A study on how a novel transcutaneous electrical nerve stimulation (TENS) device reduces pain in patients undergoing gynaecology surgeries
| ISRCTN | ISRCTN76055096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76055096 |
| Secondary identifying numbers | RSCH ID-25-06222-ISZ |
- Submission date
- 15/09/2025
- Registration date
- 23/09/2025
- Last edited
- 23/09/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Recent advances in pain management suggest that the optimal treatment requires interfering with multiple targets on pain pathways, known as multimodal analgesia. This approach uses a combination of interventions, each working on a different mechanism of pain to reach maximal pain relief using the lowest effective doses of medications. In addition to medication therapy, there are adjunctive physical and behavioral techniques such as massage therapy, physical therapy, and transcutaneous electrical nerve stimulation (TENS) therapy. According to a study by Baldini G et al, using both pharmacologic and non-pharmacologic interventions can improve pain control, enhance recovery, and increase patient satisfaction. Based on another study by Johnson MI, TENS can be used as an effective adjunct for managing postsurgical pain and to minimize the need for opioid and non-opioid analgesics as part of a multimodal approach to pain. While the basic premise of TENS has remained relatively consistent, advancements in the device technology have led to more sophisticated devices that can target different nerve pathways, offering potential for more effective pain relief. The evidence for the use of these novel TENS devices in controlling pain is still evolving. This study aims to evaluate the analgesic efficacy and patient acceptability of a novel TENS device in the post-operative period.
Who can participate?
Adult patients aged ≥ 18 years old who are undergoing elective or emergency gynaecology surgery (eg: myomectomy, hysterectomy, ovarian/ tubal surgeries) via transverse suprapubic incision under general anaesthesia
What does the study involve?
On Day 1 post-operation, participants will be approached by the researcher to be included in the study. If participants agree to take part, consent will be taken. Participants will then be randomly allocated into one of the two groups: either receiving the active TENS device first, followed by the dummy device or another group receiving the dummy device first, followed by the active TENS device. For example, if a participant is in the group that receives the active TENS first, the active TENS device will be administered for 15 minutes and the pain score immediately, 1-,2-, and 4- hours post-application will be recorded. Participants will be rested from any device for 4 hours. Following that, the dummy device will be applied for 15 minutes and the pain score immediately, 1-,2- and 4- hours post application will be recorded. Blood pressure and pulse rate post-application of the device will be evaluated. The total opioid consumption after each session will also be recorded. In addition to that, participants' satisfaction with both devices will be recorded. While the study is ongoing, the standard analgesics post-operation will still be administered. The duration of the study is two years.
What are the possible benefits and risks to participants?
There might not be any direct benefit to the participants. However, the outcome of this study will contribute to the future understanding and application of TENS. A TENS device may possibly reduce postoperative pain, thus enhancing recovery and shortening the duration of hospital stay.
A potential risk would be a skin reaction at the site of administration of the TENS device. However, this risk is rare and careful monitoring will be done during the study period.
Where is the study run from?
Obstetrics & Gynaecology Department, University of Malaya.
When is the study starting and how long is it expected to run for?
August 2025 to October 2027
Who is funding the study?
Obstetrics & Gynaecology Department, University of Malaya.
Who is the main contact?
Dr Lavina A/P Belayutham, kj_obg@ummc.edu.my, lavina2040@yahoo.com
Contact information
Public, Scientific, Principal investigator
University Malaya Medical Centre, Jalan Profesor Ungku Aziz, Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Phone | +603-79492049 |
|---|---|
| kj_obg@ummc.edu.my |
Study information
| Study design | Single center interventional triple-blinded, placebo-controlled counterbalanced crossover randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | 47999_PIS_v1.0_15July2025.pdf |
| Scientific title | A novel transcutaneous electrical nerve stimulation (TENS) device in patients post gynaecology surgeries: a triple-blind, placebo-controlled counterbalanced crossover trial |
| Study acronym | nTENS study |
| Study objectives | To evaluate the impact of a novel TENS device on pain in post gynaecology surgery patients through a counterbalanced crossover trial : immediately, 1-, 2- and 4- hours after novel TENS application using a 0-10 Numerical Rating Scale (11 point NRS). |
| Ethics approval(s) |
Approved 20/08/2025, Medical Research Ethics Committee, University Malaya Medical Centre (University Malaya, Jalan Profesor Ungku Aziz, Lembah Pantai, Kuala Lumpur, 50603, Malaysia; +603 7949 3209 / 2251 / 8473 / 4656; ummc-mrec@ummc.edu.my), ref: 2025715-15344 |
| Health condition(s) or problem(s) studied | Pain control using novel TENS device in patients post transverse suprapubic gynaecology surgeries |
| Intervention | 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 100 Hz and 5 mA intensity will be delivered to the subumbilical region, briefly for 30 seconds only to generate a TENS sensation and enhance the sham. 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. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | The Remedius ExStim Pro novel TENS device |
| Primary outcome measure | Pain score on movement measured using a 0-10 Numerical Rating Scale (11-point NRS) immediately, 1-, 2- and 4- hours after application of active-TENS vs sham-TENS sessions |
| Secondary outcome measures | 1. Variance in serial pain scores between active TENS and sham TENS sessions, measured using data from the repeated measurement of pain scores at one timepoint 2. Pain score on movement will be measured at specified time points following a single 15-minute session of active-TENS or sham-TENS. Comparisons will be made across randomised arms at one timepoint. 3. Pain score on movement, measured using repeated measures ANOVA across all treatment sessions at one timepoint 4. Blood pressure and pulse, measured using standard clinical methods and analysed using repeated measures at 0, 1, 2, and 4 hours after active-TENS or sham-TENS sessions 5. Satisfaction with intervention, measured using an 11-point NRS immediately after each session 6. Opioid consumption, measured using medication usage records after application of active-TENS or sham-TENS device |
| Overall study start date | 20/08/2025 |
| Completion date | 01/10/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 110 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. Contraindications to TENS (pacemaker, skin lesions) 2. Chronic pain on regular opioids |
| Date of first enrolment | 29/09/2025 |
| Date of final enrolment | 01/10/2027 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
50603
Malaysia
Sponsor information
Hospital/treatment centre
Obstetrics & Gynaecology Department, Level 7, Kompleks Kesihatan Wanita & Kanak-Kanak, Jalan Profesor Ungku Aziz, Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | https://www.um.edu.my/ |
|---|---|
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Research institutes and centers
- Alternative name(s)
- Faculty of Medicine - Universiti Malaya, Medicine Department - Faculty of Medicine - Universiti Malaya, medicineumalaya, University of Malaya Faculty of Medicine
- Location
- Malaysia
Results and Publications
| Intention to publish date | 29/09/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as they are not approved by UM-MREC for sharing. The data can only be assessed by the principal investigator and co-investigators directly involved in the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 15/07/2025 | 23/09/2025 | No | Yes |
| Protocol file | version 1.0 | 15/07/2025 | 23/09/2025 | No | No |
Additional files
Editorial Notes
23/09/2025: Study's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.
