- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828877
The Effect of Acupuncture on the Treatment of Endovenous Ablation on Pain, IL17 and IL 23
March 12, 2019 updated by: Yavuz Orak, Kahramanmaras Sutcu Imam University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Onikişubat
-
Kahramanmaraş, Onikişubat, Turkey, 251/A 46040
- Kahramanmaras Sutcu Imam University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group C
Arm: Group C control group.
Non-acupuncture group.
Gruop C will be Control group.
|
|
Active Comparator: Group A
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
before operation and after the operation 3. days
|
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
|
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)
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vessel measurement
Time Frame: before the operation, after operation and after operation 3. days
|
Change from Baseline measurement (mm)with ultrasonografi
|
before the operation, after operation and after operation 3. days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: yavuz orak, Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2019
Primary Completion (Actual)
March 5, 2019
Study Completion (Actual)
March 7, 2019
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
February 1, 2019
First Posted (Actual)
February 4, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 12, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2018/13-26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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