Neck PainNCT04794647
The Effects of Manual Therapy on Balance and Cervical Proprioception
A study testing Cervical mobilization in people with Neck Pain, run by Gazi University at 3 sites in Turkey (Türkiye).
Trial summary
Introduction: Neck pain causes disturbances in both proprioception and balance. The aim of the present study is to determine the effect of mobilization applied to the cervical region on static/dynamic balance and cervical proprioception in patients with nonspecific neck pain (NSNP). Materials and Methods: ... Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cervical mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 2 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- to be diagnosed with NSNP by a physiatrist
- to be in the age range of 18-60 years
- to have pain affected by neck movements
- to have restriction of cervical region in at least the last three weeks
Who cannot join
- Neurological or orthopedic disease that may affect balance / proprioception
- presence of neurological / inflammatory symptoms
- presence of cervical instability
- to have trauma / cervical surgery / severe osteoporosis
- to use of drugs that may affect balance (antidepressants, anticonvulsants, antihistamines, sedatives, betahistine)
- to have visual / vestibular disorder
- pregnancy
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Gazi University Faculty of Medicine
Ankara, 06500
Gazi Univercity
Ankara, 06560
Gazi University
Ankara
About this study
Official title: The Effects of Manual Therapy Applied to the Cervical Region on Balance and Proprioception in Patients With Nonspesific Neck Pain: A Randomised Placebo Controlled Study
Introduction: Neck pain causes disturbances in both proprioception and balance. The aim of the present study is to determine the effect of mobilization applied to the cervical region on static/dynamic balance and cervical proprioception in patients with nonspecific neck pain (NSNP).
Materials and Methods: ... patients were randomly allovated into two groups. Both grups received conventional physiotherapy program (hot pack with transcutaneous electrical nerve stimulation); additionally, the experimental group received mobilization, and the control group received placebo mobilization twice a week for 3 weeks. Before and 3 weeks later, static/dynamic balance, cervical proprioception, cervical mobility and pain were evaluated respectively with Kinesthetic Skill Training System 3000 device, joint position error test, Cervical Joint Range of Motion Device, Visual Analogue Scale.
Read the detailed description
Nonspecific neck pain (NSNP) is one of the most common causes of neck pain and it occurs as a result of postural or mechanical causes without a specific musculoskeletal pathology or injury history. Neck pain leads to a decrease in the activity of the deep cervical muscle which contains a large amount of muscle spindles, with an increase in the activity of the superficial cervical muscle. Depending on the pain, chemical changes occur in the cervical receptors and differentiation in sensitivity of the muscle spindle is observed. These changes in the structures of the cervical region predispose to deterioration in the sense of proprioception, which is an important component of balance. The disruption in proprioceptive abilities causes sensori-motor defects, muscle inhibition, muscle atrophy, and muscle fatigue. Changing cervical afferent information can affect proprioception as well as balance. Both the presence of neck pain and disruptions in the proprioceptive sense may reflect negatively on balance and postural control. In a study comparing patients with neck pain with asymptomatic individuals, increases in postural sway were found in patients with neck pain, and it was stated that the increased sway was associated with the dysfunction of the postural control system.
In the light of these informations, treatment approaches that can positively contribute to proprioception and balance gain importance in patients with NSNP. Although manual therapy is used both to reduce pain, and to increase cervical mobility in patients with NSNP, the number of studies investigating the effects of manual therapy on balance and proprioception is quite insufficient.
It was thought that mobilization applied to the cervical region can improve cervical proprioception and mobility, reduce pain and contribute positively to balance. The purpose of this study is to examine the effect of mobilization applications on the balance and cervical proprioception in patients with NSNP.
- Conditions
- Neck Pain
- Being tested
- Cervical mobilization, Placebo mobilization
- Keywords
- Mobilization, Balance, Pain, Mobility, Joint position sense.
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical mobilizationOther
Also called Manual therapy
A kind of manual therapy tecnique applied to the cervical region
Placebo mobilizationOther
It was applied to the randomly selected cervical faset without any pushing or pulling in the same position and the same grip with cervical mobilization.
| Study group | Role | What they receive |
|---|---|---|
| cervical mobilization | Experimental | 'Rotation mobilization' was applied to the symptomatic segment / segments after the detailed evaluation (symptom localization tests, cervical region safety tests, joint play tests, pain provocation/alleviation tests) in accordance with the Kaltenborn-Evjenth system in cervical region. Five series of 45-s mobilizations were performed with 15 s of rest. Each patient received 6 treatment sessions over a period of 3 week. Receives: Other: Cervical mobilization |
| placebo mobilization | Placebo comparator | Placebo mobilization was applied to the cervical region in the same position and the same grip with the mobilization group. The physiotherapist put her hand on a randomly selected faset without any pushing or pulling, The duration of placebo mobilization was the same as the duration of the other group. Each patient received 6 treatment sessions over a period of 3 week. Receives: Other: Placebo mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance measured with the Kinesthetic Ability Training System 3000 (Med-Fit Systems Inc., Fallbrook, C.A., USA) for static and dynamic balance. The increase in the balance index indicates a deterioration in balance, while the decrease in the index represents an improvement in stability.
Measured: baseline-3rd week
Cervical proprioception
Cervical joint position error test was conducted using the CROM device in transverse plane (right and left rotation). A travel eye mask was used to blindfold the patient. The examiner held the patient's head and moved slowly to the target head position, which is 50% of the maximum cervical range of motion. When patient reached actively the target position that memorized, the difference between the target position and the position obtained was recorded. Each direction of testing was performed three times and the mean error of these trials was used in the analysis.
Measured: baseline-3rd week
Secondary outcomes (2)
Cervical mobility
Active cervical range of motion was measured with the CROM device (Cervical Range of Motion-Perfomance Attainment Associates, St. Paul, MN, 55117, United States) for each direction (flexion, extension, right and left lateral flexion, right and left rotation). It is an inclinometer system that utilizes gravity and magnetic effects.
Measured: baseline-3rd week
Cervical pain
The visual analog scale (VAS) was used to assess patient's pain intensity.
Measured: baseline-3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start2 Jan 2020
- Primary completion2 Jan 2021
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Gazi 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, controlled and double blind clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Günendi, Gazi University
- Investigators
- Nevin Atalay Güzel, Prof., Study chair, Gazi Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794647
- Sponsor's protocol ID
- 24074710-604.01.01
- Status last verified
- Oct 2023
- First submitted
- 9 Mar 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
PubMed 17369782Falla DL, Jull GA, Hodges PW. Patients with neck pain demonstrate reduced electromyographic activity of the deep cervical flexor muscles during performance of the craniocervical flexion test. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2108-14. doi: 10.1097/01.brs.0000141170.89317.0e.
PubMed 15454700Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
PubMed 29097026Duray M, Simsek S, Altug F, Cavlak U. Effect of proprioceptive training on balance in patients with chronic neck pain. Agri. 2018 Jul;30(3):130-137. doi: 10.5505/agri.2018.61214.
PubMed 30028479Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.
PubMed 17702636Ruhe A, Fejer R, Walker B. Altered postural sway in patients suffering from non-specific neck pain and whiplash associated disorder - A systematic review of the literature. Chiropr Man Therap. 2011 May 24;19(1):13. doi: 10.1186/2045-709X-19-13.
PubMed 21609469Voogt L, de Vries J, Meeus M, Struyf F, Meuffels D, Nijs J. Analgesic effects of manual therapy in patients with musculoskeletal pain: a systematic review. Man Ther. 2015 Apr;20(2):250-6. doi: 10.1016/j.math.2014.09.001. Epub 2014 Sep 19.
PubMed 25282440Jun P, Page I, Vette A, Kawchuk G. Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review. Chiropr Man Therap. 2020 Mar 23;28(1):15. doi: 10.1186/s12998-020-00304-x.
PubMed 32293493Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
PubMed 28356648Fisher AR, Bacon CJ, Mannion JVH. The effect of cervical spine manipulation on postural sway in patients with nonspecific neck pain. J Manipulative Physiol Ther. 2015 Jan;38(1):65-73. doi: 10.1016/j.jmpt.2014.10.014. Epub 2014 Nov 18.
PubMed 25467613Beinert K, Lutz B, Zieglgansberger W, Diers M. Seeing the site of treatment improves habitual pain but not cervical joint position sense immediately after manual therapy in chronic neck pain patients. Eur J Pain. 2019 Jan;23(1):117-123. doi: 10.1002/ejp.1290. Epub 2018 Aug 13.
PubMed 29999203Palmgren PJ, Sandstrom PJ, Lundqvist FJ, Heikkila H. Improvement after chiropractic care in cervicocephalic kinesthetic sensibility and subjective pain intensity in patients with nontraumatic chronic neck pain. J Manipulative Physiol Ther. 2006 Feb;29(2):100-6. doi: 10.1016/j.jmpt.2005.12.002.
PubMed 16461168Heikkila H, Johansson M, Wenngren BI. Effects of acupuncture, cervical manipulation and NSAID therapy on dizziness and impaired head repositioning of suspected cervical origin: a pilot study. Man Ther. 2000 Aug;5(3):151-7. doi: 10.1054/math.2000.0357.
PubMed 11034885Law EY, Chiu TT. Measurement of cervical range of motion (CROM) by electronic CROM goniometer: a test of reliability and validity. J Back Musculoskelet Rehabil. 2013;26(2):141-8. doi: 10.3233/BMR-2012-00358.
PubMed 23640315Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.
PubMed 31615495
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual Therapy Applied to the Cervical Region on Balance and Proprioception in Patients With Nonspesific Neck Pain: A Randomised Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT04794647
- Acronym / sponsor ID
- 24074710-604.01.01
- Conditions
- Neck Pain
- Keywords
- Mobilization, Balance, Pain, Mobility, Joint position sense.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 12 Mar 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.
Introduction: Neck pain causes disturbances in both proprioception and balance. The aim of the present study is to determine the effect of mobilization applied to the cervical region on static/dynamic balance and cervical proprioception in patients with nonspecific neck pain (NSNP).
Materials and Methods: ... patients were randomly allovated into two groups. Both grups received conventional physiotherapy program (hot pack with transcutaneous electrical nerve stimulation); additionally, the experimental group received mobilization, and the control group received placebo mobilization twice a week for 3 weeks. Before and 3 weeks later, static/dynamic balance, cervical proprioception, cervical mobility and pain were evaluated respectively with Kinesthetic Skill Training System 3000 device, joint position error test, Cervical Joint Range of Motion Device, Visual Analogue Scale.
Detailed description
Nonspecific neck pain (NSNP) is one of the most common causes of neck pain and it occurs as a result of postural or mechanical causes without a specific musculoskeletal pathology or injury history. Neck pain leads to a decrease in the activity of the deep cervical muscle which contains a large amount of muscle spindles, with an increase in the activity of the superficial cervical muscle. Depending on the pain, chemical changes occur in the cervical receptors and differentiation in sensitivity of the muscle spindle is observed. These changes in the structures of the cervical region predispose to deterioration in the sense of proprioception, which is an important component of balance. The disruption in proprioceptive abilities causes sensori-motor defects, muscle inhibition, muscle atrophy, and muscle fatigue. Changing cervical afferent information can affect proprioception as well as balance. Both the presence of neck pain and disruptions in the proprioceptive sense may reflect negatively on balance and postural control. In a study comparing patients with neck pain with asymptomatic individuals, increases in postural sway were found in patients with neck pain, and it was stated that the increased sway was associated with the dysfunction of the postural control system.
In the light of these informations, treatment approaches that can positively contribute to proprioception and balance gain importance in patients with NSNP. Although manual therapy is used both to reduce pain, and to increase cervical mobility in patients with NSNP, the number of studies investigating the effects of manual therapy on balance and proprioception is quite insufficient.
It was thought that mobilization applied to the cervical region can improve cervical proprioception and mobility, reduce pain and contribute positively to balance. The purpose of this study is to examine the effect of mobilization applications on the balance and cervical proprioception in patients with NSNP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled and double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| cervical mobilization | Experimental | Other: Cervical mobilization'Rotation mobilization' was applied to the symptomatic segment / segments after the detailed evaluation (symptom localization tests, cervical region safety tests, joint play tests, pain provocation/alleviation tests) in accordance with the Kaltenborn-Evjenth system in cervical region. Five series of 45-s mobilizations were performed with 15 s of rest. Each patient received 6 treatment sessions over a period of 3 week. |
| placebo mobilization | Placebo comparator | Other: Placebo mobilizationPlacebo mobilization was applied to the cervical region in the same position and the same grip with the mobilization group. The physiotherapist put her hand on a randomly selected faset without any pushing or pulling, The duration of placebo mobilization was the same as the duration of the other group. Each patient received 6 treatment sessions over a period of 3 week. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- to be diagnosed with NSNP by a physiatrist
- to be in the age range of 18-60 years
- to have pain affected by neck movements
- to have restriction of cervical region in at least the last three weeks
Key exclusion criteria (7 listed)
- Neurological or orthopedic disease that may affect balance / proprioception
- presence of neurological / inflammatory symptoms
- presence of cervical instability
- to have trauma / cervical surgery / severe osteoporosis
- to use of drugs that may affect balance (antidepressants, anticonvulsants, antihistamines, sedatives, betahistine)
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 |
|---|---|---|
| Cervical mobilizationAlso: Manual therapyA kind of manual therapy tecnique applied to the cervical region | Other | cervical mobilization |
| Placebo mobilizationIt was applied to the randomly selected cervical faset without any pushing or pulling in the same position and the same grip with cervical mobilization. | Other | placebo mobilization |
Primary outcome
Balance
Time frame: baseline-3rd week
Balance measured with the Kinesthetic Ability Training System 3000 (Med-Fit Systems Inc., Fallbrook, C.A., USA) for static and dynamic balance. The increase in the balance index indicates a deterioration in balance, while the decrease in the index represents an improvement in stability.
Cervical proprioception
Time frame: baseline-3rd week
Cervical joint position error test was conducted using the CROM device in transverse plane (right and left rotation). A travel eye mask was used to blindfold the patient. The examiner held the patient's head and moved slowly to the target head position, which is 50% of the maximum cervical range of motion. When patient reached actively the target position that memorized, the difference between the target position and the position obtained was recorded. Each direction of testing was performed three times and the mean error of these trials was used in the analysis.
2 secondary outcomes
Cervical mobility
Time frame: baseline-3rd week
Cervical pain
Time frame: baseline-3rd week
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 31 Oct 2023.
- Background: PubMed 17369782Binder A. The diagnosis and treatment of nonspecific neck pain and whiplash. Eura Medicophys. 2007 Mar;43(1):79-89.
- Background: PubMed 15454700Falla DL, Jull GA, Hodges PW. Patients with neck pain demonstrate reduced electromyographic activity of the deep cervical flexor muscles during performance of the craniocervical flexion test. Spine (Phila Pa 1976). 2004 Oct 1;29(19):2108-14. doi: 10.1097/01.brs.0000141170.89317.0e.
- Background: PubMed 29097026Sahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
- Background: PubMed 30028479Duray M, Simsek S, Altug F, Cavlak U. Effect of proprioceptive training on balance in patients with chronic neck pain. Agri. 2018 Jul;30(3):130-137. doi: 10.5505/agri.2018.61214.
- Background: PubMed 17702636Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008 Feb;13(1):2-11. doi: 10.1016/j.math.2007.06.003. Epub 2007 Aug 16.
- Background: PubMed 21609469Ruhe A, Fejer R, Walker B. Altered postural sway in patients suffering from non-specific neck pain and whiplash associated disorder - A systematic review of the literature. Chiropr Man Therap. 2011 May 24;19(1):13. doi: 10.1186/2045-709X-19-13.
- Background: PubMed 25282440Voogt L, de Vries J, Meeus M, Struyf F, Meuffels D, Nijs J. Analgesic effects of manual therapy in patients with musculoskeletal pain: a systematic review. Man Ther. 2015 Apr;20(2):250-6. doi: 10.1016/j.math.2014.09.001. Epub 2014 Sep 19.
- Background: PubMed 32293493Jun P, Page I, Vette A, Kawchuk G. Potential mechanisms for lumbar spinal stiffness change following spinal manipulative therapy: a scoping review. Chiropr Man Therap. 2020 Mar 23;28(1):15. doi: 10.1186/s12998-020-00304-x.
- Background: PubMed 28356648Lee KS, Lee JH. Effect of maitland mobilization in cervical and thoracic spine and therapeutic exercise on functional impairment in individuals with chronic neck pain. J Phys Ther Sci. 2017 Mar;29(3):531-535. doi: 10.1589/jpts.29.531. Epub 2017 Mar 22.
- Background: PubMed 25467613Fisher AR, Bacon CJ, Mannion JVH. The effect of cervical spine manipulation on postural sway in patients with nonspecific neck pain. J Manipulative Physiol Ther. 2015 Jan;38(1):65-73. doi: 10.1016/j.jmpt.2014.10.014. Epub 2014 Nov 18.
- Background: PubMed 29999203Beinert K, Lutz B, Zieglgansberger W, Diers M. Seeing the site of treatment improves habitual pain but not cervical joint position sense immediately after manual therapy in chronic neck pain patients. Eur J Pain. 2019 Jan;23(1):117-123. doi: 10.1002/ejp.1290. Epub 2018 Aug 13.
- Background: PubMed 16461168Palmgren PJ, Sandstrom PJ, Lundqvist FJ, Heikkila H. Improvement after chiropractic care in cervicocephalic kinesthetic sensibility and subjective pain intensity in patients with nontraumatic chronic neck pain. J Manipulative Physiol Ther. 2006 Feb;29(2):100-6. doi: 10.1016/j.jmpt.2005.12.002.
- 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.
Nevin Atalay Güzel, Prof. study chair
Gazi Univercity
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical mobilization in people with Neck Pain, run by Gazi University at 3 sites 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 4 inclusion and 7 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Balance (time frame: baseline-3rd week). The study lists 2 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 NCT04794647, which also lists 17 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 31 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.