PainNCT03828877
The Effect of Acupuncture on the Treatment of Endovenous Ablation on Pain, IL17 and IL 23
A study testing Group A ( Group Acupuncture) in people with Pain and Interleukin, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world. Acupuncture continued to evolve and develop over the centuries, and gradually became one of the standard treatments used in China. Introduced to other regions such as Asia, Europe and the United States. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Interleukin, Vessels; Varicose
- What is being tested?
- Group A ( Group Acupuncture)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2019to 7 Mar 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers to participate in the study,
- 18-65 years of age,
- patients with a saphenous vein diameter greater than 5.5 mm
- small saphenous vein diameter of less than 4 mm with reflux for greater than 0.5 s
Who cannot join
- Patients outside the 18-65 age range,
- patients with deep venous system obstruction,
- patients who have previously used another invasive treatment method (thermal and chemical ablation, surgery),
- patients with heart and kidney failure,
- patients with secondary varicose veins,
- patients with hypercoagulable state patients,
Show all 10Show fewer
- patients with local or systemic infections,
- patients with obesity (body mass index> 35),
- patients with impaired consciousness,
- patients who do not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, Onikişubat, 251/A 46040
About this study
Official title: The Effect of Acupuncture on Pain, IL 17 and IL 23 in Endovenous Ablation; Prospective, Randomized, Controlled Study.
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world. Acupuncture continued to evolve and develop over the centuries, and gradually became one of the standard treatments used in China. Introduced to other regions such as Asia, Europe and the United States. The most extensive use of acupuncture is for pain relief. The aim of this study was to prevent complications due to pain frequently seen in patients who would be treated with endovenous ablation in the postoperative period. In addition, the effect of acupuncture on operative hemodynamics, pain, vascular diameter, postoperative, nausea, vomiting, pain and analgesic needs, IL17 and IL 23.
Read the detailed description
Patients will be divided into two groups. Control group (Group C, n: 35) and Acupuncture group (Group A, n: 35). Inclusion criteria: willing to participate in the study, being in the 18-65 age range, a saphenous vein diameter greater than 5.5 mm and a small saphenous vein diameter of less than 4 mm with reflux for greater than 0.5 s The patients with the study will be taken.Exclusion criteria: patients outside the 18-65 age range, patients with deep venous system obstruction, patients who have previously used another invasive treatment method (thermal and chemical ablation, surgery), patients with heart and kidney failure, patients with secondary varicose veins patients with hypercoagulable state, patients with local or systemic infection, patients with obesity (body mass index> 35), patients with impaired consciousness, patients who do not want to participate in the study. Blood will be taken from Group A and Group C patients for the measurement of IL 17 and IL 23 prior 24 hours before the endovenous ablation procedure. Group A will be done LU 9 (Taiyuan), LU 7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Suzanli), LI 4 (Hegu) and LIV 3 (Taichong) points to be acupunctured. Vasculer access will be opened in the preoperative patient preparation room in both patient groups.The points of the acupuncture group will be checked and recorded. The falling press needle will be reapplied to replace the needles. Patients will be taken to the operating room. In both patient groups, measurement of the vessel diameter by ultrasound before the endovenous ablation procedure will be performed.During the endovenous ablation procedure, SBP (Systolic blood pressure), DBP (Diastolic blood pressure), OAB (Mean arterial pressure), HR (Heart rate), SPO2 (Oxygen) , the number of interventional procedures needed to be successful and the duration of the procedure, the pain conditions during operation (VAS) will be recorded in 1, 3, 5, 7, 10, 15 minutes.After completion of the procedure, ultrasound vein ablation and measurement will be reassessed by the surgeon to evaluate the success of the procedure.Nausea, vomiting, itching and pain conditions (VAS) will be measured again in the postoperative 1, 30 and 60 minutes and a comparison will be made between the groups.After the operation, the acupuncture points will be checked in the postoperative resting room and if there are falling needles, the needles will be replaced again.Patients will be told that acupuncture points should be stimulated from time to time and pres needle needles should be protected for three days.On the 3rd postoperative day, patients will be referred to the cardiovascular surgery outpatient clinic. Pain conditions (VAS) and analgesic consumption will be evaluated.Preoperatively, postoperatively and on the 3rd day, the vessel diameters will be measured and compared with ultrasonography.IL17 and IL 23 values will be compared between both groups and before and after endovenous ablation.The effect of acupuncture on IL 17 and IL 23 will be investigated.Patients will also be told to return to the hospital immediately in cases such as shortness of breath, edema, redness, pain in the legs and the complications will be recorded.The aim of this study was to investigate the effect of acupuncture on pain, IL17, IL 23 and vessel diameters in patients treated with N-Butyl Cyanoacrylate, a new method in the treatment of endovenous ablation.
- Conditions
- Pain, Interleukin, Vessels; Varicose
- Being tested
- Group A ( Group Acupuncture)
- Keywords
- Acupuncture, Pain , IL 17, IL 23 and Vessel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A ( Group Acupuncture)Other
Group A; Acupunctur will be done with Pres Needle (0.22x1.5 mm).Acupuncture will be done points fo SP 6, LI 4 , ST 36 , LİV 3, LU 9 ,LU 7.
| Study group | Role | What they receive |
|---|---|---|
| Group C | No intervention | Arm: Group C control group. Non-acupuncture group. Gruop C will be Control group. |
| Group A | Active comparator | Arm: Group A, group of acupuncture Akupunktur will be done with Pres Needle (0.22x1.5 mm) Blood will be taken for the measurement of IL 17 and IL 23 from Group A (Acupuncture) patients 24 hours prior to endovenous ablation procedure. Then, with press needle (0.22x1.5) LU 9 (Taiyuan), LU7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Zusanli), LI 4 (Hegu) and LIV 3 (Taichong) points will be applied acupuncture.On the 3rd day, patients will be called for control. Blood will also be taken from the blood to measure IL 17, IL 23 values. Receives: Other: Group A ( Group Acupuncture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL 17 and IL 23 values
Change From Baseline on the circulating levels of IL 17 and IL 23 ng/ L
Measured: before operation and after the operation 3. days
Pain (VAS Score)
Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: Change From Baseline of VAS Score in 1 minute,3 minute,5 minute,7 minute, 10 minute, 15 minute of pain level during operation.Each unit will be evaluated separately within itself
Pain (VAS Score)
Change from Baseline VAS Score (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Measured: Change From Baseline of VAS Score in1 minute,30 minute, 60 minute after operation and 3. days. Each unit will be evaluated separately within itself
Secondary outcomes (1)
vessel measurement
Change from Baseline measurement (mm)with ultrasonografi
Measured: before the operation, after operation and after operation 3. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start29 Jan 2019
- Primary completion5 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- yavuz orak, Principal investigator, Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828877
- Sponsor's protocol ID
- 2018/13-26
- Status last verified
- Mar 2019
- First submitted
- 29 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Pain, IL 17 and IL 23 in Endovenous Ablation; Prospective, Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT03828877
- Acronym / sponsor ID
- 2018/13-26
- Conditions
- Pain, Interleukin, Vessels; Varicose
- Keywords
- Acupuncture, Pain , IL 17, IL 23 and Vessel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 4 Feb 2019 (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.
Acupuncture has emerged in China about 2,000 years ago and is one of the oldest medical procedures in the world. Acupuncture continued to evolve and develop over the centuries, and gradually became one of the standard treatments used in China. Introduced to other regions such as Asia, Europe and the United States. The most extensive use of acupuncture is for pain relief. The aim of this study was to prevent complications due to pain frequently seen in patients who would be treated with endovenous ablation in the postoperative period. In addition, the effect of acupuncture on operative hemodynamics, pain, vascular diameter, postoperative, nausea, vomiting, pain and analgesic needs, IL17 and IL 23.
Detailed description
Patients will be divided into two groups. Control group (Group C, n: 35) and Acupuncture group (Group A, n: 35). Inclusion criteria: willing to participate in the study, being in the 18-65 age range, a saphenous vein diameter greater than 5.5 mm and a small saphenous vein diameter of less than 4 mm with reflux for greater than 0.5 s The patients with the study will be taken.Exclusion criteria: patients outside the 18-65 age range, patients with deep venous system obstruction, patients who have previously used another invasive treatment method (thermal and chemical ablation, surgery), patients with heart and kidney failure, patients with secondary varicose veins patients with hypercoagulable state, patients with local or systemic infection, patients with obesity (body mass index> 35), patients with impaired consciousness, patients who do not want to participate in the study. Blood will be taken from Group A and Group C patients for the measurement of IL 17 and IL 23 prior 24 hours before the endovenous ablation procedure. Group A will be done LU 9 (Taiyuan), LU 7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Suzanli), LI 4 (Hegu) and LIV 3 (Taichong) points to be acupunctured. Vasculer access will be opened in the preoperative patient preparation room in both patient groups.The points of the acupuncture group will be checked and recorded. The falling press needle will be reapplied to replace the needles. Patients will be taken to the operating room. In both patient groups, measurement of the vessel diameter by ultrasound before the endovenous ablation procedure will be performed.During the endovenous ablation procedure, SBP (Systolic blood pressure), DBP (Diastolic blood pressure), OAB (Mean arterial pressure), HR (Heart rate), SPO2 (Oxygen) , the number of interventional procedures needed to be successful and the duration of the procedure, the pain conditions during operation (VAS) will be recorded in 1, 3, 5, 7, 10, 15 minutes.After completion of the procedure, ultrasound vein ablation and measurement will be reassessed by the surgeon to evaluate the success of the procedure.Nausea, vomiting, itching and pain conditions (VAS) will be measured again in the postoperative 1, 30 and 60 minutes and a comparison will be made between the groups.After the operation, the acupuncture points will be checked in the postoperative resting room and if there are falling needles, the needles will be replaced again.Patients will be told that acupuncture points should be stimulated from time to time and pres needle needles should be protected for three days.On the 3rd postoperative day, patients will be referred to the cardiovascular surgery outpatient clinic. Pain conditions (VAS) and analgesic consumption will be evaluated.Preoperatively, postoperatively and on the 3rd day, the vessel diameters will be measured and compared with ultrasonography.IL17 and IL 23 values will be compared between both groups and before and after endovenous ablation.The effect of acupuncture on IL 17 and IL 23 will be investigated.Patients will also be told to return to the hospital immediately in cases such as shortness of breath, edema, redness, pain in the legs and the complications will be recorded.The aim of this study was to investigate the effect of acupuncture on pain, IL17, IL 23 and vessel diameters in patients treated with N-Butyl Cyanoacrylate, a new method in the treatment of endovenous ablation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | No intervention | –Arm: Group C control group. Non-acupuncture group. Gruop C will be Control group. |
| Group A | Active comparator | Other: Group A ( Group Acupuncture)Arm: Group A, group of acupuncture Akupunktur will be done with Pres Needle (0.22x1.5 mm) Blood will be taken for the measurement of IL 17 and IL 23 from Group A (Acupuncture) patients 24 hours prior to endovenous ablation procedure. Then, with press needle (0.22x1.5) LU 9 (Taiyuan), LU7 (Lieque), SP 6 (Sanyinjiao) , ST 36 (Zusanli), LI 4 (Hegu) and LIV 3 (Taichong) points will be applied acupuncture.On the 3rd day, patients will be called for control. Blood will also be taken from the blood to measure IL 17, IL 23 values. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers to participate in the study,
- 18-65 years of age,
- patients with a saphenous vein diameter greater than 5.5 mm
- small saphenous vein diameter of less than 4 mm with reflux for greater than 0.5 s
Key exclusion criteria (10 listed)
- Patients outside the 18-65 age range,
- patients with deep venous system obstruction,
- patients who have previously used another invasive treatment method (thermal and chemical ablation, surgery),
- patients with heart and kidney failure,
- patients with secondary varicose veins,
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 |
|---|---|---|
| Group A ( Group Acupuncture)Group A; Acupunctur will be done with Pres Needle (0.22x1.5 mm).Acupuncture will be done points fo SP 6, LI 4 , ST 36 , LİV 3, LU 9 ,LU 7. | Other | Group A |
Primary outcome
IL 17 and IL 23 values
Time frame: before operation and after the operation 3. days
Change From Baseline on the circulating levels of IL 17 and IL 23 ng/ L
Pain (VAS Score)
Time frame: Change From Baseline of VAS Score in 1 minute,3 minute,5 minute,7 minute, 10 minute, 15 minute of pain level during operation.Each unit will be evaluated separately within itself
Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Pain (VAS Score)
Time frame: Change From Baseline of VAS Score in1 minute,30 minute, 60 minute after operation and 3. days. Each unit will be evaluated separately within itself
Change from Baseline VAS Score (Visual analog scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
1 secondary outcome
vessel measurement
Time frame: before the operation, after operation and after operation 3. days
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 Mar 2019.
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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.
yavuz orak principal investigator
Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A ( Group Acupuncture) in people with Pain and Interleukin, run by Kahramanmaras Sutcu Imam 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 4 inclusion and 10 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 Mar 2019. 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?
IL 17 and IL 23 values (time frame: before operation and after the operation 3. days). The study lists 3 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 13 Mar 2019.