ThoracicNCT04879108
The Effectiveness of Transcutaneous Electrical Nerve Stimulation After Thoracic Surgery
A study testing Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation and Physiotherapy Rehabilitation in people with Thoracic and Surgery, run by Marmara University.
Trial summary
The purpose of this randomised and controlled study is to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation and Physiotherapy Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2009to 5 Sep 2011
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lobectomy for lung cancer
Who cannot join
- Patients undergoing pneumonectomy.
- Patients undergoing smaller resection than lobectomy.
- Presence of serious arrhythmia, pacemaker, severe cardiac failure,
- Patients with cooperation disorder
- Presence of neurological or orthopedic problems affecting the extremities.
- Patients with severe psychiatric disorders
About this study
Official title: The Role of Transcutaneous Electrical Nerve Stimulation Combined With Physiotherapy and Rehabilitation Program on Pulmonary Function and Functional Exercise Capacity in Patients Undergoing Thoracic Surgery? A Randomized Controlled Trial
The purpose of this randomised and controlled study is to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity.
Read the detailed description
Post-thoracotomy pain is one of the most severe types of post-surgical pain. When pain after thoracotomy is not treated effectively, it causes decrease in pulmonary compliance, inability to cough and deep breathing. Increased secretion leads to atelectasis and pneumonia. After surgery, early mobilization, providing airway cleaning (humidification, aspiration, forced expiration, assisted coughing), oxygen therapy, controlled breathing exercises, the use of incentive spirometry and such selected exercises, including posture and general exercises physiotherapy and rehabilitation approaches can prevent complications. A carefully planned pre and postoperative chest physiotherapy and rehabilitation program minimizes postoperative complications; it will restore normal function in these patients. Post-surgical physiotherapy applications should be combined with pain therapy for effective participation of the patient.
Local anesthetics, opioids and different special analgesia techniques including intercostal, paravertebral, interpleural and epidural blocks are used to relieve pain after thoracotomy. However, these techniques have serious side effects such as nausea, vomiting, respiratory depression, and sleepiness. It has been reported that the use of Transcutaneous Electrical Nerve Stimulation (TENS), in addition to traditional analgesia methods, may reduce the use of analgesics, side effects, and postoperative recovery period, and is useful for pain control. After cardiac surgery, TENS has been found useful in the treatment of postoperative incision pain. It has been reported that TENS therapy after thoracotomy as effective as patient-controlled analgesia.
Therefore, this study planned to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity in patients undergoing thoracic surgery.
- Conditions
- Thoracic, Surgery, Pain, Pulmonary Function, Functional Capacity
- Being tested
- Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation, Physiotherapy Rehabilitation
- Keywords
- transcutaneous electrical nerve stimulation, physiotherapy and rehabilitation, thoracic surgery, pain, pulmonary function, functional capacity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy rehabilitation and Transcutaneous Electrical Nerve StimulationOther
Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation after thoracic surgery.
Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.
Transcutaneous Electrical Nerve Stimulation was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy and Rehabilitation for 30 min, twice a day, 5 day a week.
Patients were evaluated before the surgery and the end of postoperative 5th day.
Physiotherapy RehabilitationOther
Physiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility.
Patients were evaluated before the surgery and the end of postoperative 5th day.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group | Experimental | Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation approaches after thoracic surgery.
Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.
TENS therapy was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy rehabilitation for 30 min, twice a day, 5 day a week.
Patients were evaluated before the surgery and the end of postoperative 5th day. Receives: Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation |
| Physiotherapy rehabilitation Group | Active comparator | This group was enrolled only physiotherapy and rehabilitation program after thoracic surgery.
Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.
Patients were evaluated before the surgery and the end of postoperative 5th day. Receives: Other: Physiotherapy Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Exercise Capacity
Functional exercise capacity was measured with the 6 Minute Walk Test according to the American Thoracic Society guidelines. The 6 minutes walking distance was recorded in meters.
Measured: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced expiratory volume in one second Spirometric measurement
Forced expiratory volume in one second spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Measured: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced Vital Capacity Spirometric measurement
Forced Vital Capacity spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Measured: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Pain severity
Visual Analogue Scale that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.
Measured: Baseline and postoperative 5th days.
Peak cough flow
It was evaluated with the peak flow meter device while the patient was sitting upright in a chair with a back. The test method is explained and a trial test is carried out. The nosepiece was attached to the nose and the mouthpiece of the device was wrapped tightly with the lips.
It was asked to take a deep breath and suddenly and quickly blow into the device fron the patient. The best out of three acceptable tests was recorded.
Measured: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Secondary outcomes (1)
Evaluation of dyspnea
It was evaluated with a 0-10 point borg scale. Dyspnea was measured at rest and after exertion. An increase in score is interpreted as an increase in dyspnea.
Measured: Baseline and postoperative 5th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start20 Jul 2009
- Primary completion30 Apr 2011
- Study completion5 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Crossover
- Model description
- Crossover Assignment Randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aysel Yildiz Ozer, PT, PhD, Principal investigator, Marmara UniversityNilgun Gurses, Prof, Study director, Bezmialem Vakif UniversityAlper Toker, Prof, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879108
- Sponsor's protocol ID
- 5563
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.
PubMed 16331341Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
PubMed 17442449Kaneda H, Saito Y, Okamoto M, Maniwa T, Minami K, Imamura H. Early postoperative mobilization with walking at 4 hours after lobectomy in lung cancer patients. Gen Thorac Cardiovasc Surg. 2007 Dec;55(12):493-8. doi: 10.1007/s11748-007-0169-8. Epub 2007 Dec 11.
PubMed 18066640Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. doi: 10.1016/s0003-4975(96)01249-0.
PubMed 9066400Sancho J, Servera E, Diaz J, Marin J. Comparison of peak cough flows measured by pneumotachograph and a portable peak flow meter. Am J Phys Med Rehabil. 2004 Aug;83(8):608-12. doi: 10.1097/01.phm.0000133431.70907.a2.
PubMed 15277962Meek PM. Measurement of dyspnea in chronic obstructive pulmonary disease: what is the tool telling you? Chron Respir Dis. 2004;1(1):29-37. doi: 10.1191/1479972304cd008ra.
PubMed 16281665Freynet A, Falcoz PE. Is transcutaneous electrical nerve stimulation effective in relieving postoperative pain after thoracotomy? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):283-8. doi: 10.1510/icvts.2009.219576. Epub 2009 Nov 12.
PubMed 19910359
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transcutaneous Electrical Nerve Stimulation Combined With Physiotherapy and Rehabilitation Program on Pulmonary Function and Functional Exercise Capacity in Patients Undergoing Thoracic Surgery? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04879108
- Acronym / sponsor ID
- 5563
- Conditions
- Thoracic, Surgery, Pain, Pulmonary Function, Functional Capacity
- Keywords
- transcutaneous electrical nerve stimulation, physiotherapy and rehabilitation, thoracic surgery, pain, pulmonary function, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Jul 2009 (actual)
- Primary completion
- 30 Apr 2011 (actual)
- Study completion
- 5 Sep 2011 (actual)
- First posted
- 10 May 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 purpose of this randomised and controlled study is to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity.
Detailed description
Post-thoracotomy pain is one of the most severe types of post-surgical pain. When pain after thoracotomy is not treated effectively, it causes decrease in pulmonary compliance, inability to cough and deep breathing. Increased secretion leads to atelectasis and pneumonia. After surgery, early mobilization, providing airway cleaning (humidification, aspiration, forced expiration, assisted coughing), oxygen therapy, controlled breathing exercises, the use of incentive spirometry and such selected exercises, including posture and general exercises physiotherapy and rehabilitation approaches can prevent complications. A carefully planned pre and postoperative chest physiotherapy and rehabilitation program minimizes postoperative complications; it will restore normal function in these patients. Post-surgical physiotherapy applications should be combined with pain therapy for effective participation of the patient.
Local anesthetics, opioids and different special analgesia techniques including intercostal, paravertebral, interpleural and epidural blocks are used to relieve pain after thoracotomy. However, these techniques have serious side effects such as nausea, vomiting, respiratory depression, and sleepiness. It has been reported that the use of Transcutaneous Electrical Nerve Stimulation (TENS), in addition to traditional analgesia methods, may reduce the use of analgesics, side effects, and postoperative recovery period, and is useful for pain control. After cardiac surgery, TENS has been found useful in the treatment of postoperative incision pain. It has been reported that TENS therapy after thoracotomy as effective as patient-controlled analgesia.
Therefore, this study planned to investigate the effects of transcutaneous electrical nerve stimulation combined with physiotherapy and rehabilitation program on pulmonary function and functional exercise capacity in patients undergoing thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group | Experimental | Other: Physiotherapy rehabilitation and Transcutaneous Electrical Nerve StimulationPhysiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation approaches after thoracic surgery. Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility. TENS therapy was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy rehabilitation for 30 min, twice a day, 5 day a week. Patients were evaluated before the surgery and the end of postoperative 5th day. |
| Physiotherapy rehabilitation Group | Active comparator | Other: Physiotherapy RehabilitationThis group was enrolled only physiotherapy and rehabilitation program after thoracic surgery. Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility. Patients were evaluated before the surgery and the end of postoperative 5th day. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lobectomy for lung cancer
Key exclusion criteria (6 listed)
- Patients undergoing pneumonectomy.
- Patients undergoing smaller resection than lobectomy.
- Presence of serious arrhythmia, pacemaker, severe cardiac failure,
- Patients with cooperation disorder
- Presence of neurological or orthopedic problems affecting the extremities.
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 |
|---|---|---|
| Physiotherapy rehabilitation and Transcutaneous Electrical Nerve StimulationPhysiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation after thoracic surgery. Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility. Transcutaneous Electrical Nerve Stimulation was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy and Rehabilitation for 30 min, twice a day, 5 day a week. Patients were evaluated before the surgery and the end of postoperative 5th day. | Other | Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group |
| Physiotherapy RehabilitationPhysiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility. Patients were evaluated before the surgery and the end of postoperative 5th day. | Other | Physiotherapy rehabilitation Group |
Primary outcome
Functional Exercise Capacity
Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Functional exercise capacity was measured with the 6 Minute Walk Test according to the American Thoracic Society guidelines. The 6 minutes walking distance was recorded in meters.
Forced expiratory volume in one second Spirometric measurement
Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced expiratory volume in one second spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Forced Vital Capacity Spirometric measurement
Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
Forced Vital Capacity spirometric measurement was measured. Test was carried out according to American Thoracic Society / European Respiratory Society criteria.
Pain severity
Time frame: Baseline and postoperative 5th days.
Visual Analogue Scale that is an easy, reproducible, minimal tool-requiring, and understandable measurement tool for the assessment of pain intensity was used. This scale consists of a horizontal, straight line. There is a value of 0 at the beginning of the line and 10 at the end.
Peak cough flow
Time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.
It was evaluated with the peak flow meter device while the patient was sitting upright in a chair with a back. The test method is explained and a trial test is carried out. The nosepiece was attached to the nose and the mouthpiece of the device was wrapped tightly with the lips. It was asked to take a deep breath and suddenly and quickly blow into the device fron the patient. The best out of three acceptable tests was recorded.
1 secondary outcome
Evaluation of dyspnea
Time frame: Baseline and postoperative 5th days.
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 10 May 2021.
- Results publication: PubMed 16331341Erdogan M, Erdogan A, Erbil N, Karakaya HK, Demircan A. Prospective, Randomized, Placebo-controlled Study of the Effect of TENS on postthoracotomy pain and pulmonary function. World J Surg. 2005 Dec;29(12):1563-70. doi: 10.1007/s00268-005-7934-6.
- Results publication: PubMed 17442449Cesario A, Ferri L, Galetta D, Pasqua F, Bonassi S, Clini E, Biscione G, Cardaci V, di Toro S, Zarzana A, Margaritora S, Piraino A, Russo P, Sterzi S, Granone P. Post-operative respiratory rehabilitation after lung resection for non-small cell lung cancer. Lung Cancer. 2007 Aug;57(2):175-80. doi: 10.1016/j.lungcan.2007.02.017. Epub 2007 Apr 17.
- Results publication: PubMed 18066640Kaneda H, Saito Y, Okamoto M, Maniwa T, Minami K, Imamura H. Early postoperative mobilization with walking at 4 hours after lobectomy in lung cancer patients. Gen Thorac Cardiovasc Surg. 2007 Dec;55(12):493-8. doi: 10.1007/s11748-007-0169-8. Epub 2007 Dec 11.
- Results publication: PubMed 9066400Benedetti F, Amanzio M, Casadio C, Cavallo A, Cianci R, Giobbe R, Mancuso M, Ruffini E, Maggi G. Control of postoperative pain by transcutaneous electrical nerve stimulation after thoracic operations. Ann Thorac Surg. 1997 Mar;63(3):773-6. doi: 10.1016/s0003-4975(96)01249-0.
- Results publication: PubMed 15277962Sancho J, Servera E, Diaz J, Marin J. Comparison of peak cough flows measured by pneumotachograph and a portable peak flow meter. Am J Phys Med Rehabil. 2004 Aug;83(8):608-12. doi: 10.1097/01.phm.0000133431.70907.a2.
- Results publication: PubMed 16281665Meek PM. Measurement of dyspnea in chronic obstructive pulmonary disease: what is the tool telling you? Chron Respir Dis. 2004;1(1):29-37. doi: 10.1191/1479972304cd008ra.
- Results publication: PubMed 19910359Freynet A, Falcoz PE. Is transcutaneous electrical nerve stimulation effective in relieving postoperative pain after thoracotomy? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):283-8. doi: 10.1510/icvts.2009.219576. Epub 2009 Nov 12.
- 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.
Aysel Yildiz Ozer, PT, PhD principal investigator
Marmara University
Nilgun Gurses, Prof study director
Bezmialem Vakif University
Alper Toker, Prof study chair
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation and Physiotherapy Rehabilitation in people with Thoracic and Surgery, run by Marmara University.
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 1 inclusion and 6 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional Exercise Capacity (time frame: Change from Baseline Functional Exercise Capacity at postoperative 5th days.). The study lists 5 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 NCT04879108, which also lists 7 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 10 May 2021; AzTrials last refreshed its copy on 6 Nov 2026.