StrokeNCT06126523
Effect of ESWT Applied After Botulinum Toxin Injection on Ankle Spasticity in Stroke Patients.
A study testing Radial Extracorporeal Shock Wave Therapy ONCE and Radial Extracorporeal Shock Wave Therapy TWİCE in people with Stroke and Spasticity as Sequela of Stroke, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Spasticity as Sequela of Stroke
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy ONCE and Radial Extracorporeal Shock Wave Therapy TWİCE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an ischemic or hemorrhagic stroke, in subacute or chronic phase,
- Patients with ankle plantar flexor spasticity MAS score > 1 and patients who received BTX-A injection due to spasticity
- Stroke history of at least 3 months
Who cannot join
- History of neuromuscular disease
- Compared to the unaffected side; More than 50% reduction in dorsiflexion range of motion of the affected side
- Dynamic ankle contracture
- Affected side lower extremity surgery in the last 12 months
- Having Botox or phenol application to the affected gastrocnemius in the last 3 months
- Change in the dose of antispastic medication used in the last 3 months
Show all 9Show fewer
- Infection/wound in the affected lower extremity
- Contraindications for ESWT (pregnancy, cancer, bleeding disorders, inflammatory disease, pacemakers or other electronic implants).
- Significant muscle atrophy or fibrosis of the target muscle (Heckmatt scale III and IV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy Applied After Botulinum Toxin Injection on Ankle Plantar Flexor Spasticity in Stroke Patients: Placebo-controlled Double-blind Study.
Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. BTX-A has been successfully used in the treatment of spasticity in patients with stroke. ESWT is a physical therapy method applying high intensity pressure waves.
ESWT has been increasingly used in the management of spasticity as a safe and effective method, but the literature about ESWT in spasticity is heterogeneous and the treatment protocols are not very clear about the number of applications.
The aim of this study is to determine the effects of rESWT treatment on ankle plantar flexors spasticity applied after BTX-A injection.
Read the detailed description
In this double-blind randomized placebo-controlled trial, 45 patient (aged 18-75) diagnosed as stroke with appropriate criteria will be included.
Patients who meet the inclusion criteria for the study will be seperated into three groups with the randomizer.org randomization program.
Group I: A single session of rESWT will be applied on the same day after BTX-A injection.
Group II: A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A injection.
Group III: A single session of placebo rESWT will be applied after BTX-A injection.
BTX-A injections to gastrocnemius and soleus muscles will be performed under ultrasonography guidance. rESWT will be applied to the injection points in gastrocnemius and soleus muscles.
The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. (Number of pulses: 1500 pulses, frequency: 6 Hz, Energy level/Pressure: 2.2 bar air pressure, duration: 12 minutes) Patients will be evaluated by the same researcher before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment.
Patients will be evaluated using the Modified Ashworth Scale, Modified Tardieu Scale, Visual Analog Scale, 10 m walk test, Timed Up and Go Test, Timed Sit and Go Test, Barthel Activities of Daily Living Index, Functional Ambulation Scale, Brunnstrom Staging.
- Conditions
- Stroke, Spasticity as Sequela of Stroke
- Being tested
- Radial Extracorporeal Shock Wave Therapy ONCE, Radial Extracorporeal Shock Wave Therapy TWİCE, Radial Extracorporeal Shock Wave Therapy SHAM
- Keywords
- spasticity, ESWT, Botulinum Toxin
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave Therapy ONCEDevice
rESWT application ONCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle.
Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes
Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.
Radial Extracorporeal Shock Wave Therapy TWİCEDevice
rESWT application TWİCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle.
A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A.
Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes
Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves.
Radial Extracorporeal Shock Wave Therapy SHAMDevice
Radial Extracorporeal Shock Wave Therapy- SHAM The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle.
Sham ESWT will be administered with the r-ESWT probe. The device will be switched on, the frequency, pressure and duration values will be set and then the device will be switched off and the probe will be kept in equal time with the active treatment, by playing a sound previously recorded during the real application.
| Study group | Role | What they receive |
|---|---|---|
| ESWT once | Active comparator | A single session of rESWT will be applied on the same day after BTX-A injection. Receives: Device: Radial Extracorporeal Shock Wave Therapy ONCE |
| ESWT twice | Active comparator | A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A. Receives: Device: Radial Extracorporeal Shock Wave Therapy ONCE; Device: Radial Extracorporeal Shock Wave Therapy TWİCE |
| Sham ESWT | Sham comparator | A single session of placebo rESWT will be applied after BTX-A injection. Receives: Device: Radial Extracorporeal Shock Wave Therapy SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Evaluation Form
Demographic information, stroke history, and medications used by all stroke patients included in the study will be recorded.
Measured: BEFORE TREATMENT
Modified Ashworth Scale (MAS)
It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination Modified Ashworth Scale is graded between 0 and 4 points. 0: No increase in muscle tone, 4: affected part is rigid in flexion or extension.
It means that the higher the score the patient receives, the higher the degree of spasticity.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Modified Tardieu Scale (MTS)
The severity of muscle tone is evaluated at different determined speeds. The first angle at which an increase in resistance is detected in the joint is recorded. The range of motion is compared with the angle at completion.The minimum value in evaluating the joint angle is 0 degrees.The maximum value varies depending on the patient's joint.Higher angle value means worse result.
Modified Tardieu Scale is rated between 0 and 5 points. 0: no resistance during passive motion, 5: The joint can not be moved. It means that the higher the score the patient receives, the higher the degree of spasticity.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
10m walking test
Subjects are asked to walk at maximum speed in a 10-meter corridor. The time it takes them to complete the distance is measured in seconds with a stopwatch. The measurement is repeated three times and the average time of the three measurements is recorded.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Timed Up and Go Test
The person is asked to get up from the chair, walk 3 meters at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Timed sit and stand test
It is a test that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands up within 30 seconds gives the test score.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Barthel Activities of Daily Living Index
It is used to measure the independence of the individual in daily living activities.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Functional Ambulation Scale
It classifies individuals between 0 and 5 according to the basic motor skills required for functional ambulation.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Secondary outcomes (2)
Visual Analog Scale (VAS)
It is a scale used to measure contraction from a 10 cm horizontal axis.A score of zero means no contraction, and a score of ten means the most severe contraction felt.
The higher the score the patient receives, the higher the degree of contraction.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Brunnstrom Staging
It classifies stroke patients with improvement in upper extremity, lower extremity and hand functions.
Measured: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023
- Primary completion26 Feb 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Selimoğlu Ayneli, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126523
- Sponsor's protocol ID
- ZSAYNELI
- Status last verified
- Dec 2023
- First submitted
- 6 Nov 2023
- Last updated
- 26 Dec 2023
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy Applied After Botulinum Toxin Injection on Ankle Plantar Flexor Spasticity in Stroke Patients: Placebo-controlled Double-blind Study.
- ClinicalTrials.gov ID
- NCT06126523
- Acronym / sponsor ID
- ZSAYNELI
- Conditions
- Stroke, Spasticity as Sequela of Stroke
- Keywords
- spasticity, ESWT, Botulinum Toxin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 26 Feb 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 13 Nov 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.
Stroke is the second most common cause of death and the third most important cause of disability worldwide, with an annual death rate of 5.5 million. Spasticity is a common condition in stroke patients and has a negative impact on daily living activities. BTX-A has been successfully used in the treatment of spasticity in patients with stroke. ESWT is a physical therapy method applying high intensity pressure waves.
ESWT has been increasingly used in the management of spasticity as a safe and effective method, but the literature about ESWT in spasticity is heterogeneous and the treatment protocols are not very clear about the number of applications.
The aim of this study is to determine the effects of rESWT treatment on ankle plantar flexors spasticity applied after BTX-A injection.
Detailed description
In this double-blind randomized placebo-controlled trial, 45 patient (aged 18-75) diagnosed as stroke with appropriate criteria will be included.
Patients who meet the inclusion criteria for the study will be seperated into three groups with the randomizer.org randomization program.
Group I: A single session of rESWT will be applied on the same day after BTX-A injection.
Group II: A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A injection.
Group III: A single session of placebo rESWT will be applied after BTX-A injection.
BTX-A injections to gastrocnemius and soleus muscles will be performed under ultrasonography guidance. rESWT will be applied to the injection points in gastrocnemius and soleus muscles.
The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. (Number of pulses: 1500 pulses, frequency: 6 Hz, Energy level/Pressure: 2.2 bar air pressure, duration: 12 minutes) Patients will be evaluated by the same researcher before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment.
Patients will be evaluated using the Modified Ashworth Scale, Modified Tardieu Scale, Visual Analog Scale, 10 m walk test, Timed Up and Go Test, Timed Sit and Go Test, Barthel Activities of Daily Living Index, Functional Ambulation Scale, Brunnstrom Staging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESWT once | Active comparator | Device: Radial Extracorporeal Shock Wave Therapy ONCEA single session of rESWT will be applied on the same day after BTX-A injection. |
| ESWT twice | Active comparator | Device: Radial Extracorporeal Shock Wave Therapy ONCE, Device: Radial Extracorporeal Shock Wave Therapy TWİCEA total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A. |
| Sham ESWT | Sham comparator | Device: Radial Extracorporeal Shock Wave Therapy SHAMA single session of placebo rESWT will be applied after BTX-A injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having an ischemic or hemorrhagic stroke, in subacute or chronic phase,
- Patients with ankle plantar flexor spasticity MAS score > 1 and patients who received BTX-A injection due to spasticity
- Stroke history of at least 3 months
Key exclusion criteria (9 listed)
- History of neuromuscular disease
- Compared to the unaffected side; More than 50% reduction in dorsiflexion range of motion of the affected side
- Dynamic ankle contracture
- Affected side lower extremity surgery in the last 12 months
- Having Botox or phenol application to the affected gastrocnemius in the last 3 months
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 |
|---|---|---|
| Radial Extracorporeal Shock Wave Therapy ONCErESWT application ONCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves. | Device | ESWT once, ESWT twice |
| Radial Extracorporeal Shock Wave Therapy TWİCErESWT application TWİCE The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. A total of 2 sessions of rESWT will be applied on the same day after BTX-A injection and on the 7th day after BTX-A. Number of pulses: 1500 pulses Frequency: 6 Hz Energy level/Pressure: 2.2 bar air pressure Duration: 12 minutes Device to be used in research ELMED VIBROLITH ESWT SW. Give. 3.3 It is based on the principle that currents produced outside the body spread in the tissue in the form of sound waves. | Device | ESWT twice |
| Radial Extracorporeal Shock Wave Therapy SHAMRadial Extracorporeal Shock Wave Therapy- SHAM The points where rESWT will be applied will be determined under ultrasonography guidance. The pressure pulses will be focused on the injection site in the medial and lateral heads of the gastrocnemius muscle and the soleus muscle. Sham ESWT will be administered with the r-ESWT probe. The device will be switched on, the frequency, pressure and duration values will be set and then the device will be switched off and the probe will be kept in equal time with the active treatment, by playing a sound previously recorded during the real application. | Device | Sham ESWT |
Primary outcome
Patient Evaluation Form
Time frame: BEFORE TREATMENT
Demographic information, stroke history, and medications used by all stroke patients included in the study will be recorded.
Modified Ashworth Scale (MAS)
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is a method used to determine the severity of spasticity. It is based on the subjective rating of the resistance felt during the examination Modified Ashworth Scale is graded between 0 and 4 points. 0: No increase in muscle tone, 4: affected part is rigid in flexion or extension. It means that the higher the score the patient receives, the higher the degree of spasticity.
Modified Tardieu Scale (MTS)
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
The severity of muscle tone is evaluated at different determined speeds. The first angle at which an increase in resistance is detected in the joint is recorded. The range of motion is compared with the angle at completion.The minimum value in evaluating the joint angle is 0 degrees.The maximum value varies depending on the patient's joint.Higher angle value means worse result. Modified Tardieu Scale is rated between 0 and 5 points. 0: no resistance during passive motion, 5: The joint can not be moved. It means that the higher the score the patient receives, the higher the degree of spasticity.
10m walking test
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Subjects are asked to walk at maximum speed in a 10-meter corridor. The time it takes them to complete the distance is measured in seconds with a stopwatch. The measurement is repeated three times and the average time of the three measurements is recorded.
Timed Up and Go Test
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
The person is asked to get up from the chair, walk 3 meters at a safe and normal pace, turn, walk back and sit on the chair, and the time is recorded in seconds.
Timed sit and stand test
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is a test that evaluates the patient's sit-to-stand activity, lower extremity strength and dynamic balance. The number of times the patient sits and stands up within 30 seconds gives the test score.
Barthel Activities of Daily Living Index
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It is used to measure the independence of the individual in daily living activities.
Functional Ambulation Scale
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
It classifies individuals between 0 and 5 according to the basic motor skills required for functional ambulation.
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Brunnstrom Staging
Time frame: BEFORE TREATMENT, 2 WEEKS LATER AFTER TREATMENT, 1 MOUNTH LATER AFTER TREATMENT, 3MOUNTH LATER AFTER TREATMENT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock Wave Therapy ONCE and Radial Extracorporeal Shock Wave Therapy TWİCE in people with Stroke and Spasticity as Sequela of Stroke, run by Saglik Bilimleri Universitesi 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 3 inclusion and 9 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 26 Dec 2023. 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. Some participants in this study may receive a placebo. 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?
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?
Patient Evaluation Form (time frame: BEFORE TREATMENT). The study lists 8 primary outcomes in all. 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 26 Dec 2023.