FibromyalgiaNCT06226376
Mollii Suit and Fibromyalgia (EXOFIB 2)
A study testing EXOPULSE Mollii Suit Stimulation in people with Fibromyalgia and Rheumatic Diseases, run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
Trial summary
The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Rheumatic Diseases, Muscular Diseases
- What is being tested?
- EXOPULSE Mollii Suit Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 8 Jan 2024to 24 May 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month.
- Patients should be able to understand verbal instructions.
Who cannot join
- Patient with VAS < 4
- Patient included in another research protocol during the study period
- Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
- Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
- Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
- Any change in the pharmacological therapy in the last three months
- Introduction of a medical device other than Exopulse Mollii suit during the study period
- Patient under juridical protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial
The goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:
Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.
Read more
Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)
Study subjects will participate in:
A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
- Conditions
- Fibromyalgia, Rheumatic Diseases, Muscular Diseases, Neuromuscular Diseases, Nervous System Diseases
- Being tested
- EXOPULSE Mollii Suit Stimulation
- Medical subject headings
- Fibromyalgia, Rheumatic Diseases, Muscular Diseases, Neuromuscular Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXOPULSE Mollii Suit StimulationDevice
We designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
| Study group | Role | What they receive |
|---|---|---|
| EXOPULSE Mollii Suit Stimulation Active. | Active comparator | This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes. Receives: Device: EXOPULSE Mollii Suit Stimulation |
| EXOPULSE Mollii Suit Stimulation Sham. | Sham comparator | This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes Receives: Device: EXOPULSE Mollii Suit Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire (FIQ)
It is an 11-item scale that assesses health status and functional disability by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0-38), moderate (scores: 39-58), and severe (scores: 59-100)
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Secondary outcomes (7)
Brief Pain Inventory (BPI)
will be used to assess pain severity (4 items) and pain interference (7 items). BPI items are rated on a 10-point scale running from 0 (no pain/does not interfere) to 10 (pain as bad as the participant can imagine/interferes completely).
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS) will be employed, which is a valid and reliable scale that includes 13 items assessing the presence and severity of feelings or thoughts that emerge when experiencing pain. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time). It is possible to calculate a total and three subscale scores (i.e., helplessness, magnification, and rumination)
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Quality of life as per the Short Form 36 Health Survey (SF-36)
It is a generic survey that contains 36 items which assess the quality of life and yield eight dimensions: physical functioning, physical role, emotional role, bodily pain, general health, vitality, social functioning, and mental health. The score of each dimension ranges from 0 to 100, with higher scales implying better health status.
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Visual Analogue Scale for Pain
Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain.
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Visual Analogue Scale for Fatigue
Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Hospital Anxiety and Depression Scale (HADS)
It is a 14-item generic scale with good psychometric properties and consists of seven items assessing anxiety and seven others assessing depression. Scores can range from 0 to 21 on each subscale, with higher scores indicating worse symptomatology.
Measured: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Clinical Global Impression (CGI)
Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows:
Very much improved. Much improved. Slightly improved. No change. Slightly worse Much worse. Very much worse The score will range from 1-7, 1 being the best clinical outcome and 7 the worst.
Measured: This to be assessed at week 2, week 6 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start8 Jan 2024
- Primary completion24 Mar 2025
- Study completion24 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Shakhbout Medical City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naji Joseph Riachi, Sheikh Shakhbout Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226376
- Sponsor's protocol ID
- EXOFIB2
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annemans L, Le Lay K, Taieb C. Societal and patient burden of fibromyalgia syndrome. Pharmacoeconomics. 2009;27(7):547-59. doi: 10.2165/11313650-000000000-00000.
PubMed 19663526Bengtsson A, Henriksson KG. The muscle in fibromyalgia--a review of Swedish studies. J Rheumatol Suppl. 1989 Nov;19:144-9.
PubMed 2691674Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
PubMed 25511175Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.
PubMed 1865419Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.
PubMed 15943960Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.
PubMed 2278111Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Coskun Benlidayi I. The effectiveness and safety of electrotherapy in the management of fibromyalgia. Rheumatol Int. 2020 Oct;40(10):1571-1580. doi: 10.1007/s00296-020-04618-0. Epub 2020 Jun 10.
PubMed 32524302Da Silva TFG, Suda EY, Marçulo CA, Paes FHS, Pinheiro GT. Comparison of transcutaneous electrical nerve stimulation and hydrotherapy effects on pain, flexibility and quality of life in patients with fibromyalgia [Comparação dos efeitos da estimulação elétrica nervosa transcutânea e da hidroterapia na dor, flexibilidade e qualidade de vida de pacientes com fibromialgia]. Fisioterapia e Pesquisa 2008;15:118-24.
Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
PubMed 23900134Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824-836. doi: 10.1002/art.41170. Epub 2020 Mar 18.
PubMed 31738014Drewes AM, Andreasen A, Schroder HD, Hogsaa B, Jennum P. Pathology of skeletal muscle in fibromyalgia: a histo-immuno-chemical and ultrastructural study. Br J Rheumatol. 1993 Jun;32(6):479-83. doi: 10.1093/rheumatology/32.6.479.
PubMed 8508284Elvin A, Siosteen AK, Nilsson A, Kosek E. Decreased muscle blood flow in fibromyalgia patients during standardised muscle exercise: a contrast media enhanced colour Doppler study. Eur J Pain. 2006 Feb;10(2):137-44. doi: 10.1016/j.ejpain.2005.02.001.
PubMed 16310717Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of EXOPULSE Mollii Suit on Fibromyalgia Syndrome in Patients With Fibromyalgia (EXOFIB 2): A Sham Controlled Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT06226376
- Acronym / sponsor ID
- EXOFIB2
- Conditions
- Fibromyalgia, Rheumatic Diseases, Muscular Diseases, Neuromuscular Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sheikh Shakhbout Medical CityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 May 2025 (actual)
- First posted
- 26 Jan 2024 (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 goal of this clinical trial is to demonstrate the improvement of fibromyalgia syndrome obtained following active stimulation compared to sham, with diminished functional disability and improved health status using Exopulse Molli suit stimulation. The main questions it aims to answer are:
Evaluation of pain, fatigue, mood and quality of life changes observed after active stimulation in comparison to sham.
Improvement of fibromyalgia syndrome as per the Fibromyalgia Impact Questionnaire (FIQ)
Study subjects will participate in:
A randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXOPULSE Mollii Suit Stimulation Active. | Active comparator | Device: EXOPULSE Mollii Suit StimulationThis will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes. |
| EXOPULSE Mollii Suit Stimulation Sham. | Sham comparator | Device: EXOPULSE Mollii Suit StimulationThis will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least one month.
- Patients should be able to understand verbal instructions.
Key exclusion criteria (8 listed)
- Patient with VAS < 4
- Patient included in another research protocol during the study period
- Patient unable to undergo medical monitor for the study purposes due to geographical or social reasons
- Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
- Patient with other somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
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 |
|---|---|---|
| EXOPULSE Mollii Suit StimulationWe designed a randomized sham controlled double-blind trial to demonstrate the improvement of pain, quality of life, fatigue and mood in adult patients with fibromyalgia following a 2-week intervention of "active" versus "sham" Exopulse Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for 4 weeks (7 sessions per week) on the studied outcomes. | Device | EXOPULSE Mollii Suit Stimulation Active., EXOPULSE Mollii Suit Stimulation Sham. |
Primary outcome
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
It is an 11-item scale that assesses health status and functional disability by exploring the impact of fibromyalgia on work, wellbeing, fatigue, sleep, stiffness, anxiety, and depression. FIQ scores can range from 0 to 100, with higher scores reflecting worse health status. Scores could be used to classify fibromyalgia as mild (scores: 0-38), moderate (scores: 39-58), and severe (scores: 59-100)
7 secondary outcomes
Brief Pain Inventory (BPI)
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Pain Catastrophizing Scale (PCS)
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Quality of life as per the Short Form 36 Health Survey (SF-36)
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Visual Analogue Scale for Pain
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Visual Analogue Scale for Fatigue
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Hospital Anxiety and Depression Scale (HADS)
Time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.
Clinical Global Impression (CGI)
Time frame: This to be assessed at week 2, week 6 and week 12.
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 8 Sep 2025.
- Background: PubMed 19663526Annemans L, Le Lay K, Taieb C. Societal and patient burden of fibromyalgia syndrome. Pharmacoeconomics. 2009;27(7):547-59. doi: 10.2165/11313650-000000000-00000.
- Background: PubMed 2691674Bengtsson A, Henriksson KG. The muscle in fibromyalgia--a review of Swedish studies. J Rheumatol Suppl. 1989 Nov;19:144-9.
- Background: PubMed 25511175Bocerean C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.
- Background: PubMed 1865419Burckhardt CS, Clark SR, Bennett RM. The fibromyalgia impact questionnaire: development and validation. J Rheumatol. 1991 May;18(5):728-33.
- Background: PubMed 15943960Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background: PubMed 2278111Campbell WI, Lewis S. Visual analogue measurement of pain. Ulster Med J. 1990 Oct;59(2):149-54.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 32524302Coskun Benlidayi I. The effectiveness and safety of electrotherapy in the management of fibromyalgia. Rheumatol Int. 2020 Oct;40(10):1571-1580. doi: 10.1007/s00296-020-04618-0. Epub 2020 Jun 10.
- BackgroundDa Silva TFG, Suda EY, Marçulo CA, Paes FHS, Pinheiro GT. Comparison of transcutaneous electrical nerve stimulation and hydrotherapy effects on pain, flexibility and quality of life in patients with fibromyalgia [Comparação dos efeitos da estimulação elétrica nervosa transcutânea e da hidroterapia na dor, flexibilidade e qualidade de vida de pacientes com fibromialgia]. Fisioterapia e Pesquisa 2008;15:118-24.
- Background: PubMed 23900134Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
- Background: PubMed 31738014Dailey DL, Vance CGT, Rakel BA, Zimmerman MB, Embree J, Merriwether EN, Geasland KM, Chimenti R, Williams JM, Golchha M, Crofford LJ, Sluka KA. Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial. Arthritis Rheumatol. 2020 May;72(5):824-836. doi: 10.1002/art.41170. Epub 2020 Mar 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXOPULSE Mollii Suit Stimulation in people with Fibromyalgia and Rheumatic Diseases, run by Sheikh Shakhbout Medical City at 1 site in United Arab Emirates.
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 2 inclusion and 8 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 8 Sep 2025. 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 Arab Emirates. 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?
Fibromyalgia Impact Questionnaire (FIQ) (time frame: This to be assessed at baseline, then at week 2, week 4, week 6, week 8 and week 12.). 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 NCT06226376, which also lists 40 linked publications.
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 8 Sep 2025.