Rotator Cuff InjuriesNCT05277077
Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair
A study testing Pain neuroscience education and Conventional treatment in people with Rotator Cuff Injuries and Tear, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Pain neuroscience education (PNE) aims to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Tear, Pain, Shoulder
- What is being tested?
- Pain neuroscience education and Conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2022to 12 Jul 2023
- 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
- being in the age range of 18-65 years
- being diagnosed with a small and medium-sized RCT based on magnetic resonance imaging and clinical continuity tests
- history of arthroscopic rotator cuff repair (ARCR)
- having a good command of the Turkish language
- scoring above 24 in the Mini Mental State Test
- ≥80% compliance in completing the post-ARCR Phase 1 trainings
- volunteering to participate in the study.
Who cannot join
- diabetes mellitus
- neurological problems
- cervical disc herniation
- visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
- osteoarthritis, rheumatoid arthritis or other systemic inflammatory problems
- hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
Show all 13Show fewer
- former shoulder fractures on the affected side
- partial RCT
- former surgery on the affected side
- a history of adhesive capsulitis;
- traumatic shoulder instability (subluxation-dislocation)
- patients who are in stage 3 and above on the Goutallier classification system
- receiving a corticosteroid injection on the affected side within 6 weeks prior to diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair on Clinical Outcomes
Pain neuroscience education (PNE) aims to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. It has been demonstrated for musculoskeletal pain, PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.
Read the detailed description
Therapeutic interventions based on pain neuroscience education (PNE) have emerged as promising. It consists of educational sessions describing the neurobiology and neurophysiology of chronic pain and pain processing, with a particular focus on the role of the central nervous system on chronic pain and deemphasizing anatomical issues. PNE promotes the patients' understanding of chronic pain and changes maladaptive thoughts and cognitions (e.g. pain catastrophizing), which are important barriers to active therapy and exercise. Despite the apparent complexity of neuroscience education, patients are able to understand and remember it. Furthermore, there is evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophizing, and physical performance, especially if combined with exercise. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.
- Conditions
- Rotator Cuff Injuries, Tear, Pain, Shoulder
- Being tested
- Pain neuroscience education, Conventional treatment
- Keywords
- Rotator Cuff Injuries, tear, pain, shoulder
- Medical subject headings
- Rotator Cuff Injuries, Lacerations, Shoulder Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
The experimental group will follow a PNE protocol based on previous procedure for a whole period of 6 weeks in addition the conventional treatment.
Conventional treatmentOther
Patients from both groups will receive a conventional 6-week treatment programme (30 treatment sessions, five a week, for 90min duration).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In addition to the conservative treatment, the experimental group will follow PNE sessions (one session per week over six consecutive weeks). Each session will take between 45 min and 1 h. The physiotherapist with 6 years of clinical and PNE experience will conduct all sessions. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience. The theoretical information will be complemented with pictures and diagrams based on previous procedures. A booklet with the contents of each session and containing a mixture of text, figures, and activities to perform between sessions will be developed for the purpose of this study and given to participants. Time devoted to PNE will decrease from session 1 (60 min) to session 6 (15 min). Receives: Other: Pain neuroscience education |
| Control Group | Active comparator | The control group will follow a conservative treatment. The 90-minute-long training sessions will be held 5 days per week. The training program will include the following exercises: cold-pack for 20 minutes; 20 minutes of Conventional TENS; 3 minutes of soft tissue massage for deltoid and biceps muscles; scapula and glenohumeral joint mobilizations; towel sliding and duster slide exercises on the wall; wand-assisted bilateral shoulder elevation; external rotation in increasing abduction angles, internal rotation in abduction, horizontal adduction and functional internal rotation exercises; strengthening exercises; finger ladder exercises; activation of deltoid, rotator cuff, and scapular muscles at chest level as the degree of active elevation increases; anterior elevation using an elastic band; strength training in "Full Can" position; closed kinetic chain trainings; isometric exercises of the periscapular muscles, deltoid and trapezius; and posterior capsule stretching. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 6 weeks
Shoulder Pain and Disability Index (SPADI)
The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.
Measured: 6 weeks
The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
DASH questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Measured: 6 weeks
Secondary outcomes (4)
Catastrophizing
Pain Catastrophizing Scale (PCS) will be used to evaluate the patient's feelings, thoughts, and emotions related to cognitive characteristics of pain. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points.
Measured: 6 weeks
Hospital Anxiety and Depression Scale (HADS)
HADS will be used to assess anxiety and depression. HADS consists of 7 items for anxiety and 7 for depression. The items are scored on a 4-point scale from 0 (not present) to 3 (considerable).
Measured: 6 weeks
Tampa-Scale of Kinesiophobia (TSK)
Participants will be assessed with Tampa-Scale of Kinesiophobia (TSK) in terms of presence of kinesiophobia. The TSK is a 17-item scale that measures the somatic focus of patients (beliefs about underlying and serious medical problems), and activity avoidance (beliefs about (re) injury or increased pain). The TSK has moderate construct, concurrent and predictive validity, good internal consistency, and a moderate to good retest reliability. Patients scoring high on the TSK, above 37 points, are likely to have fear of movement.
Measured: 6 weeks
12-Item Short-Form Health Survey (SF-12)
Participants will be assessed with 12-Item Short-Form Health Survey (SF-12) in terms of quality of life. It is a self-administered survey and two scores can be measured: the Physical Component and the Mental Component. In both, scores range from 0 to 100, with the highest scores associated with better levels of quality of life.
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 Mar 2022
- Study start31 Mar 2022
- Primary completion12 Jun 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caner Karartı, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277077
- Sponsor's protocol ID
- 2022100
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.
PubMed 29319386Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
PubMed 29710099Wijma AJ, van Wilgen CP, Meeus M, Nijs J. Clinical biopsychosocial physiotherapy assessment of patients with chronic pain: The first step in pain neuroscience education. Physiother Theory Pract. 2016 Jul;32(5):368-84. doi: 10.1080/09593985.2016.1194651. Epub 2016 Jun 28.
PubMed 27351769Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
PubMed 30178503Ryosa A, Laimi K, Aarimaa V, Lehtimaki K, Kukkonen J, Saltychev M. Surgery or conservative treatment for rotator cuff tear: a meta-analysis. Disabil Rehabil. 2017 Jul;39(14):1357-1363. doi: 10.1080/09638288.2016.1198431. Epub 2016 Jul 6.
PubMed 27385156
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain Neuroscience Education Following Arthroscopic Rotator Cuff Repair on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05277077
- Acronym / sponsor ID
- 2022100
- Conditions
- Rotator Cuff Injuries, Tear, Pain, Shoulder
- Keywords
- Rotator Cuff Injuries, tear, pain, shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 14 Mar 2022 (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.
Pain neuroscience education (PNE) aims to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. It has been demonstrated for musculoskeletal pain, PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.
Detailed description
Therapeutic interventions based on pain neuroscience education (PNE) have emerged as promising. It consists of educational sessions describing the neurobiology and neurophysiology of chronic pain and pain processing, with a particular focus on the role of the central nervous system on chronic pain and deemphasizing anatomical issues. PNE promotes the patients' understanding of chronic pain and changes maladaptive thoughts and cognitions (e.g. pain catastrophizing), which are important barriers to active therapy and exercise. Despite the apparent complexity of neuroscience education, patients are able to understand and remember it. Furthermore, there is evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophizing, and physical performance, especially if combined with exercise. Rotator cuff tears (RCT) often lead to pain aggrevation, deterioration of patients' functioning and considerable economic burden for health care resources requiring consultations, physiotherapy, radiological examinations and surgery. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, satisfactory results are scarce. The lack of satisfactory results at the end of all this effort suggests that some practices should be revised. Although PNE is likely to have beneficial effects on shoulder pathomechanics, to our knowledge, there is no randomized controlled research in the relevant literature investigating the effects of PNE in patients with an RCT. The present study aims to examine the effectiveness of PNE on clinical outcomes in a sample of patients with RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Pain neuroscience educationIn addition to the conservative treatment, the experimental group will follow PNE sessions (one session per week over six consecutive weeks). Each session will take between 45 min and 1 h. The physiotherapist with 6 years of clinical and PNE experience will conduct all sessions. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience. The theoretical information will be complemented with pictures and diagrams based on previous procedures. A booklet with the contents of each session and containing a mixture of text, figures, and activities to perform between sessions will be developed for the purpose of this study and given to participants. Time devoted to PNE will decrease from session 1 (60 min) to session 6 (15 min). |
| Control Group | Active comparator | Other: Conventional treatmentThe control group will follow a conservative treatment. The 90-minute-long training sessions will be held 5 days per week. The training program will include the following exercises: cold-pack for 20 minutes; 20 minutes of Conventional TENS; 3 minutes of soft tissue massage for deltoid and biceps muscles; scapula and glenohumeral joint mobilizations; towel sliding and duster slide exercises on the wall; wand-assisted bilateral shoulder elevation; external rotation in increasing abduction angles, internal rotation in abduction, horizontal adduction and functional internal rotation exercises; strengthening exercises; finger ladder exercises; activation of deltoid, rotator cuff, and scapular muscles at chest level as the degree of active elevation increases; anterior elevation using an elastic band; strength training in "Full Can" position; closed kinetic chain trainings; isometric exercises of the periscapular muscles, deltoid and trapezius; and posterior capsule stretching. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- being in the age range of 18-65 years
- being diagnosed with a small and medium-sized RCT based on magnetic resonance imaging and clinical continuity tests
- history of arthroscopic rotator cuff repair (ARCR)
- having a good command of the Turkish language
- scoring above 24 in the Mini Mental State Test
Key exclusion criteria (13 listed)
- diabetes mellitus
- neurological problems
- cervical disc herniation
- visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
- osteoarthritis, rheumatoid arthritis or other systemic inflammatory problems
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 |
|---|---|---|
| Pain neuroscience educationThe experimental group will follow a PNE protocol based on previous procedure for a whole period of 6 weeks in addition the conventional treatment. | Other | Experimental Group |
| Conventional treatmentPatients from both groups will receive a conventional 6-week treatment programme (30 treatment sessions, five a week, for 90min duration). | Other | Control Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 6 weeks
VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 weeks
The SPADI is a 13 item self-reported questionnaire assessing pain and functional status. Each item is measured on a 0-10 scale and a 0-100 score calculated. Higher scores represent greater levels of pain and disability. The SPADI has been shown to have good test-re-test reliability and be sensitive to change.
The Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)
Time frame: 6 weeks
DASH questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
4 secondary outcomes
Catastrophizing
Time frame: 6 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 weeks
Tampa-Scale of Kinesiophobia (TSK)
Time frame: 6 weeks
12-Item Short-Form Health Survey (SF-12)
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 21 Jul 2023.
- Background: PubMed 29319386Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.
- Background: PubMed 29710099Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
- Background: PubMed 27351769Wijma AJ, van Wilgen CP, Meeus M, Nijs J. Clinical biopsychosocial physiotherapy assessment of patients with chronic pain: The first step in pain neuroscience education. Physiother Theory Pract. 2016 Jul;32(5):368-84. doi: 10.1080/09593985.2016.1194651. Epub 2016 Jun 28.
- Background: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 30178503Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
- Background: PubMed 27385156Ryosa A, Laimi K, Aarimaa V, Lehtimaki K, Kukkonen J, Saltychev M. Surgery or conservative treatment for rotator cuff tear: a meta-analysis. Disabil Rehabil. 2017 Jul;39(14):1357-1363. doi: 10.1080/09638288.2016.1198431. Epub 2016 Jul 6.
- 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 Pain neuroscience education and Conventional treatment in people with Rotator Cuff Injuries and Tear, run by Hacettepe 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 7 inclusion and 13 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 21 Jul 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. 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?
Visual Analogue Scale (VAS) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277077, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.