DysmenorrheaNCT06011928
MOPEXE and RE in Treating Dysmenorrhea
A study testing MOPEX Exercise, Relaxation Exercise and Combine Exercise in people with Dysmenorrhea and Gynecologic Disease, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Dysmenorrhea, Gynecologic Disease
- What is being tested?
- MOPEX Exercise, Relaxation Exercise and Combine Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Nov 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having a normal menstrual cycle (24-35 days),
- never having given birth
- According to the Visual Analogue Scale (VAS), the pain level during the menstruation period is 10.
- to give a score of 5 or more out of cooperative and oriented
- Volunteer to participate in the study.
Who cannot join
- Having an active sexual life
- Receiving psychiatric treatment for stress disorder or anxiety, using birth control pills,
- Those with irregular menstrual cycles (less than 21 days or longer than 35 days)
- those with a menstrual cycle period),
- undergoing any gynecological surgery,
- A mental, cardiovascular, pulmonary, or orthopedic disorder that may interfere with exercise have a disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Motor Imagery Focused Pelvic Floor Exercises And Relaxation Exercises For Treating Dysmenorrhea: A Randomized Controlled Study
The aim of this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms.
Read the detailed description
Quantitative research methods were used in the study and it was a randomized type study. The sample of the study consisted of women between the ages of 18-30 who volunteered to participate in the study, showed symptoms of dysmenorrhea and can be accessed online. The names of female participants who volunteered to participate in the study and met the inclusion criteria were written on papers and put in a bag. Papers will be randomly selected by the evaluator by drawing lots. Participants will be randomly divided into 3 groups: motor imagery focused pelvic floor exercise group, relaxation exercise group, and combined group. Among the participants who agreed to participate in the study, the sociodemographic and menstrual characteristics information form and the Visual Analogue Scale value of 5 and above on the day when the menstrual cycle is most severe were included in the study, and the McGill Pain Questionnaire-Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) they will be asked to fill in. After the groups are formed, video home exercise programs will be delivered online (whatsApp, mail, etc.) to the participants. Individuals will be asked to apply the created video home exercise program individually in their own environment. Before the participants start their exercise programs, exercise programs will be taught by online interview. You will be asked to do the exercises for 8 weeks, 3 days a week. After the 8-week exercise program is over, the participants will be asked to fill in the McGill Pain Questionnaire- Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) on the day when the menstrual pain is most severe. Pre- and post-intervention data were statistically analyzed and compared.
- Conditions
- Dysmenorrhea, Gynecologic Disease
- Being tested
- MOPEX Exercise, Relaxation Exercise, Combine Exercise
- Keywords
- Dysmenorrhea, Menstrual symptom, Imagination, Relaxation, Pelvic floor exercises, exercise
- Medical subject headings
- Dysmenorrhea, Genital Diseases, Female, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOPEX ExerciseOther
Exercises to be done in order:
- Pelvic tilt in supine position
- Bridge building
- Pelvic stretching
- Ball spin
- Cat-camel exercise
Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds
Relaxation ExerciseOther
Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened.
Combine ExerciseOther
Exercises to be done in order:
Pelvic tilt in supine position Bridge building Pelvic stretching Ball spin Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds.
Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery focused pelvic floor exercise (MOPEXE) | Active comparator | Internal imagery technique, one of the imagery techniques, will be applied to the participants.
Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. Receives: Other: MOPEX Exercise |
| Relaxation exercise (RE) group | Active comparator | One of the relaxation methods, Progressive Relaxation Exercises will be used.Exercises will be required to be applied 3 days a week, as 1 set of 10 repetitions per day. Receives: Other: Relaxation Exercise |
| Combined exercise group (CEG) | Active comparator | With the video home exercise program, the participants performed progressive relaxation exercises, respectively. then they will be provided with motor imagery focused pelvic floor exercises. A rest period of 5 minutes will be applied between two different exercise programs. Receives: Other: Combine Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The VAS was used on the most severe day of the menstrual cycle to determine the severity of pain, which is one of the inclusion criteria of the participants before starting the study. Subjects were asked to mark the degree of pain they felt on a straight line of 100 millimeters (mm). A 0 at the beginning means no pain and a maximum of 10 at the end of the line means unbearable pain. The point determined on the line expresses the intensity of pain that people feel during menstruation.
Measured: 10 weeks
McGill pain questionnaire- short form
It is a questionnaire used to describe the severity and quality of the pain that a person feels during menstruation. A high score indicates a high level of pain. The questionnaire consists of three parts. In the first part, there are 15 descriptive word groups, 11 of which are to evaluate the emotional/perceptual dimension of pain and 4 to evaluate the emotional/emotional dimension of pain. Words are rated from 0 to 3 (0= None at all, 1= Mild, 2=Moderate, 3= Severe). In the first part, three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Pain quality scores are obtained with sensory/perceptual 0-33 points, emotional/emotional 0-12 points, and a total of 0-45 points. The second part is the display of the pain intensity of his work on a scale. A low value indicates a low level of pain, and a high value indicates severe. The third section has five word groups ranging from 'mild pain' to 'unbearable pain' to describe one's pain.
Measured: 10 weeks
Menstruation attitude scale (MBI)
It is used to evaluate the positive / negative aspects of menstruation. The scale is a Likert-type scale consisting of 33 items and five subscales. The subscales and the items of the subscales are as follows:
- Menstruation as a debilitating phenomenon (12 items),
- Menstruation as a disturbing phenomenon (6 items),
- Menstruation as a natural phenomenon (5 items),
- Noticing/anticipating that menstruation will occur (5 items),
- Denial of the effects of menstruation (7 items) The scale is evaluated by scoring between 1 and 7, and the Turkish form has been converted into scoring between 1 and 5. Participants are asked to mark the most appropriate option (1. Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Totally agree).
Measured: 10 weeks
Functional and emotional dysmenorrhea scale (FEDS)
Evaluates dysmenorrhea functionally and emotionally. It consists of 14 items and 2 sub-dimensions. In the scale, each item is scored between 1 and 5 (1. Not at all similar to my situation, 2. Not similar to my situation, 3. Similar or not similar to my situation, 4. Considered similar to my situation, 5. Very similar to my situation). The presence of a high score indicates that the level of functional and emotional impact of dysmenorrhea is high.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Selda KOÇOĞLU, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011928
- Sponsor's protocol ID
- UskudarU65
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
PubMed 34383437Boztas Elverisli G, Armagan N, Atilgan E. Comparison of the efficacy of pharmacological and nonpharmacological treatments in women with primary dysmenorrhea: randomized controlled parallel-group study. Ginekol Pol. 2023;94(9):687-697. doi: 10.5603/GP.a2022.0009. Epub 2022 Apr 14.
PubMed 35419791Daley AJ. Exercise and primary dysmenorrhoea : a comprehensive and critical review of the literature. Sports Med. 2008;38(8):659-70. doi: 10.2165/00007256-200838080-00004.
PubMed 18620466Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.
PubMed 31538328Fuentes-Aparicio L, Cuenca-Martinez F, Munoz-Gomez E, Molla-Casanova S, Aguilar-Rodriguez M, Sempere-Rubio N. Effects of therapeutic exercise in primary dysmenorrhea: an umbrella and mapping review. Pain Med. 2023 Dec 1;24(12):1386-1395. doi: 10.1093/pm/pnad104.
PubMed 37555833Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
PubMed 34360122
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Motor Imagery Focused Pelvic Floor Exercises And Relaxation Exercises For Treating Dysmenorrhea: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06011928
- Acronym / sponsor ID
- UskudarU65
- Conditions
- Dysmenorrhea, Gynecologic Disease
- Keywords
- Dysmenorrhea, Menstrual symptom, Imagination, Relaxation, Pelvic floor exercises, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 25 Aug 2023 (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 this study is to compare the effects of motor imagery focused pelvic floor exercises and relaxation exercises used in the treatment of dysmenorrhea on pain and menstrual symptoms.
Detailed description
Quantitative research methods were used in the study and it was a randomized type study. The sample of the study consisted of women between the ages of 18-30 who volunteered to participate in the study, showed symptoms of dysmenorrhea and can be accessed online. The names of female participants who volunteered to participate in the study and met the inclusion criteria were written on papers and put in a bag. Papers will be randomly selected by the evaluator by drawing lots. Participants will be randomly divided into 3 groups: motor imagery focused pelvic floor exercise group, relaxation exercise group, and combined group. Among the participants who agreed to participate in the study, the sociodemographic and menstrual characteristics information form and the Visual Analogue Scale value of 5 and above on the day when the menstrual cycle is most severe were included in the study, and the McGill Pain Questionnaire-Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) they will be asked to fill in. After the groups are formed, video home exercise programs will be delivered online (whatsApp, mail, etc.) to the participants. Individuals will be asked to apply the created video home exercise program individually in their own environment. Before the participants start their exercise programs, exercise programs will be taught by online interview. You will be asked to do the exercises for 8 weeks, 3 days a week. After the 8-week exercise program is over, the participants will be asked to fill in the McGill Pain Questionnaire- Short Form, Menstruation Attitude Scale (MBI), Functional and Emotional Dysmenorrhea Scale (FEDS) on the day when the menstrual pain is most severe. Pre- and post-intervention data were statistically analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor imagery focused pelvic floor exercise (MOPEXE) | Active comparator | Other: MOPEX ExerciseInternal imagery technique, one of the imagery techniques, will be applied to the participants. Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. |
| Relaxation exercise (RE) group | Active comparator | Other: Relaxation ExerciseOne of the relaxation methods, Progressive Relaxation Exercises will be used.Exercises will be required to be applied 3 days a week, as 1 set of 10 repetitions per day. |
| Combined exercise group (CEG) | Active comparator | Other: Combine ExerciseWith the video home exercise program, the participants performed progressive relaxation exercises, respectively. then they will be provided with motor imagery focused pelvic floor exercises. A rest period of 5 minutes will be applied between two different exercise programs. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having a normal menstrual cycle (24-35 days),
- never having given birth
- According to the Visual Analogue Scale (VAS), the pain level during the menstruation period is 10.
- to give a score of 5 or more out of cooperative and oriented
- Volunteer to participate in the study.
Key exclusion criteria (6 listed)
- Having an active sexual life
- Receiving psychiatric treatment for stress disorder or anxiety, using birth control pills,
- Those with irregular menstrual cycles (less than 21 days or longer than 35 days)
- those with a menstrual cycle period),
- undergoing any gynecological surgery,
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 |
|---|---|---|
| MOPEX ExerciseExercises to be done in order: 1. Pelvic tilt in supine position 2. Bridge building 3. Pelvic stretching 4. Ball spin 5. Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds | Other | Motor imagery focused pelvic floor exercise (MOPEXE) |
| Relaxation ExerciseProgressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened. | Other | Relaxation exercise (RE) group |
| Combine ExerciseExercises to be done in order: Pelvic tilt in supine position Bridge building Pelvic stretching Ball spin Cat-camel exercise Exercise program 8 weeks, 3 days a week, 3 sets of 10 repetitions of each movement and between sets It is planned to rest for 10 seconds. Progressive muscle relaxation exercises, respectively, facial muscles, neck and shoulders, right-left arm, right-left hand, back muscles, chest muscles, abdominal muscles, hip, right-left leg, right-left foot muscles are contracted while breathing deeply and slowly, and relaxing when exhaling. will be displayed. Each muscle is contracted for 5 seconds and relaxed for 10 seconds. will be held. Before moving on to the new muscle group in intermuscular contraction and relaxation, several times in between Slow and deep breathing will be practiced. After all the muscles are contracted and relaxed in sequence, Then, while inhaling, all the muscles contract simultaneously and while exhaling, will be loosened. | Other | Combined exercise group (CEG) |
Primary outcome
Visual Analogue Scale
Time frame: 10 weeks
The VAS was used on the most severe day of the menstrual cycle to determine the severity of pain, which is one of the inclusion criteria of the participants before starting the study. Subjects were asked to mark the degree of pain they felt on a straight line of 100 millimeters (mm). A 0 at the beginning means no pain and a maximum of 10 at the end of the line means unbearable pain. The point determined on the line expresses the intensity of pain that people feel during menstruation.
McGill pain questionnaire- short form
Time frame: 10 weeks
It is a questionnaire used to describe the severity and quality of the pain that a person feels during menstruation. A high score indicates a high level of pain. The questionnaire consists of three parts. In the first part, there are 15 descriptive word groups, 11 of which are to evaluate the emotional/perceptual dimension of pain and 4 to evaluate the emotional/emotional dimension of pain. Words are rated from 0 to 3 (0= None at all, 1= Mild, 2=Moderate, 3= Severe). In the first part, three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Pain quality scores are obtained with sensory/perceptual 0-33 points, emotional/emotional 0-12 points, and a total of 0-45 points. The second part is the display of the pain intensity of his work on a scale. A low value indicates a low level of pain, and a high value indicates severe. The third section has five word groups ranging from 'mild pain' to 'unbearable pain' to describe one's pain.
Menstruation attitude scale (MBI)
Time frame: 10 weeks
It is used to evaluate the positive / negative aspects of menstruation. The scale is a Likert-type scale consisting of 33 items and five subscales. The subscales and the items of the subscales are as follows: * Menstruation as a debilitating phenomenon (12 items), * Menstruation as a disturbing phenomenon (6 items), * Menstruation as a natural phenomenon (5 items), * Noticing/anticipating that menstruation will occur (5 items), * Denial of the effects of menstruation (7 items) The scale is evaluated by scoring between 1 and 7, and the Turkish form has been converted into scoring between 1 and 5. Participants are asked to mark the most appropriate option (1. Strongly disagree, 2. Disagree, 3. Undecided, 4. Agree, 5. Totally agree).
Functional and emotional dysmenorrhea scale (FEDS)
Time frame: 10 weeks
Evaluates dysmenorrhea functionally and emotionally. It consists of 14 items and 2 sub-dimensions. In the scale, each item is scored between 1 and 5 (1. Not at all similar to my situation, 2. Not similar to my situation, 3. Similar or not similar to my situation, 4. Considered similar to my situation, 5. Very similar to my situation). The presence of a high score indicates that the level of functional and emotional impact of dysmenorrhea is high.
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 Nov 2023.
- Background: PubMed 34383437McKenna KA, Fogleman CD. Dysmenorrhea. Am Fam Physician. 2021 Aug 1;104(2):164-170.
- Background: PubMed 35419791Boztas Elverisli G, Armagan N, Atilgan E. Comparison of the efficacy of pharmacological and nonpharmacological treatments in women with primary dysmenorrhea: randomized controlled parallel-group study. Ginekol Pol. 2023;94(9):687-697. doi: 10.5603/GP.a2022.0009. Epub 2022 Apr 14.
- Background: PubMed 18620466Daley AJ. Exercise and primary dysmenorrhoea : a comprehensive and critical review of the literature. Sports Med. 2008;38(8):659-70. doi: 10.2165/00007256-200838080-00004.
- Background: PubMed 31538328Armour M, Ee CC, Naidoo D, Ayati Z, Chalmers KJ, Steel KA, de Manincor MJ, Delshad E. Exercise for dysmenorrhoea. Cochrane Database Syst Rev. 2019 Sep 20;9(9):CD004142. doi: 10.1002/14651858.CD004142.pub4.
- Background: PubMed 37555833Fuentes-Aparicio L, Cuenca-Martinez F, Munoz-Gomez E, Molla-Casanova S, Aguilar-Rodriguez M, Sempere-Rubio N. Effects of therapeutic exercise in primary dysmenorrhea: an umbrella and mapping review. Pain Med. 2023 Dec 1;24(12):1386-1395. doi: 10.1093/pm/pnad104.
- Background: PubMed 34360122Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.
- 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.
Selda KOÇOĞLU study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOPEX Exercise, Relaxation Exercise and Combine Exercise in people with Dysmenorrhea and Gynecologic Disease, run by Uskudar 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 5 inclusion and 6 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 Nov 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 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?
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?
Visual Analogue Scale (time frame: 10 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?
On the ClinicalTrials.gov record for NCT06011928, which also lists 6 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 Nov 2023.