WorkplaceWORKCITNCT04928989
Convergence Dialogue Meeting With or Without Neck-specific Exercise Promoting Work Ability
A study testing convergence dialogue meeting in people with Workplace, run by Linkoeping University at 2 sites in Sweden.
Trial summary
The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to convergenge dialogue meeting with or without neck-specific exercise. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Workplace
- What is being tested?
- convergence dialogue meeting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- May 2022to Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-reported neck problems that the person experiences as troublesome, affecting ability to perform work, and lasting at least 4 weeks.
- Neck problems as being predominant.
- Current neck pain ≥ 3 on the numeric rating scale (0-10) [53, 55].
- Persons of working age, 18-65 years, who have a permanent job.
- Neck problems clinically verified through a clinical examination to ensure study criteria are met.
- Answers the baseline questionnaire and attends the first intervention visit.
- Confirms being motivated to participate and completes and signs informed consent, including approval, to contact their immediate supervisor regarding a CDM.
Who cannot join
- Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results, such as severe cardiovascular/lung disease, malignancy, severe rheumatic disease, severe neurological disease, spinal cord injury, diagnosed severe mental illness, drug or alcohol abuse, neck surgery, neck fracture or dislocation, severe cervical radiculopathy, myelopathy, general body pain (e.g., fibromyalgia, Ehlers-Danlos syndrome, generalized osteoarthritis).
- Known pregnancy.
- Cannot understand/communicate in Swedish and thus would be unable to understand information in the study.
- For blood samples (not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added: increased tendency to bleed and use of blood thinners.
- For the subgroup for microdialysis (n = 30, consecutively asked, 15 persons/group; not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added:
- Patients who cannot imagine refraining from non-steroid anti-inflammatory drugsduring 2 days before microdialysis may not participate in the microdialysis part of the study.
- Hypersensitivity to anesthetic and antibiotics.
- Increased tendency to bleed and use of blood-thinning drugs.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Anneli Peolsson
Linköping, Östergötland County, 58183
Dep. Medical and Health Sciences, Physiotherapy
Linköping, Östergötland County, 58183
About this study
Official title: What Does Web-based Neck-specific Exercise Add to a Digital Convergence Dialogue Meeting Promoting the Work Situation for Employees With Neck Pain?
The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to convergenge dialogue meeting with or without neck-specific exercise. The main outcome measure is work ability, measured via the Work Ability Score.
Read the detailed description
Background: Collaboration between employees, manager and occupational health expert is needed to promote work ability. One effective method is a convergence dialogue meeting (CDM). Based on the existing work situation, factors are identified in these meetings that can strengthen the employee's work ability and opportunities for a sustainable working life. A combination of workplace and individual interventions is recommended for best effect. Neck-specific exercise (NSE) is the method with the most evidence for neck problems. NSE in evidence based form has not been investigated for work-related neck pain. More knowledge is needed regarding how CDM can be combined with NSE because clear guidelines are lacking on the best intervention for increased work ability in the case of neck problems. Also lacking are evaluations of digitally distributed CDMs and NSE with support from a web-based program for the current population. The aim of the proposed randomized controlled study is to investigate the contribution of NSE with four visits to a physiotherapist and support from a web-program in addition to three digital CDMs promoting the work situation.
Methods: The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to CDM with or without NSE. The main outcome measure is work ability, measured via the Work Ability Score. Secondary outcome measures are pain, function, health-related quality of life, work absenteeism and presenteeism, work-related factors, and cost-effectiveness. Pathophysiological aspects regarding inflammation and stress markers measured in blood and saliva will be studied, as will muscular changes measured by microdialysis. Interviews are planned with both employees and managers.
Discussion: The goal of the study is to contribute to improved rehabilitation, strengthened work ability, and a sustainable working life for employees with neck problems.
- Conditions
- Workplace
- Being tested
- convergence dialogue meeting
- Keywords
- Neck pain, Workplace, Counceling, Exercise, Internet-based intervention
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
convergence dialogue meetingOther
Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.
| Study group | Role | What they receive |
|---|---|---|
| Convergence dialogue meeting | Active comparator | Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability. Receives: Other: convergence dialogue meeting |
| Neck-specific exercise in addition to convergence dialogue meeting | Experimental | Neck-specific exercise with digital web-based support and four visits to a physiotherapist. Neck-specific exercise will be performed based on a well-structured framework of neck-specific exercise for facilitation of deep neck muscles, increased muscle coordination, improved neck posture and increased neck muscle endurance. Plus additional convergence dialogue meeting as treatment arm no 1. Receives: Other: convergence dialogue meeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Ability Score
Current work ability compared to when it was at its best
Measured: Change in work Ability Score from baseline, to every month until the 15 month follow-up
Secondary outcomes (36)
Intensity of pain and bothersomeness
neck pain intensity and bothersomeness, headache intensity on a numeric ratin scale.
Measured: change from baseline to 3 month and 15 month follow-up
Frequency of pain, symtoms and medications
Frequency of pain, pain medication, neck stiffness, numbness/tingling into the arms, having problems lifting the arms, dizziness, sleep, concentration
Measured: change from baseline to 3 month and 15 month follow-up
Neck specific function
Neck Disability Index
Measured: change from baseline to 3 month and 15 month follow-up
Symptom satisfaction
Symptom satisfaction according to Cherkin
Measured: change from baseline to 3 month and 15 month follow-up
Exercise/physical activity level
Exercise/physical activity level
Measured: change from baseline to 3 month and 15 month follow-up
Health related quality of life
EQ-5D-3L
Measured: change from baseline to 3 month and 15 month follow-up
Fear avoidance
Fear avoidance beliefs questionnaire
Measured: change from baseline to 3 month and 15 month follow-up
self rated function
Patient Specific Functional Scale
Measured: change from baseline to 3 month follow-up
work situation
description of work tasks
Measured: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding working hours
working hours
Measured: description and change from baseline to 3 month and 15 month follow-up
perceived exertion at work
Borg ratings of perceived exertion
Measured: change from baseline to 3 month and 15 month follow-up
Work ability
work ability index
Measured: change from baseline to 3 month and 15 month follow-up
Sick leave,
sick leave numbers of days/ month
Measured: change from baseline to 3 month and 15 month follow-up
Presenteeism
presenteeism number of days/ month and Stanford presenteeism scale
Measured: change from baseline to 3 month and 15 month follow-up
Effort-Reward Imbalance
Effort Reward Imbalance questionnaire
Measured: change from baseline to 3 month and 15 month follow-up
Demand-control, support
Swedish Demand Control Support Questionnaire which is a short version of the Job centent questionnaire
Measured: change from baseline to 3 month and 15 month follow-up
Risk identifaction at work
Structured multidisciplinary work evaluation tool
Measured: change from baseline to 3 month and 15 month follow-up
work adaptation
work adaptation such as self strategies to be able to work
Measured: change from baseline to 3 month and 15 month follow-up
Time sitting
Time sitting at work and during leisure time
Measured: change from baseline to 3 month and 15 month
Anxiety and depression
Hospital Anxiety and Depression scale
Measured: change from baseline to 3 month and 15 month follow-up
Overall outcome
Global rating of change scale
Measured: change from baseline to follw-ups at 3 month and 15 month
Fulfilment of treatment expectation
Fulfilment of treatment expectation, have your expectations been fulfilled: yes, yes partly, no
Measured: 3 month and 15 month related to the patient own expectations
Satisfaction with the caregiver visits in the study
Patient enablement questionnaire
Measured: 3 month, 15 month
Adverse events/ side-effects
adverese events/ side effects of treatment in the study
Measured: 3 month, 15 month
Cost-effectiveness
Cost effectiveness through calculation of direct costs; quantity and type of care (inside and outside the study also including drugs related to pain) from registers and from questionnaires, indirect costs;mainly production loss from registers and from questionnaire.
Measured: From the time period between baseline to 15 month follow-up
Saliva samples and blood samples
Inflammation markers, stress markers. The samples will be taken in the morning on an empty stomach. Saliva will be collected with Salivette. Venous blood samples (10-20 ml) from the elbow fold will be collected in EDTA tubes. identification and quantification of proteins.
Measured: change from baseline to 3 month in a subgroup of the RCT population, all those who agree and are without contra indication
Microdialysis, tissue changes in the middle Trapezius
Biomechanical changes interstitialli in M. Trapezius. Through microdialysis technology, it is possible to monitor biochemical changes interstitially in the tissue. The technique involves the exchange of substances via diffusion between the tissue and a diaphragmatic catheter inserted into the tissue and flushed by a fluid (perfusate) that is similar in chemical composition to the fluid in the muscle interstitium.
Measured: baseline, 3 month, subgroup of the RCT population approximately n=30
Interview study of employers
employers experience with interventions and their impact on work ability, health and work situation
Measured: 3 month, subgroup of the RCT population, n=20 approximately
Interview with managers
Interviews with managers regarding the experience of the convergence dialogue meeting
Measured: 3 month, approximately n=20
Observation study
Observation study regarding the interaction between the participants in the converge dialogue meeting. Qualitative data in natural clinical settings of CDMs will be collected through video recordings (≈ 20) to find the meaning of what happen and the interactions during the dialogue. Tripartiate dialogue between patient, manager and care giver regarding the work situation and how to improve it.
Measured: During the 3 month treatment period at tripartiate convergence dialogue meeting
Health related quality of life on vertical visual analogue scale
EQ thermometer
Measured: change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding stress at work
work stress
Measured: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding work environment
work environment
Measured: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding satisfaction at work
workplace and work satisfaction
Measured: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding self-rated work performance
work performance
Measured: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding neck position at work
neck position
Measured: description and change from baseline to 3 month and 15 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 posted18 Jun 2021
- Study startMay 2022 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WorkplaceStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Anneli Peolsson, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928989
- Sponsor's protocol ID
- 2021-00373
- Acronym
- WORKCIT
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is protected by the Swedish health secrets acts and the European General Data Protection Regulation. Data will be presented on a group level without possibility for individual identification.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Does Web-based Neck-specific Exercise Add to a Digital Convergence Dialogue Meeting Promoting the Work Situation for Employees With Neck Pain?
- ClinicalTrials.gov ID
- NCT04928989
- Acronym / sponsor ID
- WORKCIT / 2021-00373
- Conditions
- Workplace
- Keywords
- Neck pain, Workplace, Counceling, Exercise, Internet-based intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Jun 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.
The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to convergenge dialogue meeting with or without neck-specific exercise. The main outcome measure is work ability, measured via the Work Ability Score.
Detailed description
Background: Collaboration between employees, manager and occupational health expert is needed to promote work ability. One effective method is a convergence dialogue meeting (CDM). Based on the existing work situation, factors are identified in these meetings that can strengthen the employee's work ability and opportunities for a sustainable working life. A combination of workplace and individual interventions is recommended for best effect. Neck-specific exercise (NSE) is the method with the most evidence for neck problems. NSE in evidence based form has not been investigated for work-related neck pain. More knowledge is needed regarding how CDM can be combined with NSE because clear guidelines are lacking on the best intervention for increased work ability in the case of neck problems. Also lacking are evaluations of digitally distributed CDMs and NSE with support from a web-based program for the current population. The aim of the proposed randomized controlled study is to investigate the contribution of NSE with four visits to a physiotherapist and support from a web-program in addition to three digital CDMs promoting the work situation.
Methods: The study will be conducted at workplaces, where the work environment and tasks increase employee risk of developing neck problems. A total of 320 participants will be recruited consecutively and after informed consent randomized to CDM with or without NSE. The main outcome measure is work ability, measured via the Work Ability Score. Secondary outcome measures are pain, function, health-related quality of life, work absenteeism and presenteeism, work-related factors, and cost-effectiveness. Pathophysiological aspects regarding inflammation and stress markers measured in blood and saliva will be studied, as will muscular changes measured by microdialysis. Interviews are planned with both employees and managers.
Discussion: The goal of the study is to contribute to improved rehabilitation, strengthened work ability, and a sustainable working life for employees with neck problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convergence dialogue meeting | Active comparator | Other: convergence dialogue meetingDigital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability. |
| Neck-specific exercise in addition to convergence dialogue meeting | Experimental | Other: convergence dialogue meetingNeck-specific exercise with digital web-based support and four visits to a physiotherapist. Neck-specific exercise will be performed based on a well-structured framework of neck-specific exercise for facilitation of deep neck muscles, increased muscle coordination, improved neck posture and increased neck muscle endurance. Plus additional convergence dialogue meeting as treatment arm no 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-reported neck problems that the person experiences as troublesome, affecting ability to perform work, and lasting at least 4 weeks.
- Neck problems as being predominant.
- Current neck pain ≥ 3 on the numeric rating scale (0-10) [53, 55].
- Persons of working age, 18-65 years, who have a permanent job.
- Neck problems clinically verified through a clinical examination to ensure study criteria are met.
Key exclusion criteria (8 listed)
- Red flags and illness/injury that are contraindicated for or hinder exercise or may be confounding factors for the results, such as severe cardiovascular/lung disease, malignancy, severe rheumatic disease, severe neurological disease, spinal cord injury, diagnosed severe mental illness, drug or alcohol abuse, neck surgery, neck fracture or dislocation, severe cervical radiculopathy, myelopathy, general body pain (e.g., fibromyalgia, Ehlers-Danlos syndrome, generalized osteoarthritis).
- Known pregnancy.
- Cannot understand/communicate in Swedish and thus would be unable to understand information in the study.
- For blood samples (not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added: increased tendency to bleed and use of blood thinners.
- For the subgroup for microdialysis (n = 30, consecutively asked, 15 persons/group; not wanting to participate does not constitute exclusion for the randomized controlled trial), the following exclusion criteria are added:
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 |
|---|---|---|
| convergence dialogue meetingDigital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability. | Other | Convergence dialogue meeting, Neck-specific exercise in addition to convergence dialogue meeting |
Primary outcome
Work Ability Score
Time frame: Change in work Ability Score from baseline, to every month until the 15 month follow-up
Current work ability compared to when it was at its best
36 secondary outcomes
Intensity of pain and bothersomeness
Time frame: change from baseline to 3 month and 15 month follow-up
Frequency of pain, symtoms and medications
Time frame: change from baseline to 3 month and 15 month follow-up
Neck specific function
Time frame: change from baseline to 3 month and 15 month follow-up
Symptom satisfaction
Time frame: change from baseline to 3 month and 15 month follow-up
Exercise/physical activity level
Time frame: change from baseline to 3 month and 15 month follow-up
Health related quality of life
Time frame: change from baseline to 3 month and 15 month follow-up
Fear avoidance
Time frame: change from baseline to 3 month and 15 month follow-up
self rated function
Time frame: change from baseline to 3 month follow-up
work situation
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding working hours
Time frame: description and change from baseline to 3 month and 15 month follow-up
perceived exertion at work
Time frame: change from baseline to 3 month and 15 month follow-up
Work ability
Time frame: change from baseline to 3 month and 15 month follow-up
Sick leave,
Time frame: change from baseline to 3 month and 15 month follow-up
Presenteeism
Time frame: change from baseline to 3 month and 15 month follow-up
Effort-Reward Imbalance
Time frame: change from baseline to 3 month and 15 month follow-up
Demand-control, support
Time frame: change from baseline to 3 month and 15 month follow-up
Risk identifaction at work
Time frame: change from baseline to 3 month and 15 month follow-up
work adaptation
Time frame: change from baseline to 3 month and 15 month follow-up
Time sitting
Time frame: change from baseline to 3 month and 15 month
Anxiety and depression
Time frame: change from baseline to 3 month and 15 month follow-up
Overall outcome
Time frame: change from baseline to follw-ups at 3 month and 15 month
Fulfilment of treatment expectation
Time frame: 3 month and 15 month related to the patient own expectations
Satisfaction with the caregiver visits in the study
Time frame: 3 month, 15 month
Adverse events/ side-effects
Time frame: 3 month, 15 month
Cost-effectiveness
Time frame: From the time period between baseline to 15 month follow-up
Saliva samples and blood samples
Time frame: change from baseline to 3 month in a subgroup of the RCT population, all those who agree and are without contra indication
Microdialysis, tissue changes in the middle Trapezius
Time frame: baseline, 3 month, subgroup of the RCT population approximately n=30
Interview study of employers
Time frame: 3 month, subgroup of the RCT population, n=20 approximately
Interview with managers
Time frame: 3 month, approximately n=20
Observation study
Time frame: During the 3 month treatment period at tripartiate convergence dialogue meeting
Health related quality of life on vertical visual analogue scale
Time frame: change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding stress at work
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding work environment
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding satisfaction at work
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding self-rated work performance
Time frame: description and change from baseline to 3 month and 15 month follow-up
self-rated work situation regarding neck position at work
Time frame: description and change from baseline to 3 month and 15 month follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No. The data is protected by the Swedish health secrets acts and the European General Data Protection Regulation. Data will be presented on a group level without possibility for individual identification.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing convergence dialogue meeting in people with Workplace, run by Linkoeping University at 2 sites in Sweden.
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 7 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: withdrawn, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Work Ability Score (time frame: Change in work Ability Score from baseline, to every month until the 15 month follow-up). 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 11 Jul 2022.