Focused transcutaneous electrical nerve simulation (TENS) to the caesarean wound for pain relief
| ISRCTN | ISRCTN28379502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28379502 |
| University of Malaya Special Research Assistance - Early Career Research Grant (BKP-ECRG) Project No | BKP022-2024-ECRG |
| Sponsor | University of Malaya |
| Funder | Universiti Malaya |
- Submission date
- 09/12/2025
- Registration date
- 18/12/2025
- Last edited
- 18/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Women who undergo caesarean section often experience moderate to severe pain in the first 48 hours. After a caesarean section, a multimodal analgesic approach is often employed to minimize opioid usage and provide synergistic or additive analgesia. Some studies have shown that transcutaneous electrical nerve simulation (TENS) can help with pain following a caesarean section, but the results vary depending on how it's applied.
In the University Malaya Medical Centre, the standard analgesia for post-caesarean patients is typically paracetamol and celecoxib with opioids as needed. There is sparse data on the impact of focused-TENS applied immediately around the caesarean wound. This study aims to evaluate the application of focused-TENS on localized wound pain.
Who can take part?
Women aged 18 years and above, within 6-24 hours after undergoing caesarean-section under spinal or combined spinal-epidural anaesthesia.
What does the study involve?
The focused-TENS device will deliver TENS through two prongs which are small ball-shaped ended that delivers TENS with a tighter focus and deeper penetration than pad electrodes. These are used to to deliver specific stimulation of 100 Hz frequency and amplitude 5 mA for 15 minutes at 6 fixed points for 5 minutes at each point located 1-2 cm lateral to and 1-2 cm above, along the transverse suprapubic incision similar in principle to multipoint wound infiltration technique with a local anaesthetic. Sham-control with a deactivated identical devices will be similarly applied.
All participants will receive two 15 minutes intervention sessions 4 hours apart. In one group, the session will start with the focused-TENS function activated followed 4 hours later by a second session when the deactivated TENS device will be similarly applied. In the other group, the order is reversed; first session deactivated-TENS device is applied and second session the activated focused-TENS will be similarly applied. Group assignment of participants will be performed by a computer.
Immediately, 1, 2 and 4 hours after each session, the participants will rate wound pain level when moving about and satisfaction with intervention and blood pressure and pulse rate will be measured with automated device. The standard use of pain killers are permitted as required without any restriction.
What are the possible benefits and risks of participating?
Focused-TENS application may reduce wound pain on moving about. For this short term crossover study, no major benefit is anticipated as focused-TENS will be applied to all participants. Some participants may feel tingling or notice slight redness of the skin at the application site. These effects are expected to be temporary and usually resolve quickly. Participants are instructed that they can withdraw from the study at any time and for any reason including for discomfort.
Where is the study run from?
The study will be conducted at University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
When is the study starting and how long is it expected to run for?
December 2025 to December 2026.
Who is funding the study?
The University Malaya - Special Research Assistance (Bantuan Khas Penyelidikan)- Early Career Research Grant (BKP-ECRG) 2024, Malaysia.
Who is the main contact?
1. Dr Wong Thai Ying, thai.wong@um.edu.my
2. Prof Tan Peng Chiong, tanpengchiong@yahoo.com
3. Dr Che Mas Fairoza Binti Che Harun, fairoza@um.edu.my
Contact information
Principal investigator
Pusat Perubatan Universiti Malaya, Lembah Pantai
Kuala Lumpur
59100
Malaysia
 ORCID ID |
0000-0002-0957-6220 |
|---|---|
| Phone | +60 03-79492473 |
| thai.wong@um.edu.my |
Scientific
Pusat Perubatan Universiti Malaya, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| ORCID ID |
0000-0001-8713-6581 |
|---|---|
| Phone | +60 03-7949 2059 |
| tanpengchiong@yahoo.com |
Public
Pusat Perubatan Universiti Malaya, Lembah Pantai
Kuala Lumpur
59100
Malaysia
| Phone | +60 17-3532965 |
|---|---|
| fairoza_cmf@gmail.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Crossover | |
| Purpose | Prevention, Treatment | |
| Scientific title | Focused transcutaneous electrical nerve stimulation to the caesarean wound for pain relief: a blinded randomised sham controlled trial | |
| Study acronym | F-TENSPC | |
| Study objectives | To evaluate the impact of applying focused-TENS (Transcutaneous electrical nerve stimulation) around the caesarean section wound on the hypothesis that the intervention will reduce wound pain on moving about in the next 4 hours. | |
| Ethics approval(s) |
Approved 11/04/2025, Medical Research Ethics Committee University of Malaya Medical Centre (University of Malaya Medical Centre, LEMBAH PANTAI, 59100, Malaysia; +60 03-79493209/2251; ummc-mrec@ummc.edu.my), ref: 20241223-14516 | |
| Health condition(s) or problem(s) studied | Post-caesarean section wound pain on movement | |
| Intervention | This study will employ a blinded randomized, sham-controlled counterbalanced crossover trial design with 4 hours wash out period. Randomization will be conducted using a computerized sequence generator. The sequence will be generated in random blocks of 4 or 8 (1:1 ratio) via https://www.sealedenvelope.com/simple-randomiser/v1/lists by a co-investigator not involved in trial recruitment. Participants will be assigned to one of two trial arms by opening a numbered, sealed, opaque envelope, with the lowest numbered envelope still available assigned to the latest recruit. ARM 1 : Focused-TENS followed by SHAM-CONTROL after a 4 hour gap Or ARM 2 : SHAM-CONTROL followed by focused-TENS after a 4 hour gap The intervention will be initiated at least 6 hours after the caesarean section and no later than 24 hours post-caesarean section. ARM 1: Focused-TENS First: Participants will receive focused-TENS therapy at a frequency of 100 Hz and 5 mA intensity (set at medium pulse width). The focused-TENS device prongs will be applied at 6 fixed points for 5 minutes each, 1-2 cm lateral to wound edge and 1-2 cm above, along the transverse suprapubic incision. After 4 hours wash out, the same focused-TENS device will be used in exactly the same manner with output at sham setting 0 Hz and 0 mA intensity. ARM 2: Control(Sham) First: Participants will receive sham-controlled TENS therapy with output setting 0 Hz and 0 mA intensity. The focused-TENS device prongs will be applied at 6 fixed points for 5 minutes each, 1-2 cm lateral to wound edge and 1-2 cm above, along the transverse suprapubic incision. After 4 hours wash out, participants will receive focused-TENS therapy at a frequency of 100 Hz and 5 mA intensity (set at medium pulse width). At the start of both sessions, focused-TENS device prongs set at initial 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. | |
| Intervention type | Device | |
| Phase | Not Applicable | |
| Drug / device / biological / vaccine name(s) | Remedius ExStim Pro TENS device | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Target sample size at registration | 140 |
| Key inclusion criteria | 1. Elective and emergency lower segment caesarean section (intervention will be initiated at least 6 hours after the caesarean section and no later than 24 hours post-caesarean section) 2. Transverse suprapubic incision 3. Spinal or combined spinal-epidural anaesthesia 4. Age ≥ 18 years 5. Able to communicate in English or Malay 6. Competent to consent |
| Key exclusion criteria | 1. Contraindications to TENS (e.g., cardiac pacemaker, skin lesions at electrode sites). 2. Chronic pain conditions requiring ongoing analgesic therapy. 3. Postoperative epidural analgesia 4. Postoperative opioid patient controlled analgesia |
| Date of first enrolment | 31/12/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
PETALING JAYA
50603
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Wong Thai Ying (thai.wong@um.edu.my) and/or Prof Tan Peng Chiong (tanpengchiong@yahoo.com) subject to institutional review board approval |
Editorial Notes
18/12/2025: The target number of participants was changed from 10 to 140.
09/12/2025: Study’s existence confirmed by the Medical Research Ethics Committee of The University of Malaya Medical Centre, Malaysia.
