Dysmenorrhea PrimaryNCT04896814
Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea
A study testing Transcutaneous tibial nerve stimulation in people with Dysmenorrhea Primary, run by University of Salamanca at 1 site in Spain.
Trial summary
The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium-long term. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Transcutaneous tibial nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 18 and 43.
- Women with regular menstrual cycles (range between 21 and 35 days).
- Women with a visual analogue scale (VAS) between 4 and 10 (moderate to severe pain) during at least 50% of annual menstrual cycles and / or during the last 3 cycles in the suprapubic area, abdomen, lower lumbar area , perineum and / or medial side of the thighs during the first and / or second day of your menstrual cycle.
- Sign the informed consent document to participate in the study.
Who cannot join
- Women on hormonal therapy or who have an Intrauterine Device implanted.
- Women diagnosed of secondary dysmenorrhea by their gynecologist (endometriosis, ovarian cyst, etc.) in the last 18 months.
- Women who have underwent a surgery during the study.
- Women who have underwent abdominal and pelvic surgery or who have given birth (vaginal or cesarean section) in the last 6 months.
- Women with lesions on the skin of the upper-internal face of the ankles (scars, erosions or cysts).
- Women who are pregnant or planning a pregnancy.
- Women with pacemakers, uncorrected coagulopathies, severe comorbid disorder, cancer (in the last 5 years or now), severe mental disorders or neuropathies that affect the nerves of the pelvis or lower extremities.
- Physiotherapy or electrotherapy treatments that are related to the pathology or study areas of the month prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea: A Randomized Controlled Trial
The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium-long term.
The hypothesis of the study states that by applying that method to the patients, a decrease or disappearance of pain in menstruation should happen, as well as an improvement in quality of life and sleep deficiency.
Read more
The study will consist of:
- An interview, lasting 30 minutes, in which the characteristics of the study will be explained. In case of wishing to participate, it will be required to sign the informed consent document and to fill out the medical history sheet.
- An evaluation phase: in which it will be necessary to fill out a number of questionnaires during two consecutive menstrual periods.
- An intervention phase: consisting of 12 30-minute treatment sessions, once a week. The patients will be randomly assigned to one of the two groups. In both groups, a current will be applied to different locations on the legs. The technique will be performed through four/two electrodes leg attached to the skin. This stimulation will not be painful at any time nor will it have harmful effects on the patients health. In this phase, the individual should continue filling out the questionnaires provided in each period. On the last day of treatment, a scale of satisfaction with the treatment will be retrieved.
- A re-evaluation phase: in which the individual shall fill out a number of questionnaires a month, 3 and 6 months after finishing the treatment.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Transcutaneous tibial nerve stimulation, Placebo
- Keywords
- Dysmenorrhea, Menstruation Disturbances
- Medical subject headings
- Dysmenorrhea, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous tibial nerve stimulationProcedure or surgery
The participant will be placed in the supine position with the soles of the feet together and the knees flexed and abducted at 90º. Two adhesive electrodes will be used for each leg. First one: 32 mm of diameter that will be placed in the posterior tibial nerve, that is, 4-5 cm cranial to the internal malleolus, between the posterior edge of the medial border of the tibia and the soleus tendon. Second one: 50x50 mm to be placed in the ipsilateral calcaneus. The electrodes will be connected to the NeuroTracTM PelviTone stimulation device. The stimulation range will be selected according to the tolerable pain limit for the patient, between 0.5 and 20 mA (adjustable in 1 mA levels).The intensity elevation will be allowed each time the patient perceives the fading of the previous sensation due to accommodation. Under no circumstances should the stimulation cause a painful feeling.
PlaceboProcedure or surgery
The participant will be placed in the same position. Two 50 x 50 mm adhesive electrodes will be placed on the external face of the thigh, on a single leg. This area is outside the territory of the posterior tibial nerve. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied. This simulated current being considered to be insufficient to achieve therapeutic effects in the body and to be outside of the usual ranges described in electrotherapy manuals regarding pain management. The intensity will be selected according to the paint limit level of the patient, between 0.5 and 60 mA (adjustable in 0.1 mA levels), where a low or moderate sensation of the patient will be sought, without muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous tibial nerve stimulation | Experimental | The participant will receive an intervention session per week that will be held for a period of 12 weeks. The total application time will be 30 minutes. A symmetrical biphasic current will be applied, with a frequency of 20 Hz in continuous mode and a pulsed frequency of 200 µs. Receives: Procedure: Transcutaneous tibial nerve stimulation |
| Placebo | Placebo comparator | The participant will receive one intervention session per week will be performed during a 12 weeks period time. The total application time will be 30 minutes. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied in other localization. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain perception assessed using a 100 mm Visual Analogue Scale (VAS).
The scale will be self-administered. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lower and lower scores mean a better result.
Measured: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
Changes in pain perception assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ®).
The questionnaire will be self-administered. The total score ranges from 0 to 45. Higher score = Higher level of pain. Lower and lower scores mean a better result.
Measured: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
Changes in the non-steroidal anti-inflammatory drugs (NSAID) intake using a NSAID diary designed for this study.
The questionnaire will be self-administered.
Measured: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
Changes in life quality assessed using the SF36 Health Survey (SF-36v2®).
The questionnaire will be self-administered. Minimum value 0. Maximum value 100. The higher the score, the better the state of health.
Measured: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI®).
The scale will be self-administered. The total score ranges from 0 to 21. The higher the score, the worse the sleep state.
Measured: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
Secondary outcomes (3)
To assess the overall improvement and satisfaction of the treatment using the Patient Global Impression of Change (PGIC®) questionnaire.
The questionnaire will be self-administered. The total score ranges from 1 to 7. The higher the score, the worse the impression of change.
Measured: At 5 months and at 11 months.
To assess the overall improvement and satisfaction of the treatment using a Likert Scale designed for this study.
The questionnaire will be self-administered. The scale qualitatively expresses the degree of agreement or disagreement with the treatment. The higher the score, the better the satisfaction with the treatment.
Measured: At 5 months and at 11 months.
To collect the possible adverse reactions caused by the treatment.
It will be assessed using an adverse reactions questionnaire that was designed for the study. It will be self-administered. This questionnaire does not have minimum and maximum values, it is an open question.
Measured: Once a week for 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start25 May 2021
- Primary completion31 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Correyero-León, University of Salamanca
- Investigators
- Marta Correyero-León, Doc student, Principal investigator, University of SalamancaInés Llamas-Ramos, PhD, Study director, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896814
- Sponsor's protocol ID
- Tibial2021
- Status last verified
- Feb 2024
- First submitted
- 9 May 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation as Treatment for Women With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04896814
- Acronym / sponsor ID
- Tibial2021
- Conditions
- Dysmenorrhea Primary
- Keywords
- Dysmenorrhea, Menstruation Disturbances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to verify whether transcutaneous stimulation of the posterior tibial nerve improves pain, quality of life and sleep deficiency in patients with pain related to their menstrual period in the short and medium-long term.
The hypothesis of the study states that by applying that method to the patients, a decrease or disappearance of pain in menstruation should happen, as well as an improvement in quality of life and sleep deficiency.
The study will consist of:
- An interview, lasting 30 minutes, in which the characteristics of the study will be explained. In case of wishing to participate, it will be required to sign the informed consent document and to fill out the medical history sheet.
- An evaluation phase: in which it will be necessary to fill out a number of questionnaires during two consecutive menstrual periods.
- An intervention phase: consisting of 12 30-minute treatment sessions, once a week. The patients will be randomly assigned to one of the two groups. In both groups, a current will be applied to different locations on the legs. The technique will be performed through four/two electrodes leg attached to the skin. This stimulation will not be painful at any time nor will it have harmful effects on the patients health. In this phase, the individual should continue filling out the questionnaires provided in each period. On the last day of treatment, a scale of satisfaction with the treatment will be retrieved.
- A re-evaluation phase: in which the individual shall fill out a number of questionnaires a month, 3 and 6 months after finishing the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous tibial nerve stimulation | Experimental | Procedure: Transcutaneous tibial nerve stimulationThe participant will receive an intervention session per week that will be held for a period of 12 weeks. The total application time will be 30 minutes. A symmetrical biphasic current will be applied, with a frequency of 20 Hz in continuous mode and a pulsed frequency of 200 µs. |
| Placebo | Placebo comparator | Procedure: PlaceboThe participant will receive one intervention session per week will be performed during a 12 weeks period time. The total application time will be 30 minutes. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied in other localization. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged between 18 and 43.
- Women with regular menstrual cycles (range between 21 and 35 days).
- Women with a visual analogue scale (VAS) between 4 and 10 (moderate to severe pain) during at least 50% of annual menstrual cycles and / or during the last 3 cycles in the suprapubic area, abdomen, lower lumbar area , perineum and / or medial side of the thighs during the first and / or second day of your menstrual cycle.
- Sign the informed consent document to participate in the study.
Key exclusion criteria (8 listed)
- Women on hormonal therapy or who have an Intrauterine Device implanted.
- Women diagnosed of secondary dysmenorrhea by their gynecologist (endometriosis, ovarian cyst, etc.) in the last 18 months.
- Women who have underwent a surgery during the study.
- Women who have underwent abdominal and pelvic surgery or who have given birth (vaginal or cesarean section) in the last 6 months.
- Women with lesions on the skin of the upper-internal face of the ankles (scars, erosions or cysts).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous tibial nerve stimulationThe participant will be placed in the supine position with the soles of the feet together and the knees flexed and abducted at 90º. Two adhesive electrodes will be used for each leg. First one: 32 mm of diameter that will be placed in the posterior tibial nerve, that is, 4-5 cm cranial to the internal malleolus, between the posterior edge of the medial border of the tibia and the soleus tendon. Second one: 50x50 mm to be placed in the ipsilateral calcaneus. The electrodes will be connected to the NeuroTracTM PelviTone stimulation device. The stimulation range will be selected according to the tolerable pain limit for the patient, between 0.5 and 20 mA (adjustable in 1 mA levels).The intensity elevation will be allowed each time the patient perceives the fading of the previous sensation due to accommodation. Under no circumstances should the stimulation cause a painful feeling. | Procedure or surgery | Transcutaneous tibial nerve stimulation |
| PlaceboThe participant will be placed in the same position. Two 50 x 50 mm adhesive electrodes will be placed on the external face of the thigh, on a single leg. This area is outside the territory of the posterior tibial nerve. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied. This simulated current being considered to be insufficient to achieve therapeutic effects in the body and to be outside of the usual ranges described in electrotherapy manuals regarding pain management. The intensity will be selected according to the paint limit level of the patient, between 0.5 and 60 mA (adjustable in 0.1 mA levels), where a low or moderate sensation of the patient will be sought, without muscle contraction. | Procedure or surgery | Placebo |
Primary outcome
Changes in pain perception assessed using a 100 mm Visual Analogue Scale (VAS).
Time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
The scale will be self-administered. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lower and lower scores mean a better result.
Changes in pain perception assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ®).
Time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
The questionnaire will be self-administered. The total score ranges from 0 to 45. Higher score = Higher level of pain. Lower and lower scores mean a better result.
Changes in the non-steroidal anti-inflammatory drugs (NSAID) intake using a NSAID diary designed for this study.
Time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
The questionnaire will be self-administered.
Changes in life quality assessed using the SF36 Health Survey (SF-36v2®).
Time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
The questionnaire will be self-administered. Minimum value 0. Maximum value 100. The higher the score, the better the state of health.
Changes in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI®).
Time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.
The scale will be self-administered. The total score ranges from 0 to 21. The higher the score, the worse the sleep state.
3 secondary outcomes
To assess the overall improvement and satisfaction of the treatment using the Patient Global Impression of Change (PGIC®) questionnaire.
Time frame: At 5 months and at 11 months.
To assess the overall improvement and satisfaction of the treatment using a Likert Scale designed for this study.
Time frame: At 5 months and at 11 months.
To collect the possible adverse reactions caused by the treatment.
Time frame: Once a week for 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Correyero-León, Doc student principal investigator
University of Salamanca
Inés Llamas-Ramos, PhD study director
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation in people with Dysmenorrhea Primary, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain perception assessed using a 100 mm Visual Analogue Scale (VAS). (time frame: Once a month for 6 months. Thereafter, at 3 months and at 6 months.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.