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.
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.
Indonesia3 sites, 3 recruiting
- 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
- Not yet recruiting
RSUPN Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
Agil Agil, 0213912477
Suci Martayoga, doctor
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.
- Conditions
- Post-operative Pain, Spine, Open
- 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 group | Role | What they receive |
|---|---|---|
| Press needle and medication | Experimental | Not described Receives: Device: Press needle |
| Sham press needle and medication | Sham comparator | Not described Receives: Device: Sham press needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted11 Dec 2023
- Study start13 Oct 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suci Sekarini Martayoga, Universitas Indonesia
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06165575
- Acronym / sponsor ID
- 23081272
- Conditions
- Post-operative Pain, Spine, Open
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Press needle and medication | Experimental | Device: Press needle |
| Sham press needle and medication | Sham comparator | Device: Sham press needle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Having ear shape abnormalities.
- Wound/infection at acupuncture point areas.
- Having allergies to patches and/or stainless steel.
- Suffering from malignancies.
- Fever > 38°C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Press needlePress 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. | Device | Press needle and medication |
| Sham press needleSham press needle is a surgical adhesive patch placed on acupuncture points | Device | Sham press needle and medication |
Primary outcome
Visual Analog Scale
Time frame: 24 hours and 72 hours post operative
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
1 secondary outcome
The American Pain Society Patient Outcome Questionnaire Revised
Time frame: 24 hours post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
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.