The Effects of Electroacupuncture on Postoperative Pain

March 24, 2023 updated by: Didem OZKAL EMINOGLU

In this study,the investigators aimed to examine the effect of electroacupuncture application on the amount of pain felt by patients after periodontal surgery.

The main question it aims to answer is there any efficiacy of electroacupuncture application on postoperative pain reduction.

Participants will get periodontal flap surgery treatment with/without electroacupuncture

Researchers will compare EA and control groups to see if there is any relationship between acupuncture application and postoperative pain

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is an acute pain that begins with surgical trauma and decreases over time with tissue healing. The level of pain and discomfort felt varies from person to person. The patient's sex and age, physiological and psychological structure, operation area, duration of surgery, premedication, type of anesthetic used, postoperative complications and several other environmental factors can affect this level. After the operation, especially within 48 hours, the pain increases and gradually decreases. Postoperative pain may cause an increase in anxiety and general fear and concern. The stress level caused by surgical trauma in the patient delays recovery and increases mortality and morbidity.

Electroacupuncture (EA) applies electrical stimulation current to needles placed on acupuncture points. It is mainly used to relieve pain and provide operative analgesia.

No study has been found in the literature on the pain-reducing functionality of acupuncture applications in periodontal surgical treatments. In this study, the investigators aimed to examine the effect of electroacupuncture application on the amount of pain felt by patients after periodontal surgery.

Study Type

Interventional

Enrollment (Actual)

44

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

  • Turkey
      • Erzurum, Turkey, 25240_
        • Ataturk University

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:

  • absence of any systemic disease,
  • pregnancy or breast feeding;
  • not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;
  • having 6 mm or more probable pocket depth and clinical attachment loss in at least 4 or more teeth when called for control 6 weeks after Phase I treatment

Exclusion Criteria:

  • Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
  • pregnant/breastfeeding
  • medication for any reason
  • smoker/tobacco user
  • other periodontal disease other than periodontitis
  • chronic inflammatory disease (COPD, asthma)

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA (electroacupuncture)
Individuals who underwent electroacupuncture before and after flap surgery
Procedure: Electroacupuncture
Electroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery
Procedure: periodontal flap surgery
periodontal flap surgery
Active Comparator: Control
Individuals who have undergone flap surgery only
Procedure: periodontal flap surgery
periodontal flap surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 7 days
The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative analgesic requirement
Time Frame: 7 days
the number of analgesic requirements taken by patients after periodontal surgery.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Didem OZKAL EMINOGLU

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)

March 30, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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