LipedemaNCT05329324
Is The Pain in Lipedema Patients Neuropathic Pain?
An observational study of Lipedema, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Lipedema is a chronic progressive disease characterized by abnormal increase of subcutaneous adipose tissue. It is characterized by bilateral enlargement of the lower and/or upper extremities, typically sparing the hands and feet. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lipedema
- What is being tested?
- Questionnaire for study group
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2022to 1 Jun 2023
- Phase
- Observational
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 42 patients will be included to study who apply to the outpatient clinic of Dokuz Eylul University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, and who are diagnosed or followed up with the diagnosis of lipoedema, aged between 18- 65 years. For the control group, 42 patients who had shoulder pain for less than 3 months and is diagnosed with acute subacromial impingement will be included as the nociceptive pain model.
Who may be able to join
- Ages between 18-65
- Diagnosed with lipoedema
- Those who agreed to participate in the study
- To be at the appropriate sociocultural level to participate in the study
- For the control group, the patient has a diagnosis of acute subacromial impingement syndrome
Who cannot join
- Having type 1 or type 2 diabetes
- Patients with uncontrolled thyroid dysfunction
- Patients with chronic venous insufficiency and/or lymphedema
- Patients with acute or chronic renal failure
- Heart failure
- Having cancer or continuing cancer treatment
Show all 12Show fewer
- Diagnosed with polyneuropathy
- Those with radiculopathy
- Patients with advanced degenerative joint disease in the affected extremity
- Those who have received antiepileptic, antidepressant medication in the last 6 months
- Persons with visual and hearing impairments that impair adaptation to work
- Patients who are illiterate and have cognitive impairment that will prevent them from giving written consent will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Neuropathic Pain in Lipedema
Lipedema is a chronic progressive disease characterized by abnormal increase of subcutaneous adipose tissue. It is characterized by bilateral enlargement of the lower and/or upper extremities, typically sparing the hands and feet. This disease, which almost always affects women, has rarely been described in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although the results vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women are affected by this disease. Although it is a common disease, it can often be missed in daily practice. Therefore, it is very important to define the disease clinic well. Lipedema usually presents with swelling in the bilateral extremities. It begins in the post-adolescent period and is progressive. It does not respond to diet and exercise, does not improve with elevation, is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. In early lipedema, pain may be the main complaint in the extremities before the development of skin findings. Because of the absence of a defined clear pain pattern in these patients, diagnosis can be missed and confused with other diseases. In addition, it causes limitations in treatment of the pain. Adipose tissue can cause nociceptive and neuropathic pain because it contains both nociceptive neurons and neural innervation. It isn't known whether lipedema pain is of nociceptive or neuropathic origin. In different studies, the pain pattern is defined in different ways such as hyperalgesia, allodynia, spontaneous pain, blunt, heaviness, pressure, tearing, stabbing, severe and unbearable. In this study, the investigators aim to determine if the pain characteristics of patients with lipedema is neuropathic or not and to define the pain characteristics better in order to ensure earlier recognition and treatment of pain.
Read the detailed description
This study is a descriptive cross-sectional study. 42 patients will be included to study who apply to the outpatient clinic of Dokuz Eylul University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, and who are diagnosed or followed up with the diagnosis of lipoedema, aged between 18- 65 years. For the control group, 42 patients who had shoulder pain for less than 3 months and is diagnosed with acute subacromial impingement will be included as the nociceptive pain model. The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics, the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients. LANSS Pain Scale is an evaluation form that helps to understand whether the nerves carrying pain signals are working normally, and it consists of two parts, including a pain questionnaire and a sensory evaluation. As a result of the calculation made according to answers, a score above 12 is associated with the presence of neuropathic pain. Pain Detect Questionnaire consists of questions about characteristics, severity and spread of the pain, and it provides the opportunity to score with 5 options as none, very mild, mild, moderate, severe, very severe. This survey, which consists of 38 points in total; in the presence of above 19 points, the neuropathic pain component is interpreted as possible. Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life. Hospital Anxiety and Depression Scale consists of 14 questions about anxiety and depression and 4 options for each question. According to the results, 0-7 points were interpreted as normal, 8-10 points were considered borderline, and 11 points and above were interpreted as abnormal. According to results of questionnaires, the datas will be compared with statistical analysis. As a result, the investigators aim to say that lipedema pain is or is not a neurpathic pain.
- Conditions
- Lipedema
- Being tested
- Questionnaire for study group, Questionnaire for control group
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire for study groupOther
Demographic features, Stage and Type, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients.
Questionnaire for control groupOther
Demographic features, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients.
| Study group | Role | What they receive |
|---|---|---|
| Study Group - Lipedema | Questionnaire for study group Receives: Other: Questionnaire for study group | |
| Control Group - Acute Subacromial Impingement | Questionnaire for control group Receives: Other: Questionnaire for control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
LANSS Pain Scale
LANSS Pain Scale is an evaluation form that helps to understand whether the nerves carrying pain signals are working normally, and it consists of two parts, including a pain questionnaire and a sensory evaluation. As a result of the calculation made according to answers, a score above 12 is associated with the presence of neuropathic pain.
Measured: Baseline
Pain Detect Questionnaire
Pain Detect Questionnaire consists of questions about characteristics, severity and spread of the pain, and it provides the opportunity to score with 5 options as none, very mild, mild, moderate, severe, very severe. This survey, which consists of 38 points in total; in the presence of above 19 points, the neuropathic pain component is interpreted as possible
Measured: Baseline
Secondary outcomes (2)
Nottingham Health Profile
Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life
Measured: Baseline
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale consists of 14 questions about anxiety and depression and 4 options for each question. According to the results, 0-7 points were interpreted as normal, 8-10 points were considered borderline, and 11 points and above were interpreted as abnormal
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start20 Apr 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan ERDINC GUNDUZ, Dokuz Eylul University
- Investigators
- Ebru sahin, MD, Study director, Dokuz EU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329324
- Sponsor's protocol ID
- İzellipodemTez
- Status last verified
- Aug 2024
- First submitted
- 4 Apr 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
PubMed 14830102Akçalı Y, Atabey R. Lipödem ve Lipolenfödem: Tanı ve Tedavi, Türkiye Klinikleri J Cardiovasc Surg-Special Topics. 2018; 10:56-72
Herbst KL, Mirkovskaya L, Bharhagava A, Chava Y, T. Te CH. Lipedema Fat and Signs and Symptoms of Illness, Increase with Advencing Stage, Archives of Medicine. 2015; 7:1-8
Torre YS, Wadeea R, Rosas V, Herbst KL. Lipedema: friend and foe. Horm Mol Biol Clin Investig. 2018 Mar 9;33(1):/j/hmbci.2018.33.issue-1/hmbci-2017-0076/hmbci-2017-0076.xml. doi: 10.1515/hmbci-2017-0076.
PubMed 29522416Child AH, Gordon KD, Sharpe P, Brice G, Ostergaard P, Jeffery S, Mortimer PS. Lipedema: an inherited condition. Am J Med Genet A. 2010 Apr;152A(4):970-6. doi: 10.1002/ajmg.a.33313.
PubMed 20358611Szel E, Kemeny L, Groma G, Szolnoky G. Pathophysiological dilemmas of lipedema. Med Hypotheses. 2014 Nov;83(5):599-606. doi: 10.1016/j.mehy.2014.08.011. Epub 2014 Aug 23.
PubMed 25200646Ayhan FF. Lipödem: Klinik Tanı, Evreleme, Tiplendirme, Değerlendirme ve Tanı Kriterleri.Tanıdan Tedaviye Lipödem Sağlık Profesyonelleri İçin Rehber Kitap. Borman P, Dalyan M, Figen Ayhan FF eds. Hipokrat Kitabevi, Ankara 2019:17-34
Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12.
PubMed 33001552Angst F, Benz T, Lehmann S, Sandor P, Wagner S. Common and Contrasting Characteristics of the Chronic Soft-Tissue Pain Conditions Fibromyalgia and Lipedema. J Pain Res. 2021 Sep 17;14:2931-2941. doi: 10.2147/JPR.S315736. eCollection 2021.
PubMed 34557035Shavit E, Wollina U, Alavi A. Lipoedema is not lymphoedema: A review of current literature. Int Wound J. 2018 Dec;15(6):921-928. doi: 10.1111/iwj.12949. Epub 2018 Jun 29.
PubMed 29956468Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. doi: 10.1016/j.jpain.2004.07.001.
PubMed 15501424Alkan H, Ardic F, Erdogan C, Sahin F, Sarsan A, Findikoglu G. Turkish version of the painDETECT questionnaire in the assessment of neuropathic pain: a validity and reliability study. Pain Med. 2013 Dec;14(12):1933-43. doi: 10.1111/pme.12222. Epub 2013 Aug 7.
PubMed 23924395Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.
PubMed 10826123Ömer A, Güvenir T, Küey, L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeği Türkçe Formunun Geçerlilik ve Güvenilirlik Çalışması. Türk Psikiyatri Dergisi. 1997; 8: 280- 287.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neuropathic Pain in Lipedema
- ClinicalTrials.gov ID
- NCT05329324
- Acronym / sponsor ID
- İzellipodemTez
- Conditions
- Lipedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipedema is a chronic progressive disease characterized by abnormal increase of subcutaneous adipose tissue. It is characterized by bilateral enlargement of the lower and/or upper extremities, typically sparing the hands and feet. This disease, which almost always affects women, has rarely been described in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although the results vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women are affected by this disease. Although it is a common disease, it can often be missed in daily practice. Therefore, it is very important to define the disease clinic well. Lipedema usually presents with swelling in the bilateral extremities. It begins in the post-adolescent period and is progressive. It does not respond to diet and exercise, does not improve with elevation, is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. In early lipedema, pain may be the main complaint in the extremities before the development of skin findings. Because of the absence of a defined clear pain pattern in these patients, diagnosis can be missed and confused with other diseases. In addition, it causes limitations in treatment of the pain. Adipose tissue can cause nociceptive and neuropathic pain because it contains both nociceptive neurons and neural innervation. It isn't known whether lipedema pain is of nociceptive or neuropathic origin. In different studies, the pain pattern is defined in different ways such as hyperalgesia, allodynia, spontaneous pain, blunt, heaviness, pressure, tearing, stabbing, severe and unbearable. In this study, the investigators aim to determine if the pain characteristics of patients with lipedema is neuropathic or not and to define the pain characteristics better in order to ensure earlier recognition and treatment of pain.
Detailed description
This study is a descriptive cross-sectional study. 42 patients will be included to study who apply to the outpatient clinic of Dokuz Eylul University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, and who are diagnosed or followed up with the diagnosis of lipoedema, aged between 18- 65 years. For the control group, 42 patients who had shoulder pain for less than 3 months and is diagnosed with acute subacromial impingement will be included as the nociceptive pain model. The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics, the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients. LANSS Pain Scale is an evaluation form that helps to understand whether the nerves carrying pain signals are working normally, and it consists of two parts, including a pain questionnaire and a sensory evaluation. As a result of the calculation made according to answers, a score above 12 is associated with the presence of neuropathic pain. Pain Detect Questionnaire consists of questions about characteristics, severity and spread of the pain, and it provides the opportunity to score with 5 options as none, very mild, mild, moderate, severe, very severe. This survey, which consists of 38 points in total; in the presence of above 19 points, the neuropathic pain component is interpreted as possible. Nottingham Health Profile consists of 6 sections and a total of 38 questions evaluating patients' pain, emotional reaction, sleep, social isolation, physical activity and energy. In this questionnaire, where the highest score is 600 points, a high score is associated with a deterioration in quality of life. Hospital Anxiety and Depression Scale consists of 14 questions about anxiety and depression and 4 options for each question. According to the results, 0-7 points were interpreted as normal, 8-10 points were considered borderline, and 11 points and above were interpreted as abnormal. According to results of questionnaires, the datas will be compared with statistical analysis. As a result, the investigators aim to say that lipedema pain is or is not a neurpathic pain.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group - Lipedema | – | Other: Questionnaire for study groupQuestionnaire for study group |
| Control Group - Acute Subacromial Impingement | – | Other: Questionnaire for control groupQuestionnaire for control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 42 patients will be included to study who apply to the outpatient clinic of Dokuz Eylul University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, and who are diagnosed or followed up with the diagnosis of lipoedema, aged between 18- 65 years. For the control group, 42 patients who had shoulder pain for less than 3 months and is diagnosed with acute subacromial impingement will be included as the nociceptive pain model.
Key inclusion criteria (5 listed)
- Ages between 18-65
- Diagnosed with lipoedema
- Those who agreed to participate in the study
- To be at the appropriate sociocultural level to participate in the study
- For the control group, the patient has a diagnosis of acute subacromial impingement syndrome
Key exclusion criteria (12 listed)
- Having type 1 or type 2 diabetes
- Patients with uncontrolled thyroid dysfunction
- Patients with chronic venous insufficiency and/or lymphedema
- Patients with acute or chronic renal failure
- Heart failure
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 |
|---|---|---|
| Questionnaire for study groupDemographic features, Stage and Type, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients. | Other | Study Group - Lipedema |
| Questionnaire for control groupDemographic features, The LANSS Pain Scale and Pain Detect Questionnaire to assess patients' pain characteristics,the Nottingham Health Profile to assess quality of life, and the Hospital Anxiety and Depression Scale to detect the presence of depression and anxiety will be completed by patients. | Other | Control Group - Acute Subacromial Impingement |
Primary outcome
LANSS Pain Scale
Time frame: Baseline
LANSS Pain Scale is an evaluation form that helps to understand whether the nerves carrying pain signals are working normally, and it consists of two parts, including a pain questionnaire and a sensory evaluation. As a result of the calculation made according to answers, a score above 12 is associated with the presence of neuropathic pain.
Pain Detect Questionnaire
Time frame: Baseline
Pain Detect Questionnaire consists of questions about characteristics, severity and spread of the pain, and it provides the opportunity to score with 5 options as none, very mild, mild, moderate, severe, very severe. This survey, which consists of 38 points in total; in the presence of above 19 points, the neuropathic pain component is interpreted as possible
2 secondary outcomes
Nottingham Health Profile
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 14830102WOLD LE, HINES EA Jr, ALLEN EV. Lipedema of the legs; a syndrome characterized by fat legs and edema. Ann Intern Med. 1951 May;34(5):1243-50. doi: 10.7326/0003-4819-34-5-1243. No abstract available.
- BackgroundAkçalı Y, Atabey R. Lipödem ve Lipolenfödem: Tanı ve Tedavi, Türkiye Klinikleri J Cardiovasc Surg-Special Topics. 2018; 10:56-72
- BackgroundHerbst KL, Mirkovskaya L, Bharhagava A, Chava Y, T. Te CH. Lipedema Fat and Signs and Symptoms of Illness, Increase with Advencing Stage, Archives of Medicine. 2015; 7:1-8
- Background: PubMed 29522416Torre YS, Wadeea R, Rosas V, Herbst KL. Lipedema: friend and foe. Horm Mol Biol Clin Investig. 2018 Mar 9;33(1):/j/hmbci.2018.33.issue-1/hmbci-2017-0076/hmbci-2017-0076.xml. doi: 10.1515/hmbci-2017-0076.
- Background: PubMed 20358611Child AH, Gordon KD, Sharpe P, Brice G, Ostergaard P, Jeffery S, Mortimer PS. Lipedema: an inherited condition. Am J Med Genet A. 2010 Apr;152A(4):970-6. doi: 10.1002/ajmg.a.33313.
- Background: PubMed 25200646Szel E, Kemeny L, Groma G, Szolnoky G. Pathophysiological dilemmas of lipedema. Med Hypotheses. 2014 Nov;83(5):599-606. doi: 10.1016/j.mehy.2014.08.011. Epub 2014 Aug 23.
- BackgroundAyhan FF. Lipödem: Klinik Tanı, Evreleme, Tiplendirme, Değerlendirme ve Tanı Kriterleri.Tanıdan Tedaviye Lipödem Sağlık Profesyonelleri İçin Rehber Kitap. Borman P, Dalyan M, Figen Ayhan FF eds. Hipokrat Kitabevi, Ankara 2019:17-34
- Background: PubMed 33001552Aksoy H, Karadag AS, Wollina U. Cause and management of lipedema-associated pain. Dermatol Ther. 2021 Jan;34(1):e14364. doi: 10.1111/dth.14364. Epub 2020 Oct 12.
- Background: PubMed 34557035Angst F, Benz T, Lehmann S, Sandor P, Wagner S. Common and Contrasting Characteristics of the Chronic Soft-Tissue Pain Conditions Fibromyalgia and Lipedema. J Pain Res. 2021 Sep 17;14:2931-2941. doi: 10.2147/JPR.S315736. eCollection 2021.
- Background: PubMed 29956468Shavit E, Wollina U, Alavi A. Lipoedema is not lymphoedema: A review of current literature. Int Wound J. 2018 Dec;15(6):921-928. doi: 10.1111/iwj.12949. Epub 2018 Jun 29.
- Background: PubMed 15501424Yucel A, Senocak M, Kocasoy Orhan E, Cimen A, Ertas M. Results of the Leeds assessment of neuropathic symptoms and signs pain scale in Turkey: a validation study. J Pain. 2004 Oct;5(8):427-32. doi: 10.1016/j.jpain.2004.07.001.
- Background: PubMed 23924395Alkan H, Ardic F, Erdogan C, Sahin F, Sarsan A, Findikoglu G. Turkish version of the painDETECT questionnaire in the assessment of neuropathic pain: a validity and reliability study. Pain Med. 2013 Dec;14(12):1933-43. doi: 10.1111/pme.12222. Epub 2013 Aug 7.
- Individual participant dataSharing planned: Undecided
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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.
Ebru sahin, MD study director
Dokuz EU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Dokuz Eylul 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 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. 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?
LANSS Pain Scale (time frame: Baseline). The study lists 2 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 NCT05329324, which also lists 14 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 13 Aug 2024.