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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain; Spine, Open
• Intervention / Treatment: Device: Press needle; Device: Sham press needle

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suci S Martayoga, doctor; Phone Number: 085959537162; Email: suci.sekarini@ui.ac.id

Study Locations

• Indonesia
  • Jakarta, Indonesia, 12430
    • Recruiting
    • RSUP Fatmawati
    • Principal Investigator: Suci Martayoga, doctor
    • Contact: Nurul Muchtar, doctor; Phone Number: 0217501524
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Not yet recruiting
      • RSUPN Cipto Mangunkusumo
      • Contact: Agil Agil; Phone Number: 0213912477
      • Principal Investigator: Suci Martayoga, doctor
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia, 16424
      • Recruiting
      • RS Universitas Indonesia
      • Contact: Muhammad Purwanto; Phone Number: 02150829292
      • Principal Investigator: Suci Sekarini, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged >=18 years to <= 65 years.
• Patients who have undergone open spine surgery using a conventional method, which involves a surgical procedure with an incision along the spine area for therapeutic purposes, not limited to the entire spine, with or without the use of implants, due to various pathologies other than malignancies.
• Patients are returned to regular inpatient rooms post-surgery.
• Willing to participate in the study until completion.
• Patients with VAS (Visual Analog Scale) >= 6.

Exclusion Criteria:

• Having ear shape abnormalities.
• Wound/infection at acupuncture point areas.
• Having allergies to patches and/or stainless steel.
• Suffering from malignancies.
• Fever > 38°C.
• Taking pre-operative anti-nausea medication.
• Having a history of vertigo complaints

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Press needle and medication	Device: Press needle; Press needle is a very small needles (1-3 mm long) that are 'pressed' onto acupuncture point and are held in place with a small, sterile surgical adhesive patch.
Sham Comparator: Sham press needle and medication	Device: Sham press needle; Sham press needle is a surgical adhesive patch placed on acupuncture points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	The visual analog scale is measured using a visual ruler with a line scale of 10 cm, where patients are asked to draw a line on the ruler according to the pain they are experiencing. Pain scale measurements are taken at 24 hours post-operation and 72 hours post-operation, where a lower scale indicates better progress, which indicates less pain	24 hours and 72 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The American Pain Society Patient Outcome Questionnaire Revised	The American Pain Society Patient Outcome Questionnaire Revised is a questionnaire designed to assess the quality of postoperative pain management. This questionnaire consists of 6 aspects, pain severity, adverse effects, interference to different activities including sleep, emotional state, perception of care, and nonpharmacological therapies. It has 12 items, which rated on 11-point continuous scale from 0 - 10 where 10 signifies the highest score. Frequency of pain and pain relief were measured using worst pain and frequency of pain in 24 h. pain-related interference to activities in bed like turning, repositioning, or out the bed like walking, sitting, standing, and sleep were observed. They were further categorized into: no interference (0), mild (1-3), moderate (4-6), and severe (7-10). Side effect include nausea, drowsiness, itching, dizziness, whereas anxiety, depression, frightened, and helpless behavior were evaluated in emotional state.	24 hours post operative

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Pain, Postoperative; Spinal Dysraphism
• Other Study ID Numbers: 23081272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No