Carpal Tunnel SyndromeNCT06598748
Effect of Mechanical Interface Mobilization Technique on Pain and Functional Status in Carpal Tunnel Syndrome
A study testing Mechanical Interface Mobilisation Technique and Exercise Therapy in people with Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 24 to 45 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Mechanical Interface Mobilisation Technique and Exercise Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive Phalen test and Tinel Test.
- Positive symptoms of CTS (Pain, numbness, or tingling in the first three and lateral half of the fourth finger.
Who cannot join
- No previous surgical treatments at the wrist joint, no fractures or open wounds at the wrist.
- Patients with thoracic outlet syndrome, and cervical radiculopathy.
- History of carpal tunnel release surgery.
- Steroid injection in the carpal tunnel.
- Pregnant females.
- Metabolic diseases such as diabetes, severe thyroid disorders and anemia.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome.
Read the detailed description
The median nerve gets entrapped in the wrist, causing carpal tunnel syndrome (CTS), the most prevalent peripheral neuropathy in the upper limb. A number of clinical findings, such as sensory issues with the first three digits of the hand sensory distribution of the median nerve, a positive Phalen test, weakness and atrophy of the thenar muscle, and electrophysiological findings (prolonged motor and sensory distal latencies of the median nerve) are used to diagnose CTS . The most frequent occupational risk factors for CTS are repetitive wrist and finger motions or holding uncomfortable wrist positions for extended periods of time. Tenosynovitis of the finger flexors, a thicker transverse carpal ligament, a fracture or dislocation of the distal radius or lunate, rheumatoid arthritis, lipoma, diabetes, and hyperthyroidism are other non-occupational causes . A combination of techniques has been used in the studies of Seradge H. et al and Sucher Benjamin M. Et al which included mechanical interface and neuro-dynamics, but the isolated effects of each method is yet to be determined by further studies as their combined effects are more focused on in the current literature. And that leads to an unclear decision about, which group of manual therapy techniques has better effects on individuals suffering from CTS .
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Mechanical Interface Mobilisation Technique, Exercise Therapy
- Keywords
- CTS
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Interface Mobilisation TechniqueOther
In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17).
Exercise TherapyOther
Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist.
The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26).
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Interface Mobilisation Technique | Experimental | In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17). Receives: Other: Mechanical Interface Mobilisation Technique |
| Exercise Therapy | Active comparator | Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist.
The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26). Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
The VAS consists of a line, often 10 cm long, with verbal anchors at each end of the line, similar to a Numeric Rating Scale (i.e, no pain on the far left and severe pain on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Measured: 4 week (will be measured at the end of every week)]
Symptom Severity Scale
Symptom Severity Scale (SSS) (24) The SSS consists of 11 items related to six domains said to be critical for the evaluation of CTS.
Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
Measured: 1st week(pre) and 4th week(post)]
Hand functional status scale
Hand functional status scale (FSS) (24) The FSS consists of eight-items related to a variety of activities commonly performed by a diverse of patients. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
Measured: 1st week(pre) and 4th week(post)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Participants were randomly assigned to the experimental group or control group. Participants were not notified which group was assigned to
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramsha Tariq, MsOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598748
- Sponsor's protocol ID
- RCRAHS-ISB/REC/MS-PT/017
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chammas M, Boretto J, Burmann LM, Ramos RM, Dos Santos Neto FC, Silva JB. Carpal tunnel syndrome - Part I (anatomy, physiology, etiology and diagnosis). Rev Bras Ortop. 2014 Aug 20;49(5):429-36. doi: 10.1016/j.rboe.2014.08.001. eCollection 2014 Sep-Oct.
PubMed 26229841Michlovitz SL. Conservative interventions for carpal tunnel syndrome. J Orthop Sports Phys Ther. 2004 Oct;34(10):589-600. doi: 10.2519/jospt.2004.34.10.589.
PubMed 15552705Rota E, Morelli N. Entrapment neuropathies in diabetes mellitus. World J Diabetes. 2016 Sep 15;7(17):342-53. doi: 10.4239/wjd.v7.i17.342.
PubMed 27660694Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.
PubMed 12098159Bland JD. Treatment of carpal tunnel syndrome. Muscle Nerve. 2007 Aug;36(2):167-71. doi: 10.1002/mus.20802.
PubMed 17534984Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.
PubMed 26281946Kanaan N, Sawaya RA. Carpal tunnel syndrome: modern diagnostic and management techniques. Br J Gen Pract. 2001 Apr;51(465):311-4.
PubMed 11458486Zaralieva A, Georgiev GP, Karabinov V, Iliev A, Aleksiev A. Physical Therapy and Rehabilitation Approaches in Patients with Carpal Tunnel Syndrome. Cureus. 2020 Mar 3;12(3):e7171. doi: 10.7759/cureus.7171.
PubMed 32257712Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):981-1004. doi: 10.1016/j.apmr.2010.03.022.
PubMed 20599038Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
PubMed 19782873Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PubMed 19027342Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.
PubMed 20036180Lim YH, Chee DY, Girdler S, Lee HC. Median nerve mobilization techniques in the treatment of carpal tunnel syndrome: A systematic review. J Hand Ther. 2017 Oct-Dec;30(4):397-406. doi: 10.1016/j.jht.2017.06.019. Epub 2017 Jul 29.
PubMed 28764878Medina McKeon JM, Yancosek KE. Neural gliding techniques for the treatment of carpal tunnel syndrome: a systematic review. J Sport Rehabil. 2008 Aug;17(3):324-41. doi: 10.1123/jsr.17.3.324.
PubMed 18708684Burke J, Buchberger DJ, Carey-Loghmani MT, Dougherty PE, Greco DS, Dishman JD. A pilot study comparing two manual therapy interventions for carpal tunnel syndrome. J Manipulative Physiol Ther. 2007 Jan;30(1):50-61. doi: 10.1016/j.jmpt.2006.11.014.
PubMed 17224356
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Interface Mobilization Technique on Pain and Functional Status in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06598748
- Acronym / sponsor ID
- RCRAHS-ISB/REC/MS-PT/017
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- CTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Sep 2024 (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 aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome.
Detailed description
The median nerve gets entrapped in the wrist, causing carpal tunnel syndrome (CTS), the most prevalent peripheral neuropathy in the upper limb. A number of clinical findings, such as sensory issues with the first three digits of the hand sensory distribution of the median nerve, a positive Phalen test, weakness and atrophy of the thenar muscle, and electrophysiological findings (prolonged motor and sensory distal latencies of the median nerve) are used to diagnose CTS . The most frequent occupational risk factors for CTS are repetitive wrist and finger motions or holding uncomfortable wrist positions for extended periods of time. Tenosynovitis of the finger flexors, a thicker transverse carpal ligament, a fracture or dislocation of the distal radius or lunate, rheumatoid arthritis, lipoma, diabetes, and hyperthyroidism are other non-occupational causes . A combination of techniques has been used in the studies of Seradge H. et al and Sucher Benjamin M. Et al which included mechanical interface and neuro-dynamics, but the isolated effects of each method is yet to be determined by further studies as their combined effects are more focused on in the current literature. And that leads to an unclear decision about, which group of manual therapy techniques has better effects on individuals suffering from CTS .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to the experimental group or control group. Participants were not notified which group was assigned to
| Arm | Type | Receives |
|---|---|---|
| Mechanical Interface Mobilisation Technique | Experimental | Other: Mechanical Interface Mobilisation TechniqueIn the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17). |
| Exercise Therapy | Active comparator | Other: Exercise TherapyParticipants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist. The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26). |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Positive Phalen test and Tinel Test.
- Positive symptoms of CTS (Pain, numbness, or tingling in the first three and lateral half of the fourth finger.
Key exclusion criteria (6 listed)
- No previous surgical treatments at the wrist joint, no fractures or open wounds at the wrist.
- Patients with thoracic outlet syndrome, and cervical radiculopathy.
- History of carpal tunnel release surgery.
- Steroid injection in the carpal tunnel.
- Pregnant females.
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 |
|---|---|---|
| Mechanical Interface Mobilisation TechniqueIn the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17). | Other | Mechanical Interface Mobilisation Technique |
| Exercise TherapyParticipants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist. The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26). | Other | Exercise Therapy |
Primary outcome
Visual analogue scale (VAS)
Time frame: 4 week (will be measured at the end of every week)]
The VAS consists of a line, often 10 cm long, with verbal anchors at each end of the line, similar to a Numeric Rating Scale (i.e, no pain on the far left and severe pain on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
Symptom Severity Scale
Time frame: 1st week(pre) and 4th week(post)]
Symptom Severity Scale (SSS) (24) The SSS consists of 11 items related to six domains said to be critical for the evaluation of CTS. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
Hand functional status scale
Time frame: 1st week(pre) and 4th week(post)]
Hand functional status scale (FSS) (24) The FSS consists of eight-items related to a variety of activities commonly performed by a diverse of patients. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
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 19 Sep 2024.
- Background: PubMed 26229841Chammas M, Boretto J, Burmann LM, Ramos RM, Dos Santos Neto FC, Silva JB. Carpal tunnel syndrome - Part I (anatomy, physiology, etiology and diagnosis). Rev Bras Ortop. 2014 Aug 20;49(5):429-36. doi: 10.1016/j.rboe.2014.08.001. eCollection 2014 Sep-Oct.
- Background: PubMed 15552705Michlovitz SL. Conservative interventions for carpal tunnel syndrome. J Orthop Sports Phys Ther. 2004 Oct;34(10):589-600. doi: 10.2519/jospt.2004.34.10.589.
- Background: PubMed 27660694Rota E, Morelli N. Entrapment neuropathies in diabetes mellitus. World J Diabetes. 2016 Sep 15;7(17):342-53. doi: 10.4239/wjd.v7.i17.342.
- Background: PubMed 12098159Naeser MA, Hahn KA, Lieberman BE, Branco KF. Carpal tunnel syndrome pain treated with low-level laser and microamperes transcutaneous electric nerve stimulation: A controlled study. Arch Phys Med Rehabil. 2002 Jul;83(7):978-88. doi: 10.1053/apmr.2002.33096.
- Background: PubMed 17534984Bland JD. Treatment of carpal tunnel syndrome. Muscle Nerve. 2007 Aug;36(2):167-71. doi: 10.1002/mus.20802.
- Background: PubMed 26281946Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.
- Background: PubMed 11458486Kanaan N, Sawaya RA. Carpal tunnel syndrome: modern diagnostic and management techniques. Br J Gen Pract. 2001 Apr;51(465):311-4.
- Background: PubMed 32257712Zaralieva A, Georgiev GP, Karabinov V, Iliev A, Aleksiev A. Physical Therapy and Rehabilitation Approaches in Patients with Carpal Tunnel Syndrome. Cureus. 2020 Mar 3;12(3):e7171. doi: 10.7759/cureus.7171.
- Background: PubMed 20599038Huisstede BM, Hoogvliet P, Randsdorp MS, Glerum S, van Middelkoop M, Koes BW. Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review. Arch Phys Med Rehabil. 2010 Jul;91(7):981-1004. doi: 10.1016/j.apmr.2010.03.022.
- Background: PubMed 19782873Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
- Background: PubMed 19027342Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
- Background: PubMed 20036180Nijs J, Van Houdenhove B, Oostendorp RA. Recognition of central sensitization in patients with musculoskeletal pain: Application of pain neurophysiology in manual therapy practice. Man Ther. 2010 Apr;15(2):135-41. doi: 10.1016/j.math.2009.12.001. Epub 2009 Dec 24.
- 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.
Ramsha Tariq, MsOMPT principal investigator
Riphah International 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 Mechanical Interface Mobilisation Technique and Exercise Therapy in people with Carpal Tunnel Syndrome, run by Riphah International University at 1 site in Pakistan.
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 2 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 19 Sep 2024. 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 Pakistan. 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: 4 week (will be measured at the end of every week)]). 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 NCT06598748, which also lists 26 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 19 Sep 2024.