Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06165575
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-11-01
Brief Title:
The Effect of Press Needle in the Combination of Ear and Body Acupuncture Points on Visual Analog Scale in Post-Operative Patients of Open Spine Surgery
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Press Needle in the Combination of Ear and Body Acupuncture Points on Visual Analog Scale in Post-Operative Patients of Open Spine Surgery
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative pain is pain that arises after a surgical procedure resulting from trauma during the surgical incision process It is generally acute in nature and is accompanied by an inflammatory response Spinal surgery is a surgical procedure used to address issues typically involving pain in the spinal or back area Commonly used postoperative analgesics are opioid types administered intravenously All types of opioids exhibit similar side effects particularly in terms of respiratory depression which can lead to hypoxia and respiratory arrest Other side effects include nausea vomiting itching decreased intestinal motility leading to ileus and constipation
The press needle acupuncture a specialized acupuncture needle developed from intradermal needles is being used The advantage of the press needle is its minimally invasive nature relative affordability safety and the ability to continuously stimulate acupuncture points for several days generally without causing serious side effects
This study aims to determine the effectiveness of the combined therapy of press needle acupuncture and medication in treating postoperative pain in patients who have undergone open spinal surgery The study follows a double-blind randomized clinical trial design and is conducted at the inpatient units of Dr Cipto Mangunkusumo National General Hospital Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo University of Indonesia Hospital Rumah Sakit Universitas Indonesia and Fatmawati General Hospital The research is a collaboration between the Medical Acupuncture Department of Faculty of Medicine at the University of Indonesia and the Orthopedics and Traumatology Department The study employs press needle acupuncture on 8 acupuncture points 4 ear acupuncture points and 4 body acupuncture points
There are three hypothesis for this trial included first there is a change in the mean pain intensity before the placement of press needles and 24 hours after open spine surgery following the placement of press needles in the press needle and medication group at LI4 Hegu LR3 Taichong ear acupoint MA TF-1 Shenmen and MA AT-1 Thalamus compared to the change in mean pain intensity before the placement of sham press needles and 24 hours after open spine surgery following the placement of sham press needles in the sham press needle and medication group as measured using the visual analog scale Second there is a lower mean postoperative pain intensity in the press needle and medication group at LI4 Hegu LR3 Taichong ear acupoint MA TF-1 Shenmen and MA AT-1 Thalamus compared to the sham press needle and medication group as measured using the visual analog scale at 24 hours and 72 hours after open spine surgery Third there is a higher score for postoperative pain management quality in the press needle and medication group at LI4 Hegu LR3 Taichong ear point MA TF-1 Shenmen and MA AT-1 Thalamus compared to the sham press needle and medication group as assessed using the American Pain Society Patient Outcome Questionnaire Revised questionnaire at 24 hours after open spine surgery
The outcome of this research is the intensity of pain scores measured using the visual analog scale assessed prior to press needle acupuncture insertion 24 hours post-operation and 72 hours post-operation Additionally the quality of postoperative pain management is assessed using the American Pain Society Patient Outcome Questionnaire Revised APS-POQ-R at 24 hours post-operation
The press needle acupuncture a specialized acupuncture needle developed from intradermal needles is being used The advantage of the press needle is its minimally invasive nature relative affordability safety and the ability to continuously stimulate acupuncture points for several days generally without causing serious side effects
This study aims to determine the effectiveness of the combined therapy of press needle acupuncture and medication in treating postoperative pain in patients who have undergone open spinal surgery The study follows a double-blind randomized clinical trial design and is conducted at the inpatient units of Dr Cipto Mangunkusumo National General Hospital Rumah Sakit Umum Pusat Nasional Dr Cipto Mangunkusumo University of Indonesia Hospital Rumah Sakit Universitas Indonesia and Fatmawati General Hospital The research is a collaboration between the Medical Acupuncture Department of Faculty of Medicine at the University of Indonesia and the Orthopedics and Traumatology Department The study employs press needle acupuncture on 8 acupuncture points 4 ear acupuncture points and 4 body acupuncture points
There are three hypothesis for this trial included first there is a change in the mean pain intensity before the placement of press needles and 24 hours after open spine surgery following the placement of press needles in the press needle and medication group at LI4 Hegu LR3 Taichong ear acupoint MA TF-1 Shenmen and MA AT-1 Thalamus compared to the change in mean pain intensity before the placement of sham press needles and 24 hours after open spine surgery following the placement of sham press needles in the sham press needle and medication group as measured using the visual analog scale Second there is a lower mean postoperative pain intensity in the press needle and medication group at LI4 Hegu LR3 Taichong ear acupoint MA TF-1 Shenmen and MA AT-1 Thalamus compared to the sham press needle and medication group as measured using the visual analog scale at 24 hours and 72 hours after open spine surgery Third there is a higher score for postoperative pain management quality in the press needle and medication group at LI4 Hegu LR3 Taichong ear point MA TF-1 Shenmen and MA AT-1 Thalamus compared to the sham press needle and medication group as assessed using the American Pain Society Patient Outcome Questionnaire Revised questionnaire at 24 hours after open spine surgery
The outcome of this research is the intensity of pain scores measured using the visual analog scale assessed prior to press needle acupuncture insertion 24 hours post-operation and 72 hours post-operation Additionally the quality of postoperative pain management is assessed using the American Pain Society Patient Outcome Questionnaire Revised APS-POQ-R at 24 hours post-operation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None