Breast CancerPaiNEdNCT04877860
Pain Treatment in a Breast Cancer Population. PaiNEd Study.
A study testing Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) and Multimodal rehabilitation program + traditional biomedical information in people with Breast Cancer, run by Universidad de Granada at 1 site in Spain.
Trial summary
The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) and Multimodal rehabilitation program + traditional biomedical information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to Apr 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over 18 years of age.
- Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
- Not having active cancer.
- Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for> 4 weeks
- Present musculoskeletal or functional alterations in the previous regions.
Who cannot join
- Identification by the research team of physical or mental impossibility to carry out the tests of the study.
- Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Health Sciences Faculty, University of Granada
Granada, 18071
Carolina Fernández Lao, PhD, 958248037 ext. +34, carolinafl@ugr.es
Patrocinio Ariza Vega, PhD, 958248729 ext. +34, pariza@ugr.es
About this study
Official title: Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information.
This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.
Read the detailed description
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.
- Conditions
- Breast Cancer
- Being tested
- Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE), Multimodal rehabilitation program + traditional biomedical information, Control group
- Keywords
- E-health, exercise, telehealth, telerehabilitation, pain management, cancer
- Medical subject headings
- Breast Neoplasms, Motor Activity, Agnosia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)Other
The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.
4 sessions of myofascial induction.
Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.
Multimodal rehabilitation program + traditional biomedical informationOther
The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.
4 sessions of myofascial induction.
Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.
Control groupOther
Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) | Experimental | Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system. Receives: Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) |
| Multimodal rehabilitation program + traditional biomedical information | Active comparator | Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability. Receives: Other: Multimodal rehabilitation program + traditional biomedical information |
| Control group | Active comparator | Information dossier with recommendations on pain control and dysfunction improvement. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.
Measured: Baseline, 2 and 6 months.
Secondary outcomes (10)
Changes from baseline in Pain Catastrophizing Scale at 2 and 6 months.
Used to assess catastrophic thinking related to pain. Pain catastrophizing scale is a 13-item self-reported questionnaire.
Patients rate how frequent they experience each of 13 items or types of pain experience. It uses a 5-point Likert scale, from 0 (mild symptoms) to 4 (worst symptoms). The total score is derived from the sum of the individual scores for the 13 items. The higher the total score, the more the patient exhibits pain catastrophizing characteristics.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 6 months.
Used to assess if participants have symptoms that may be related to central sensitisation.
The Central Sensitization Inventory (CSI) is composed of two different parts. The first one consists of 25 statements, each answer is scored: 0 Never, 1 Rarely, 2 Sometimes, 3 Often, and 4 Always. So that, at most we will be able to obtain a score of 100 and a minimum of 0. The second part is a survey in which patients explain if they have been diagnosed of specific disorders. Higher CSI scores mean greater symptoms of central sensitization. If patients obtain a score greater than or equal to 40, we will consider that they have sufficient psychometrics to be correlated with central sensitization syndromes
Measured: Baseline, 2 and 6 months.
Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 6 months.
Kinesiophobia will be measured by an 11-item version of the Tampa Scale for Kinesiophobia (TSK-11). Each item has 4 response options, "strongly disagree" scores 1 point, and "strongly agree" scores 4 points. The maximum possible score is 44 points and the minimum is 11 points. Greater scores mean strong fear of movement.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 6 months.
A plastic universal goniometer with two adjustable overlapping arms is used to objectively measure the active range of motion of the shoulder joint.
An inclinometer device is used to objectively measure the active range of motion of the cervical joints.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 6 months.
This questionnaire is a breast cancer module of the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire that contains 23 items rated on a four-point scale ranging from 1 (not at all) to 4 (very much). The items assess the side effects of therapy, arm symptoms, breast symptoms, body image, and sexual function. Additionally, there are single items assessing sexual enjoyment, anxiety caused by hair loss, and future outlook. The scores range between 0-100 points. For scales evaluating function, a higher score represents a higher level of functioning. For scales evaluating symptoms, a higher score indicates more severe symptoms.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 6 months.
The Six-Minute Walk Test determines the maximum distance (meters) that a person can walk in 6 minutes. The participants are instructed to set their own pace, to "walk as far as they can in 6 minutes", and to volitionally increase or decrease the speed during the test. Standardized phrases of encouragement are given.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Isometric handgrip strength on Hand-held Dynamometry at 2 and 6 months.
Using manual isometric dynamometry with adjustable grip in a standing position with elbow in complete extension. The test is performed 3 times per hand (alternating both hands), with a 1-minute rest between trials. The average score for each hand is registered.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 6 months.
This test measures the strength of the deep flexor muscles of the neck. It consists of placing the patient in supine position with the spine fully supported on the stretcher and asking him to first, to do a flexion of the upper cervical spine and to simultaneously flex the lower cervical spine. The time that the patient is able to maintain the position without loosing the initial distance that separated him from the stretcher is counted.
Measured: Baseline, 2 and 6 months.
Changes from baseline in Body composition by using electrical bioimpedance analysis at 2 and 6 months.
The electrical impedance analysis is used for estimating body composition, in particular body fat and muscle mass.
Measured: Baseline, 2 and 6 months.
Changes from baseline in stress and inflammatory responses at 2 and 6 months.
Salivary Cortisol, Interleukin-6 and C-reactive protein biomarkers are analyzed.
Measured: Baseline, 2 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start4 Apr 2022
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (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 Breast CancerStudies 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
- Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Fernández Lao, Universidad de Granada
- Investigators
- Carolina Fernández Lao, PhD, Study director, Health Sciences Faculty, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877860
- Sponsor's protocol ID
- PI-0171-2020
- Acronym
- PaiNEd
- Status last verified
- May 2023
- First submitted
- 18 Mar 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fernandez-Gualda MA, Ariza-Vega P, Lozano-Lozano M, Cantarero-Villanueva I, Martin-Martin L, Castro-Martin E, Arroyo-Morales M, Tovar-Martin I, Lopez-Garzon M, Postigo-Martin P, Gonzalez-Santos A, Artacho-Cordon F, Ortiz-Comino L, Galiano-Castillo N, Fernandez-Lao C. Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol. PLoS One. 2023 Aug 15;18(8):e0290096. doi: 10.1371/journal.pone.0290096. eCollection 2023.
PubMed 37582097
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
- ClinicalTrials.gov ID
- NCT04877860
- Acronym / sponsor ID
- PaiNEd / PI-0171-2020
- Conditions
- Breast Cancer
- Keywords
- E-health, exercise, telehealth, telerehabilitation, pain management, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 7 May 2021 (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 objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information.
This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.
Detailed description
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.
| Arm | Type | Receives |
|---|---|---|
| Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) | Experimental | Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system. |
| Multimodal rehabilitation program + traditional biomedical information | Active comparator | Other: Multimodal rehabilitation program + traditional biomedical informationPhysical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability. |
| Control group | Active comparator | Other: Control groupInformation dossier with recommendations on pain control and dysfunction improvement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects over 18 years of age.
- Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
- Not having active cancer.
- Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for> 4 weeks
- Present musculoskeletal or functional alterations in the previous regions.
Key exclusion criteria (2 listed)
- Identification by the research team of physical or mental impossibility to carry out the tests of the study.
- Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.
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 |
|---|---|---|
| Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement. | Other | Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) |
| Multimodal rehabilitation program + traditional biomedical informationThe sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment. | Other | Multimodal rehabilitation program + traditional biomedical information |
| Control groupWaiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase. | Other | Control group |
Primary outcome
Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.
10 secondary outcomes
Changes from baseline in Pain Catastrophizing Scale at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Isometric handgrip strength on Hand-held Dynamometry at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in Body composition by using electrical bioimpedance analysis at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Changes from baseline in stress and inflammatory responses at 2 and 6 months.
Time frame: Baseline, 2 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 37582097Fernandez-Gualda MA, Ariza-Vega P, Lozano-Lozano M, Cantarero-Villanueva I, Martin-Martin L, Castro-Martin E, Arroyo-Morales M, Tovar-Martin I, Lopez-Garzon M, Postigo-Martin P, Gonzalez-Santos A, Artacho-Cordon F, Ortiz-Comino L, Galiano-Castillo N, Fernandez-Lao C. Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol. PLoS One. 2023 Aug 15;18(8):e0290096. doi: 10.1371/journal.pone.0290096. eCollection 2023.
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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.
Carolina Fernández Lao, PhD study director
Health Sciences Faculty, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) and Multimodal rehabilitation program + traditional biomedical information in people with Breast Cancer, run by Universidad de Granada at 1 site 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 2 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 9 May 2023. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Fernández Lao, PhD (958248037 ext. +34, carolinafl@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months. (time frame: Baseline, 2 and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877860, 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 9 May 2023.