Using press needle acupuncture to reduce pain after open spine surgery
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
This study tests if press needle acupuncture can help reduce pain after open spine surgery for patients looking for alternatives to pain medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Indonesia University Academic / other |
| Locations | 3 sites (Jakarta Pusat, Jakarta and 2 other locations) |
| Trial ID | NCT06165575 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of press needle acupuncture combined with ear and body acupuncture points in alleviating postoperative pain in patients who have undergone open spine surgery. The approach aims to provide a minimally invasive alternative to traditional opioid analgesics, which often come with significant side effects. Participants will be assessed using the Visual Analog Scale (VAS) to measure pain levels before and after the intervention. The study compares the effects of actual press needle acupuncture against a sham treatment to evaluate its efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who have undergone open spine surgery and experience moderate to severe postoperative pain.
Not a fit: Patients with ear shape abnormalities, infections at acupuncture points, or those with malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and reliance on opioids, improving recovery outcomes for patients.
How similar studies have performed: Previous studies have shown positive outcomes with acupuncture for pain management, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jakarta Pusat, Jakarta and 2 other locations
- RSUPN Cipto Mangunkusumo — Jakarta Pusat, Jakarta, Indonesia (Not_yet_recruiting)
- RS Universitas Indonesia — Depok, Jawa Barat, Indonesia (Recruiting)
- RSUP Fatmawati — Jakarta, Indonesia (Recruiting)
Study contacts
- Study coordinator: Suci S Martayoga, doctor
- Email: suci.sekarini@ui.ac.id
- Phone: 085959537162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.