Low Back PainNCT04759430
The Effects of Telerehabilitation and Supervised Stabilization Exercises in Individuals With Nonspecific Chronic Low Back Pain
A study testing Supervised Group and Telerehabilitation group in people with Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of telerehabilitation and supervised stabilization exercises on pain, functionality, kinesophobia and quality of life in individuals with non-specific chronic low back pain. 72 individuals who voluntarily agree to participate in the study will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Supervised Group and Telerehabilitation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 14 May 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having non-specific chronic low back pain
- Non-specific chronic low back pain ⩾three months
- Being over the age of 18
- Score of ⩾4 on the Roland-Morris Disability Questionnaire (RMQ)
- Agree to voluntarily participate in the research
Who cannot join
- Presence of lumbar stenosis
- Presence of clinical signs or symptoms of radiculopathy
- Diagnosis of spondylolisthesis
- Diagnosis of fibromyalgia
- Treatment with corticosteroids or other drugs in the previous two weeks
- History of spinal surgery
- Presence of central or peripheral system pathology (i.e. stroke, peripheral nerve etc.)
- Have received a physiotherapy treatment for low back pain before 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Medigold Sultan Hospital
Istanbul, Sultangazi, 34265
About this study
Official title: The Effects of Telerehabilitation and Supervised Stabilization Exercises on Pain, Functionality, Kinesiophobia and Quality of Life in Individuals With Nonspecific Chronic Low Back Pain: A Single Blind Randomized Controlled Trial
This study aims to investigate the effects of telerehabilitation and supervised stabilization exercises on pain, functionality, kinesophobia and quality of life in individuals with non-specific chronic low back pain. 72 individuals who voluntarily agree to participate in the study will be included. This study divides the patients in three groups: the supervised group: face-to-face stabilization exercises are applied, the telerehabilitation group: treatment through online meetings, and the control group: patients will do home-based exercises that prescribed by physiothrerapist. Evaluations will be made by the same physiotherapist. The researcher who will make the measurements in this study will not know which treatment program was applied to the participants. In this study, The same stabilization exercises will be applied in three different groups. Ten different stabilization exercises will be applied to the participants. Exercises will be performed for 20-30 minutes in each session, three times a week, for four weeks in total, twelve sessions. Clinical and demographic data of the 72 people participating in the study will be taken before treatment. Participants will also fill out questionnaires before and after the treatment that involve; the Oswestry Disability Index to measure(ODI) daily life activity limitations; the Visual Analogue Scale(VAS) for assessing the intensity of pain; Tampa Scale for Kinesiophobia(TSK) to assess fear of movement; and the Short Form(SF-36) in order to assess self-perceived health-related quality of life. Statistical analysis is going to be used in this research through the SPSS 20.0 package program.
Read the detailed description
Today, low back pain is one of the most common health problems in the world in which create a considerable individual, social and financial burden on the society. Low back pain is classified as specific and nonspecific. While, 10 percent of the paints are suffered from specific low back pain, non-specific low back pain is occured in approximately 90 percent of the population. If low back pain persists for six weeks, it is classified as acute back pain, subacute back pain between six weeks and three months, and chronic low back pain if it lasts for more than three months.
Chronic low back pain (CLBP) is a complex problem that continues for a long time without a cause and is the most common in the musculoskeletal system, leading to disability. Individuals with CLBP have a lower quality of life than the general population. It causes individuals to decrease their activities due to pain and prepares the ground for the continuation of pain. Lack of movement caused by pain in individuals; It negatively affects the quality of life by triggering the continuation of symptoms, causing a decrease in functional levels, limitation in daily life activities, problems in family and work life. There are many physical, psychological and social factors that cause low back pain to become chronic. Age, race, occupation, obesity, smoking, alcohol consumption and stress are the most important factors that trigger the chronicity of low back pain. The effectiveness of a multidisciplinary treatment program and determination of risk factors in the management of CLBP is known. Treatment approaches include medical treatment, surgical treatment and physiotherapy applications. In physiotherapy programs, patient education, back schools, electrotherapy applications, traction, massage, superficial heat applications, corsets and exercise approaches are used. Stretching exercises, trunk flexion-extension exercises, resistantce exercises, stabilization exercises are the main exercise approaches used to cope with low back pain. In addition to exercises performed under the supervision of a physiotherapist, home exercise programs are also provided for low back pain. Stabilization exercises have various benefits on the musculoskeletal system. Stabilization exercises that aim to protect and support the spine by regenerating muscle control, applied in muscle activation losses caused by injury or degenerative changes, increase strength and flexibility. Stabilization exercise has been reported to be effective in reducing pain and improving functional disability in patients with nonspecific CLBP, improving individuals psychologically and also increasing the quality of life of patients. Stabilization exercises have been found to be effective in increasing the cross-sectional area of the lumbar multifidus muscle, which is one of the muscles needed to maintain the proper stability of the spine.
Today, in line with technological developments, the use of common information processing, sensor networks, three-dimensional (3D) computer graphics, internet and mobile phone applications in healthcare services is widespread. Telerehabilitation refers to the provision of rehabilitation services through information and communication technologies. Clinically this term; covers a range of rehabilitation and habilitation services including assessment, monitoring, prevention, response, control, training, consultation and counseling. Along with telerehabilitation, rehabilitation practices can be applied in health centers as well as homes, schools or community-based work sites. Mostly, there are studies in the literature regarding its use in musculoskeletal disorders, coronary heart disease, some types of cancer, type 2 diabetes, hypertension and physically disabled individuals. Due to the social distance and isolation, which are the effects of the covid-19, which spread in a short time in our country and all over the world, there are disruptions in individuals' continuing their treatment. Telerehabilitation allows one-to-one physiotherapist-patient meetings without the need for contact and provides flexibility to patients in terms of time. Exercise is one of the treatments that physiotherapists can give using telerehabilitation. With the applications made with telerehabilitation, individuals are provided to take an active role in their own rehabilitation and individuals can have the ability to manage themselves.
- Conditions
- Low Back Pain
- Being tested
- Supervised Group, Telerehabilitation group
- Keywords
- chronic pain, exercise, low back pain, quality of life, telerehabilitation
- Medical subject headings
- Low Back Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised GroupOther
Individuals will apply ten different stabilization exercises in company with a physiotherapist.
Telerehabilitation groupOther
Same stabilization exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Group | Active comparator | 24 individuals will participate in the Supervised group. Patients in the supervised group will be treated individually by the researcher at the hospital. During the application, individuals will apply ten different stabilization exercises in company with a physiotherapist. Exercises will be applied under the supervision of a physiotherapist in the center where the work will be done for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks. The exercises program to be applied to the participants in the group is listed below: Supine position; Abdominal bracing, while continuing the abdominal bracing; heel slides, bridging, 90 degrees hip flexion. Quadruped position; Abdominal bracing while continuing the abdominal bracing; single arm lift, single leg lift, cross-arm leg raises activities. Standing position; Abdominal bracing. Receives: Other: Supervised Group |
| Telerehabilitation Group | Experimental | 24 individuals will participate in the Telerehabilitation group. Patients in the telerehabilitation group will attend the treatment from their homes. The exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone. The same stabilization exercises will be applied to the participants in the supervised group. Exercises will be applied for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks. Receives: Other: Telerehabilitation group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index(ODI)
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
Measured: Change between baseline and 4 weeks
Visual Analogue Scale(VAS)
The Visual Analog Scale (VAS) is a scale used to determine the intensity of pain experienced by individuals. It consists of a line approximately 10-15 cm long; the patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain the left side means no pain with 0 points, while the right side means 10 points the worst pain ever.
Measured: Change between baseline and 4 weeks
Tampa Scale for Kinesiophobia(TSK)
The Tampa Scale of Kinesiophobiais (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. It was first developed to distinguish between non-excessive fear and phobia in patients with chronic musculoskeletal pain, specifically the fear of movement in patients with chronic low back pain then widely used for different parts of the body. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.(1 = Strongly Disagree, 4 = Strongly Agree).The total score of the scale range from 17-68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.
Measured: Change between baseline and 4 weeks
Short Form(SF-36)
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It comprises 36 questions which cover eight domains of health:1) Limitations in physical activities because of health problems 2) Limitations in social activities because of physical or emotional problems 3) Limitations in usual role activities because of physical health problems 4) Bodily pain 5) General mental health (psychological distress and well-being) 6) Limitations in usual role activities because of emotional problems 7) Vitality (energy and fatigue) 8) General health perceptions. The SF-36 is often used as a measure of a person or population's quality of life (QOL). In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: Change between baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 Feb 2021
- Primary completion19 Mar 2021
- Study completion14 May 2021
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.
- 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
- The individuals are randomly allocated into supervised group, telerehabilitation group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Karaduman, Bahçeşehir University
- Investigators
- Leyla ATAŞ BALCI, Assist Prof, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759430
- Sponsor's protocol ID
- 1506581
- Status last verified
- May 2021
- First submitted
- 15 Feb 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation and Supervised Stabilization Exercises on Pain, Functionality, Kinesiophobia and Quality of Life in Individuals With Nonspecific Chronic Low Back Pain: A Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04759430
- Acronym / sponsor ID
- 1506581
- Conditions
- Low Back Pain
- Keywords
- chronic pain, exercise, low back pain, quality of life, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 18 Feb 2021 (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.
This study aims to investigate the effects of telerehabilitation and supervised stabilization exercises on pain, functionality, kinesophobia and quality of life in individuals with non-specific chronic low back pain. 72 individuals who voluntarily agree to participate in the study will be included. This study divides the patients in three groups: the supervised group: face-to-face stabilization exercises are applied, the telerehabilitation group: treatment through online meetings, and the control group: patients will do home-based exercises that prescribed by physiothrerapist. Evaluations will be made by the same physiotherapist. The researcher who will make the measurements in this study will not know which treatment program was applied to the participants. In this study, The same stabilization exercises will be applied in three different groups. Ten different stabilization exercises will be applied to the participants. Exercises will be performed for 20-30 minutes in each session, three times a week, for four weeks in total, twelve sessions. Clinical and demographic data of the 72 people participating in the study will be taken before treatment. Participants will also fill out questionnaires before and after the treatment that involve; the Oswestry Disability Index to measure(ODI) daily life activity limitations; the Visual Analogue Scale(VAS) for assessing the intensity of pain; Tampa Scale for Kinesiophobia(TSK) to assess fear of movement; and the Short Form(SF-36) in order to assess self-perceived health-related quality of life. Statistical analysis is going to be used in this research through the SPSS 20.0 package program.
Detailed description
Today, low back pain is one of the most common health problems in the world in which create a considerable individual, social and financial burden on the society. Low back pain is classified as specific and nonspecific. While, 10 percent of the paints are suffered from specific low back pain, non-specific low back pain is occured in approximately 90 percent of the population. If low back pain persists for six weeks, it is classified as acute back pain, subacute back pain between six weeks and three months, and chronic low back pain if it lasts for more than three months.
Chronic low back pain (CLBP) is a complex problem that continues for a long time without a cause and is the most common in the musculoskeletal system, leading to disability. Individuals with CLBP have a lower quality of life than the general population. It causes individuals to decrease their activities due to pain and prepares the ground for the continuation of pain. Lack of movement caused by pain in individuals; It negatively affects the quality of life by triggering the continuation of symptoms, causing a decrease in functional levels, limitation in daily life activities, problems in family and work life. There are many physical, psychological and social factors that cause low back pain to become chronic. Age, race, occupation, obesity, smoking, alcohol consumption and stress are the most important factors that trigger the chronicity of low back pain. The effectiveness of a multidisciplinary treatment program and determination of risk factors in the management of CLBP is known. Treatment approaches include medical treatment, surgical treatment and physiotherapy applications. In physiotherapy programs, patient education, back schools, electrotherapy applications, traction, massage, superficial heat applications, corsets and exercise approaches are used. Stretching exercises, trunk flexion-extension exercises, resistantce exercises, stabilization exercises are the main exercise approaches used to cope with low back pain. In addition to exercises performed under the supervision of a physiotherapist, home exercise programs are also provided for low back pain. Stabilization exercises have various benefits on the musculoskeletal system. Stabilization exercises that aim to protect and support the spine by regenerating muscle control, applied in muscle activation losses caused by injury or degenerative changes, increase strength and flexibility. Stabilization exercise has been reported to be effective in reducing pain and improving functional disability in patients with nonspecific CLBP, improving individuals psychologically and also increasing the quality of life of patients. Stabilization exercises have been found to be effective in increasing the cross-sectional area of the lumbar multifidus muscle, which is one of the muscles needed to maintain the proper stability of the spine.
Today, in line with technological developments, the use of common information processing, sensor networks, three-dimensional (3D) computer graphics, internet and mobile phone applications in healthcare services is widespread. Telerehabilitation refers to the provision of rehabilitation services through information and communication technologies. Clinically this term; covers a range of rehabilitation and habilitation services including assessment, monitoring, prevention, response, control, training, consultation and counseling. Along with telerehabilitation, rehabilitation practices can be applied in health centers as well as homes, schools or community-based work sites. Mostly, there are studies in the literature regarding its use in musculoskeletal disorders, coronary heart disease, some types of cancer, type 2 diabetes, hypertension and physically disabled individuals. Due to the social distance and isolation, which are the effects of the covid-19, which spread in a short time in our country and all over the world, there are disruptions in individuals' continuing their treatment. Telerehabilitation allows one-to-one physiotherapist-patient meetings without the need for contact and provides flexibility to patients in terms of time. Exercise is one of the treatments that physiotherapists can give using telerehabilitation. With the applications made with telerehabilitation, individuals are provided to take an active role in their own rehabilitation and individuals can have the ability to manage themselves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The individuals are randomly allocated into supervised group, telerehabilitation group and control group
| Arm | Type | Receives |
|---|---|---|
| Supervised Group | Active comparator | Other: Supervised Group24 individuals will participate in the Supervised group. Patients in the supervised group will be treated individually by the researcher at the hospital. During the application, individuals will apply ten different stabilization exercises in company with a physiotherapist. Exercises will be applied under the supervision of a physiotherapist in the center where the work will be done for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks. The exercises program to be applied to the participants in the group is listed below: Supine position; Abdominal bracing, while continuing the abdominal bracing; heel slides, bridging, 90 degrees hip flexion. Quadruped position; Abdominal bracing while continuing the abdominal bracing; single arm lift, single leg lift, cross-arm leg raises activities. Standing position; Abdominal bracing. |
| Telerehabilitation Group | Experimental | Other: Telerehabilitation group24 individuals will participate in the Telerehabilitation group. Patients in the telerehabilitation group will attend the treatment from their homes. The exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone. The same stabilization exercises will be applied to the participants in the supervised group. Exercises will be applied for 20-30 minutes in each session, three days a week, for a total of 12 sessions for four weeks. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having non-specific chronic low back pain
- Non-specific chronic low back pain ⩾three months
- Being over the age of 18
- Score of ⩾4 on the Roland-Morris Disability Questionnaire (RMQ)
- Agree to voluntarily participate in the research
Key exclusion criteria (8 listed)
- Presence of lumbar stenosis
- Presence of clinical signs or symptoms of radiculopathy
- Diagnosis of spondylolisthesis
- Diagnosis of fibromyalgia
- Treatment with corticosteroids or other drugs in the previous two weeks
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 |
|---|---|---|
| Supervised GroupIndividuals will apply ten different stabilization exercises in company with a physiotherapist. | Other | Supervised Group |
| Telerehabilitation groupSame stabilization exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone. | Other | Telerehabilitation Group |
Primary outcome
Oswestry Disability Index(ODI)
Time frame: Change between baseline and 4 weeks
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
Visual Analogue Scale(VAS)
Time frame: Change between baseline and 4 weeks
The Visual Analog Scale (VAS) is a scale used to determine the intensity of pain experienced by individuals. It consists of a line approximately 10-15 cm long; the patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain the left side means no pain with 0 points, while the right side means 10 points the worst pain ever.
Tampa Scale for Kinesiophobia(TSK)
Time frame: Change between baseline and 4 weeks
The Tampa Scale of Kinesiophobiais (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. It was first developed to distinguish between non-excessive fear and phobia in patients with chronic musculoskeletal pain, specifically the fear of movement in patients with chronic low back pain then widely used for different parts of the body. The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.(1 = Strongly Disagree, 4 = Strongly Agree).The total score of the scale range from 17-68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.
Short Form(SF-36)
Time frame: Change between baseline and 4 weeks
The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health. It comprises 36 questions which cover eight domains of health:1) Limitations in physical activities because of health problems 2) Limitations in social activities because of physical or emotional problems 3) Limitations in usual role activities because of physical health problems 4) Bodily pain 5) General mental health (psychological distress and well-being) 6) Limitations in usual role activities because of emotional problems 7) Vitality (energy and fatigue) 8) General health perceptions. The SF-36 is often used as a measure of a person or population's quality of life (QOL). In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
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 17 May 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.
Leyla ATAŞ BALCI, Assist Prof study director
Bahçeşehir 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 Supervised Group and Telerehabilitation group in people with Low Back Pain, run by Bahçeşehir 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 5 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 17 May 2021. 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?
Oswestry Disability Index(ODI) (time frame: Change between baseline and 4 weeks). The study lists 4 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 17 May 2021.