The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA
ConditionPain, Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Acu-TENS
DeviceAfter 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).
Sham acu-TENS
DeviceAfter 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).
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: Au-TENS groupExperimental treatment 1 intervention
Group B: Sham acu-TENS groupSham comparator 1 intervention
Trial outcomes
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).
Time frame
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
1
Stress level measured by STAI questionnaire
STAI is a 40-items scale which used 4 point Likert scale ranged from almost never to almost always. It consists of two parts, the S-AD questionnaire for stress level and the T-AI questionnaire for traits. The validated Chinese version of STAI was used to measure the changing psychological status before and after USG-guided MVA, with a score ranging from 20 to 80.
Time frame
2 hours before and 1 hour after USG-MVA2
Stress level measured by saliva cortisol
We test the cortisol level in saliva instead of blood to avoid the stress brought by blood drawing which will result in elevated cortisol levels. Studies indicate elevated saliva cortisol levels in pain, for example, chronic widespread pain or fibromyalgia(Begum et al., 2022), and myofascial pain(Nadendla et al., 2014). Vice versa, when pain is relieved, saliva cortisol level will decrease. For example, pain is relieved by dance and yoga in functional abdominal pain disorders(Areskoug Sandberg et al., 2022).
Time frame
2 hours before, right after, and 30 minutes after USG-MVA3
VAS Anxiety 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.
Time frame
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)4
Blood pressure
Studies have shown that in acute pain, with ascending nociception, segmental spinal reflexes are recruited to activate the sympathetic system, resulting in increased peripheral resistance, heart rate, and stroke volume(Bruehl et al., 2010; Fagius et al., 1989; Saccò et al., 2013(Bruehl et al., 2002)).
Time frame
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)Sponsors and contacts
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Source ClinicalTrials.gov