Chronic PainExiGenceNCT02459639
Existential Genomics: Effects of Multimodal Rehabilitation and Integrative Care on Patients With Chronic Pain
An observational study of Chronic Pain, run by The Integrative Care Science Center.
Trial summary
Using a comprehensive prospective clinical study design, the investigators intend to compare changes in health-related markers in patients with chronic widespread pain (CWP), undergoing one of two intervention "packages" of multimodal health care, namely anthroposophical integrative care (AIC) or standard care (SC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Anthroposophic integrative care rehabilitation program and Conventional multi-modal care rehabilitation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2017
- Phase
- Observational
- 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
Study population: 100 pain patients will be recruited into the study. They will be invited to participate in the study upon admission to Integrative Care pain rehabilitation at the Vidar Clinic (n=50) or the Pain Clinic, University Hospital, Linköping (n=50).
Who may be able to join
- Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain,
- fluency in Swedish and
- allowing for co-morbidity/ multiple secondary diagnoses.
Who cannot join
- Psychotic illness,
- schizophrenia,
- bipolar disorder,
- substance dependency problems, and
- cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Existential Genomics (ExiGence): Effects of Multimodal Rehabilitation and Integrative Care on Pain, Quality of Life, and Genomic Stability in Patients With Chronic Pain
Using a comprehensive prospective clinical study design, the investigators intend to compare changes in health-related markers in patients with chronic widespread pain (CWP), undergoing one of two intervention "packages" of multimodal health care, namely anthroposophical integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based conventional care with complementary/alternative (CAM) treatments. As markers, the investigators will use indicators of drug utilization and sick leave, as well as constructs mirroring possible changes in psychological and existential factors and genomic stability (such as telomere length and telomerase levels).
Read the detailed description
The purpose of this comprehensive prospective clinical study is to compare and contrast two different but well-established multimodal chronic widespread pain rehabilitation programmes, i.e. one at a conventional county council hospital (CC) and one involving integrative care at a private non-profit hospital (IC), in terms of changes in health-related outcomes, ranging from DNA stability to health economy, in patients with chronic pain. Notably, for the first time, differences can be seen and correlations made between CC and IC outcomes with relevance for clinical care development and implementation of multimodal interventions for people with chronic pain.
The overall aim of the present prospective clinical trial is to achieve a better understanding of the possible effects of, and useful measure for evaluating, two different multimodal treatment interventions for pain.
More specifically, the aims of this trial are to explore two different, but well-established multimodal pain rehabilitation programmes. The investigators will specifically investigate 1. If chronic pain impacts on patients' telomerase activity and telomere length over time; 2. If multimodal rehabilitation can be linked to positive changes in telomerase activity and telomere length after rehabilitation, and if these changes can be correlated to: Clinical diagnosis, pain characteristics (e.g. intensity, duration, frequency and spread of pain), co-morbidities (e.g. anxiety, depression and catastrophizing), time lost from work/sick-leave and self-rated health and stress, and; 3. If and how the two programmes and their treatment components differ in outcomes over time.
The project outcomes will be of great relevance for clinical rehabilitation development and the implementation of multimodal interventions for people with chronic pain. Given that the most significant demographic and clinical factors associated with pain help-seeking are increasing age, female gender, pain severity and disability, we will also address such issues including gender differences when relevant.
Specific work packages (WP): WP1 - Genomics (telomerase activity and telomere length); WP2 - Patient-reported outcomes ("existential" validated questionnaires regarding depression, anxiety, stress, quality of life, pain, mindfulness, spirituality/religiosity); WP3 - Health care experiences (interviews); WP4 - Registry data (drugs, health care, sick leave, return-to-work, morbidity, mortality); WP5 - The design of treatment programs; WP6 - Standardized and exploratory statistical analyses of differences and correlations between the collected data and the conventional and integrated care programs. WP7 - Implementation of the results problematized through the participation of representatives of the patient and care provider organizations.
- Conditions
- Chronic Pain
- Being tested
- Anthroposophic integrative care rehabilitation program, Conventional multi-modal care rehabilitation
- Keywords
- Chronic Widespread Pain, Telomere length, Multimodal rehabilitation, Integrative care, Existential aspects
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthroposophic integrative care rehabilitation programOther
The programme for chronic pain at AIC consists of two phases:
- A three-week in-patient period. During the first three-week in-patient stay, patients meet regularly with a multi-professional team. Usually, each patient receives two of the following therapies 2-4 times per week: art therapy, massage, physiotherapy, eurhythmy and baths. Nursing care is provided twice daily. Moreover, patients are offered to participate in group activities.
- Two-three day inpatient follow-up and treatment period closure. The second phase of the treatment programme consists of a 2-3 day inpatient stay, 6 months after closure. During this time, physician, nurse and therapist appointments are made according to individual needs. The patients who have been engaged in group activities are gathered in groups.
Conventional multi-modal care rehabilitationOther
The standard approach at Linköping University Hospital admits patients for bio-psycho-social assessment, pharmacological treatment and multimodal rehabilitation (main components: education, intense physical exercise, cognitive behavioural therapy and workplace interventions) for a 6 week intensive phase period (75%) followed by 4 weeks (25%). Here a number of professional disciplines collaborate and form a team of professionals focused on individual patient needs The multimodal rehabilitation outpatient program delivered by this team has the following aims: 1) reduce pain and psychological burden, 2) improve work capacity and decrease sick-leave and 3) increase perceived health and quality of life. These general aims are combined with the aims of the patient in a plan of rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Anthroposophic integrative care | Inclusion criteria are: Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain, fluency in Swedish and allowing for co-morbidity/ multiple secondary diagnoses.
The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer. Receives: Other: Anthroposophic integrative care rehabilitation program | |
| Multimodal pain rehabilitation | Inclusion criteria are: Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain, fluency in Swedish and allowing for co-morbidity/ multiple secondary diagnoses.
The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer. Receives: Other: Conventional multi-modal care rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length from blood sample leucocyte cells
telomere length from blood sample leucocyte cells
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Telomerase activity from blood sample leucocyte cells
telomerase activity from blood sample leucocyte cells
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Secondary outcomes (19)
Hb - hemoglobin status
blood hemoglobin status
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Cholesterol: Blood cholesterol levels
Blood cholesterol levels
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
C-Reactive Protein levels in blood sample
C-Reactive Protein
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Trigyceride levels in blood sample
Triglyceride levels in blood sample
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Glucose levels in blood sample
Glucose levels in blood sample
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
LDL-cholesterol levels in blood sample
LDL-cholesterol levels in blood sample
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
HDL-cholesterol levels in blood sample
HDL-cholesterol levels in blood sample
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Blood pressure
Resting systolic and diastolic blood pressure
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Body Mass Index
Body Mass Index calculated from weight and length
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain
8 question questionnaire assessing self-rated chronic pain acceptance, numerical total score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Five Facet Mindfulness Questionnaire: measuring level of mindfulness
29 questionnaire assessing self-rated mindfulness, numerical composite score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Hospital Anxiety and Depression scale: measuring level of anxiety and depression
self-rating scale for assessing anxiety and depression levels, numeric total score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
EuroQol 5 Dimensions: measuring health-related quality of life
salf-rating scale for health-related quality of life, numeric total score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Indicator Questions of Physical Activity: measuring level of physical activity
Self-rated assessment of physical activity, three questions, numeric total score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
sociodemographic questionnaire
baseline and follow-up sociodemographic questionnaire from NRS (Nationalle Registret över Smärtrehabilitering), numeric descriptive data
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
WHO Quality of Life - Spiritual, Religious and Personal Beliefs
a medium- length 37 question version of a self-rating scale for quality of life, spiritual, religious and personal beliefs, numeric total score
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Use of prescription drugs
register-based data on use of prescription drugs, dose and frequency
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Sick-leave data
register-based data on sick-leave, extent and time period
Measured: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
patient records
treatment records on the treatment components obtained by patient, amount and frequency
Measured: up to 6 weeks and 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Integrative Care Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Ekhagastiftelsen
- Responsible party
- Principal investigator, Torkel Falkenberg, The Integrative Care Science Center
- Investigators
- Torkel Falkenberg, Ass. Prof, Principal investigator, Integrative Care Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459639
- Sponsor's protocol ID
- 2014-37
- Acronym
- ExiGence
- Status last verified
- Jun 2015
- First submitted
- 21 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ronne-Petersen L, Niemi M, Walach H, Lavebratt C, Yang LL, Gerdle B, Ghafouri B, Falkenberg T. Exploring emotional well-being, spiritual, religious and personal beliefs and telomere length in chronic pain patients-A pilot study with cross-sectional design. PLoS One. 2024 Sep 4;19(9):e0308924. doi: 10.1371/journal.pone.0308924. eCollection 2024.
PubMed 39231146
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Existential Genomics (ExiGence): Effects of Multimodal Rehabilitation and Integrative Care on Pain, Quality of Life, and Genomic Stability in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT02459639
- Acronym / sponsor ID
- ExiGence / 2014-37
- Conditions
- Chronic Pain
- Keywords
- Chronic Widespread Pain, Telomere length, Multimodal rehabilitation, Integrative care, Existential aspects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Integrative Care Science CenterUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Ekhagastiftelsen
- Study start
- Jun 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 2 Jun 2015 (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.
Using a comprehensive prospective clinical study design, the investigators intend to compare changes in health-related markers in patients with chronic widespread pain (CWP), undergoing one of two intervention "packages" of multimodal health care, namely anthroposophical integrative care (AIC) or standard care (SC), respectively. AIC combines evidence-based conventional care with complementary/alternative (CAM) treatments. As markers, the investigators will use indicators of drug utilization and sick leave, as well as constructs mirroring possible changes in psychological and existential factors and genomic stability (such as telomere length and telomerase levels).
Detailed description
The purpose of this comprehensive prospective clinical study is to compare and contrast two different but well-established multimodal chronic widespread pain rehabilitation programmes, i.e. one at a conventional county council hospital (CC) and one involving integrative care at a private non-profit hospital (IC), in terms of changes in health-related outcomes, ranging from DNA stability to health economy, in patients with chronic pain. Notably, for the first time, differences can be seen and correlations made between CC and IC outcomes with relevance for clinical care development and implementation of multimodal interventions for people with chronic pain.
The overall aim of the present prospective clinical trial is to achieve a better understanding of the possible effects of, and useful measure for evaluating, two different multimodal treatment interventions for pain.
More specifically, the aims of this trial are to explore two different, but well-established multimodal pain rehabilitation programmes. The investigators will specifically investigate 1. If chronic pain impacts on patients' telomerase activity and telomere length over time; 2. If multimodal rehabilitation can be linked to positive changes in telomerase activity and telomere length after rehabilitation, and if these changes can be correlated to: Clinical diagnosis, pain characteristics (e.g. intensity, duration, frequency and spread of pain), co-morbidities (e.g. anxiety, depression and catastrophizing), time lost from work/sick-leave and self-rated health and stress, and; 3. If and how the two programmes and their treatment components differ in outcomes over time.
The project outcomes will be of great relevance for clinical rehabilitation development and the implementation of multimodal interventions for people with chronic pain. Given that the most significant demographic and clinical factors associated with pain help-seeking are increasing age, female gender, pain severity and disability, we will also address such issues including gender differences when relevant.
Specific work packages (WP): WP1 - Genomics (telomerase activity and telomere length); WP2 - Patient-reported outcomes ("existential" validated questionnaires regarding depression, anxiety, stress, quality of life, pain, mindfulness, spirituality/religiosity); WP3 - Health care experiences (interviews); WP4 - Registry data (drugs, health care, sick leave, return-to-work, morbidity, mortality); WP5 - The design of treatment programs; WP6 - Standardized and exploratory statistical analyses of differences and correlations between the collected data and the conventional and integrated care programs. WP7 - Implementation of the results problematized through the participation of representatives of the patient and care provider organizations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthroposophic integrative care | – | Other: Anthroposophic integrative care rehabilitation programInclusion criteria are: Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain, fluency in Swedish and allowing for co-morbidity/ multiple secondary diagnoses. The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer. |
| Multimodal pain rehabilitation | – | Other: Conventional multi-modal care rehabilitationInclusion criteria are: Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain, fluency in Swedish and allowing for co-morbidity/ multiple secondary diagnoses. The exclusion criteria are: psychotic illness, schizophrenia, bipolar disorder, substance dependency problems, and cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 pain patients will be recruited into the study. They will be invited to participate in the study upon admission to Integrative Care pain rehabilitation at the Vidar Clinic (n=50) or the Pain Clinic, University Hospital, Linköping (n=50).
Key inclusion criteria (3 listed)
- Pain patients with a primary diagnosis corresponding to ICD-10 M79, or long-term pain for a period of over 3 months in neck/shoulders and/or low back, or generalised pain,
- fluency in Swedish and
- allowing for co-morbidity/ multiple secondary diagnoses.
Key exclusion criteria (5 listed)
- Psychotic illness,
- schizophrenia,
- bipolar disorder,
- substance dependency problems, and
- cancer.
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 |
|---|---|---|
| Anthroposophic integrative care rehabilitation programThe programme for chronic pain at AIC consists of two phases: 1. A three-week in-patient period. During the first three-week in-patient stay, patients meet regularly with a multi-professional team. Usually, each patient receives two of the following therapies 2-4 times per week: art therapy, massage, physiotherapy, eurhythmy and baths. Nursing care is provided twice daily. Moreover, patients are offered to participate in group activities. 2. Two-three day inpatient follow-up and treatment period closure. The second phase of the treatment programme consists of a 2-3 day inpatient stay, 6 months after closure. During this time, physician, nurse and therapist appointments are made according to individual needs. The patients who have been engaged in group activities are gathered in groups. | Other | Anthroposophic integrative care |
| Conventional multi-modal care rehabilitationThe standard approach at Linköping University Hospital admits patients for bio-psycho-social assessment, pharmacological treatment and multimodal rehabilitation (main components: education, intense physical exercise, cognitive behavioural therapy and workplace interventions) for a 6 week intensive phase period (75%) followed by 4 weeks (25%). Here a number of professional disciplines collaborate and form a team of professionals focused on individual patient needs The multimodal rehabilitation outpatient program delivered by this team has the following aims: 1) reduce pain and psychological burden, 2) improve work capacity and decrease sick-leave and 3) increase perceived health and quality of life. These general aims are combined with the aims of the patient in a plan of rehabilitation. | Other | Multimodal pain rehabilitation |
Primary outcome
Telomere length from blood sample leucocyte cells
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
telomere length from blood sample leucocyte cells
Telomerase activity from blood sample leucocyte cells
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
telomerase activity from blood sample leucocyte cells
19 secondary outcomes
Hb - hemoglobin status
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Cholesterol: Blood cholesterol levels
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
C-Reactive Protein levels in blood sample
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Trigyceride levels in blood sample
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Glucose levels in blood sample
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
LDL-cholesterol levels in blood sample
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
HDL-cholesterol levels in blood sample
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Blood pressure
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Body Mass Index
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Chronic Pain Acceptance Questionnaire - 8: measuring acceptance of chronic pain
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Five Facet Mindfulness Questionnaire: measuring level of mindfulness
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Hospital Anxiety and Depression scale: measuring level of anxiety and depression
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
EuroQol 5 Dimensions: measuring health-related quality of life
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Indicator Questions of Physical Activity: measuring level of physical activity
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
sociodemographic questionnaire
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
WHO Quality of Life - Spiritual, Religious and Personal Beliefs
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Use of prescription drugs
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
Sick-leave data
Time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up
patient records
Time frame: up to 6 weeks and 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 39231146Ronne-Petersen L, Niemi M, Walach H, Lavebratt C, Yang LL, Gerdle B, Ghafouri B, Falkenberg T. Exploring emotional well-being, spiritual, religious and personal beliefs and telomere length in chronic pain patients-A pilot study with cross-sectional design. PLoS One. 2024 Sep 4;19(9):e0308924. doi: 10.1371/journal.pone.0308924. eCollection 2024.
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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.
Torkel Falkenberg, Ass. Prof principal investigator
Integrative Care Science Center
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by The Integrative Care Science Center.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torkel Falkenberg, Ass. Prof. (+46706183868, torkel.falkenberg@integrativecare.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length from blood sample leucocyte cells (time frame: baseline, up to 6 weeks, 6 month-, and 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459639, which also lists 1 linked publication.
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 3 Jun 2015.