The acute effect of percutaneous tibial nerve stimulation on postural control
| ISRCTN | ISRCTN17765352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17765352 |
- Submission date
- 30/11/2024
- Registration date
- 13/12/2024
- Last edited
- 22/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to explore how stimulating a specific nerve in the leg (the posterior tibial nerve) affects balance in healthy young men. The goal is to see if this technique can improve postural control, which is important for maintaining stability and preventing falls.
Who can participate?
Healthy young men aged 18 to 35 years who are physically active and do not have any neurological, musculoskeletal, or cardiovascular disorders that could affect their balance.
What does the study involve?
Participants will be divided into three groups:
PTNS intervention group: This group will receive electrical stimulation to the posterior tibial nerve using a small needle and a certified medical device.
SHAM group: This group will have a needle inserted, but no electrical stimulation will be applied.
Control group: This group will only undergo balance tests without any needle insertion or stimulation.
Balance will be tested by having participants stand on one leg with their hands on their hips, both with their eyes open and closed. These tests will be repeated immediately after the intervention, and then at 2 hours, 24 hours, and 48 hours later.
What are the possible benefits and risks of participating?
The main benefit is contributing to research that could improve treatments for balance disorders. Risks are minimal but may include mild numbness or small bruises at the needle site, which should go away in a few days.
Where is the study run from?
Fundación Universitaria San Pablo CEU (Spain)
When is the study starting and how long is it expected to run for?
September 2024 to January 2025
Who is funding the study?
Fundación Universitaria San Pablo CEU (Spain)
Who is the main contact?
Miguel Rodríguez Rosal, mrodriguezr@ceu.es
Contact information
Public, Scientific, Principal Investigator
Glorieta Ángel Herrera Oria, s/n
Bormujos/ Sevilla
41930
Spain
 ORCID ID |
0000-0001-7816-1654 |
|---|---|
| Phone | +34 954 48 80 00 |
| mrodriguezr@ceu.es |
Study information
| Study design | Prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Prevention, Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | The acute effect of percutaneous tibial nerve stimulation on postural control: a randomized controlled trial |
| Study objectives | We hypothesize that percutaneous neuromodulation of the posterior tibial nerve will have an acute effect on postural control in healthy subjects. Specifically, we expect that this intervention will lead to improvements in postural control compared to baseline measures. |
| Ethics approval(s) |
Approved 02/09/2024, Universidad San Pablo-CEU, CEU Universities (Glorieta Ángel Herrera Oria, s/n, Bormujos/ Sevilla, 41930, Spain; +34 954 48 80 00; investigacion@ceuandalucia.es), ref: - |
| Health condition(s) or problem(s) studied | Postural control |
| Intervention | Participants were randomly and equally assigned to each group using a 1:1:1 design via the Random.org program. The therapist was informed only through sealed envelopes. Group Percutaneous tibial nerve stimulation (PTNS) Participants in the PTNS group will receive the PTNS intervention, which will involve the application of a biphasic electrical current (10 Hz frequency, 250 μs pulse width) at the maximum tolerable intensity for 1.5 minutes, sufficient to induce a visible muscle contraction. A certified medical device (Physio Invasiva; PRIM Physio®, Madrid, Spain) will be used for this procedure. Participants will be positioned prone with their feet hanging off the edge of the treatment table. The posterior tibial nerve will be located using an ultrasound machine (Logic; GE Healthcare, Chicago, IL, USA) for the insertion of a needle (0.30 mm x 40 mm). Prior to insertion, the skin surface will be cleaned with alcohol. The procedure will be performed by a physiotherapist with 8 years of experience in invasive physiotherapy. Group SHAM In the SHAM group, a puncture will be performed with a needle (0.30 mm × 40 mm) following the same methodology as in the PTNS group. A "nonacupoint deep puncture" technique will be employed to create the sensation of needle insertion without applying electrical current. The same timing and procedural techniques described for the PTNS group will be maintained. Group CON In the control group, no intervention will be performed For the intervention groups, a single session was conducted, and the acute effect was followed up. All measurements were repeated before and immediately after the intervention, as well as at 2, 24, and 48 hours. |
| Intervention type | Other |
| Primary outcome measure | Postural control will be measured using a force platform (Accupower; AMTI, Watertown, MA, USA) with a sampling frequency of 1000 Hz. Participants will stand on one leg, with their hands on their hips and their gaze fixed on a point 2 meters away. The tests will be conducted with eyes open and closed. For each condition, three attempts will be made. Each test will last 30 seconds, followed by a 1-minute rest period. The displacement of the center of pressure will be analyzed using linear variables: total center of pressure displacement (DOT) and the total length of its path; total displacement area (Area); mediolateral displacement (Displ_ML) and anteroposterior displacement (Displ_AP); and the amplitude of the center of pressure in the mediolateral (Ampl_ML) and anteroposterior (Ampl_AP) directions, defined as the distance between the minimum and maximum values. 1. Variable DOT measured using force platform at baseline, 0, 2, 24 and 48 h 2. Variable Area measured using force platform at baseline, 0, 2, 24 and 48 h 3. Variable Displ_ML measured using force platform at baseline, 0, 2, 24 and 48 h 4. Variable Displ_AP measured using force platform at baseline, 0, 2, 24 and 48 h 5. Variable Ampl_ML measured using force platform at baseline, 0, 2, 24 and 48 h 5. Variable Ampl_AP measured using force platform at baseline, 0, 2, 24 and 48 h |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 02/09/2024 |
| Completion date | 15/01/2025 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | Male |
| Target number of participants | The required sample size to detect a medium effect was calculated to be at least 39 participants for inclusion in a multifactorial ANOVA with repeated measures and three intervention groups |
| Key inclusion criteria | 1. Healthy young adults 2. Engage in at least 150 minutes of moderate aerobic activity per week (or the equivalent in vigorous activity), or at least 20 minutes per week of vigorous physical activity |
| Key exclusion criteria | 1. An injury affecting balance in one limb within the past year that prevented participation in sports for at least 1 day 2. A Personal Psychological Apprehension Scale (EPPAS) score >37.5 3. Commonly accepted contraindications for invasive physiotherapy techniques, including chronic joint disease, surgery, prosthetics, or osteosynthesis in the intervention area, as well as cardiac diseases, neoplasms, coagulopathies, and the use of certain medications 4. Any contraindication to the puncture itself 5. Epilepsy |
| Date of first enrolment | 16/12/2024 |
| Date of final enrolment | 12/02/2025 |
Locations
Countries of recruitment
- Spain
Study participating centre
Bormujos/Sevilla
41930
Spain
Sponsor information
University/education
Glorieta Ángel Herrera Oria, s/n
Bormujos/ Sevilla
41930
Spain
| Phone | +34 954 48 80 00 |
|---|---|
| investigacion@ceuandalucia.es | |
| Website | https://www.uspceu.com |
"ROR" |
https://ror.org/04a0dbe36 |
Funders
Funder type
University/education
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- San Pablo CEU University Foundation, CEU San Pablo University Foundation, Centro de Estudios Universitarios, FUSP-CEU, CEU
- Location
- Spain
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 will be available upon request mrodriguezr@ceu.es |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 11/12/2024 | No | No | ||
| Results article | 21/08/2025 | 22/08/2025 | Yes | No |
Additional files
Editorial Notes
22/08/2025: Publication reference added.
19/03/2025: The following changes were made:
1. The recruitment start date was changed from 01/11/2024 to 16/12/2024.
2. The recruitment end date was changed from 15/12/2024 to 12/02/2025.
13/12/2024: Contact details updated.
02/12/2024: Trial's existence confirmed by Universidad San Pablo-CEU, CEU Universities.
