Osteoarthritis, KneePhase 3EMSOATNCT05672264
Whole-Body Electromyostimulation and Knee Osteoarthritis
A Phase 3 study testing Whole-Body Electromyostimulation and Physiotherapy in people with Osteoarthritis, Knee, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Whole-Body Electromyostimulation and Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2022to 1 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight (BMI>25 kg/m2)
- radiographically confirmed early to moderate femorotibial osteoarthritis (Kellgren- Lawrence grades 2 and 3)
- osteoarthritic knee pain for at least 3 months
- average pain intensity > 2.5 (NRS 0-10)
Who cannot join
- WB-EMS in the last year or resistance exercise >1 session/week in the last year
- present glucocorticoid or opioid medication
- trauma of the knee joint within the last 3 months
- intra-articular injections in the knee joint within the last 3 months
- malignant diseases
- serious cardiovascular diseases
- conditions or diseases that are contraindications for WB-EMS
- absence ≥3 weeks during the intervention period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial
The aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
Read the detailed description
Studies consistently show a positive effect of strength training on pain and function in knee osteoarthritis. In addition to local neuromuscular effects, systemic mechanisms that modulate inflammatory processes are increasingly being discussed as mechanisms of action. Overweight and obesity might be involved in this process. Despite high evidence, unfortunately only few people with osteoarthritic knee pain are willing or able to perform conventional muscular strength training on a regular basis. In this context, whole-body electromyostimulation (WB-EMS) is a time-efficient, joint-friendly and subjectively less strenuous training alternative. In WB-EMS, all large muscle groups of the body are simultaneously activated and brought to contraction by electrical impulses. Together with easy movements with minor mechanical stress on the knee joint, the additive WB-EMS activates muscle contraction and results in measurable muscular effects.
The aim of the present study is to evaluate the effects of a 6-month WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial (RCT) 72 overweight patients (BMI >25 kg/m2) with knee osteoarthritis (radiographic severity Kellgren-Lawrence 2 and 3) aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol (85 Hz, 350 µs) with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
At baseline, after 6 months of intervention and after a further 6 months of follow-up, knee pain and function will be determined by the KOOS instrument (Knee Injury and Osteoarthritis Outcome Score). Functional tests and isokinetic leg strength measurements will also be performed. In parallel, MRI assessments are applied to quantify effects on joint structure (whole organ assessment; MRI Osteoarthritis Knee Score (MOAKS)) and visceral fat as well as muscle quality changes at the mid-thigh. Whole body composition analyses are performed using segmental whole-body bioimpedance analysis (BIA) for quantification of body fat and fat-free mass. Blood samples are obtained at baseline, 6 and 12 months to determine inflammatory biomarkers (CRP, IL-1beta, MMP-3) and cartilage formation (PIINP).
The study will provide evidence and detailed insights of the WB-EMS induced effects on pain, function, muscle structure and strength, body composition, joint tissues and anti-inflammatory effects in knees with osteoarthritis. From a clinical perspective, the study will provide important information regarding a promising non-pharmacological therapeutic approach for the treatment of knee osteoarthritis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Whole-Body Electromyostimulation, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body ElectromyostimulationOther
Consistently supervised, video-guided WB-EMS application 1.5 times per week for 28 weeks. Bipolar electric current with a frequency of 85Hz, an impulse-width of 350 µs will be used in an interval approach with 6 sec of EMS stimulation with a direct impulse boost and 4 sec of rest. Low intensity movements or exercises in a standing position were performed during the 6 s stimulation period.
PhysiotherapyOther
Six standardised physiotherapy sessions (20 min each)
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS group | Experimental | WB-EMS application Receives: Other: Whole-Body Electromyostimulation |
| Control | Active comparator | Standardised physiotherapy (six sessions) Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Changes in pain of the knee joint as determined by the Knee Injury and Osteoarthritis Outcome Score (KOOS) in the WB-EMS- compared to changes in the control group.KOOS score for "knee pain" vary from 1 (never/no pain) to 5 (always/very severe pain)
Measured: baseline to 6 month follow up
Secondary outcomes (18)
Self rated symptoms
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension "self-rated symptoms" in the WB-EMS- compared to changes in the control group. KOOS score for "self related symptoms" vary from 1 (never) to 5 (always).
Measured: baseline to 6-month follow-up
Knee stiffness
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension "knee stiffness" in the WB-EMS- compared to changes in the control group. KOOS score for "knee stiffness" vary from 1 (no problems) to 5 (very hard).
Measured: baseline to 6-month follow-up
Function in daily living
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension "function in daily living" in the WB-EMS- compared to changes in the control group. KOOS score for "function in daily living" vary from 1 (no problems) to 5 (very serious problems).
Measured: baseline to 6-month follow-up
Function in sports and recreational activities
Changes in Knee Injury and Osteoarthritis Outcome Score Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension "function in sports and recreational activities" in the WB-EMS- compared to changes in the control group. KOOS score for "function in sports and recreational activities" vary from 1 (no problems) to 5 (very serious problems).
Measured: baseline to 6-month follow-up
Quality of Life
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)-dimension "quality of life" in the WB-EMS- compared to changes in the control group. KOOS score for "quality of life vary" from 1 (never/no problems) to 5 (always/very serious problems).
Measured: baseline to 6-month follow-up
Total Knee Injury and Osteoarthritis Outcome Score (KOOS) score
Changes in total KOOS-score in the WB-EMS- compared to changes in the control group. Average total KOOS score vary" from 1 (never/no problems) to 5 (always/very serious problems).
Measured: baseline to 6-month follow-up
Pain intensity of the knee
Changes in pain intensity of the knee as determined by a 7-day knee pain protocol (applying the NRS 0-10 scale) in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Joint and cartilage structure
Changes in joint and cartilage structure as determined by the MRI Osteoarthritis Knee Score (MOAKS) in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Intrafascial muscle tissue at the mid-thigh
Changes in volume adjusted intrafascial muscle tissue volume (MT) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Intermuscular adipose tissue at the mid-thigh
Changes in volume adjusted intermuscular adipose tissue (IMAT) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Intrafascial fat fraction at the mid-thigh
Changes in volume adjusted intrafascial fat fraction (IFFF) at the mid-thigh, as determined by MRI in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Visceral fat mass
Changes in visceral fat mass as determined by determined by MRI in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
C-reactive Protein (CRP)
Changes in CRP-levels in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Interleukin 1beta (IL1beta)
Changes in IL1beta-levels in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Matrix metalloprotease 3 (MMP-3)
Changes in MMP-3 levels in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Serum N-terminal pro-peptide of collagen IIA (PIINP)
Changes in PIINP levels in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Maximum strength of the hip-/leg extensors
Changes in maximum strength of the hip-/leg extensors as determined by an isokinetic leg press in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Chair Rise Test
Changes in the 30-second Chair Rise Test in the WB-EMS- compared to changes in the control group.
Measured: baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Jun 2022
- Primary completion31 Oct 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Kast, MSc, Principal investigator, Institute of Radiology, University Hospital-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672264
- Sponsor's protocol ID
- UKER_EMS_Knee
- Acronym
- EMSOAT
- Status last verified
- Dec 2022
- First submitted
- 2 Jan 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kemmler W, Kleinoder H, Frohlich M. Editorial: Whole-body electromyostimulation: A training technology to improve health and performance in humans? volume II. Front Physiol. 2022 Aug 5;13:972011. doi: 10.3389/fphys.2022.972011. eCollection 2022. No abstract available.
PubMed 36111142Bloeckl J, Raps S, Weineck M, Kob R, Bertsch T, Kemmler W, Schoene D. Feasibility and Safety of Whole-Body Electromyostimulation in Frail Older People-A Pilot Trial. Front Physiol. 2022 Jun 24;13:856681. doi: 10.3389/fphys.2022.856681. eCollection 2022.
PubMed 35812334Kemmler W, Shojaa M, Steele J, Berger J, Frohlich M, Schoene D, von Stengel S, Kleinoder H, Kohl M. Efficacy of Whole-Body Electromyostimulation (WB-EMS) on Body Composition and Muscle Strength in Non-athletic Adults. A Systematic Review and Meta-Analysis. Front Physiol. 2021 Feb 26;12:640657. doi: 10.3389/fphys.2021.640657. eCollection 2021.
PubMed 33716787
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05672264
- Acronym / sponsor ID
- EMSOAT / UKER_EMS_Knee
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Jan 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 aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
Detailed description
Studies consistently show a positive effect of strength training on pain and function in knee osteoarthritis. In addition to local neuromuscular effects, systemic mechanisms that modulate inflammatory processes are increasingly being discussed as mechanisms of action. Overweight and obesity might be involved in this process. Despite high evidence, unfortunately only few people with osteoarthritic knee pain are willing or able to perform conventional muscular strength training on a regular basis. In this context, whole-body electromyostimulation (WB-EMS) is a time-efficient, joint-friendly and subjectively less strenuous training alternative. In WB-EMS, all large muscle groups of the body are simultaneously activated and brought to contraction by electrical impulses. Together with easy movements with minor mechanical stress on the knee joint, the additive WB-EMS activates muscle contraction and results in measurable muscular effects.
The aim of the present study is to evaluate the effects of a 6-month WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial (RCT) 72 overweight patients (BMI >25 kg/m2) with knee osteoarthritis (radiographic severity Kellgren-Lawrence 2 and 3) aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol (85 Hz, 350 µs) with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
At baseline, after 6 months of intervention and after a further 6 months of follow-up, knee pain and function will be determined by the KOOS instrument (Knee Injury and Osteoarthritis Outcome Score). Functional tests and isokinetic leg strength measurements will also be performed. In parallel, MRI assessments are applied to quantify effects on joint structure (whole organ assessment; MRI Osteoarthritis Knee Score (MOAKS)) and visceral fat as well as muscle quality changes at the mid-thigh. Whole body composition analyses are performed using segmental whole-body bioimpedance analysis (BIA) for quantification of body fat and fat-free mass. Blood samples are obtained at baseline, 6 and 12 months to determine inflammatory biomarkers (CRP, IL-1beta, MMP-3) and cartilage formation (PIINP).
The study will provide evidence and detailed insights of the WB-EMS induced effects on pain, function, muscle structure and strength, body composition, joint tissues and anti-inflammatory effects in knees with osteoarthritis. From a clinical perspective, the study will provide important information regarding a promising non-pharmacological therapeutic approach for the treatment of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WB-EMS group | Experimental | Other: Whole-Body ElectromyostimulationWB-EMS application |
| Control | Active comparator | Other: PhysiotherapyStandardised physiotherapy (six sessions) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- overweight (BMI>25 kg/m2)
- radiographically confirmed early to moderate femorotibial osteoarthritis (Kellgren- Lawrence grades 2 and 3)
- osteoarthritic knee pain for at least 3 months
- average pain intensity > 2.5 (NRS 0-10)
Key exclusion criteria (8 listed)
- WB-EMS in the last year or resistance exercise >1 session/week in the last year
- present glucocorticoid or opioid medication
- trauma of the knee joint within the last 3 months
- intra-articular injections in the knee joint within the last 3 months
- malignant diseases
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 |
|---|---|---|
| Whole-Body ElectromyostimulationConsistently supervised, video-guided WB-EMS application 1.5 times per week for 28 weeks. Bipolar electric current with a frequency of 85Hz, an impulse-width of 350 µs will be used in an interval approach with 6 sec of EMS stimulation with a direct impulse boost and 4 sec of rest. Low intensity movements or exercises in a standing position were performed during the 6 s stimulation period. | Other | WB-EMS group |
| PhysiotherapySix standardised physiotherapy sessions (20 min each) | Other | Control |
Primary outcome
Knee pain
Time frame: baseline to 6 month follow up
Changes in pain of the knee joint as determined by the Knee Injury and Osteoarthritis Outcome Score (KOOS) in the WB-EMS- compared to changes in the control group.KOOS score for "knee pain" vary from 1 (never/no pain) to 5 (always/very severe pain)
18 secondary outcomes
Self rated symptoms
Time frame: baseline to 6-month follow-up
Knee stiffness
Time frame: baseline to 6-month follow-up
Function in daily living
Time frame: baseline to 6-month follow-up
Function in sports and recreational activities
Time frame: baseline to 6-month follow-up
Quality of Life
Time frame: baseline to 6-month follow-up
Total Knee Injury and Osteoarthritis Outcome Score (KOOS) score
Time frame: baseline to 6-month follow-up
Pain intensity of the knee
Time frame: baseline to 6-month follow-up
Joint and cartilage structure
Time frame: baseline to 6-month follow-up
Intrafascial muscle tissue at the mid-thigh
Time frame: baseline to 6-month follow-up
Intermuscular adipose tissue at the mid-thigh
Time frame: baseline to 6-month follow-up
Intrafascial fat fraction at the mid-thigh
Time frame: baseline to 6-month follow-up
Visceral fat mass
Time frame: baseline to 6-month follow-up
C-reactive Protein (CRP)
Time frame: baseline to 6-month follow-up
Interleukin 1beta (IL1beta)
Time frame: baseline to 6-month follow-up
Matrix metalloprotease 3 (MMP-3)
Time frame: baseline to 6-month follow-up
Serum N-terminal pro-peptide of collagen IIA (PIINP)
Time frame: baseline to 6-month follow-up
Maximum strength of the hip-/leg extensors
Time frame: baseline to 6-month follow-up
Chair Rise Test
Time frame: baseline to 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 36111142Kemmler W, Kleinoder H, Frohlich M. Editorial: Whole-body electromyostimulation: A training technology to improve health and performance in humans? volume II. Front Physiol. 2022 Aug 5;13:972011. doi: 10.3389/fphys.2022.972011. eCollection 2022. No abstract available.
- Results publication: PubMed 35812334Bloeckl J, Raps S, Weineck M, Kob R, Bertsch T, Kemmler W, Schoene D. Feasibility and Safety of Whole-Body Electromyostimulation in Frail Older People-A Pilot Trial. Front Physiol. 2022 Jun 24;13:856681. doi: 10.3389/fphys.2022.856681. eCollection 2022.
- Results publication: PubMed 33716787Kemmler W, Shojaa M, Steele J, Berger J, Frohlich M, Schoene D, von Stengel S, Kleinoder H, Kohl M. Efficacy of Whole-Body Electromyostimulation (WB-EMS) on Body Composition and Muscle Strength in Non-athletic Adults. A Systematic Review and Meta-Analysis. Front Physiol. 2021 Feb 26;12:640657. doi: 10.3389/fphys.2021.640657. eCollection 2021.
- 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.
Stephanie Kast, MSc principal investigator
Institute of Radiology, University Hospital-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole-Body Electromyostimulation and Physiotherapy in people with Osteoarthritis, Knee, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 8 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: baseline to 6 month follow up). 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 NCT05672264, which also lists 3 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 8 May 2024.