Pain Predominant Chronic Multisymptom IllnessNCT04157101
Health Coaching for Chronic Multisymptom Illness
A study testing Health Coaching and Supportive Psychotherapy in people with Pain Predominant Chronic Multisymptom Illness, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain Predominant Chronic Multisymptom Illness
- What is being tested?
- Health Coaching and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to 23 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Study Population. Participants will consist of 250 Veterans with Pain-CMI
- CMI meets Kansas City (Steele) definition of CMI
- reports wide-spread pain rated at least 4 on a 0 to 10 point pain bothersome scale
- rates their activity limitations at least 3 on a 0 to 10 point scale
Who cannot join
- life-threatening condition,
- severe cognitive impairment
- psychotic disorder, pregnant
- plans to become pregnant in the next year
- suicidal intent
Trial locations and contacts
1 site in 1 country.
United States1 site
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, 07018
About this study
Official title: Health Coaching for Chronic Multi-symptom Illness
The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive service connected condition for Veterans who deployed to the Gulf region. Health coaching is an appealing potential approach to improve the disability of Pain-CMI because it is personalized to the Veteran's unique goals and beliefs about Pain-CMI and it will be widely available as the VA is rolling out health coaching. The goal of this proposal is to understand if health coaching is also efficacious for a complex pain condition, Pain-CMI.
Read the detailed description
Purpose:
Chronic pain is one of the most common healthcare issues that Veterans face; it can be very debilitating as well as difficult to treat. Pain Predominant Chronic Multi-symptom Illness (CMI) (e.g., fibromyalgia) is a particularly debilitating and treatment-resistant chronic pain condition and a presumptive service-connected condition for Veterans who deployed to the Gulf region from 1990-2021 (VA Benefits Administration, 2018). There is an urgent need for evidence-based non-pharmaceutical treatments for chronic pain. This study will explore the efficacy of remote-delivered health coaching intervention aimed at modifying lifestyle factors of diet, exercise, social connections, stress, and sleep. The control condition will be supportive psychotherapy.
Study Aims:
Primary Aim 1: Determine if remote-delivered health coaching reduces (H1a) disability and (H2a) pain impairment as compared to remote-delivered supportive psychotherapy for Veterans with Pain-CMI. The investigators will also assess the improvement in (H1b) disability and (H2b) pain impairment at the 24-month follow-up.
Primary Aim 2: Determine if health coaching results in more frequent clinically significant improvement in (H3) disability (20%) and (H4) pain impairment (1 point) as compared to supportive psychotherapy.
Secondary Aim 3: Determine if health coaching reduces (H5) physical symptoms, (H6) catastrophizing, (H7) limiting activity and increases (H8) pain control as compared to supportive psychotherapy.
Exploratory Aim 4: Determine if the reduction in (H9) catastrophizing, (H10) limiting activity and increases in (H11) pain control mediate the relationship between health coaching and reductions in disability and pain impairment.
Study Design:
The current proposal is a randomized clinical trial to determine the efficacy of remote-delivered health coaching in reducing disability and pain impairment for Veterans with Pain-CMI as compared to supportive psychotherapy (n=250). Additionally, the investigators will explore mechanisms of change. Participants will complete four assessments at four different timepoints: baseline, 6-week mid treatment (~6 weeks after baseline), post-treatment (~12 weeks after baseline), and 24-week follow-up (~24 weeks after baseline).
- Being tested
- Health Coaching, Supportive Psychotherapy
- Keywords
- Pain, Veteran, Health Coaching, Clinical Trial, Supportive Psychotherapy, Illness beliefs
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward.
Supportive PsychotherapyBehavioural
Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward. Receives: Behavioral: Health Coaching |
| Supportive Psychotherapy | Placebo comparator | Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers. Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Disability Assessment Schedule
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity. Consistent with IMMPACT, our primary outcomes include a general measure of disability (WHO-DAS) and a pain specific measure. A 20% improvement will be considered clinically significant. The WHO-DAS is scored on a scale of 0-100 with higher scores = worse disability.
Measured: Post-treatment (12 weeks)
Brief Pain Inventory
Brief Pain Inventory (BPI). Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. There are 7-items for the pain interference subscale which are scored from 0-10 with higher = worse pain interference.
Measured: post-treatment (12-weeks)
World Health Organization Disability Assessment Schedule
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity and is scored from 0-100 with higher = worse disability.
Measured: follow up (24 week)
Brief Pain Inventory
Brief Pain Inventory (BPI). We will compare the % who have a 1 point improvement between arms. Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. We will use the 7-item interference scale which is scored on a scale of 0-10 with higher = worse pain interference.
Measured: follow-up (24 weeks)
Secondary outcomes (6)
Patient Health Questionnaire-15
Patient Health Questionnaire (PHQ-15). The PHQ-15 measures physical symptoms and is scored from 0-30 with higher scores = worse symptom burden. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change.
Measured: post-treatment (12-weeks)
Illness Perception Questionnaire-Revised
Illness Perception Questionnaire-Revised (IPQ-R).17 Perceived control beliefs will be measured by the IPQ-R. The IPQ-R measures a broad range of illness beliefs, including severity of illness consequences, chronicity, and controllability of illness. The IPQ has been found to be reliable and valid among patients with CMI, predictive of outcomes and responsive to clinical intervention. We will use the control subscale where higher scores = greater perceived control.
Measured: post-treatment (12-weeks)
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS). Catastrophizing will be measured by the PCS. The PCS is a 13-item measure of the degree of pain catastrophizing. The PCS is reliable, valid, predictive of outcomes and responsive to clinical intervention. The PCS is scored on a scale of 0-52 with higher = worse catastrophizing.
Measured: post-treatment (12-weeks)
Behavioral Response to Illness Questionnaire
Behavioral Response to Illness Questionnaire. Limiting behaviors will be assessed with the BRIQ which measures behavioral responses to CMI. The BRIQ has four subscales: limiting behaviors, all or nothing behaviors, practical support and emotional support. The BRIQ is reliable, valid and predicts onset of CMI. We will use the limiting behaviors and all or nothing subscales where higher is more limiting and all or nothing behaviors respectively.
Measured: post-treatment (12-weeks)
World Health Organization Disability Assessment Schedule
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). We will compare the % who decrease by 20% between arms. The WHO-DAS measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity and is scored from 0-100 with higher = worse disability.
Measured: post-treatment (12-weeks)
Brief Pain Inventory
Brief Pain Inventory (BPI). We will compare the % who have a 1 point improvement between arms. Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. The BPI interference scale is 7 items scored from 0-10 with higher = greater interference.
Measured: post-treatment (12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start30 Apr 2020
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Predominant Chronic Multisymptom IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa Marie McAndrew, PhD, Principal investigator, East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157101
- Sponsor's protocol ID
- F3254-R
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2019
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching for Chronic Multi-symptom Illness
- ClinicalTrials.gov ID
- NCT04157101
- Acronym / sponsor ID
- F3254-R
- Keywords
- Pain, Veteran, Health Coaching, Clinical Trial, Supportive Psychotherapy, Illness beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 8 Nov 2019 (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.
The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive service connected condition for Veterans who deployed to the Gulf region. Health coaching is an appealing potential approach to improve the disability of Pain-CMI because it is personalized to the Veteran's unique goals and beliefs about Pain-CMI and it will be widely available as the VA is rolling out health coaching. The goal of this proposal is to understand if health coaching is also efficacious for a complex pain condition, Pain-CMI.
Detailed description
Purpose:
Chronic pain is one of the most common healthcare issues that Veterans face; it can be very debilitating as well as difficult to treat. Pain Predominant Chronic Multi-symptom Illness (CMI) (e.g., fibromyalgia) is a particularly debilitating and treatment-resistant chronic pain condition and a presumptive service-connected condition for Veterans who deployed to the Gulf region from 1990-2021 (VA Benefits Administration, 2018). There is an urgent need for evidence-based non-pharmaceutical treatments for chronic pain. This study will explore the efficacy of remote-delivered health coaching intervention aimed at modifying lifestyle factors of diet, exercise, social connections, stress, and sleep. The control condition will be supportive psychotherapy.
Study Aims:
Primary Aim 1: Determine if remote-delivered health coaching reduces (H1a) disability and (H2a) pain impairment as compared to remote-delivered supportive psychotherapy for Veterans with Pain-CMI. The investigators will also assess the improvement in (H1b) disability and (H2b) pain impairment at the 24-month follow-up.
Primary Aim 2: Determine if health coaching results in more frequent clinically significant improvement in (H3) disability (20%) and (H4) pain impairment (1 point) as compared to supportive psychotherapy.
Secondary Aim 3: Determine if health coaching reduces (H5) physical symptoms, (H6) catastrophizing, (H7) limiting activity and increases (H8) pain control as compared to supportive psychotherapy.
Exploratory Aim 4: Determine if the reduction in (H9) catastrophizing, (H10) limiting activity and increases in (H11) pain control mediate the relationship between health coaching and reductions in disability and pain impairment.
Study Design:
The current proposal is a randomized clinical trial to determine the efficacy of remote-delivered health coaching in reducing disability and pain impairment for Veterans with Pain-CMI as compared to supportive psychotherapy (n=250). Additionally, the investigators will explore mechanisms of change. Participants will complete four assessments at four different timepoints: baseline, 6-week mid treatment (~6 weeks after baseline), post-treatment (~12 weeks after baseline), and 24-week follow-up (~24 weeks after baseline).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingThe 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward. |
| Supportive Psychotherapy | Placebo comparator | Behavioral: Supportive PsychotherapyOur control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Study Population. Participants will consist of 250 Veterans with Pain-CMI
- CMI meets Kansas City (Steele) definition of CMI
- reports wide-spread pain rated at least 4 on a 0 to 10 point pain bothersome scale
- rates their activity limitations at least 3 on a 0 to 10 point scale
Key exclusion criteria (5 listed)
- life-threatening condition,
- severe cognitive impairment
- psychotic disorder, pregnant
- plans to become pregnant in the next year
- suicidal intent
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 |
|---|---|---|
| Health CoachingThe 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward. | Behavioural | Health Coaching |
| Supportive PsychotherapyOur control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers. | Behavioural | Supportive Psychotherapy |
Primary outcome
World Health Organization Disability Assessment Schedule
Time frame: Post-treatment (12 weeks)
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity. Consistent with IMMPACT, our primary outcomes include a general measure of disability (WHO-DAS) and a pain specific measure. A 20% improvement will be considered clinically significant. The WHO-DAS is scored on a scale of 0-100 with higher scores = worse disability.
Brief Pain Inventory
Time frame: post-treatment (12-weeks)
Brief Pain Inventory (BPI). Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. There are 7-items for the pain interference subscale which are scored from 0-10 with higher = worse pain interference.
World Health Organization Disability Assessment Schedule
Time frame: follow up (24 week)
World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity and is scored from 0-100 with higher = worse disability.
Brief Pain Inventory
Time frame: follow-up (24 weeks)
Brief Pain Inventory (BPI). We will compare the % who have a 1 point improvement between arms. Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. We will use the 7-item interference scale which is scored on a scale of 0-10 with higher = worse pain interference.
6 secondary outcomes
Patient Health Questionnaire-15
Time frame: post-treatment (12-weeks)
Illness Perception Questionnaire-Revised
Time frame: post-treatment (12-weeks)
Pain Catastrophizing Scale
Time frame: post-treatment (12-weeks)
Behavioral Response to Illness Questionnaire
Time frame: post-treatment (12-weeks)
World Health Organization Disability Assessment Schedule
Time frame: post-treatment (12-weeks)
Brief Pain Inventory
Time frame: post-treatment (12-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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.
Lisa Marie McAndrew, PhD principal investigator
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Supportive Psychotherapy in people with Pain Predominant Chronic Multisymptom Illness, run by VA Office of Research and Development at 1 site 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 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: finished, as of the sponsor's last update on 20 Apr 2026. 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 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. 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?
World Health Organization Disability Assessment Schedule (time frame: Post-treatment (12 weeks)). 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?
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 20 Apr 2026.