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Post-operative PainNCT06165575

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

A study testing Press needle in people with Post-operative Pain and Spine, Open, run by Universitas Indonesia at 3 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post-operative Pain, Spine, Open
What is being tested?
Press needle
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
3 sitesIndonesia
Study dates
13 Oct 2023to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Suci S Martayoga, doctor contact

085959537162

suci.sekarini@ui.ac.id

Indonesia3 sites, 3 recruiting
  • RS Universitas Indonesia

    Depok, West Java, 16424

    Muhammad Purwanto, 02150829292

    Suci Sekarini, doctor

    Recruiting
  • RSUP Fatmawati

    Jakarta, 12430

    Nurul Muchtar, doctor, 0217501524

    Suci Martayoga, doctor

    Recruiting
  • RSUPN Cipto Mangunkusumo

    Jakarta Pusat, Jakarta Special Capital Region, 10430

    Agil Agil, 0213912477

    Suci Martayoga, doctor

    Not yet recruiting

Other trials in Indonesia

About this study

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.

Read more

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.

Being tested
Press needle, Sham press needle
Medical subject headings
Pain, Postoperative, Spinal Dysraphism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Press needleDevice

    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 press needleDevice

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

Study groups in NCT06165575
Study groupRoleWhat they receive
Press needle and medicationExperimentalNot described
Receives: Device: Press needle
Sham press needle and medicationSham comparatorNot described
Receives: Device: Sham press needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 hours and 72 hours post operative

Secondary outcomes (1)
  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.

    Measured: 24 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start13 Oct 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165575
Sponsor's protocol ID
23081272
Status last verified
Dec 2023
First submitted
1 Nov 2023
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Press needle in people with Post-operative Pain and Spine, Open, run by Universitas Indonesia at 3 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suci S Martayoga, doctor (085959537162, suci.sekarini@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: 24 hours and 72 hours post operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.

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