Quality of LifeNCT05559021
What Concept of Manual Therapy is More Effective?
A study testing Myofascial Therapy Treatments and Passive Mobilizations Approach in people with Quality of Life and Self Efficacy, run by Universidad Europea de Madrid at 2 sites in Spain.
Trial summary
The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 62 years, women only
- Conditions the study is for
- Quality of Life, Self Efficacy, Kinesiophobia
- What is being tested?
- Myofascial Therapy Treatments and Passive Mobilizations Approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSpain
- Study dates
- 20 Oct 2022to 15 Dec 2023
- 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 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Less than 62 years old
- Medical Diagnosis of Fibromyalgia
- The individuals included in the study had a minimum one-year history of symptoms
- To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.
- The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.
Who cannot join
- Intolerance to touch
- A change of medication in the last 2-3 months
- Agree not to change their medication during the study
- -
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Eleuterio A. Sánchez Romero
Madrid, 28670
Universidad Europea de Madrid
Madrid, 28670
About this study
Official title: What Concept of Manual Therapy is More Effective to Improved Health Status in Women With Fibromyalgia Syndrome?: An Experimental Study
The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.
Read the detailed description
A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.
- Conditions
- Quality of Life, Self Efficacy, Kinesiophobia, Catastrophizing, Central Sensitisation, Anxiety
- Being tested
- Myofascial Therapy Treatments, Passive Mobilizations Approach
- Keywords
- Manual Therapy, Chronic Pain, Fibromyalgia, Passive Mobilizations, Myofascial Approach, Symptom Severity
- Medical subject headings
- Kinesiophobia, Anxiety Disorders, Depression, Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial Therapy TreatmentsOther
- Myofascial approach: After the bibliographic review of myofascial therapy treatments in fibromyalgia patients based on the articles by CastroSánchez AM et al., and an expert consensus, the following approach was decided: patients would have 4 sessions in total with 1 session per week of 30 minutes each.
- Transverse planes in the thoracolumbar fascia (TCL) and abdomen: Performing a myofascial induction as described by Pilat.
- Transverse planes at C7-D3 and sternum: Performing a myofascial induction as described by Pilat.
- Suboccipital inhibition: Performing a myofascial induction as described by Pilat
Passive Mobilizations ApproachOther
- Approach with passive mobilizations: After the literature review of manual therapy treatments in fibromyalgia patients and a consensus of experts in Manual Therapy with more than 15 years of experience, the following approach was agreed upon by the expert: patients would have 4 sessions in total with 1 session per week of 30 minutes each.
- Postero-anterior cervical sliding
- Postero-anterior lumbar slippage
- Postero anterior dorsal slippage
| Study group | Role | What they receive |
|---|---|---|
| Myofascial Treatment Approach | Experimental | Patients will have 1 session per week, during 4 weeks, making 4 sessions in total. Each session will last 30 minutes. Each session consists of:
* Transverse planes in the thoracolumbar fascia and abdomen: The physical therapist place his hands facing each other so that one hand is between the tables and the patient's thoracolumbar fascia and the other on the abdomen
* Transverse planes at C7-D3 and sternum: The physical therapist, places one hand between the table and the patient's first 4 thoracic vertebrae (C7-T4) and the other on the sternum.
* Suboccipital inhibition: the physical therapist, places his hands under the patient's head transversely between the occipital and the spinous process of C2. After, the head is lowered in such a way that the occipital bone rests on the tenar eminences and a slight traction is maintained cranially. Receives: Other: Myofascial Therapy Treatments |
| Mobilization Approach. | Experimental | Patients will have 1 session per week, for 4 weeks, which means 4 sessions in total. Each session will last 30 minutes. Each session consists of:
* Postero-anterior cervical sliding: the patient's cervical vertebrae will be evaluated with the 4 degrees of postero-anterior sliding, and the pain at each vertebral level is recorded. Then, the most painful vertebra previously detected will be treated.
* Postero-anterior lumbar slippage: the patient's lumbar vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Afterwards, the most painful vertebra previously detected will be treated.
* Postero-anterior dorsal slippage: the patient's dorsal vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Then, Afterwards, it will treat during the most painful vertebra previously detected. Receives: Other: Passive Mobilizations Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Expansion
This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Symptom severity
This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Fibromyalgia Impact Questionnaire
Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Secondary outcomes (7)
kinesiophobia
For this purpose, we will use the Tampa Kinesiophobia Scale (TSK), also translated and validated in Spanish. It is a 17-item self-report measure that will be used to measure fear of movement. A high score indicates an extreme fear of movement, while a low score indicates a negligible fear of movement.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Self-Efficacy
For this purpose, we will use the Pain Self-Efficacy Questionnaire, in its Spanish validated version. The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire developed to assess the confidence that people with persistent pain have in performing activities while in pain. The PSEQ is applicable to all presentations of persistent pain. It inquires about the level of self-efficacy in relation to a range of functions, such as housework, socializing, work, as well as coping with pain without medication. The PSEQ is a 10-item questionnaire developed to assess the confidence that people with persistent pain have in performing activities while in pain. The PSEQ is applicable to all presentations of persistent pain. It inquiries about the level of self-efficacy in relation to a range of functions, such as housework, socializing, work, as well as coping with pain without medication.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Anxiety
The the State-Trait Anxiety Inventory (STAI) questionnaire will be used to assess two independent concepts of anxiety, each with 20 items:
Anxiety as a state: assesses a transient emotional state, characterized by subjective, consciously perceived feelings of alertness and apprehension and by hyperactivity of the autonomic nervous system.
Anxiety as a trait: indicates a relatively stable anxious propensity that characterizes individuals with a tendency to perceive situations as threatening.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Depression
The Beck Depression Inventory is a useful tool to assess somatic symptoms of depression, both in anxiety disorders and depressive conditions. The questionnaire consists of 21 questions, providing a range of scores between 0 and 63.
The questionnaire proposes the following cut-off scores and corresponding degrees of depression: 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Quality of life (EQ-5D-5L)
It will be evaluated by means of the the EuroQol 5-dimensions 5-levels (EQ-5D-5L), which is a generic instrument for measuring health-related quality of life. The patient himself assesses his state of health, in levels of severity by dimensions The first allows the respondent to define the state of health according to the EQ-5D multi-attribute classification system, composed of 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression), and in each of them there are 3 levels of severity (1, 2 or 3).
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score.
The PSQI, developed by the Department of Psychiatry at the University of Pittsburgh in 1988, is a questionnaire that assesses both qualitative and quantitative aspects of sleep quality in the month prior to its administration.
It shows that subjective sleep quality, duration, efficiency, disturbances and daytime dysfunction have better quality in those with moderate and severe impairment; while in those with average and higher performance, higher sleep latencies are observed. The total score is 21, and scores above 5 indicate significant sleep disturbance.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Visual Analog Scale (VAS)
To evaluate the pain that the patient has, we use the VAS. This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies.
Measured: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start20 Oct 2022
- Primary completion15 Sep 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized clinical trial will be conducted between October 2022 and December 2023 in 52 female patients impacted by Fibromyalgia who will undergo a myofascial treatment approach or mobilization treatment approach , with 3 months of follow-up post-treatment.
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleuterio Atanasio Sánchez Romero, Universidad Europea de Madrid
- Investigators
- Eleuterio A. Sánchez Romero, PhD, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559021
- Sponsor's protocol ID
- Concept of Manual Therapy
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2022
- Last updated
- 13 Mar 2024
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Concept of Manual Therapy is More Effective to Improved Health Status in Women With Fibromyalgia Syndrome?: An Experimental Study
- ClinicalTrials.gov ID
- NCT05559021
- Acronym / sponsor ID
- Concept of Manual Therapy
- Conditions
- Quality of Life, Self Efficacy, Kinesiophobia, Catastrophizing, Central Sensitisation, Anxiety
- Keywords
- Manual Therapy, Chronic Pain, Fibromyalgia, Passive Mobilizations, Myofascial Approach, Symptom Severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 29 Sep 2022 (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 aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.
Detailed description
A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized clinical trial will be conducted between October 2022 and December 2023 in 52 female patients impacted by Fibromyalgia who will undergo a myofascial treatment approach or mobilization treatment approach , with 3 months of follow-up post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Myofascial Treatment Approach | Experimental | Other: Myofascial Therapy TreatmentsPatients will have 1 session per week, during 4 weeks, making 4 sessions in total. Each session will last 30 minutes. Each session consists of: * Transverse planes in the thoracolumbar fascia and abdomen: The physical therapist place his hands facing each other so that one hand is between the tables and the patient's thoracolumbar fascia and the other on the abdomen * Transverse planes at C7-D3 and sternum: The physical therapist, places one hand between the table and the patient's first 4 thoracic vertebrae (C7-T4) and the other on the sternum. * Suboccipital inhibition: the physical therapist, places his hands under the patient's head transversely between the occipital and the spinous process of C2. After, the head is lowered in such a way that the occipital bone rests on the tenar eminences and a slight traction is maintained cranially. |
| Mobilization Approach. | Experimental | Other: Passive Mobilizations ApproachPatients will have 1 session per week, for 4 weeks, which means 4 sessions in total. Each session will last 30 minutes. Each session consists of: * Postero-anterior cervical sliding: the patient's cervical vertebrae will be evaluated with the 4 degrees of postero-anterior sliding, and the pain at each vertebral level is recorded. Then, the most painful vertebra previously detected will be treated. * Postero-anterior lumbar slippage: the patient's lumbar vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Afterwards, the most painful vertebra previously detected will be treated. * Postero-anterior dorsal slippage: the patient's dorsal vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Then, Afterwards, it will treat during the most painful vertebra previously detected. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Less than 62 years old
- Medical Diagnosis of Fibromyalgia
- The individuals included in the study had a minimum one-year history of symptoms
- To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.
- The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.
Key exclusion criteria (4 listed)
- Intolerance to touch
- A change of medication in the last 2-3 months
- Agree not to change their medication during the study
- -
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 |
|---|---|---|
| Myofascial Therapy Treatments• Myofascial approach: After the bibliographic review of myofascial therapy treatments in fibromyalgia patients based on the articles by CastroSánchez AM et al., and an expert consensus, the following approach was decided: patients would have 4 sessions in total with 1 session per week of 30 minutes each. * Transverse planes in the thoracolumbar fascia (TCL) and abdomen: Performing a myofascial induction as described by Pilat. * Transverse planes at C7-D3 and sternum: Performing a myofascial induction as described by Pilat. * Suboccipital inhibition: Performing a myofascial induction as described by Pilat | Other | Myofascial Treatment Approach |
| Passive Mobilizations Approach• Approach with passive mobilizations: After the literature review of manual therapy treatments in fibromyalgia patients and a consensus of experts in Manual Therapy with more than 15 years of experience, the following approach was agreed upon by the expert: patients would have 4 sessions in total with 1 session per week of 30 minutes each. * Postero-anterior cervical sliding * Postero-anterior lumbar slippage * Postero anterior dorsal slippage | Other | Mobilization Approach. |
Primary outcome
Pain Expansion
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week
Symptom severity
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)
Fibromyalgia Impact Questionnaire
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms
7 secondary outcomes
kinesiophobia
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Self-Efficacy
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Anxiety
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Depression
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Quality of life (EQ-5D-5L)
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Sleep quality
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Visual Analog Scale (VAS)
Time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
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 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Eleuterio A. Sánchez Romero, PhD principal investigator
European University of Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial Therapy Treatments and Passive Mobilizations Approach in people with Quality of Life and Self Efficacy, run by Universidad Europea de Madrid at 2 sites in Spain.
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 5 inclusion and 4 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 13 Mar 2024. 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 Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Expansion (time frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention). The study lists 3 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 13 Mar 2024.