Low Back PainLOLANCT04576611

LOw Level of Activity (LOLA): Education and Exercise-based Intervention for Low Back Pain

A study testing face-to-face protocol and self-managed protocol in people with Low Back Pain, run by University of the Balearic Islands at 1 site in Spain.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 59 years
Conditions the study is for: Low Back Pain
What is being tested?: face-to-face protocol and self-managed protocol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteSpain
Study dates: 6 Mar 2019to 11 Feb 2020
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 59 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subjects between 18 and 59 years, with non-specific low back pain for more than 6 weeks and which have experienced at least 3 episodes of low back pain lasting more than 1 week during the year prior to the study, and, at the time of evaluation and/or intervention, presenting pain of mild/moderate intensity (not exceeding 5 out of 10 in a Visual Analogue Scale (VAS)).

Who cannot join

High functional impairment compromising activities such as walking, sitting or getting up from a chair.
Pain at the time of evaluation and/or intervention greater than 5 (out of 10) in a VAS.
Presence of irradiated pain (sciatic type) or referred to lower extremities.
History of spine surgery, spinal or pelvic fracture
Hospitalization for serious trauma or injuries due to traffic accidents.
History of osteoarthritis in the lower extremities.
History of any systematic diseases with involvement of the locomotor system.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of the Balearic Islands
Palma, Balearic Islands, 07122

Other trials in Spain

About this study

Official title: Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)

Chronic pain of moderate to severe intensity occurs in 19% of adult Europeans. Non-specific low-back pain is one of the most prevalent symptoms and the main cause of disability in industrialized countries, generating significant public health expenditure on health and occupational care. The combination of pain neurophysiology education and therapeutic exercise has shown positive effects in patients with chronic non-specific low back pain. Mobile health tools (mHealth) are proposed as a cost-effective alternative to continuously record the daily activities of patients and to provide rapid feedback to users and clinicians, reducing visits to clinics. A 4-week (8-session) education and exercise-based intervention will be carried out in a group of patients with non-specific chronic low back pain using two modalities: (1) face-to-face guided by a health professional or (2) self-managed through BackFit App. The sample will be divided into two groups and will be evaluated before (pre), after (post) and 3 months (follow-up) after the intervention.

Read the detailed description

The objectives of this study are:

To assess the influence of a 4-week (8 sessions) intervention based on education (about pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and cognitive functioning (selective attention), as primary variable outcomes, and on physical condition (balance and range of movement), affective and cognitive symptoms (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain interference and self-reported clinical pain, as secondary variable outcomes, in patients with non-specific chronic low back pain.
To evaluate the effectiveness of a mobile health application developed by researchers (BackFit App) to carry out the intervention, in comparison with a supervised intervention by a health professional.

The hypotheses of the study are:

This intervention based on education and physical exercise will increase PPT and improve selective attention.
This intervention will also improve physical condition, self-reported clinical pain, affective and cognitive symptoms and pain interference presented by patients with chronic low back pain.
The intervention performed with BackFit App will be as effective as that supervised by a health professional.

Conditions: Low Back Pain
Being tested: face-to-face protocol, self-managed protocol
Keywords: Mobile Applications, Muscle and Stretching Exercises, Physical Exercise, Behavior
Medical subject headings: Low Back Pain, Motor Activity, Behavior

What participants receive

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

face-to-face protocolOther
The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).
self-managed protocolOther
Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

Study groups in NCT04576611
Study group	Role	What they receive
face-to-face	Experimental	A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using face-to-face modality guided by a health professional. Receives: Other: face-to-face protocol
self-managed	Experimental	A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using self-managed modality through BackFit App. Receives: Other: self-managed protocol

What is being measured

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

Cognitive functioning assessment.
Cognitive functioning was assessed by recording electroencephalographic activity during a computerized version of the Flanker task, which measures selective attention, under two experimental conditions: congruent flanks (arrows) with the target (pointing in the same direction as the central arrow) and incongruent (pointing the opposite direction).Regarding Resting EEG a Fast Fourier Transform (FFT) analysis has been made (delta, theta, "Alpha" and beta 1, 2 and 3. The EEG during the "Flanker task" was analyzed by means of a "Cluster-based analysis". Primary outcome measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Measured: Up to 4 weeks.
Heart Rate Variability (HRV)
Heart Rate Variability (HRV) has been analyzed from ECG data. Primary outcome Measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Measured: Up to 4 weeks.
Pressure pain thresholds (PPT).
To evaluate Pressure pain thresholds (PPT )(with a maximum of 5kg/cm2) will be applied pressure on the erector spinae and index finger with an algometer (area 1cm2). Primary outcome measures were recorded in a counterbalanced order and were measured at baseline, 4 and 12 weeks.
Measured: Up to 12 weeks.

Secondary outcomes (9)

Balance
Mono and bipedal static balance will be measured with the Wii balance board. Measurements will be performed after 15 minutes of rest once the subject arrives at baseline, 4 and 12 weeks.
Measured: Up to 12 weeks.
Range of movement
Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and 12 weeks.
Measured: Up to 12 weeks.
Clinical pain
Clinical pain will be measured with Visual Analog Scale (VAS) (0-10cm) This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater pain intensity.
Measured: Up to 12 weeks.
Pain interference
Pain interference data will be collected with the Spanish version of Oswestry Disability Index (ODI) (0-100%). This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater functional disability.
Measured: Up to 12 weeks.
Affective symptoms (Mood)
Mood, often associated to chronic pain, will be assessed by the Spanish versions of Profile of Mood States (POMS) questionnaire.
The POMS questionnaire (Ranges from 0-200) assesses six mood subscales: tension-anxiety (0-36), anger-hostility (0-48), vigor (0-32), fatigue (0-28), depression (0-60) and confusion (0-28).
High vigor scores reflect a good mood or emotion. Low scores in the other subscales reflect a good mood or emotion
Measured: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Affective symptoms (anxiety)
Anxiety, often associated to chronic pain, will be assessed by the State Trait Anxiety Inventory (STAI) questionnaire. State (0-30) and Trate (0-30). Higher scores indicates greater anxiety.
Measured: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (catastrophizing)
Other cognitive symptoms, such as catastrophyzing, will be assessed using the Spanish version of Pain Catastrophizing Scale (PCS)(Ranges from 0-52), a 13-item scale where low scores show little catastrophization, and high values, high catastrophization.
Measured: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (fear-avoidance beliefs)
Other cognitive symptoms, such as fear-avoidance beliefs will be also assessed using Fear Avoidance Beliefs Questionnaire (FABQ).(ranges from 0-96) Higher scores indicate more strongly held fear avoidance beliefs.
Measured: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (kinesiophobia)
Other cognitive symptoms, such as kinesiophobia (or fear of movement) will be also assessed using the spanish version of Tampa Scale for Kinesiophobia (TSK).
It consists of 11 items scored from 1 (strongly disagree) to 4 (strongly agree). The higher the score, the higher the degree of kinesiophobia.
Measured: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Timeline

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

6 Mar 201911 Feb 2020

First posted6 Oct 2020
Study start6 Mar 2019
Primary completion11 Feb 2020
Study completion11 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04576611
Sponsor's protocol ID: PSI2015-66295
Acronym: LOLA
Status last verified: Mar 2021
First submitted: 10 Jul 2020
Last updated: 2 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
PubMed 16095934
van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
PubMed 16550447
Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
PubMed 22466247
Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.
PubMed 28359011
Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
PubMed 29138049
Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
PubMed 25090974
Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.
PubMed 21989632
Sitges C, Terrasa JL, Garcia-Dopico N, Segur-Ferrer J, Velasco-Roldan O, Crespi-Palmer J, Gonzalez-Roldan AM, Montoya P. An Educational and Exercise Mobile Phone-Based Intervention to Elicit Electrophysiological Changes and to Improve Psychological Functioning in Adults With Nonspecific Chronic Low Back Pain (BackFit App): Nonrandomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Mar 15;10(3):e29171. doi: 10.2196/29171.
PubMed 35289758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)
ClinicalTrials.gov ID: NCT04576611
Acronym / sponsor ID: LOLA / PSI2015-66295
Conditions: Low Back Pain
Keywords: Mobile Applications, Muscle and Stretching Exercises, Physical Exercise, Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: University of the Balearic IslandsUniversity, hospital or other
Collaborators: Ministerio de Economía y Competitividad, Spain
Study start: 6 Mar 2019 (actual)
Primary completion: 11 Feb 2020 (actual)
Study completion: 11 Feb 2020 (actual)
First posted: 6 Oct 2020 (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.

Detailed description

The objectives of this study are:

To assess the influence of a 4-week (8 sessions) intervention based on education (about pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and cognitive functioning (selective attention), as primary variable outcomes, and on physical condition (balance and range of movement), affective and cognitive symptoms (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain interference and self-reported clinical pain, as secondary variable outcomes, in patients with non-specific chronic low back pain.
To evaluate the effectiveness of a mobile health application developed by researchers (BackFit App) to carry out the intervention, in comparison with a supervised intervention by a health professional.

The hypotheses of the study are:

This intervention based on education and physical exercise will increase PPT and improve selective attention.
This intervention will also improve physical condition, self-reported clinical pain, affective and cognitive symptoms and pain interference presented by patients with chronic low back pain.
The intervention performed with BackFit App will be as effective as that supervised by a health professional.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
face-to-face	Experimental	Other: face-to-face protocolA 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using face-to-face modality guided by a health professional.
self-managed	Experimental	Other: self-managed protocolA 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using self-managed modality through BackFit App.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Subjects between 18 and 59 years, with non-specific low back pain for more than 6 weeks and which have experienced at least 3 episodes of low back pain lasting more than 1 week during the year prior to the study, and, at the time of evaluation and/or intervention, presenting pain of mild/moderate intensity (not exceeding 5 out of 10 in a Visual Analogue Scale (VAS)).

Key exclusion criteria (7 listed)

High functional impairment compromising activities such as walking, sitting or getting up from a chair.
Pain at the time of evaluation and/or intervention greater than 5 (out of 10) in a VAS.
Presence of irradiated pain (sciatic type) or referred to lower extremities.
History of spine surgery, spinal or pelvic fracture
Hospitalization for serious trauma or injuries due to traffic accidents.

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
face-to-face protocolThe intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).	Other	face-to-face
self-managed protocolSubjects of this group receive the same intervention content as the other experimental group, but through a mobile application.	Other	self-managed

Primary outcome

Cognitive functioning assessment.
Time frame: Up to 4 weeks.
Cognitive functioning was assessed by recording electroencephalographic activity during a computerized version of the Flanker task, which measures selective attention, under two experimental conditions: congruent flanks (arrows) with the target (pointing in the same direction as the central arrow) and incongruent (pointing the opposite direction).Regarding Resting EEG a Fast Fourier Transform (FFT) analysis has been made (delta, theta, "Alpha" and beta 1, 2 and 3. The EEG during the "Flanker task" was analyzed by means of a "Cluster-based analysis". Primary outcome measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Heart Rate Variability (HRV)
Time frame: Up to 4 weeks.
Heart Rate Variability (HRV) has been analyzed from ECG data. Primary outcome Measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Pressure pain thresholds (PPT).
Time frame: Up to 12 weeks.
To evaluate Pressure pain thresholds (PPT )(with a maximum of 5kg/cm2) will be applied pressure on the erector spinae and index finger with an algometer (area 1cm2). Primary outcome measures were recorded in a counterbalanced order and were measured at baseline, 4 and 12 weeks.

9 secondary outcomes

Balance
Time frame: Up to 12 weeks.
Range of movement
Time frame: Up to 12 weeks.
Clinical pain
Time frame: Up to 12 weeks.
Pain interference
Time frame: Up to 12 weeks.
Affective symptoms (Mood)
Time frame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Affective symptoms (anxiety)
Time frame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (catastrophizing)
Time frame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (fear-avoidance beliefs)
Time frame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (kinesiophobia)
Time frame: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Background: PubMed 16095934Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006 May;10(4):287-333. doi: 10.1016/j.ejpain.2005.06.009. Epub 2005 Aug 10.
Background: PubMed 16550447van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
Background: PubMed 22466247Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.
Background: PubMed 28359011Bardin LD, King P, Maher CG. Diagnostic triage for low back pain: a practical approach for primary care. Med J Aust. 2017 Apr 3;206(6):268-273. doi: 10.5694/mja16.00828.
Background: PubMed 29138049Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
Background: PubMed 25090974Nijs J, Lluch Girbes E, Lundberg M, Malfliet A, Sterling M. Exercise therapy for chronic musculoskeletal pain: Innovation by altering pain memories. Man Ther. 2015 Feb;20(1):216-20. doi: 10.1016/j.math.2014.07.004. Epub 2014 Jul 18.
Background: PubMed 21989632Dobkin BH, Dorsch A. The promise of mHealth: daily activity monitoring and outcome assessments by wearable sensors. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):788-98. doi: 10.1177/1545968311425908.
Derived from this study: PubMed 35289758Sitges C, Terrasa JL, Garcia-Dopico N, Segur-Ferrer J, Velasco-Roldan O, Crespi-Palmer J, Gonzalez-Roldan AM, Montoya P. An Educational and Exercise Mobile Phone-Based Intervention to Elicit Electrophysiological Changes and to Improve Psychological Functioning in Adults With Nonspecific Chronic Low Back Pain (BackFit App): Nonrandomized Clinical Trial. JMIR Mhealth Uhealth. 2022 Mar 15;10(3):e29171. doi: 10.2196/29171.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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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.

Carolina Sitges, PhD principal investigator

University of Balearic Islands, Department of Psychology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing face-to-face protocol and self-managed protocol in people with Low Back Pain, run by University of the Balearic Islands at 1 site in Spain.

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 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 2 Apr 2021. 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 Spain. 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?

Cognitive functioning assessment. (time frame: Up to 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04576611, which also lists 8 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 2 Apr 2021.