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

NCT06411054 | Recruiting

• 1 other identifier: CRE-2023.578
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Manual vacuum aspiration; Ultrasound-guided; Acupuncture transcutaneous electrical nerve stimulation; Alternative medicine; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• VAS pain score

  Women will be asked to move the cursor along the VAS ruler, which does not have markings other than '0' and '10', to indicate her pain level at different time intervals. With a change of more than or equal to 10 for the 100 mm VAS, the analgesic intervention is clinical important (Myles et al., 2017).

  Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA)

Secondary Outcomes (11)

• Stress level measured by STAI questionnaire

  2 hours before and 1 hour after USG-MVA

• Stress level measured by saliva cortisol

  2 hours before, right after, and 30 minutes after USG-MVA

• VAS Anxiety Score

  Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA)

• Blood pressure

  Before taking misoprostol, right before the surgery, during (during cannula insertion, and for every suction), and after USG-MVA (0 minutes, 15 minutes, 30 minutes, and 1-hour post-USG-MVA)

• Heart rate and heart rate variability

  One hour before USG-MVA to one hour after USG-MVA

Study Arms (2)

Au-TENS group

EXPERIMENTAL

Women will receive acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA.

Device: Acu-TENS

Sham acu-TENS group

SHAM COMPARATOR

Women will receive sham acu-TENS from 15 minutes before USG-MVA to 15 minutes after USG-MVA. In the sham acu-TENS, TENS pads will be placed on the same acupoints, connected to the machine, but without electric current.

Device: Sham acu-TENS

Interventions

Acu-TENS DEVICE

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).

Au-TENS group

Sham acu-TENS DEVICE

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).

Sham acu-TENS group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above;
• Patient diagnosed with first-trimester miscarriage, who is eligible for USG-MVA;
• Patient diagnosed with incomplete miscarriage after medical treatment;
• Willing to be randomized to receive acupuncture.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

HK (1)