced pain levels and improved motor function in Chronic low back pain (CLBP) patients. These results suggest that TENS and IASTM could be beneficial as a complementary approach for managing chronic low back pain.
In a randomized trial which shows the results by comparing the efficacy of dry needling (DN) and Graston techniques (GR) in treating upper trapezius myofascial trigger points. Both interventions, were administered twice a week for 2 weeks and when combined with conventional treatment and home exercises, showed significant improvements. However, DN demonstrated superior outcomes in terms of the myofascial diagnostic scale, neck disability index, pain rating, and cervical range of motion. These findings highlight the effectiveness of DN in targeting trigger points and optimizing clinical outcomes.
A notable lacuna persists in the literature concerning the effects of dry needling (DN) and instrument-assisted soft tissue mobilization (IASTM) on patients diagnosed with hamstring tightness and concurrent posterior pelvic tilt. The dearth of comparative research, inadequate incorporation of comprehensive outcome measures, and the paucity of studies targeting this specific patient cohort contribute to this research gap. Addressing this gap would yield valuable insights into the comparative efficacies and outcomes of DN and IASTM pertaining to pain modulation, range of motion enhancement and optimization of lower extremity functional status in this distinct population subset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Device: Dry needlingdry needling with multimodal physical therapy approach containing hurdler stretch and extended triangular pose |
| IASTM | Experimental | Device: IASTMIASTM with multimodal physical therapy approach containing hurdler stretch and extended triangular pose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Lack of greater or equal to 20 degrees of supine active knee extension
- Passive SLR less or equal to 75 degrees
- Atraumatic back or knee pain greater or equal to 2 weeks
- Individuals willing to participate in the required treatment sessions and follow-up assessments
- Posterior pelvic tilt 8.9 standard deviation of 4.5 degree
Key exclusion criteria (7 listed)
- History of herniated lumbar disc/radiculopathy
- Prior surgery in the hip, knee, or back
- Self-reported pregnancy
- History of blood borne pathogens/infectious disease/active infection
- Metal allergy
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 |
|---|---|---|
| Dry needlingdry needling using 50mm or 60mm sized needles based on individual muscle bulk. Targeted dry needling will be performed on the muscles presenting with tight hamstrings. hurdler Hamstring stretch, extended triangular pose 10 repetitions, 3 sets per session and 2 sessions per week for 4weeks. total 8 sessions , each consisting of 40mins | Device | Dry needling |
| IASTMInstrument assisted soft tissue mobilization tools targeting tight hamstrings. hurdler Hamstring stretch, extended triangular pose 10 repetitions, 3 sets per session and 2 sessions per week for 4weeks. total 8 sessions , each consisting of 40mins | Device | IASTM |
Primary outcome
ROM( Posterior pelvic tilt)
Time frame: 4th week
The pelvic tilt is the angle between the horizontal plan and a line drawn from the anterior superior iliac spine (ASIS) to the posterior superior iliac spine (PSIS) in quiet standing. The average ranges of anterior and posterior pelvic tilting are 13.0 ± 4.9°, and 8.9 ± 4.5°,
ROM(AKE)
Time frame: 4th week
The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.The subject is positioned on the examination table in supine, the lower limb that is'nt examined is positioned in stabilised on the support surface. The opposite limb is elevated so that the hip is in 90degrees of flexion and the knees are extended to reach a position perpendicular to the ground. A lag of 20degrees is considered normal from full extension, anything less than 20degrees is considered as hamstrings tightness. This range needs to be measure using a digital inclinometer
ROM(SLR)
Time frame: 4th week
The straight leg raise or straight leg lift is a hamstring muscle flexibility test. While the subject is lying on their back, the straight leg is raised as far as possible, and the angle of the leg from the horizontal is measured. The straight leg raise test measures hamstring tightness. Restricted flexibility in the hamstrings will contribute to lower back, pelvis, hip, and knee malalignment. The straight leg raise test focuses on proximal hamstring tightness. The test is performed passively.
1 secondary outcome
Numeric pain rating scale
Time frame: 4th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 36394725Allam NM, Eladl HM, Elruwaili LT, Elruwaili LF, Elbenya TJ, Elanzi EM, Elquobisi FF, Elgadoa HM, Elghaleb MA, Elsaeid MS, Elquarenes RA, Elrashed SM, Elmobarak SS, Elkholi SM, Eid MM, Alanazi AM, Nambi G, Abdelbasset WK. Correlation between hamstring muscle tightness and incidence of low back pain in female students at Jouf University, Saudi Arabia. Eur Rev Med Pharmacol Sci. 2022 Nov;26(21):7779-7787. doi: 10.26355/eurrev_202211_30127.
- BackgroundDhingani M, Mody V. Short Term Effects of Remote Myofascial Release versus Mulligan's Bent Leg Raise on Hamstring and Lumbar Spine Flexibility in College Going Students: An Experimental Study. Indian Journal of Physiotherapy & Occupational Therapy Print-(ISSN 0973-5666) and Electronic-(ISSN 0973-5674). 2022;16(2):106-13.
- BackgroundSuhail M, Prakash A, Sonali D, Sangeeta M. Effectiveness of dynamic soft tissue mobilization vs passive stretching to improve hamstring flexibility in stroke patients-A comparative study. 2022.
- BackgroundRaza A, Haq K, Naveed J, Ali S, Rizwan I. Immediate effects of post facilitation stretch technique on straight leg raise with/without thoraco-lumber direct myofacial release in non-symptomatic adults. The Rehabilitation Journal. 2022;6(04):462-7.
- BackgroundSathe SS, Rajandekar T, Thodge K, Gawande V. Comparison between immediate effects of MET and passive stretching techniques on hamstring flexibility in patients with hamstring tightness: An experimental study. Indian Journal of Forensic Medicine & Toxicology. 2020;14(4):6857-62.
- Background: PubMed 30526283Ansari NN, Alaei P, Naghdi S, Fakhari Z, Komesh S, Dommerholt J. Immediate Effects of Dry Needling as a Novel Strategy for Hamstring Flexibility: A Single-Blinded Clinical Pilot Study. J Sport Rehabil. 2020 Feb 1;29(2):156-161. doi: 10.1123/jsr.2018-0013.
- BackgroundNoreen A, Rashad A, Naeem F, Intikhab R, Angela C, Sonia A, et al. Comparative effect of graston technique and muscle energy technique on the flexibility of hamstring muscle. International Journal of Clinical Skills. 2022;16(8):255.
- BackgroundClark NG. The Neurophysiological Effects of Dry Needling to the Thoracolumbar Junction Multifidi in Subjects with Low Back Pain and Decreased Hamstring Length: Nova Southeastern University; 2020.
- Background: PubMed 34092603Kim YK, Cho SY, Lee KH. Effects of transcutaneous electrical nerve stimulation and instrument-assisted soft tissue mobilization combined treatment on chronic low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(5):895-902. doi: 10.3233/BMR-200369.
- Background: PubMed 39593656Vicente-Mampel J, Bautista IJ, Lopez-Soler J, Torregrosa-Valls J, Falaguera-Vera F, Gargallo P, Baraja-Vegas L. Acute effects of self-myofascial release compared to dry needling on myofascial pain syndrome related outcomes: Range of motion, muscle soreness and performance. A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:632-639. doi: 10.1016/j.jbmt.2024.04.005. Epub 2024 Apr 10.
- Background: PubMed 34391234Osailan A, Jamaan A, Talha K, Alhndi M. Instrument assisted soft tissue mobilization (IASTM) versus stretching: A comparison in effectiveness on hip active range of motion, muscle torque and power in people with hamstring tightness. J Bodyw Mov Ther. 2021 Jul;27:200-206. doi: 10.1016/j.jbmt.2021.03.001. Epub 2021 Mar 11.
- Background羅佳安. The Effects of Dry Needling on Gait Patterns in Subjects with Hamstring Muscle Fatigue 2021.
- Individual participant dataSharing planned: No
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.
Saba Rafique, phD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and IASTM in people with Hamstring Contractures, run by Riphah International University at 1 site in Pakistan.
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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact imran amjad, phD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROM( Posterior pelvic tilt) (time frame: 4th week). The study lists 3 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 NCT05931120, which also lists 23 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 30 Jan 2024.