Patients Diagnosed With Fibromyalgia SyndromePranayamaNCT07328763
The Effect of Pranayama Breathıng Exercıses on Paın, Anxıety,aAnd Sleep Qualıty in Indıvıduals wıth Fıbromyalgıa
A study testing Pranayama breathing exercises in people with Patients Diagnosed With Fibromyalgia Syndrome, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Individuals diagnosed with fibromyalgia syndrome have a low quality of life due to factors such as pain, sleep problems, high anxiety, depression and low self-esteem, difficulty performing daily living activities, and inhibited socialization (García-Martínez et al., 2012; Sieczkowska et al., 2020). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients Diagnosed With Fibromyalgia Syndrome
- What is being tested?
- Pranayama breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 and over,
- having experienced pain for at least three months,
- diagnosed with fibromyalgia by a physician according to the ACR 2016
- romyalgia diagnostic criteria,
- having a PUKI score of five or higher,
- having a VAS pain score of one or higher,
- having no communication problems,
- and not being pregnant.
Who cannot join
- Individuals with a history of respiratory diseases such as malignancy or tuberculosis,
- those with a psychiatric diagnosis,
- those with nasal obstruction due to septal deviation,
- and those who have previously participated in a similar breathing exercise program will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Physical Medicine and Rehabilitation Hospital
Samsun
About this study
Individuals diagnosed with fibromyalgia syndrome have a low quality of life due to factors such as pain, sleep problems, high anxiety, depression and low self-esteem, difficulty performing daily living activities, and inhibited socialization (García-Martínez et al., 2012; Sieczkowska et al., 2020). Nurses apply care with a holistic approach philosophy that includes supportive, preventive, therapeutic, and rehabilitative aspects to promote and maintain health. Pranayama is an effective, non-invasive, cost-effective, and easily applicable approach that can be implemented within the framework of holistic care (İlter \& Ovayolu, 2021). It is the nurse's responsibility to provide care and create a comfortable environment for patients, improving their quality of life (Aktaş \& İlgin, 2023). In this regard, during the application and teaching of breathing exercises, nurses should carefully assess patients' belief in these exercises. They should plan with the patient the appropriate time, duration, and environment for breathing exercises and be able to evaluate the results (ÖZ, 2020). Studies evaluating the results of applying pranayama to individuals with fibromyalgia are limited in the literature. Therefore, it is thought that pranayama could greatly facilitate and provide concrete data on improving the quality of life for individuals with fibromyalgia by reducing pain, sleep problems, anxiety, and improving functionality.
Read the detailed description
Fibromyalgia syndrome (FMS) is a rheumatological syndrome characterized by symptoms such as increased pain sensitivity, sleep disturbances, fatigue, musculoskeletal pain, stiffness, tenderness, cognitive dysfunction, and mood disorders due to dysregulation of neurophysiological functions (Singh \& Rao, 2023; Verma et al., 2020). The incidence of FMS in the general population is reported to be 2-8%, predominantly affecting women (between 61% and 90%), with a male/female ratio of 2.3 (Galvez-Sánchez et al., 2019; Jones et al., 2015; Schmidt-Wilcke \& Diers, 2017). Although there are insufficient prevalence studies in Turkey, a study conducted in the Trabzon region found the prevalence of FMS to be 3.6% in women aged 20-64 and 0.9% in women aged 20-29 (Topbas et al., 2005).
The American College of Rheumatology (ACR) first defined the FM Diagnostic Criteria in 1990, and these criteria were revised in 2010, 2011, and 2016 (Plesner \& Vaegter, 2018). While there is no definitive treatment method, pharmacological and non-pharmacological treatment methods are applied. Non-pharmacological treatments include acupuncture, biofeedback, capsaicin, chiropractic, cognitive behavioral therapy, exercise, hydrotherapy, spa therapy, massage, meditative movement (Qigong, yoga, and Tai Chi), mindfulness/mind-body therapy, multicomponent therapy, and S-adenyl methionine. In addition, methods such as physical therapy, stretching, strengthening, aerobic exercise, and endurance training are also used (Chitra et al., 2017; Prabhakar et al., 2019).
Fibromyalgia is a common disease associated with numerous comorbidities and is often difficult to diagnose, which can have a devastating impact on quality of life, impair patients' abilities, lead to social and psychological problems for patients, and create a significant socioeconomic burden on healthcare systems (Atahan et al., 2023; Kang et al., 2022).
Fibromyalgia presents with chronic pain without any apparent peripheral tissue damage. This pain results from threatening tissue damage that activates peripheral nociceptors without real or definitive evidence (Ruschak et al., 2023). The pain is characterized by morning stiffness and increasing intensity throughout the day, is anatomically widespread, and is accompanied by hyperexcitability with increased response of the central nervous system to various stimuli (pressure, temperature, light, and medication, etc.). It is characterized by hyperalgesia, allodynia, and features reflected in multiple spinal segments (Araya-Quintanilla et al., 2020).
Patients with FM syndrome may experience emotionally impactful situations in the form of high levels of stress, anger, and catastrophic scenario-based pain, and these situations can worsen existing symptoms (Galvez-Sánchez et al., 2019). Studies have reported that a significant proportion of FM patients experience depression, panic disorder, and anxiety disorder (Basar et al., 2023; Siracusa et al., 2021). It is thought that the cognitive and psychological processes experienced by patients are related to pain (Cetingok et al., 2022). One study reported that FS patients were more likely to experience depression (20%-80%) and anxiety (13%-63.8%) (Henao-Pérez et al., 2022). A meta-analysis study suggested that the lifetime prevalence of depression in fibromyalgia is approximately 65% (Galvez-Sánchez et al., 2020).
Sleep problems are one of the factors triggered by pain and impairing quality of life in individuals diagnosed with fibromyalgia (FS) (Choy, 2015; Keskindag \& Karaaziz, 2017). One study reported that poor sleep quality was perceived as a serious symptom in patients diagnosed with FS, negatively impacting multiple health-related symptoms such as pain, fatigue, cognitive complaints, poor functionality, and low work performance (Climent-Sanz et al., 2020). Another study found that compared to healthy individuals, individuals diagnosed with FS had significantly higher numbers of awakenings, awakening index, and sleep apnea syndrome, and poor sleep quality (Çetin et al., 2020). Pranayama involves the control of breath, a dynamic bridge between body and mind. In Sanskrit, "Pranayama" is a combination of the words "Prana" and "ayama." Prana means breath, vitality, life, and energy, while ayama means restriction, control, or regulation. Pranayama can be described as 'the science of breath, breath control, willful breathing' (İlter \& Ovayolu, 2021). The breathing cycle in pranayama consists of three stages: Puraka (inspiration), Rechaka (expiration), and Kumbhaka (inhalation and holding the breath after inhalation) (İyengar, 2022).
Recent studies have shown that pranayama, by providing body and mind control, contributes to the improvement of many symptoms of fibromyalgia (Singh \& Rao, 2023). Pranayama has been reported to significantly improve the management of many symptoms of fibromyalgia, including pain intensity, stiffness, anxiety, stress, low muscle strength, fatigue, sleep problems, as well as flexibility and cognition, and to improve quality of life (Chitra et al., 2017; Firestone et al., 2014; Hennard, 2011; Lazaridou et al., 2019; Verma et al., 2020). This research was designed as a pre-test-post-test, randomized controlled, experimental study to determine the effects of pranayama breathing exercises on pain, anxiety, sleep quality, and overall health status in individuals with fibromyalgia.
Research Objectives and Hypotheses This research was planned to determine the effects of pranayama breathing exercises applied to individuals with fibromyalgia on pain, anxiety, sleep quality, and health status.
H1: Pranayama breathing exercises applied to individuals with fibromyalgia have an effect on pain. H2: Pranayama breathing exercises applied to individuals with fibromyalgia have an effect on anxiety.
- Being tested
- Pranayama breathing exercises
- Keywords
- Fibromyalgia, Nursing, Pranayama, Quality of Life, Anxiety, Sleep Quality
- Medical subject headings
- Fibromyalgia, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pranayama breathing exercisesOther
Step 1: Normal breathing, focusing on the breath Step 2: Sun Breath (Surya Prana) Step 3: Alternate Nose Breathing (Nadi Shodhana) Step 4: Ocean Breath (Ujiayi) Step 5: Normal breathing, focusing on the breath
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group will be given an appointment schedule containing their scheduled interview dates. |
| Pranayama | Experimental | Pranayama breathing exercises will be taught online for 20 minutes, twice a week for 6 weeks. Receives: Other: Pranayama breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
To indicate the severity of your pain, place an (I) mark on one of the lines below. 0 points: no pain, 1-2 points: very mild pain, 3-4 points: mild pain, 5-6 points: moderate pain, 7-8 points: severe pain, 9-10 points: very severe pain.
Measured: 6 Weeks
Pittsburgh Sleep Quality Index (PSQI)
questions only relate to habits from the past month.
Measured: 6 Weeks
Beck Anxiety Scale (BAS)
Some symptoms that people experience when they are anxious or worried.
Measured: 6 Weeks
Fibromyalgia Impact Questionnaire (FIQ)
Severity of fibromyalgia symptoms
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Diagnosed With Fibromyalgia SyndromeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study used block randomization. Block randomization was performed by an independent researcher. In the randomization, two different groups were coded with different letters (A, B) and blocks were formed. Then, random numbers were assigned to the blocks using a computer. The letters assigned in the randomization were written in sealed envelopes and kept. After identifying patients who met the inclusion criteria, informed consent was obtained, pre-tests were administered, and then the independent researcher was contacted to determine which group the patient belonged to. Patients diagnosed with fibromyalgia who present to the polyclinic will be referred to the researcher. Before starting the study, informed consent will be obtained from the participating patients. Patients in the control group will be given an appointment schedule including their scheduled dates. Patients in the experimental group will have an exercise plan developed and will be given an appointment schedule including
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Kose, Ondokuz Mayıs University
- Investigators
- Aybike KÖSE, Principal investigator, Samsun Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328763
- Sponsor's protocol ID
- 2025/224
- Acronym
- Pranayama
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sample group participating in the study gave their consent for the information not to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pranayama Breathıng Exercıses on Paın, Anxıety,aAnd Sleep Qualıty in Indıvıduals wıth Fıbromyalgıa
- ClinicalTrials.gov ID
- NCT07328763
- Acronym / sponsor ID
- Pranayama / 2025/224
- Keywords
- Fibromyalgia, Nursing, Pranayama, Quality of Life, Anxiety, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
Individuals diagnosed with fibromyalgia syndrome have a low quality of life due to factors such as pain, sleep problems, high anxiety, depression and low self-esteem, difficulty performing daily living activities, and inhibited socialization (García-Martínez et al., 2012; Sieczkowska et al., 2020). Nurses apply care with a holistic approach philosophy that includes supportive, preventive, therapeutic, and rehabilitative aspects to promote and maintain health. Pranayama is an effective, non-invasive, cost-effective, and easily applicable approach that can be implemented within the framework of holistic care (İlter \& Ovayolu, 2021). It is the nurse's responsibility to provide care and create a comfortable environment for patients, improving their quality of life (Aktaş \& İlgin, 2023). In this regard, during the application and teaching of breathing exercises, nurses should carefully assess patients' belief in these exercises. They should plan with the patient the appropriate time, duration, and environment for breathing exercises and be able to evaluate the results (ÖZ, 2020). Studies evaluating the results of applying pranayama to individuals with fibromyalgia are limited in the literature. Therefore, it is thought that pranayama could greatly facilitate and provide concrete data on improving the quality of life for individuals with fibromyalgia by reducing pain, sleep problems, anxiety, and improving functionality.
Detailed description
Fibromyalgia syndrome (FMS) is a rheumatological syndrome characterized by symptoms such as increased pain sensitivity, sleep disturbances, fatigue, musculoskeletal pain, stiffness, tenderness, cognitive dysfunction, and mood disorders due to dysregulation of neurophysiological functions (Singh \& Rao, 2023; Verma et al., 2020). The incidence of FMS in the general population is reported to be 2-8%, predominantly affecting women (between 61% and 90%), with a male/female ratio of 2.3 (Galvez-Sánchez et al., 2019; Jones et al., 2015; Schmidt-Wilcke \& Diers, 2017). Although there are insufficient prevalence studies in Turkey, a study conducted in the Trabzon region found the prevalence of FMS to be 3.6% in women aged 20-64 and 0.9% in women aged 20-29 (Topbas et al., 2005).
The American College of Rheumatology (ACR) first defined the FM Diagnostic Criteria in 1990, and these criteria were revised in 2010, 2011, and 2016 (Plesner \& Vaegter, 2018). While there is no definitive treatment method, pharmacological and non-pharmacological treatment methods are applied. Non-pharmacological treatments include acupuncture, biofeedback, capsaicin, chiropractic, cognitive behavioral therapy, exercise, hydrotherapy, spa therapy, massage, meditative movement (Qigong, yoga, and Tai Chi), mindfulness/mind-body therapy, multicomponent therapy, and S-adenyl methionine. In addition, methods such as physical therapy, stretching, strengthening, aerobic exercise, and endurance training are also used (Chitra et al., 2017; Prabhakar et al., 2019).
Fibromyalgia is a common disease associated with numerous comorbidities and is often difficult to diagnose, which can have a devastating impact on quality of life, impair patients' abilities, lead to social and psychological problems for patients, and create a significant socioeconomic burden on healthcare systems (Atahan et al., 2023; Kang et al., 2022).
Fibromyalgia presents with chronic pain without any apparent peripheral tissue damage. This pain results from threatening tissue damage that activates peripheral nociceptors without real or definitive evidence (Ruschak et al., 2023). The pain is characterized by morning stiffness and increasing intensity throughout the day, is anatomically widespread, and is accompanied by hyperexcitability with increased response of the central nervous system to various stimuli (pressure, temperature, light, and medication, etc.). It is characterized by hyperalgesia, allodynia, and features reflected in multiple spinal segments (Araya-Quintanilla et al., 2020).
Patients with FM syndrome may experience emotionally impactful situations in the form of high levels of stress, anger, and catastrophic scenario-based pain, and these situations can worsen existing symptoms (Galvez-Sánchez et al., 2019). Studies have reported that a significant proportion of FM patients experience depression, panic disorder, and anxiety disorder (Basar et al., 2023; Siracusa et al., 2021). It is thought that the cognitive and psychological processes experienced by patients are related to pain (Cetingok et al., 2022). One study reported that FS patients were more likely to experience depression (20%-80%) and anxiety (13%-63.8%) (Henao-Pérez et al., 2022). A meta-analysis study suggested that the lifetime prevalence of depression in fibromyalgia is approximately 65% (Galvez-Sánchez et al., 2020).
Sleep problems are one of the factors triggered by pain and impairing quality of life in individuals diagnosed with fibromyalgia (FS) (Choy, 2015; Keskindag \& Karaaziz, 2017). One study reported that poor sleep quality was perceived as a serious symptom in patients diagnosed with FS, negatively impacting multiple health-related symptoms such as pain, fatigue, cognitive complaints, poor functionality, and low work performance (Climent-Sanz et al., 2020). Another study found that compared to healthy individuals, individuals diagnosed with FS had significantly higher numbers of awakenings, awakening index, and sleep apnea syndrome, and poor sleep quality (Çetin et al., 2020). Pranayama involves the control of breath, a dynamic bridge between body and mind. In Sanskrit, "Pranayama" is a combination of the words "Prana" and "ayama." Prana means breath, vitality, life, and energy, while ayama means restriction, control, or regulation. Pranayama can be described as 'the science of breath, breath control, willful breathing' (İlter \& Ovayolu, 2021). The breathing cycle in pranayama consists of three stages: Puraka (inspiration), Rechaka (expiration), and Kumbhaka (inhalation and holding the breath after inhalation) (İyengar, 2022).
Recent studies have shown that pranayama, by providing body and mind control, contributes to the improvement of many symptoms of fibromyalgia (Singh \& Rao, 2023). Pranayama has been reported to significantly improve the management of many symptoms of fibromyalgia, including pain intensity, stiffness, anxiety, stress, low muscle strength, fatigue, sleep problems, as well as flexibility and cognition, and to improve quality of life (Chitra et al., 2017; Firestone et al., 2014; Hennard, 2011; Lazaridou et al., 2019; Verma et al., 2020). This research was designed as a pre-test-post-test, randomized controlled, experimental study to determine the effects of pranayama breathing exercises on pain, anxiety, sleep quality, and overall health status in individuals with fibromyalgia.
Research Objectives and Hypotheses This research was planned to determine the effects of pranayama breathing exercises applied to individuals with fibromyalgia on pain, anxiety, sleep quality, and health status.
H1: Pranayama breathing exercises applied to individuals with fibromyalgia have an effect on pain. H2: Pranayama breathing exercises applied to individuals with fibromyalgia have an effect on anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study used block randomization. Block randomization was performed by an independent researcher. In the randomization, two different groups were coded with different letters (A, B) and blocks were formed. Then, random numbers were assigned to the blocks using a computer. The letters assigned in the randomization were written in sealed envelopes and kept. After identifying patients who met the inclusion criteria, informed consent was obtained, pre-tests were administered, and then the independent researcher was contacted to determine which group the patient belonged to. Patients diagnosed with fibromyalgia who present to the polyclinic will be referred to the researcher. Before starting the study, informed consent will be obtained from the participating patients. Patients in the control group will be given an appointment schedule including their scheduled dates. Patients in the experimental group will have an exercise plan developed and will be given an appointment schedule including
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will be given an appointment schedule containing their scheduled interview dates. |
| Pranayama | Experimental | Other: Pranayama breathing exercisesPranayama breathing exercises will be taught online for 20 minutes, twice a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals aged 18 and over,
- having experienced pain for at least three months,
- diagnosed with fibromyalgia by a physician according to the ACR 2016
- romyalgia diagnostic criteria,
- having a PUKI score of five or higher,
Key exclusion criteria (4 listed)
- Individuals with a history of respiratory diseases such as malignancy or tuberculosis,
- those with a psychiatric diagnosis,
- those with nasal obstruction due to septal deviation,
- and those who have previously participated in a similar breathing exercise program will be excluded from 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 |
|---|---|---|
| Pranayama breathing exercisesStep 1: Normal breathing, focusing on the breath Step 2: Sun Breath (Surya Prana) Step 3: Alternate Nose Breathing (Nadi Shodhana) Step 4: Ocean Breath (Ujiayi) Step 5: Normal breathing, focusing on the breath | Other | Pranayama |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6 Weeks
To indicate the severity of your pain, place an (I) mark on one of the lines below. 0 points: no pain, 1-2 points: very mild pain, 3-4 points: mild pain, 5-6 points: moderate pain, 7-8 points: severe pain, 9-10 points: very severe pain.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 Weeks
questions only relate to habits from the past month.
Beck Anxiety Scale (BAS)
Time frame: 6 Weeks
Some symptoms that people experience when they are anxious or worried.
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 6 Weeks
Severity of fibromyalgia symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. The sample group participating in the study gave their consent for the information not to be shared.
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Effects of and Exploring the Processes of Free Movement Dance as a Physical Therapy Intervention for Female Patients Diagnosed With Chronic Widespread Pain (Including Fibromyalgia).
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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.
Aybike KÖSE principal investigator
Samsun Provincial Health Directorate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pranayama breathing exercises in people with Patients Diagnosed With Fibromyalgia Syndrome, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 8 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) (time frame: 6 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 9 Jan 2026.