AzTrials
AzTrials

Neck PainNCT04317937

The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction

A study testing Jaw opening-closing movements, Specific Active exercises and Exercise Therapy in people with Neck Pain and PHYSIOTHERAPY, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will be focused on non- specific chronic neck pain patients. The primary objective is to study the effects of jaw sensorimotor system in the treatment of patients with neck pain and dysfunction. It will be randomized controlled trail with the estimated sample size of 80 with both genders. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Neck Pain, PHYSIOTHERAPY, JAW
What is being tested?
Jaw opening-closing movements, Specific Active exercises and Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePakistan
Study dates
15 Nov 2018to 4 Oct 2022
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • Both genders
  • 18 years to 50 years
  • Participants with history neck of more than 3 months with no related conditions
  • Non radiating pain to arms
  • Diagnosed as Nonspecific Chronic Neck pain by consultants
  • NPRS-Numeric Pain Rating Scale: score 3 to 8 (Score 3 Ending of mild pain, Score 8 Beginning of worst pain)
  • NDI- Neck Disability Index: score 5 to 34 (5 to 14 Mild disability,15- 24 Moderate disability \& 25 to 34 Severity disability)
  • No TMJ pain or dysfunction

Who cannot join

  • • NPRS-Numeric Pain Rating Scale: Score 1 \& 2 and score 9 \& 10 (Score 1 \& 2 mild pain and Score 9 \& 10 worst pain)
  • NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete disability)
  • Specific or nonspecific Acute Neck pain (Less than 7 days)
  • Neck pain- Specific or nonspecific Subacute( pain history more than seven days however less than three months)
  • Neck pain- Specific Chronic (pain history more than 3 months)
  • TMJ Dysfunction
Show all 23Show fewer
  • WAD (Whiplash Associated Disorders)
  • Cervical spondylosis
  • Rheumatoid arthritis
  • Instability of spine
  • Facial injury or dental infection
  • Any type of infection of body
  • Neck or spinal segment fracture
  • Spinal tumor or any type of tumor/cancer
  • Unexplained headache
  • Post cervical spine surgical cases
  • Signs and symptoms of Cervical spine stenosis
  • Signs and symptoms of disc bulge or herniation of cervical spine
  • Radiating neck pain or Radiculopathy of cervical spine
  • Cognitive impairment
  • Neurological conditions (MS/PD/CVA/MND)
  • Application of injection therapy in cervical spine
  • Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack, Dizziness, Double vision, Gait disturbance)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Insititute of Physical Medicine & Rehabilitation

    Karachi, Sindh

Other trials in Pakistan

About this study

The study will be focused on non- specific chronic neck pain patients. The primary objective is to study the effects of jaw sensorimotor system in the treatment of patients with neck pain and dysfunction. It will be randomized controlled trail with the estimated sample size of 80 with both genders. The experimental group will be performed Jaw opening-closing movements with active neck flexion and extension movements and control group will be performed active neck flexion and extension movements. Both groups will be received isometric strengthening exercises, Postural Advice and Home Exercise Program with Dairy. Numeric Pain Rating scale (NPRS), Neck disability Index (NDI), Neck Proprioception tests and Neck muscles endurance test will be used as outcome measures at day 0 and week 6 for treatment effect in both groups. Tables and graphs will used for demographic descriptions and appropriate statistical tests will be applied to establish treatment effect within and between groups.

Read the detailed description

Study Design : Randomized Controlled Trial

Settings: IPM\&R (Institute of Physical Medicine and Rehabilitation). This institute is a part of Dow University of Health Sciences (Karachi-Pakistan).

Duration of study: 18 months after IRB approval

Sample population: Non-specific chronic neck pain

Sample size calculation Using carried out using PASS Version 11 two sample t test with 95% confidence of interval and 80% power of test, mean of NDI (experimental 16.83± 2.3 and 19.13 ± 2.2) calculated sample size is 16 per group which we have increased up to 40 in each group (Experimental \& Control) including 8 patients as a dropout rate per group (makes at least 32 patients per group).

Sampling technique: Non probability, purposive sampling technique

Inclusion criteria:

  • Both genders
  • 18 years to 50 years
  • Participants with history neck of more than 3 months with no related conditions
  • Non radiating pain to arms
  • Diagnosed as Nonspecific Chronic Neck pain by consultants
  • NPRS-Numeric Pain Rating Scale score 3 to 8
  • NDI- Neck Disability Index : score 5 to 34
  • No TMJ pain or dysfunction

Exclusion

  • NPRS-Numeric Pain Rating Scale Score 1 \& 2 and score 9 \& 10 (Score 1 \& 2 mild pain and Score 9 \& 10 worst pain)
  • NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete disability)
  • Specific or nonspecific Acute Neck pain (Less than 7 days)
  • Neck pain- Specific or nonspecific Sub acute (pain history more than seven days however less than three months)
  • Neck pain- Specific Chronic (pain history more than 3 months)
  • TMJ Dysfunction
  • WAD (Whiplash Associated Disorders)
  • Cervical spondylosis
  • Rheumatoid arthritis
  • Instability of spine
  • Facial injury or dental infection
  • Any type of infection of body
  • Neck or spinal segment fracture
  • Spinal tumor or any type of tumor/cancer
  • Unexplained headache
  • Post cervical spine surgical cases
  • Signs and symptoms of Cervical spine stenosis
  • Signs and symptoms of disc bulge or herniation of cervical spine
  • Radiating neck pain or Radiculopathy of cervical spine
  • Cognitive impairment
  • Neurological conditions (MS/PD/CVA/MND)
  • Application of injection therapy in cervical spine
  • Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack Dizziness, Double vision, Gait disturbance)

Assessments: After consent filling form, a physiotherapy assessment form will be completed.

Outcome measures (Variables):

  1. NPRS ii. NDI iii. Neck Proprioception test iv. Neck Muscles Endurance Test

Treatment assignment (allocation):

In this study, the treatment assignment will be completed using randomization technique.

  • In this study, based on inclusion and exclusion criteria, required numbers of sample size participants will recruit first as mentioned earlier using non probability sampling technique.
  • Estimated total 80 patients (40 patients per group including dropout rate) (makes at least 32 patients per group) will be selected.
  • Total 80 study population will be divided further out in two groups based on gender for giving equal opportunity to participate in this study. 40 male patients (20 for experimental and 20 for control group) and 40 female patients (20 for experimental and 20 for control group) via simple randomization technique using computer generated Microsoft Excel sheet.
  • The above mentioned process will be run for male and female parallel or separately depending on the frequency of the patients.

Patients will not be selected in this study based on inclusion criteria, refer to the physiotherapy OPD for assessment and treatment.

Blinding:

  • Physiotherapist with minimum two years job experience will be selected and physiotherapist will receive training on how to perform the assessment.
  • Treatment blinding will be achieved by asking physiotherapist to complete initial assessment forms with all outcome measures (pre- intervention) to all subjects (referred patients) with non specific chronic neck pain and dysfunction. The physiotherapists will remain unaware about who will be selected as research sample participants including unaware about experimental and control groups.
  • At the time of getting consent, patients will be made aware of the relevant details about the research study, however they will remain unaware of their own group allocation.
  • The principal investigator alone will administer the treatment.
  • The outcome measurements will be taken at day 0 (pre-intervention) and then week 6 outcome measurements (post intervention) will be recorded by physiotherapist.

INTERVENTION: TREATMENT REGIMES FOR EXPERIMENTAL AND CONTROL Experimental group A: Jaw opening-closing movements Active jaw movements Active neck exercises B: Isometric strengthening exercises (Same as control group) C: Postural Advice and Home Exercise Program with Dairy (Same as control group)

Control group:

A: Active neck exercises. B: Isometric strengthening exercises C: Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program

  1. Postural Advise.
  • Maintain upright posture while sitting.
  • Avoid prolonged neck bending.
  • Avoid twisting movement of the neck.
  • Use a suitable pillow to maintain cervical spine.
  • Adjust computer screen at eye level.
  • Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
  • Carry light and even weight in both hands while shopping and other chores.
  • Stay hydrated.
  1. Home Exercise Program (unsupervised) The following home exercise program will be instructed to all subjects with request to repeat the program 3 times a day.
  • Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
  • Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
  • Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
  • Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15
  1. Home Dairy A home dairy will be provided to maintain home exercise program record.

Frequency and Duration of Treatment:

Non-specific Chronic Neck Pain (more than 3 months history of pain) Initial Assessment (week 1) 60 minutes, First treatment session (week1) 40 minutes, 3 treatment sessions per week (week- 2-6 ) 40 minutes, Final Assessment (week 6) 60 minutes.

ETHICAL CONSIDERATIONS

  • It will be gained from the Ethical Committee of the University before study
  • Written informed consent will be taken from all the patients
  • All information and collected data will be kept confidential.
  • Participants will remain anonymous throughout the study.
  • The Participants will be informed that there are no disadvantages or risks on the procedure of the study.
  • Participants will also be informed that they will be free to withdraw at any time during the process of the study.

DATA COLLECTION Data Collection Procedure

  • After IRB approval, Data will be collected November 2018 (Subject to approval).
  • Collection of data will be initiated once approval of synopsis will be taken.
  • Patients will be recruited from IPM\&R and consultants will assess and screen patients as indicated and will pass on to physiotherapy department with diagnosed of non specific chronic pain.
  • Initial screening proforma will be completed by a physiotherapist based on inclusion and exclusion criteria.
  • Non probability sampling technique will be used for recruitment of patients
  • A written consent form will be taken from all participants
  • Participants will be divided into two groups (Experimental and control groups) as mentioned above.
  • Assessment form including outcome measures will be completed on first visit by a trained physiotherapist with experience in the area field of physiotherapy practice at least 2 years.
  • The selected outcome measures will be taken on day 0 (pre intervention), and week 6 (post intervention) will be completed by physiotherapist.
  • Treatment will be performed for 6 weeks with postural advice and home exercise program with dairy record by principal investigator.
Being tested
Jaw opening-closing movements, Specific Active exercises, Exercise Therapy, Supportive Treatment
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jaw opening-closing movementsOther

    Also called Jaw movements

    Jaw opening-closing movements Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.

    Active jaw movements The patient will then perform maximal Jaw opening-closing movements at a pace convenient for his/her for 15 times. Three sets with two minutes rest in between will be ensured.

    Active neck exercises While performing the above movements of jaws, the patient will actively perform active neck exercise (head-neck movements in sagittal plane- Extension- Flexion).

    Head-Neck extension on jaw opening (Mandible moves vertically downward); and then from Head-Neck extension to natural flexion movement on jaw closing (Mandible moves vertically upward).

  • Specific Active exercisesOther

    Also called Active neck exercises

    Active neck exercises:

    Patient seated on a normal standard comfortable chair with proper back support and feet placed on the floor with no head support.

    Note: For Active neck exercise (flexion and extension movements of neck), firstly the patient will perform maximal Jaw opening-closing movements at a pace convenient for his/her for 5 times in order to observe (eyeball observation) the neck extension and flexion as reference point for each individual.

    Using this reference points, the patient will ask perform below mentioned active neck exercise.

    Active neck exercises: The patient will then perform active neck exercise (flexion and extension of neck) at a pace convenient for his/her for 15 times. Three sets with two minutes rest in between will be ensured.

    Active jaw movement: While performing the above movements of neck, the patient will not perform any jaws movements.

  • Exercise TherapyOther

    Also called Isometric neck exercises

    Isometric strengthening exercises For flexion the starting position will be upright head and neck. The patient will be asked to hold this position.

    For extension the starting position will be upright head and neck. The patient will be asked to hold this position.

    For rotation the starting position will be upright head and neck. The patient will be asked to hold this position.

    • In all above movements ( flexion, extension \& rotation) following method will be followed: Manual resistance will then be applied by the investigator by placing the hand on the patient's forehead, posterior part of the head and lateral part of the head with 6 second hold. 15 repetitions of this exercise will be performed. Three sets with one minute rest in between will be ensured.

  • Supportive TreatmentOther

    Also called Postural Advice and Home Exercise Program with Dairy

    Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program. Postural Advise Maintain upright posture while sitting.

    • Avoid prolonged neck bending.
    • Avoid twisting movement of the neck.
    • Use a suitable pillow to maintain cervical spine.
    • Adjust computer screen at eye level.
    • Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
    • Carry light and even weight in both hands while shopping and other chores.•Stay hydrated.

    Home Exercise Program (unsupervised) (3 times a day)

    • Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
    • Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
    • Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
    • Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15

    Home Dairy A home dairy will be provided to maintain home exercise program record.

Study groups in NCT04317937
Study groupRoleWhat they receive
Jaw Movement GroupExperimentalA: Jaw opening-closing movements * Active jaw movements * Active neck exercises B: Isometric strengthening exercises (Same as control group) C: Postural Advice and Home Exercise Program with Dairy (Same as control group)
Receives: Other: Jaw opening-closing movements; Other: Exercise Therapy; Other: Supportive Treatment
Exercise therapyActive comparatorA: Active neck exercises Active neck exercises Active jaw movements (Active Jaw movement will not be perform in this group) B: Isometric strengthening exercises C: Postural Advice and Home Exercise Program with Dairy i: Postural Advise ii: Home Exercise Program (unsupervised) iii: Home Dairy Frequency and Duration of Treatment Non-specific Chronic Neck Pain (more than 3 months history of pain) Initial Assessment (week 1) 60 minutes First treatment session (week1) 40 minutes * 3 treatment sessions per week (week- 2) 40 minutes * 3 treatment sessions per week (week- 3) 40 minutes * 3 treatment sessions per week (week- 4) 40 minutes * 3 treatment sessions per week (week- 5) 40 minutes * Last treatment session (week 6) 40 minutes * Final Assessment (week 6) 60 minutes
Receives: Other: Specific Active exercises; Other: Exercise Therapy; Other: Supportive Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Pain Rating scale (NPRS)

    Assessing the change in pain level:

    The subject will be graphically or verbally portrayed a simple depiction consisting of a horizontal bar with labels ranging from '0' to '10' (a total of 11 integers)to rate his pain intensity.'0' would be considered as 'no pain'and '10' would indicate worst pain imaginable, whereas values 1 to 3 would indicate mild pain; 4 to 6 as moderate pain and 7 to 10 would indicate severe pain. NPRS has shown to have good sensitivity and it yields data that are best suited for statistical analysis.

    Measured: Week 6

  2. Neck disability Index (NDI)

    Assessing the change in neck disability level:

    The Neck Disability Scale is a reliable outcome measure to assess the treatment effectiveness for neck disability. It consists of 10 components.

    Measured: Week 6

  3. Neck Proprioception test

    Assessing the change in neck preconception error:

    The concept adopted from Hallgren and co workers and it will be used as research instrument on baseline and final visits to find out any proprioceptive errors.

    A Neutral Reference Point (NRP) will be used and asking patient to perform cervical spine range of motion (rotation, flexion and extension). Then measures any overshoot or undershoot of movement with regard to NRP/Starting position using a cervical spine range of motion device.

    Measured: Week 6

  4. Neck muscles endurance test

    Assessing the change in neck muscle endurance level:

    Neck flexor muscle endurance test will be used to measure neck endurance in this study. It is a simple test and easy to apply. It is reliable test and achieved interrater reliability at moderate level among neck pain population.

    Cervical extensor endurance test is a simple test for measurement neck extensor muscles endurance. It has good inter-rater reliability Kappa =0.800, Kappa SE= 0.109, 95% CL) and easy to administer. Losing of chin tuck position from neutral position of cervical spine is indicating of global weakness of neck muscles (weakness of superficial and deep neck extensor muscles) whist increasing of chin length with neck extension indicates a over activity of superficial extensor muscles and weakness of deep extensor muscles of cervical spine.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start15 Nov 2018
  3. Primary completion4 Oct 2022
  4. Study completion4 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317937
Sponsor's protocol ID
013
Status last verified
Jun 2023
First submitted
6 Mar 2020
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.

    PubMed 24482302

  • Eriksson PO, Haggman-Henrikson B, Nordh E, Zafar H. Co-ordinated mandibular and head-neck movements during rhythmic jaw activities in man. J Dent Res. 2000 Jun;79(6):1378-84. doi: 10.1177/00220345000790060501.

    PubMed 10890716

  • Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.

    PubMed 18583048

  • Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.

    PubMed 3461421

  • Sihawong R, Janwantanakul P, Sitthipornvorakul E, Pensri P. Exercise therapy for office workers with nonspecific neck pain: a systematic review. J Manipulative Physiol Ther. 2011 Jan;34(1):62-71. doi: 10.1016/j.jmpt.2010.11.005.

    PubMed 21237409

  • Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.

    PubMed 28602744

  • Malchaire JB, Roquelaure Y, Cock N, Piette A, Vergracht S, Chiron H. Musculoskeletal complaints, functional capacity, personality and psychosocial factors. Int Arch Occup Environ Health. 2001 Oct;74(8):549-57. doi: 10.1007/s004200100264.

    PubMed 11768043

  • Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.

    PubMed 22094194

  • Vasseljen O, Woodhouse A, Bjorngaard JH, Leivseth L. Natural course of acute neck and low back pain in the general population: the HUNT study. Pain. 2013 Aug;154(8):1237-44. doi: 10.1016/j.pain.2013.03.032. Epub 2013 Apr 2.

    PubMed 23664654

  • Vos CJ, Verhagen AP, Passchier J, Koes BW. Clinical course and prognostic factors in acute neck pain: an inception cohort study in general practice. Pain Med. 2008 Jul-Aug;9(5):572-80. doi: 10.1111/j.1526-4637.2008.00456.x. Epub 2008 Jun 28.

    PubMed 18565009

  • Pernold G, Mortimer M, Wiktorin C, Tornqvist EW, Vingard E; Musculoskeletal Intervention Center-Norrtalje Study Group. Neck/shoulder disorders in a general population. Natural course and influence of physical exercise: a 5-year follow-up. Spine (Phila Pa 1976). 2005 Jul 1;30(13):E363-8. doi: 10.1097/01.brs.0000167819.82642.f7.

    PubMed 15990653

  • Christensen JO, Knardahl S. Time-course of occupational psychological and social factors as predictors of new-onset and persistent neck pain: a three-wave prospective study over 4 years. Pain. 2014 Jul;155(7):1262-1271. doi: 10.1016/j.pain.2014.03.021. Epub 2014 Apr 2.

    PubMed 24704365

  • Carstensen TB. The influence of psychosocial factors on recovery following acute whiplash trauma. Dan Med J. 2012 Dec;59(12):B4560.

    PubMed 23290295

  • Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.

    PubMed 25659245

  • Sharmila B. Isometric muscle energy technique and non-specific neck pain in secondary school teachers-Results of an experimental study.Indian J Physiother Occup Ther. 2014;8(2):58.

Questions about this trial

What is this clinical trial studying?

A study testing Jaw opening-closing movements, Specific Active exercises and Exercise Therapy in people with Neck Pain and PHYSIOTHERAPY, run by University of Lahore 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 8 inclusion and 23 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 13 Jun 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 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?

Numeric Pain Rating scale (NPRS) (time frame: Week 6). The study lists 4 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 NCT04317937, which also lists 47 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 13 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in