ClinicalTrials.gg
RecruitingNCT06165575Updated Jan 3, 2024

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

An interventional study of Press needle and Sham press needle in Post-operative Pain and Spine, Open, sponsored by Indonesia University. Recruiting at 3 sites in Indonesia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post-operative Pain
  • Spine, Open
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 54 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Indonesia University is the lead sponsor of 446 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

Exclusion Criteria:

  • Having ear shape abnormalities.
  • Wound/infection at acupuncture point areas.
  • Having allergies to patches and/or stainless steel.
  • Suffering from .
  • Fever > 38°C.
  • Taking pre-operative anti-nausea medication.
  • Having a history of vertigo complaints
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Press needle and medication

    Device: Press needle

  • Sham comparator
    Sham press needle and medication

    Device: Sham press needle

Interventions

  • DevicePress 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.

  • DeviceSham press needle

    Sham press needle is a surgical adhesive patch placed on acupuncture points

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours and 72 hours post operative

Secondary outcomes

  1. 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.

    Time frame: 24 hours post operative

07

Study locations

2 of 3 sites recruiting
  • RSUPN Cipto Mangunkusumo
    Jakarta Pusat, Jakarta 10430, Indonesia
    Not yet recruiting
    • Agil Agil · Contact0213912477
    • Suci Martayoga, doctor · Principal investigator
  • RS Universitas Indonesia
    Depok, Jawa Barat 16424, Indonesia
    Recruiting
    • Muhammad Purwanto · Contact02150829292
    • Suci Sekarini, doctor · Principal investigator
  • RSUP Fatmawati
    Jakarta, 12430, Indonesia
    Recruiting
    • Nurul Muchtar, doctor · Contact0217501524
    • Suci Martayoga, doctor · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165575
Responsible party
Suci Sekarini Martayoga (doctor, Indonesia University) — Principal investigator
First posted
Dec 11, 2023
Start date
Oct 13, 2023
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Jan 3, 2024

Study contacts

Suci S Martayoga, doctor
Contact
suci.sekarini@ui.ac.id
085959537162

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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