Using acu-TENS to reduce pain during ultrasound-guided manual vacuum aspiration
The Efficacy of Acupuncture-type Transcutaneous Electrical Nerve Stimulation as an Adjunct Analgesic in Reducing Pain During Ultrasound-guided Manual Vacuum Aspiration: A Prospective, Single- Blinded Two-arm Randomized Controlled Trial.
This study is testing if a new pain relief method called acu-TENS can help women feel less pain during a procedure for early pregnancy loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06411054 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of acu-TENS, a form of acupuncture transcutaneous electrical nerve stimulation, as an adjunct analgesic for women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) due to early pregnancy loss. The study will randomly assign participants to receive either acu-TENS or a sham treatment to assess pain levels during the procedure. A total of 108 women will be recruited, and their pain will be measured using heart rate variability before and after the procedure. The trial will be conducted at the Prince of Wales Hospital in Hong Kong.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older who are experiencing a first-trimester miscarriage and are eligible for USG-MVA.
Not a fit: Patients with conditions that contraindicate USG-MVA or acu-TENS, such as significant cervical canal narrowing or active pelvic infections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological method for pain management during early pregnancy loss procedures.
How similar studies have performed: While the use of acu-TENS in this specific context is novel, similar studies have shown promise in using acupuncture for pain management in various medical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 or above; 2. Patient diagnosed with first-trimester miscarriage, who is eligible for USG-MVA; 3. Patient diagnosed with incomplete miscarriage after medical treatment; 4. Willing to be randomized to receive acupuncture. Exclusion criteria a. Patient not eligible for USG-MVA i. Miscarriage \> 12 weeks of gestation; or ii. Pregnancy of unknown origin; or iii. Known narrowing of the cervical canal; or iv. Multiple uterine fibroids; or v. Congenital uterine anomalies; or vi. Active pelvic infection; or vii. Bleeding disorder; or viii. Inability to tolerate pelvic examination; or ix. History of allergy to misoprostol b. Patient not eligible for acu-TENS i. Poor skin integrity at the acupuncture site, such as open wound, infections, unknown mass, bleeding tendency; or ii. Allergic to external alcohol; or iii. Emotionally unstable or tend to restlessness (to avoid tear-off of pads). c. Patient refusal
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
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.