The Effect of Acupuncture on the Treatment of Endovenous Ablation on Pain, IL17 and IL 23

NCT03828877 | Completed

• 1 other identifier: 2018/13-26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain; Interleukin; Vessels; Varicose

Keywords

Acupuncture, Pain , IL 17, IL 23 and Vessel

Outcome Measures

Primary Outcomes (3)

• IL 17 and IL 23 values

  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)

  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)

  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 Outcomes (1)

• vessel measurement

  before the operation, after operation and after operation 3. days

Study Arms (2)

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.

Other: Group A ( Group Acupuncture)

Interventions

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.

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers to participate in the study,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, Onikişubat, 251/A 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• yavuz orak

  Kahramanmaraş Sutcu Imam University Faculty of Medicine Kahramanmaraş

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: January 29, 2019
• Primary Completion: March 5, 2019
• Study Completion: March 7, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TU (1)