Low-back PainMAS-GAHNCT02721914

The Effectiveness of the Massage and the Hypopressive Abdominal Gymnastics on Low Back Pain (MAS-GAH)

A study testing GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC, GROUP RECEIVING MASSOTHERAPY and GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC in people with Low-back Pain, run by University of Seville 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

Search all trials

Trial summary

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Low-back Pain
What is being tested?: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC, GROUP RECEIVING MASSOTHERAPY and GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: Apr 2016to Jul 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with chronic non-specific low back pain diagnosed and at least 12 weeks of mechanical pain.

Who cannot join

Patients:
With arterial hypertension diagnosed.
With progressive neurological deficits.
Pregnant or suspect that they are pregnant.
With psychological or psychiatric process diagnosed.
Under analgesic treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Seville, 41009

Other trials in Spain

About this study

Official title: The Effects of Massage Therapy and Hypopressive Abdominal Exercises on Chronic Non-specific Low Back Pain, Joint Mobility, Disability and the Patient's Quality of Life. A Controlled Clinical Trial

The main goal of this study is to get to know if applying both, massotherapy plus hypopressive abdominal gymnastics (H.A.G) will reduce the pain of chronic non-specific low back pain. It actually reduces the inability produced by the pain and improve the patient's quality of life as well as the join range of the lumbar spine, way more than these two therapies applied separately.

Read the detailed description

Background:

Back pain is one of the most common musculoskeletal disorders in the industrialized society. It is estimated to affect between 70 to 85% of the adult population over their live. The impact of low back pain is widespread in developed countries, and accounts the major spending in economic and health resources, as well as being associated with the leading causes of absenteeism and disability. Diagnosis, in most cases, nonspecific low back pain, the symptoms have no clear cause, so that the source of pain is unknown. In general, a significant percentage progresses to chronic back pain and is accompanied by a limitation of physical activity influenced by improper posture or movement patterns.

Objectives:

To assess the effectiveness of massage therapy and hypopressive abdominal gymnastics, and the combination of both therapeutic modalities, to decrease pain and lumbar disability; and increasing joint mobility and quality of life in patients with chronic nonspecific low back pain.

Conditions: Low-back Pain
Being tested: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC, GROUP RECEIVING MASSOTHERAPY, GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC
Keywords: low-back pain, massage therapy, Gymnastics, disability
Medical subject headings: Low Back Pain

What participants receive

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

GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTICProcedure or surgery
The subjects of this group will receive an amount of eight sessions that will be applied within five weeks; four massotherapy sessions and another 4 of H.A.G. The three first weeks one session of each methodology will be applied, starting always with massotherapy (with sessions on Mondays and Thursdays or on Tuesdays and Fridays). On the fourth week a session of massotherapy will be applied on the same day as usual. And, finally, on the fifth week a session of H.A.G will be applied on the same day as massotherapy is applied.
GROUP RECEIVING MASSOTHERAPYProcedure or surgery
The sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before.
Massotherapy technics will be applied all over the back, covering the thoracolumbar area as well as upper areas reaching the cervix and occiput.
In particular, posterosuperior iliac spines, iliac crests, ribs, shoulder girdle and the entire spine (sacral bone- lumbar area-backbones-cervical vertebrae) and its attached tissues will be worked down.
Massotherapy protocol will be applied by the physical therapist, always respecting the postural ergonomics. This enables the verticality of the body (avoiding the slopes) which makes work much easier thanks to the inertia triggered by the load transfer in the lower extremities in both sagittal and horizontal plane.
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTICProcedure or surgery
The subjects of this group will receive a total of 8 sessions of 30 minutes each; sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before.
The techniques applied are an assembly of rhythm, postural and breathing exercises that have to be done in a systematically. The physical therapist will check that all of the group subjects have assimilated properly the H.A.G and the breathing patterns from the exercises protocol. If they have, then the practical session which comprises 6 hypopressive exercises, can be started.
The subjects must remain in each position between 10 and 30 seconds and repeat the exercise three times, with a rest period among each that will last at least 20 seconds.

Study groups in NCT02721914
Study group	Role	What they receive
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC	Experimental	Subjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG). Receives: Procedure: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
GROUP RECEIVING MASSOTHERAPY	Experimental	The subjects of this group will receive a total of 8 sessions of 30 minutes each. Receives: Procedure: GROUP RECEIVING MASSOTHERAPY
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC	Experimental	The subjects of this group will receive a total of 8 sessions of 30 minutes each. Receives: Procedure: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

What is being measured

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

Change from Self-reported lumbar pain intensity at 3 weeks.
Evaluated by the numerical pain scale.
Measured: At the start of the study, before the fifth treatment session (third week)
Change from Self-reported lumbar pain intensity at 5 weeks.
Measured by the Oswestry disability index.
Measured: After the last treatment session (fifth week).
Change from Disability at 3 weeks.
Measured by the Oswestry disability index.
Measured: At the start of the study, before the fifth treatment session (third week)
Change from Disability at 5 weeks.
Measured by the Oswestry disability index.
Measured: After the last treatment session (fifth week).

Secondary outcomes (4)

Change from Lumbar joint mobility at 3 weeks.
Lumbar flexion measured by the modified Schober test
Measured: At the start of the study, before the fifth treatment session (third week)
Change from Lumbar joint mobility at 5 weeks.
Lumbar flexion measured by the modified Schober test
Measured: After the last treatment session (fifth week).
Change from Quality of life at 3 weeks.
Measured by the Short-Form-12 Health Survey
Measured: At the start of the study, before the fifth treatment session (third week)
Change from Quality of life at 5 weeks.
Measured by the Short-Form-12 Health Survey
Measured: After the last treatment session (fifth week).

Timeline

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

Apr 2016Jul 2018

First posted29 Mar 2016 (estimated)
Study startApr 2016
Primary completionJun 2016
Study completionJul 2018

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02721914
Sponsor's protocol ID: USeville-MSalas
Acronym: MAS-GAH
Status last verified: Jan 2019
First submitted: 18 Mar 2016
Last updated: 15 Oct 2019
Results posted: No

Publications

Trampas A, Mpeneka A, Malliou V, Godolias G, Vlachakis P. Immediate Effects of Core-Stability Exercises and Clinical Massage on Dynamic-Balance Performance of Patients With Chronic Specific Low Back Pain. J Sport Rehabil. 2015 Nov;24(4):373-83. doi: 10.1123/jsr.2014-0215. Epub 2014 Dec 4.
PubMed 25474502
Resende AP, Torelli L, Zanetti MR, Petricelli CD, Jarmy-Di Bella ZI, Nakamura MU, Araujo Junior E, Moron AF, Girao MJ, Sartori MG. Can Abdominal Hypopressive Technique Change Levator Hiatus Area?: A 3-Dimensional Ultrasound Study. Ultrasound Q. 2016 Jun;32(2):175-9. doi: 10.1097/RUQ.0000000000000181.
PubMed 26441380
Stupp L, Resende AP, Petricelli CD, Nakamura MU, Alexandre SM, Zanetti MR. Pelvic floor muscle and transversus abdominis activation in abdominal hypopressive technique through surface electromyography. Neurourol Urodyn. 2011 Nov;30(8):1518-21. doi: 10.1002/nau.21151. Epub 2011 Aug 8.
PubMed 21826719
Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Feb. Report No.: 16-EHC004-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK350276/
PubMed 26985522
Sejari N, Kamaruddin K, Ramasamy K, Lim SM, Neoh CF, Ming LC. The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: study protocol of a randomised controlled trial. BMC Complement Altern Med. 2016 Jan 15;16:16. doi: 10.1186/s12906-016-0988-1.
PubMed 26767971
Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
PubMed 26329399
Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Lorenzo-Munoz A, Pinero-Pinto E, Rebollo-Salas M. Clinical relevance of massage therapy and abdominal hypopressive gymnastics on chronic nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2022 Aug;44(16):4233-4240. doi: 10.1080/09638288.2021.1884903. Epub 2021 Feb 15.
PubMed 33587856
Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Gomez-Benitez MA, De-La-Casa-Almeida M, Rebollo-Salas M. Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Feb 22;2018:3684194. doi: 10.1155/2018/3684194. eCollection 2018.
PubMed 29681973

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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Massage Therapy and Hypopressive Abdominal Exercises on Chronic Non-specific Low Back Pain, Joint Mobility, Disability and the Patient's Quality of Life. A Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02721914
Acronym / sponsor ID: MAS-GAH / USeville-MSalas
Conditions: Low-back Pain
Keywords: low-back pain, massage therapy, Gymnastics, disability
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of SevilleUniversity, hospital or other
Study start: Apr 2016
Primary completion: Jun 2016 (actual)
Study completion: Jul 2018 (actual)
First posted: 29 Mar 2016 (estimated)
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

Background:

Objectives:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC	Experimental	Procedure: GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTICSubjects will receive 4 massotherapy sessions and 4 of HYPOPRESSIVE ABDOMINAL GYMNASTIC (HAG).
GROUP RECEIVING MASSOTHERAPY	Experimental	Procedure: GROUP RECEIVING MASSOTHERAPYThe subjects of this group will receive a total of 8 sessions of 30 minutes each.
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC	Experimental	Procedure: GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTICThe subjects of this group will receive a total of 8 sessions of 30 minutes each.

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with chronic non-specific low back pain diagnosed and at least 12 weeks of mechanical pain.

Key exclusion criteria (6 listed)

Patients:
With arterial hypertension diagnosed.
With progressive neurological deficits.
Pregnant or suspect that they are pregnant.
With psychological or psychiatric process diagnosed.

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
GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTICThe subjects of this group will receive an amount of eight sessions that will be applied within five weeks; four massotherapy sessions and another 4 of H.A.G. The three first weeks one session of each methodology will be applied, starting always with massotherapy (with sessions on Mondays and Thursdays or on Tuesdays and Fridays). On the fourth week a session of massotherapy will be applied on the same day as usual. And, finally, on the fifth week a session of H.A.G will be applied on the same day as massotherapy is applied.	Procedure or surgery	GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC
GROUP RECEIVING MASSOTHERAPYThe sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before. Massotherapy technics will be applied all over the back, covering the thoracolumbar area as well as upper areas reaching the cervix and occiput. In particular, posterosuperior iliac spines, iliac crests, ribs, shoulder girdle and the entire spine (sacral bone- lumbar area-backbones-cervical vertebrae) and its attached tissues will be worked down. Massotherapy protocol will be applied by the physical therapist, always respecting the postural ergonomics. This enables the verticality of the body (avoiding the slopes) which makes work much easier thanks to the inertia triggered by the load transfer in the lower extremities in both sagittal and horizontal plane.	Procedure or surgery	GROUP RECEIVING MASSOTHERAPY
GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTICThe subjects of this group will receive a total of 8 sessions of 30 minutes each; sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before. The techniques applied are an assembly of rhythm, postural and breathing exercises that have to be done in a systematically. The physical therapist will check that all of the group subjects have assimilated properly the H.A.G and the breathing patterns from the exercises protocol. If they have, then the practical session which comprises 6 hypopressive exercises, can be started. The subjects must remain in each position between 10 and 30 seconds and repeat the exercise three times, with a rest period among each that will last at least 20 seconds.	Procedure or surgery	GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC

Primary outcome

Change from Self-reported lumbar pain intensity at 3 weeks.
Time frame: At the start of the study, before the fifth treatment session (third week)
Evaluated by the numerical pain scale.
Change from Self-reported lumbar pain intensity at 5 weeks.
Time frame: After the last treatment session (fifth week).
Measured by the Oswestry disability index.
Change from Disability at 3 weeks.
Time frame: At the start of the study, before the fifth treatment session (third week)
Measured by the Oswestry disability index.
Change from Disability at 5 weeks.
Time frame: After the last treatment session (fifth week).
Measured by the Oswestry disability index.

4 secondary outcomes

Change from Lumbar joint mobility at 3 weeks.
Time frame: At the start of the study, before the fifth treatment session (third week)
Change from Lumbar joint mobility at 5 weeks.
Time frame: After the last treatment session (fifth week).
Change from Quality of life at 3 weeks.
Time frame: At the start of the study, before the fifth treatment session (third week)
Change from Quality of life at 5 weeks.
Time frame: After the last treatment session (fifth 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 15 Oct 2019.
Background: PubMed 25474502Trampas A, Mpeneka A, Malliou V, Godolias G, Vlachakis P. Immediate Effects of Core-Stability Exercises and Clinical Massage on Dynamic-Balance Performance of Patients With Chronic Specific Low Back Pain. J Sport Rehabil. 2015 Nov;24(4):373-83. doi: 10.1123/jsr.2014-0215. Epub 2014 Dec 4.
Results publication: PubMed 26441380Resende AP, Torelli L, Zanetti MR, Petricelli CD, Jarmy-Di Bella ZI, Nakamura MU, Araujo Junior E, Moron AF, Girao MJ, Sartori MG. Can Abdominal Hypopressive Technique Change Levator Hiatus Area?: A 3-Dimensional Ultrasound Study. Ultrasound Q. 2016 Jun;32(2):175-9. doi: 10.1097/RUQ.0000000000000181.
Results publication: PubMed 21826719Stupp L, Resende AP, Petricelli CD, Nakamura MU, Alexandre SM, Zanetti MR. Pelvic floor muscle and transversus abdominis activation in abdominal hypopressive technique through surface electromyography. Neurourol Urodyn. 2011 Nov;30(8):1518-21. doi: 10.1002/nau.21151. Epub 2011 Aug 8.
Results publication: PubMed 26985522Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt E. Noninvasive Treatments for Low Back Pain [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2016 Feb. Report No.: 16-EHC004-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK350276/
Results publication: PubMed 26767971Sejari N, Kamaruddin K, Ramasamy K, Lim SM, Neoh CF, Ming LC. The immediate effect of traditional Malay massage on substance P, inflammatory mediators, pain scale and functional outcome among patients with low back pain: study protocol of a randomised controlled trial. BMC Complement Altern Med. 2016 Jan 15;16:16. doi: 10.1186/s12906-016-0988-1.
Results publication: PubMed 26329399Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015 Sep 1;2015(9):CD001929. doi: 10.1002/14651858.CD001929.pub3.
Derived from this study: PubMed 33587856Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Lorenzo-Munoz A, Pinero-Pinto E, Rebollo-Salas M. Clinical relevance of massage therapy and abdominal hypopressive gymnastics on chronic nonspecific low back pain: a randomized controlled trial. Disabil Rehabil. 2022 Aug;44(16):4233-4240. doi: 10.1080/09638288.2021.1884903. Epub 2021 Feb 15.
Derived from this study: PubMed 29681973Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Gomez-Benitez MA, De-La-Casa-Almeida M, Rebollo-Salas M. Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Feb 22;2018:3684194. doi: 10.1155/2018/3684194. eCollection 2018.

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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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. 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?

Change from Self-reported lumbar pain intensity at 3 weeks. (time frame: At the start of the study, before the fifth treatment session (third week)). 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 NCT02721914, 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 15 Oct 2019.