The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA

Summary

Objectives: To prospectively evaluate the potential of acu-TENS to reduce the pain experienced by women undergoing ultrasound-guided manual vacuum aspiration (USG-MVA) and evaluate its safety profile.

Hypothesis to be tested: Does the use of acu-TENS reduce pain in women undergoing USG-MVA?

Design and subjects: A prospective randomized control trial will be carried out at the Department of Obstetrics and Gynaecology of the Prince of Wales Hospital. Women undergoing USG-MVA for the treatment of early pregnancy loss before 12 weeks of gestation will be randomized to receive acu-TENS (intervention group) or sham acu-TENS (control group) for pain control during USG-MVA. We will recruit 54 participants in each of the two arms, so a total of 108 patients will be recruited.

Study instruments: USG-MVA will be performed using a 60ml charged syringe (MedGyn Aspiration Kit) with a flexible curette attached to it. Transabdominal ultrasound during the MVA procedure will be performed using Mindray DC-80A Diagnostic Ultrasound System. Acu-TENS will be performed using MTR+ Myolito Multifunctional Stimulator (MTRP-00003).

Main outcome measures: Primary outcome includes pain scores before, during and after USG-MVA. Secondary outcomes include (1) stress levels measured by heart rate, heart rate variability, blood pressure, State Trait Anxiety Inventory (STAI), and salivary cortisol; (2) anxiety level; (3) Surgeon's assessment on the patient co-operation score and patient intraoperative pain, (4) Client Satisfaction Questionnaire (CSQ8) and satisfaction score, and (5) any adverse events of acu-TENS.

Data analysis: Data analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc).

Expected results: We expect that acu-TENS will result in at least a 35% reduction in pain experienced by women undergoing USG-MVA.

Conditions

• Pain, Acute

Interventions

DEVICE

Acu-TENS

After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints SP6, ST36, LI4, LR3, according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. A pulse rate of 120 Hz, current of 4-12mA, and pulse width of 300µS will be delivered continually for 45 minutes (i.e. from 15 minutes before starting the MVA to 15 minutes after the procedure has completed).

DEVICE

Sham acu-TENS

After cleaning the acupoints with alcohol, electrode pads (HC-ROUND-32 2.0) will be placed on the acupoints SP6, ST36, LI4, LR3, according to the locations described in the Standard International Acupuncture Nomenclature. The electrode pads will be connected to a TENS machine (MTRP-00003), in which ipsilateral LI4 and SP36, SP6 and LR3 serve a pair. In the sham acu-TENS, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current. The pads will be stuck on the acupoints for 45 minutes (i.e. from 15 minutes before starting the MVA to 15 minutes after the procedure has completed).

Sponsors & Collaborators

• Chinese University of Hong Kong

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2027-08-30

Completion

2027-08-31

Countries

• Hong Kong

Study Locations