Chronic PainNCT03582683
A Community-Based Chronic Pain Self-Management Program in West Virginia
A study testing Chronic Pain Self-Management Program (CPSMP) in people with Chronic Pain, run by West Virginia University at 2 sites in United States.
Trial summary
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. 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?
- Chronic Pain Self-Management Program (CPSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2018to 9 Apr 2021
- 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
- Adults over age 18
- Have chronic pain (pain on most days or everyday) for the past 3 months or more
- Able to attend 1 CPSMP workshop a week over 6 weeks
- Able to attend 3-4 testing sessions for data collection (testing sessions are scheduled before the workshops begin and then six months, one year and, for those assigned to the control group, one and a half years after the start of the study)
Who cannot join
- Chronic pain caused by current cancer diagnosis or an open wound
- Lack reliable transportation
- Having surgery for the painful area in the next year
- Not community-dwelling (i.e., living in a nursing home, assisted living or personal care home, mental hospital, or correctional facility)
- Not willing to be randomized to either start CPSMP workshop now or in six months
- Participation in another self-management program (e.g., Diabetes Self-Management Program) in the past 12 months
- Unable to speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
West Virginia School of Osteopathic Medicine
Lewisburg, West Virginia, 24901
Mid-Ohio Valley Health Department
Parkersburg, West Virginia, 26101
About this study
Official title: A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
Read the detailed description
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. The impact of CP is worse in people with both CP and comorbid chronic diseases such as arthritis, diabetes, and heart disease. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP. Thus, there is a vital need to rigorously test more interventions that can be brought to scale and widely disseminated in the US.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). With one of the worst health profiles in the US, WV has the highest rates of arthritis, diabetes, heart disease, and drug overdose deaths, and therefore has a compelling need for the CPSMP. The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Two trained leaders will facilitate group discussions on managing pain, emotions, depression, fatigue, and sleep; proper exercise, nutrition, and medication use; weight management; strategies for effective communication with healthcare professionals; evaluating treatments; and pacing/planning. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
- Conditions
- Chronic Pain
- Being tested
- Chronic Pain Self-Management Program (CPSMP)
- Keywords
- Self-Management Programs, Behavioral Health
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Pain Self-Management Program (CPSMP)Behavioural
Stanford University's Chronic Pain Self-Management Program (CPSMP) was developed by Sandra LeFort in 1996 and based on Stanford's Arthritis Self-Management Program and the Chronic Disease Self-Management Program. The 6-week community-delivered workshop consists of 2.5-hour weekly sessions for people with a primary or secondary diagnosis of Chronic Pain.
| Study group | Role | What they receive |
|---|---|---|
| CPSMP Intervention | Experimental | Participants randomly assigned to this arm will, following a baseline assessment, immediately begin attending a 6-week Chronic Pain Self-Management Program (CPSMP) workshop. Receives: Behavioral: Chronic Pain Self-Management Program (CPSMP) |
| Wait-list Control Group | Active comparator | Participants assigned to this arm will wait six months after a baseline assessment and then attend the 6-week Chronic Pain Self-Management Program (CPSMP) workshop. Receives: Behavioral: Chronic Pain Self-Management Program (CPSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Using Stanford's 0-10 Pain Visual Numeric Scale participants will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Measured: Change between baseline and 52 weeks
Defense and Veterans Pain Rating Scale
Using the Defense and Veterans Pain Rating Scale will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Measured: Change between baseline and 52 weeks
Secondary outcomes (19)
Pain interference with sleep
Defense and Veterans Pain Rating Scale Supplemental Question (revised from 24 hours to past 2 weeks)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain frequency
2016 NHIS (past 3 months)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Perceived disability
Pain Disability Index
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain avoidance
Tampa Scale of Kinesiophobia. A total score is calculated that ranges from 17 (low degree of kinesiophobia) to 68 (a high degree of kinesiophobia)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Opioid misuse
Screener and Opioid Assessment for Patients with Pain (SOAPP) v1.0-SF
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Medication Usage
Morphine milligram equivalents (MME) per day of current prescription or over-the-counter medications for pain, depression, anxiety, mood, or sleep (also usage of stimulants and muscle relaxers)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mood
Stanford Personal Health Questionnaire-Depression (PHQ-8)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Anxiety
Generalized Anxiety Disorder-7 (GAD-7)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Catastrophizing
Pain Catastrophizing Scale. The total score ranges from 0 (low catastrophizing) to 52 (high catastrophizing). There are 3 subscales (rumination, magnification, and helplessness)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mindfulness
5 Facet Mindfulness Questionnaire Short Form
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain Self-Efficacy
Pain Self-Efficacy Scale. The total score ranges from 0 (low self-efficacy) to 60 (high self-efficacy)
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Coping
Coping Strategies Questionnaire-Revised
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Activation
Patient Activation Measure
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
General Health Status
2016 BRFSS question
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Vitality
SF-36 v1
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Minutes of Physical Activity
2016 NHIS questions
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Healthcare Utilization
Emergency room visits and doctor/clinic visits
Measured: Monthly for up to 12 months
Work
Number of days missed work and number of days in bed more than half of the day
Measured: Monthly for up to 12 months
Gait speed
5- or 10-meter gait speed test
Measured: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start18 Jun 2018
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- Model description
- After a baseline assessment, participants will be randomized to the CPSMP intervention or a 6-month, wait-list control group based on an allocation sequence based on class size, that will be stratified by site and allocated via opaque envelopes.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, West Virginia School of Osteopathic Medicine, Mid-Ohio Valley Health Department
- Responsible party
- Principal investigator, Dina L Jones, PT, PhD, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582683
- Sponsor's protocol ID
- 3U48DP005004-04S1
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia
- ClinicalTrials.gov ID
- NCT03582683
- Acronym / sponsor ID
- 3U48DP005004-04S1
- Conditions
- Chronic Pain
- Keywords
- Self-Management Programs, Behavioral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, West Virginia School of Osteopathic Medicine, Mid-Ohio Valley Health Department
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 11 Jul 2018 (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.
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
Detailed description
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. The impact of CP is worse in people with both CP and comorbid chronic diseases such as arthritis, diabetes, and heart disease. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP. Thus, there is a vital need to rigorously test more interventions that can be brought to scale and widely disseminated in the US.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). With one of the worst health profiles in the US, WV has the highest rates of arthritis, diabetes, heart disease, and drug overdose deaths, and therefore has a compelling need for the CPSMP. The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Two trained leaders will facilitate group discussions on managing pain, emotions, depression, fatigue, and sleep; proper exercise, nutrition, and medication use; weight management; strategies for effective communication with healthcare professionals; evaluating treatments; and pacing/planning. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After a baseline assessment, participants will be randomized to the CPSMP intervention or a 6-month, wait-list control group based on an allocation sequence based on class size, that will be stratified by site and allocated via opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| CPSMP Intervention | Experimental | Behavioral: Chronic Pain Self-Management Program (CPSMP)Participants randomly assigned to this arm will, following a baseline assessment, immediately begin attending a 6-week Chronic Pain Self-Management Program (CPSMP) workshop. |
| Wait-list Control Group | Active comparator | Behavioral: Chronic Pain Self-Management Program (CPSMP)Participants assigned to this arm will wait six months after a baseline assessment and then attend the 6-week Chronic Pain Self-Management Program (CPSMP) workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over age 18
- Have chronic pain (pain on most days or everyday) for the past 3 months or more
- Able to attend 1 CPSMP workshop a week over 6 weeks
- Able to attend 3-4 testing sessions for data collection (testing sessions are scheduled before the workshops begin and then six months, one year and, for those assigned to the control group, one and a half years after the start of the study)
Key exclusion criteria (7 listed)
- Chronic pain caused by current cancer diagnosis or an open wound
- Lack reliable transportation
- Having surgery for the painful area in the next year
- Not community-dwelling (i.e., living in a nursing home, assisted living or personal care home, mental hospital, or correctional facility)
- Not willing to be randomized to either start CPSMP workshop now or in six months
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 |
|---|---|---|
| Chronic Pain Self-Management Program (CPSMP)Stanford University's Chronic Pain Self-Management Program (CPSMP) was developed by Sandra LeFort in 1996 and based on Stanford's Arthritis Self-Management Program and the Chronic Disease Self-Management Program. The 6-week community-delivered workshop consists of 2.5-hour weekly sessions for people with a primary or secondary diagnosis of Chronic Pain. | Behavioural | CPSMP Intervention, Wait-list Control Group |
Primary outcome
Pain severity
Time frame: Change between baseline and 52 weeks
Using Stanford's 0-10 Pain Visual Numeric Scale participants will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Defense and Veterans Pain Rating Scale
Time frame: Change between baseline and 52 weeks
Using the Defense and Veterans Pain Rating Scale will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
19 secondary outcomes
Pain interference with sleep
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain frequency
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Perceived disability
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain avoidance
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Opioid misuse
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Medication Usage
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mood
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Anxiety
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Catastrophizing
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mindfulness
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain Self-Efficacy
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Coping
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Activation
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
General Health Status
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Vitality
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Minutes of Physical Activity
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Healthcare Utilization
Time frame: Monthly for up to 12 months
Work
Time frame: Monthly for up to 12 months
Gait speed
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
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 12 Apr 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Pain Self-Management Program (CPSMP) in people with Chronic Pain, run by West Virginia University at 2 sites in United States.
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 4 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 12 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 2 sites in United States. 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?
Pain severity (time frame: Change between baseline and 52 weeks). 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?
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 12 Apr 2021.