FibromyalgiaTHERMALGINCT02265029
Evaluation of Spa Therapy in the Treatment of Fibromyalgia
A study testing Immediate spa treatment and Late spa treatment in people with Fibromyalgia and Rheumatism, Muscular, run by Association Francaise pour la Recherche Thermale at 5 sites in France.
Trial summary
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Rheumatism, Muscular
- What is being tested?
- Immediate spa treatment and Late spa treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2014to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes, more than 18 years old patients
- available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months
- with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months
- with a FIQ score > or = 39 (fibromyalgia moderate to severe)
- voluntary to participate to the study, informed consent form signed after appropriate information
- affiliation to the social security system or equivalent
Who cannot join
- contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- no previous spa treatment in rheumatology within 1 year prior to inclusion
- substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)
- subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)
- subject participating to an other clinical study inerventionnal
- pregnancy, parturient or breast feeding
- no psychiatric illness or social situation that would preclude study compliance
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
station thermale AIX LES BAINS
Aix-les-Bains, 73100
station thermale ALLEVARD LES BAINS
Allevard, 38580
station thermale BOURBON LANCY
Bourbon-Lancy, 71140
station thermale LAMALOU LES BAINS
Lamalou-les-Bains, 34240
Station thermale URIAGE LES BAINS
Uriage-les-Bains, 38410
About this study
Official title: Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.
Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
Read the detailed description
THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) > 39 will be randomized.
- Conditions
- Fibromyalgia, Rheumatism, Muscular
- Being tested
- Immediate spa treatment, Late spa treatment
- Keywords
- fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology
- Medical subject headings
- Fibromyalgia, Rheumatic Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate spa treatmentOther
Also called Spa treatment soon after randomisation
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
Late spa treatmentOther
Also called Spa treatment after 6 months visit in the study
spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
| Study group | Role | What they receive |
|---|---|---|
| Immediate spa treatment | Active comparator | Spa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...) Receives: Other: Immediate spa treatment |
| Late SPA treatment | Sham comparator | Spa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...) Receives: Other: Late spa treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handicap in everyday life
Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
Measured: 6 months
Secondary outcomes (10)
Quality of life
- Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome.
- EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months.
- Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.
Measured: at baseline, 3, 6, 9 and 12 months
Pain evolution
Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months
Measured: at baseline, 3, 6, 9 and 12 months
Sleep quality
Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months
Measured: at baseline, 3, 6, 9 and 12 months
Fatigue
Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months
Measured: at baseline, 3, 6, 9 and 12 months
Depression
Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months
Measured: at baseline, 3, 6, 9 and 12 months
Ability to cope
Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months
Measured: at baseline, 6 and 12 months
Physical activity
- Evolution of Baecke score between baseline, 3, 6, 9 and 12 months
- evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months
Measured: at baseline, 3, 6, 9 and 12 months
Medico economic impact
Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.
Measured: at baseline, 3, 6, 9 and 12 months
Objective physical activity
Record of day activity during one week with actigraphy at baseline, 3 and 6 months
Measured: at baseline, 3, and 6 months
Objective sleep quality
Record of night activity and cardiac variability at baseline, 3 and 6 months
Measured: at baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion30 Mar 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis, University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Caroline MAINDET DOMINICI, MD, Principal investigator, Hospital University Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265029
- Sponsor's protocol ID
- DCIC/13/68
- Acronym
- THERMALGI
- Status last verified
- Jan 2019
- First submitted
- 9 Oct 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Adler GK, Kinsley BT, Hurwitz S, Mossey CJ, Goldenberg DL. Reduced hypothalamic-pituitary and sympathoadrenal responses to hypoglycemia in women with fibromyalgia syndrome. Am J Med. 1999 May;106(5):534-43. doi: 10.1016/s0002-9343(99)00074-1.
PubMed 10335725Altan L, Bingol U, Aykac M, Koc Z, Yurtkuran M. Investigation of the effects of pool-based exercise on fibromyalgia syndrome. Rheumatol Int. 2004 Sep;24(5):272-7. doi: 10.1007/s00296-003-0371-7. Epub 2003 Sep 24.
PubMed 14508601Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ, Chappell AS. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry. 2009;11(5):237-44. doi: 10.4088/PCC.08m00680.
PubMed 19956462Baranowsky J, Klose P, Musial F, Hauser W, Dobos G, Langhorst J. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int. 2009 Nov;30(1):1-21. doi: 10.1007/s00296-009-0977-5. Epub 2009 Aug 12.
PubMed 19672601Bellometti S, Galzigna L. Function of the hypothalamic adrenal axis in patients with fibromyalgia syndrome undergoing mud-pack treatment. Int J Clin Pharmacol Res. 1999;19(1):27-33.
PubMed 10450540Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.
PubMed 19369473Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45. doi: 10.1016/s0002-9343(03)00116-5.
PubMed 12753877Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9.
PubMed 9604730Bircan C, Karasel SA, Akgun B, El O, Alper S. Effects of muscle strengthening versus aerobic exercise program in fibromyalgia. Rheumatol Int. 2008 Apr;28(6):527-32. doi: 10.1007/s00296-007-0484-5. Epub 2007 Nov 3.
PubMed 17982749Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
PubMed 19250656Burckhardt CS, Mannerkorpi K, Hedenberg L, Bjelle A. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. J Rheumatol. 1994 Apr;21(4):714-20.
PubMed 8035399Burckhardt CS. Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des. 2006;12(1):59-66.
PubMed 16454725Busch AJ, Schachter CL, Overend TJ, Peloso PM, Barber KA. Exercise for fibromyalgia: a systematic review. J Rheumatol. 2008 Jun;35(6):1130-44. Epub 2008 May 1.
PubMed 18464301Busch AJ, Barber KA, Overend TJ, Peloso PM, Schachter CL. Exercise for treating fibromyalgia syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003786. doi: 10.1002/14651858.CD003786.pub2.
PubMed 17943797Buskila D, Neumann L, Vaisberg G, Alkalay D, Wolfe F. Increased rates of fibromyalgia following cervical spine injury. A controlled study of 161 cases of traumatic injury. Arthritis Rheum. 1997 Mar;40(3):446-52. doi: 10.1002/art.1780400310.
PubMed 9082932
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study
- ClinicalTrials.gov ID
- NCT02265029
- Acronym / sponsor ID
- THERMALGI / DCIC/13/68
- Conditions
- Fibromyalgia, Rheumatism, Muscular
- Keywords
- fibromyalgia, rheumatism, fatigue syndrom, pain, spa treatment in rheumatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Floralis, University Hospital, Grenoble
- Study start
- Sep 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Oct 2014 (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.
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life.
Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
Detailed description
THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.
Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score (Fibromyalgia Impact Questionnaire) > 39 will be randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate spa treatment | Active comparator | Other: Immediate spa treatmentSpa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...) |
| Late SPA treatment | Sham comparator | Other: Late spa treatmentSpa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- both sexes, more than 18 years old patients
- available for a spa treatment in rheumatology during 18 days (immediate or late spa) and a follow-up period of 12 months
- with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment for at least 3 months
- with a FIQ score > or = 39 (fibromyalgia moderate to severe)
- voluntary to participate to the study, informed consent form signed after appropriate information
Key exclusion criteria (7 listed)
- contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
- no previous spa treatment in rheumatology within 1 year prior to inclusion
- substantial variation of the therapeutic coverage in the previous 3 months the inclusion (change of medicinal class, starting up of a réentrainement in the effort or a cognitivio-behavioral technique)
- subject with an other chronic severe disease (severe asthma, severe cardiac insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease, inflammatory colitis...)
- subject participating to an other clinical study inerventionnal
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 |
|---|---|---|
| Immediate spa treatmentAlso: Spa treatment soon after randomisationspa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool) | Other | Immediate spa treatment |
| Late spa treatmentAlso: Spa treatment after 6 months visit in the studyspa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool) | Other | Late SPA treatment |
Primary outcome
Handicap in everyday life
Time frame: 6 months
Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
10 secondary outcomes
Quality of life
Time frame: at baseline, 3, 6, 9 and 12 months
Pain evolution
Time frame: at baseline, 3, 6, 9 and 12 months
Sleep quality
Time frame: at baseline, 3, 6, 9 and 12 months
Fatigue
Time frame: at baseline, 3, 6, 9 and 12 months
Depression
Time frame: at baseline, 3, 6, 9 and 12 months
Ability to cope
Time frame: at baseline, 6 and 12 months
Physical activity
Time frame: at baseline, 3, 6, 9 and 12 months
Medico economic impact
Time frame: at baseline, 3, 6, 9 and 12 months
Objective physical activity
Time frame: at baseline, 3, and 6 months
Objective sleep quality
Time frame: at baseline, 3, and 6 months
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 11 Jan 2019.
- Background: PubMed 10335725Adler GK, Kinsley BT, Hurwitz S, Mossey CJ, Goldenberg DL. Reduced hypothalamic-pituitary and sympathoadrenal responses to hypoglycemia in women with fibromyalgia syndrome. Am J Med. 1999 May;106(5):534-43. doi: 10.1016/s0002-9343(99)00074-1.
- Background: PubMed 14508601Altan L, Bingol U, Aykac M, Koc Z, Yurtkuran M. Investigation of the effects of pool-based exercise on fibromyalgia syndrome. Rheumatol Int. 2004 Sep;24(5):272-7. doi: 10.1007/s00296-003-0371-7. Epub 2003 Sep 24.
- Background: PubMed 19956462Arnold LM, Clauw DJ, Wohlreich MM, Wang F, Ahl J, Gaynor PJ, Chappell AS. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim Care Companion J Clin Psychiatry. 2009;11(5):237-44. doi: 10.4088/PCC.08m00680.
- Background: PubMed 19672601Baranowsky J, Klose P, Musial F, Hauser W, Dobos G, Langhorst J. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia. Rheumatol Int. 2009 Nov;30(1):1-21. doi: 10.1007/s00296-009-0977-5. Epub 2009 Aug 12.
- Background: PubMed 10450540Bellometti S, Galzigna L. Function of the hypothalamic adrenal axis in patients with fibromyalgia syndrome undergoing mud-pack treatment. Int J Clin Pharmacol Res. 1999;19(1):27-33.
- Background: PubMed 19369473Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.
- Background: PubMed 12753877Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med. 2003 May;114(7):537-45. doi: 10.1016/s0002-9343(03)00116-5.
- Background: PubMed 9604730Biasi G, Manca S, Manganelli S, Marcolongo R. Tramadol in the fibromyalgia syndrome: a controlled clinical trial versus placebo. Int J Clin Pharmacol Res. 1998;18(1):13-9.
- Background: PubMed 17982749Bircan C, Karasel SA, Akgun B, El O, Alper S. Effects of muscle strengthening versus aerobic exercise program in fibromyalgia. Rheumatol Int. 2008 Apr;28(6):527-32. doi: 10.1007/s00296-007-0484-5. Epub 2007 Nov 3.
- Background: PubMed 19250656Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, Saraiva F, Nacci F, Thomas E, Caubere JP, Le Lay K, Taieb C, Matucci-Cerinic M. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010 Jun;39(6):448-53. doi: 10.1016/j.semarthrit.2008.12.003. Epub 2009 Feb 27.
- Background: PubMed 8035399Burckhardt CS, Mannerkorpi K, Hedenberg L, Bjelle A. A randomized, controlled clinical trial of education and physical training for women with fibromyalgia. J Rheumatol. 1994 Apr;21(4):714-20.
- Background: PubMed 16454725Burckhardt CS. Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des. 2006;12(1):59-66.
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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.
Caroline MAINDET DOMINICI, MD principal investigator
Hospital University Grenoble
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate spa treatment and Late spa treatment in people with Fibromyalgia and Rheumatism, Muscular, run by Association Francaise pour la Recherche Thermale at 5 sites in France.
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 6 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Handicap in everyday life (time frame: 6 months). 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 NCT02265029, which also lists 54 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 11 Jan 2019.