The Effects of Electroacupuncture on Postoperative Pain

Sponsor
Didem OZKAL EMINOGLU (Other)
Overall Status
Completed
CT.gov ID
NCT05783011
Collaborator
(none)
44
1
2
21
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Electroacupuncture
  • Procedure: periodontal flap surgery
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Electroacupuncture on Postoperative Pain
Actual Study Start Date :
Mar 30, 2021
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale [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')

Secondary Outcome Measures

  1. Postoperative analgesic requirement [7 days]

    the number of analgesic requirements taken by patients after periodontal surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atatürk University Erzurum Turkey 25240_

Sponsors and Collaborators

  • Didem OZKAL EMINOGLU

Investigators

  • Study Director: DİDEM ÖZKAL EMİNOĞLU, Atatürk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Didem OZKAL EMINOGLU, assistant professor, Ataturk University
ClinicalTrials.gov Identifier:
NCT05783011
Other Study ID Numbers:
  • 2022
First Posted:
Mar 24, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Didem OZKAL EMINOGLU, assistant professor, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023