Low Back PainNCT06552962
Effects of Whole Body Vibrationin in Patients With Non-Specific Low Back Pain
A study testing Whole body vibration and lumbar stabilization exercises in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
After acute low back pain, one third of patients have chronic low back pain. A sedentary lifestyle is a leading cause of mechanical stress-related low back pain and exacerbates chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain, Postural
- What is being tested?
- Whole body vibration and lumbar stabilization exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2024to 6 Feb 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being diagnosed with Non-Specific low back pain by a physician,
- Having a complaint of non-specific low back pain for at least 3 months,
- Being 18 years or older,
- Volunteer,
- Not having any diagnosed cardiac disease,
- Not having any diagnosed neuromuscular disease,
Show all 9Show fewer
- Pain level should be at least 3 according to VAS,
- Not having received physiotherapy or rehabilitation in the last 3 months
- Individuals who meet the above criteria will be included in the study.
Who cannot join
- Diagnosed stomach, kidney, liver, pancreas and bladder problems,
- Presence of mental or cognitive problems,
- History of surgery for low back pain,
- Pain level is 8 or above according to Visual Analogue Scale,
- Use of painkillers during treatment,
- Acute and severe musculoskeletal pain,
Show all 12Show fewer
- Radiculopathy,
- Malignancy,
- Pregnancy,
- Pace maker users,
- Epilepsy,
- Individuals meeting the above criteria will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole Body Vibration on Pain, Function and Viscoelasticity in Patients With Non-Specific Low Back Pain
After acute low back pain, one third of patients have chronic low back pain. A sedentary lifestyle is a leading cause of mechanical stress-related low back pain and exacerbates chronic low back pain. Balance disorders, postural adjustment disorder, abnormal spinal movements and related muscle imbalance are observed in individuals with chronic low back pain. Conservative treatment is mostly used in treatment. Langevin et al. stated that an abnormal and irregular thoracolumbar connective tissue structure is observed in chronic and recurrent low back pain. It has been said that physiotherapy and rehabilitation methods such as exercise therapy, massage, chiropractic and acupuncture provide changes in the biomechanical components of the affected connective tissue such as stiffness, viscoelasticity and density. Over the past 20 years, exercises with Whole Body Vibration (WBV) have begun to be used as an effective method for reducing pain. Exercises performed with WBV are thought to improve neuromuscular activation and increase muscle strength and joint stabilization. In non-specific chronic low back pain, increased tone is observed in the superficial back muscles. And based on this study, no study has been found examining the effect of vibratory exercise intervention on the tone of superficial back muscles that go into spasm due to pain. In this study, lumbar stabilization exercises, one of the most effective exercise methods in chronic low back pain, will be applied and exercises performed with vibration will have an additional effect.
It is aimed to reveal whether it creates or not. MyotonPRO (myometer) is a digital palpation device that can measure the viscoelastic properties of myofascial tissue. In measurements made with patients with chronic low back pain and healthy controls, While lumbar myofascial tissue elasticity was significantly low in patients; The tone of the lumbar extensor muscles was found to be significantly higher. However, this measurement has not been made before in studies conducted with WBV, which is one of the methods used to reduce pain in individuals with chronic low back pain.
The aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of the superficial back muscles, on pain, function, muscle strength, balance, proprioception and endurance parameters compared to the group exercising only.
Read the detailed description
WBV exercise is a popular method to reduce pain intensity and improve function and quality of life.
is the method. WBV exercise is currently used as a treatment for patients with chronic low back pain. The effect of WBV exercise on the treatment of low back pain can be explained by activating the core muscles and increasing stabilization. Additionally, paravertebral muscle spasm occurs in most patients, and it is said that WBV can relieve pain by relaxing the paravertebral muscles. In addition, it is thought that it may reduce the associated spinal dysfunction and instability by improving the proprioception of the lumbosacral region. Although studies have begun with WBV in patient groups with chronic low back pain, the studies are limited.
Therefore, the optimal dosage has not yet been determined. It aims to compare its effect on strength, balance, proprioception, endurance, quality of life and viscoelastic properties of the lumbar region. Thus, WBV on the specified parameters It is aimed to reveal its effectiveness and contribute to the existing literature. Measurement with the MyotonPRO device, a newly widespread and expensive measuring device, will strengthen the objective and original aspect of the study. Lumbar stabilization exercises (LSE) try to correct the disorders by activating the trunk muscles. In this respect, it is widely used by physiotherapists in the treatment of low back pain. In our study, while lumbar stabilization exercises were applied to individuals in the control group; intervention The group will be given exercise accompanied by vibration. The effect of the added vibration on the exercises accepted in the literature will be examined. The effectiveness of WBV in patients with chronic non-specific low back pain will be evaluated by making the following measurements: MyotonPRO: The measurement will be made in the prone position, without active muscle contraction. Lumbar paraspinal muscle measurement will be made from a point one finger to the right/left of the L4 level.
Pain: Participants' pain intensity will be evaluated according to the Visual Analog Scale (VAS).
Function: The Oswestry Low Back Pain Disability Questionnaire measures the functioning of patients affected by low back pain.
It is an index consisting of 10 sections used for evaluation. Quality of Life: Measurement with Short Form SF-12, which is the abbreviated version of the SF-36 Quality of Life Scale will be done. Lower Extremity Muscle Strength: Myometer is a muscle strength measurement device. More objective than manual muscle testing provides data. Endurance: The endurance of the trunk muscles is measured by lateral bridging, Sorensen and trunk flexors endurance test.
will be measured. Balance: Dynamic balance will be measured with the Y balance test. Static Balance, Single Leg Stand Test will be done. This test is performed with eyes open and hands on hips. Proprioception: With the passive positioning technique, a certain angle is applied to the lumbar region as the patient's eyes are closed.
Position is given passively with the helper and then the patient is asked to do the same without support using the same extremity.
You are asked to find the angle. The difference between the angles is recorded with a goniometer.
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain, Postural, Low Back Pain, Recurrent
- Being tested
- Whole body vibration, lumbar stabilization exercises
- Keywords
- whole body vibration, biomechanical structures, low back pain, core stabilisation, lumbar myofascia
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationDevice
The aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of superficial back muscles, as well as to investigate the effects on pain, function, muscle strength, balance, proprioception and endurance parameters, compared to the exercise-only group.
lumbar stabilization exercisesBehavioural
The control group will undergo lumbar stabilization exercises twice a week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment. Receives: Device: Whole body vibration |
| Control Group | Active comparator | Within the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. Lumbar stabilization exercises will be applied to the control group twice a week for 6 weeks. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment. Receives: Behavioral: lumbar stabilization exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
MyotonPRO myofascial palpation device
The measurement will be made in the prone position, without active muscle contraction. Lumbar paraspinal muscle measurement will be made from a point one finger to the right/left of the L4 level.
F - Natural Oscillation Frequency [Hz], characterizing Tone or Tension S - Dynamic Stiffness [N/m] D - Logarithmic Decrement [relative unit], characterizing Elasticity R - Mechanical Stress Relaxation Time [ms] C - Ratio of Relaxation and Deformation time [relative unit], characterizing Creep
Measured: 6 weeks
Secondary outcomes (8)
Pain severity for lower back (Visual analog scale)
Participants' pain intensity will be evaluated according to Visual Analog Scale. The score is from 0 to 10. The pain level increases from 0 to 10.
Measured: 6 weeks
Low Back Function Assesment
The Oswestry Low Back Pain Disability Questionnaire is a 10-part index used to assess the functioning of patients affected by low back pain.
Measured: 6 weeks
Quality of Life (SF-12 SHORT FORM)
Measurement will be made with Short Form SF-12, which is the shortened version of the SF-36 Quality of Life Scale.
Measured: 6 weeks
Lower Extremity Muscle Strength
Myometer is a muscle strength measurement device. Provides more objective data than manual muscle testing.
Measured: 6 weeks
Abdominals, side abdominals and back extenstors Endurance
The endurance of the trunk muscles will be measured by lateral bridging, Sorensen and trunk flexors endurance test.
Measured: 6 weeks
Dynamic Balance
Dynamic balance will be measured with the Y balance test.
Measured: 6 weeks
Lumbar Proprioception
With the passive positioning technique, a certain angle is applied to the lumbar region with the patient's eyes closed.
The position is given passively and then the patient is asked to find the same angle without support, using the same extremity. The difference between the angles is recorded with a goniometer [29]
Measured: 6 weeks
Static Balance
Static Balance and Single Leg Standing Test will be performed. This test is performed with eyes open and hands on hips.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start25 Jul 2024
- Primary completion20 Nov 2024
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Model description
- Within the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. The control group will undergo lumbar stabilization exercises twice a week for 6 weeks. The experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istinye University
- Responsible party
- Principal investigator, Beyza Tanrıöğen, Istanbul University
- Investigators
- Yıldız Analay Akbaba, Phd, Study director, Istanbul University - CerrahpasaBeyza Tanrıöğen, MSc (c), Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552962
- Sponsor's protocol ID
- İÜC-BT1
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration on Pain, Function and Viscoelasticity in Patients With Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06552962
- Acronym / sponsor ID
- İÜC-BT1
- Conditions
- Low Back Pain, Low Back Pain, Mechanical, Low Back Pain, Postural, Low Back Pain, Recurrent
- Keywords
- whole body vibration, biomechanical structures, low back pain, core stabilisation, lumbar myofascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istinye University
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 14 Aug 2024 (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.
After acute low back pain, one third of patients have chronic low back pain. A sedentary lifestyle is a leading cause of mechanical stress-related low back pain and exacerbates chronic low back pain. Balance disorders, postural adjustment disorder, abnormal spinal movements and related muscle imbalance are observed in individuals with chronic low back pain. Conservative treatment is mostly used in treatment. Langevin et al. stated that an abnormal and irregular thoracolumbar connective tissue structure is observed in chronic and recurrent low back pain. It has been said that physiotherapy and rehabilitation methods such as exercise therapy, massage, chiropractic and acupuncture provide changes in the biomechanical components of the affected connective tissue such as stiffness, viscoelasticity and density. Over the past 20 years, exercises with Whole Body Vibration (WBV) have begun to be used as an effective method for reducing pain. Exercises performed with WBV are thought to improve neuromuscular activation and increase muscle strength and joint stabilization. In non-specific chronic low back pain, increased tone is observed in the superficial back muscles. And based on this study, no study has been found examining the effect of vibratory exercise intervention on the tone of superficial back muscles that go into spasm due to pain. In this study, lumbar stabilization exercises, one of the most effective exercise methods in chronic low back pain, will be applied and exercises performed with vibration will have an additional effect.
It is aimed to reveal whether it creates or not. MyotonPRO (myometer) is a digital palpation device that can measure the viscoelastic properties of myofascial tissue. In measurements made with patients with chronic low back pain and healthy controls, While lumbar myofascial tissue elasticity was significantly low in patients; The tone of the lumbar extensor muscles was found to be significantly higher. However, this measurement has not been made before in studies conducted with WBV, which is one of the methods used to reduce pain in individuals with chronic low back pain.
The aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of the superficial back muscles, on pain, function, muscle strength, balance, proprioception and endurance parameters compared to the group exercising only.
Detailed description
WBV exercise is a popular method to reduce pain intensity and improve function and quality of life.
is the method. WBV exercise is currently used as a treatment for patients with chronic low back pain. The effect of WBV exercise on the treatment of low back pain can be explained by activating the core muscles and increasing stabilization. Additionally, paravertebral muscle spasm occurs in most patients, and it is said that WBV can relieve pain by relaxing the paravertebral muscles. In addition, it is thought that it may reduce the associated spinal dysfunction and instability by improving the proprioception of the lumbosacral region. Although studies have begun with WBV in patient groups with chronic low back pain, the studies are limited.
Therefore, the optimal dosage has not yet been determined. It aims to compare its effect on strength, balance, proprioception, endurance, quality of life and viscoelastic properties of the lumbar region. Thus, WBV on the specified parameters It is aimed to reveal its effectiveness and contribute to the existing literature. Measurement with the MyotonPRO device, a newly widespread and expensive measuring device, will strengthen the objective and original aspect of the study. Lumbar stabilization exercises (LSE) try to correct the disorders by activating the trunk muscles. In this respect, it is widely used by physiotherapists in the treatment of low back pain. In our study, while lumbar stabilization exercises were applied to individuals in the control group; intervention The group will be given exercise accompanied by vibration. The effect of the added vibration on the exercises accepted in the literature will be examined. The effectiveness of WBV in patients with chronic non-specific low back pain will be evaluated by making the following measurements: MyotonPRO: The measurement will be made in the prone position, without active muscle contraction. Lumbar paraspinal muscle measurement will be made from a point one finger to the right/left of the L4 level.
Pain: Participants' pain intensity will be evaluated according to the Visual Analog Scale (VAS).
Function: The Oswestry Low Back Pain Disability Questionnaire measures the functioning of patients affected by low back pain.
It is an index consisting of 10 sections used for evaluation. Quality of Life: Measurement with Short Form SF-12, which is the abbreviated version of the SF-36 Quality of Life Scale will be done. Lower Extremity Muscle Strength: Myometer is a muscle strength measurement device. More objective than manual muscle testing provides data. Endurance: The endurance of the trunk muscles is measured by lateral bridging, Sorensen and trunk flexors endurance test.
will be measured. Balance: Dynamic balance will be measured with the Y balance test. Static Balance, Single Leg Stand Test will be done. This test is performed with eyes open and hands on hips. Proprioception: With the passive positioning technique, a certain angle is applied to the lumbar region as the patient's eyes are closed.
Position is given passively with the helper and then the patient is asked to do the same without support using the same extremity.
You are asked to find the angle. The difference between the angles is recorded with a goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Within the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. The control group will undergo lumbar stabilization exercises twice a week for 6 weeks. The experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Whole body vibrationThe experimental group will have the same lumbar stabilization exercises performed on the whole body vibration device twice a week for 6 weeks. The frequency of the device will be set to 30 Hz. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment. |
| Control Group | Active comparator | Behavioral: lumbar stabilization exercisesWithin the scope of the research, individuals with chronic non-specific low back pain will be randomized and divided into two separate groups. Lumbar stabilization exercises will be applied to the control group twice a week for 6 weeks. Exercise duration, frequency, number and variety will be kept equal for the experimental and control groups. Demographic information of the patients, viscoelastic properties of the lumbar region, pain, function, quality of life, lower extremity muscle strength, endurance, balance and proprioception will be evaluated. Measurements will be made before treatment and at the end of 6 weeks of treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being diagnosed with Non-Specific low back pain by a physician,
- Having a complaint of non-specific low back pain for at least 3 months,
- Being 18 years or older,
- Volunteer,
- Not having any diagnosed cardiac disease,
Key exclusion criteria (12 listed)
- Diagnosed stomach, kidney, liver, pancreas and bladder problems,
- Presence of mental or cognitive problems,
- History of surgery for low back pain,
- Pain level is 8 or above according to Visual Analogue Scale,
- Use of painkillers during treatment,
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 vibrationThe aim of this study is to reveal the effect of exercises performed with WBV on the myofascial tissue of the lumbar region and the tone of superficial back muscles, as well as to investigate the effects on pain, function, muscle strength, balance, proprioception and endurance parameters, compared to the exercise-only group. | Device | Intervention Group |
| lumbar stabilization exercisesThe control group will undergo lumbar stabilization exercises twice a week for 6 weeks. | Behavioural | Control Group |
Primary outcome
MyotonPRO myofascial palpation device
Time frame: 6 weeks
The measurement will be made in the prone position, without active muscle contraction. Lumbar paraspinal muscle measurement will be made from a point one finger to the right/left of the L4 level. F - Natural Oscillation Frequency [Hz], characterizing Tone or Tension S - Dynamic Stiffness [N/m] D - Logarithmic Decrement [relative unit], characterizing Elasticity R - Mechanical Stress Relaxation Time [ms] C - Ratio of Relaxation and Deformation time [relative unit], characterizing Creep
8 secondary outcomes
Pain severity for lower back (Visual analog scale)
Time frame: 6 weeks
Low Back Function Assesment
Time frame: 6 weeks
Quality of Life (SF-12 SHORT FORM)
Time frame: 6 weeks
Lower Extremity Muscle Strength
Time frame: 6 weeks
Abdominals, side abdominals and back extenstors Endurance
Time frame: 6 weeks
Dynamic Balance
Time frame: 6 weeks
Lumbar Proprioception
Time frame: 6 weeks
Static Balance
Time frame: 6 weeks
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 4 Apr 2025.
- 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.
Yıldız Analay Akbaba, Phd study director
Istanbul University - Cerrahpasa
Beyza Tanrıöğen, MSc (c) principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration and lumbar stabilization exercises in people with Low Back Pain and Low Back Pain, Mechanical, run by Istanbul University at 1 site in Turkey (Türkiye).
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 9 inclusion and 12 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 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
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?
MyotonPRO myofascial palpation device (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.