A novel transcutaneous electrical nerve stimulation (TENS) device in patients post gynaecology surgeries: a triple-blind, placebo-controlled counterbalanced crossover trial
Pain control using novel TENS device in patients post transverse suprapubic gynaecology surgeries
Current interventions as of 13/04/2026: Eligible participants will be equally divided into 2 groups through a computer-generated randomisation sequence prepared before the start of the study. The groups will be as follows Group 1: TENS followed by SHAM-CONTROL after a 4-hour gap Group 2: SHAM-CONTROL followed by TENS after a 4-hour gap Participants receiving TENS first: Participants will receive TENS therapy at a frequency of 100 Hz and 5 mA intensity (set at medium pulse width). The TENS device will be applied at 6 fixed points for 5 minutes each, 1-2cm lateral to the wound edge and 1-2 cm above, covering the transverse suprapubic incision. After a 4-hour washout, the same TENS device will be used in exactly the same manner with output at sham setting 0 Hz and 0 mA intensity. Participants receiving control(sham) first: Participants will receive sham-control TENS therapy with output setting 0 Hz and 0 mA intensity. The TENS device will be applied at 6 fixed points for 5 minutes each, 1-2 cm lateral to the wound edge and 1-2 cm above, covering the transverse suprapubic incision. After a 4-hour washout, participants will receive TENS therapy at a frequency of 100 Hz and 5 mA intensity (set at medium pulse width). At the start of both sessions, TENS at a frequency of 10 Hz and 5 mA intensity will be delivered to the dorsum of the hand (at the middle finger metacarpal area) for the participant to appreciate the TENS sensation. The frequency applied will be increased in 10 Hz increments until sensation can be felt. The device prongs will then be applied at the same output setting to the sub-umbilical region to demonstrate that the sensation may or may not be felt at the sub-umbilical region when the TENS device is activated to help sustain the sham process. If the sensation cannot be tolerated, participation will be stopped. Participants will still receive standard-of-care analgesics post-gynaecology surgery while undergoing the study. _____ Previous intervention
1. Age ≥ 18 years old 2. Patients undergoing elective or emergency gynaecology surgery (eg, myomectomy, hysterectomy, ovarian/ tubal surgeries) via transverse suprapubic incision under general anaesthesia 3. Able to communicate in English or Malay 4. Able to provide informed consent
1. Contraindications to TENS (pacemaker, skin lesions) 2. Chronic pain on regular opioids