Premenstrual PainNCT05395156
EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Premenstrual Pain, run by Cairo University.
Trial summary
These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)? Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Pain
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2022to 10 Oct 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Their age will range from 18 to 25 years.
- The regularity of menstrual cycle is 28-35 days.
- All of them suffering from moderate and sever PMS.
- All participants are virgin.
- Their BMI will range from 25-30 kg\m2.
Who cannot join
- Any pathological findings in the pelvic cavity as PCO, Endometriosis and pelvic inflammatory disease.
- Any history of gynecological intervention.
- Have any condition impedes the use of electrotherapy.
- Receiving sedatives or any medical treatment.
- Having irregular menstruation.
Trial locations and contacts
No sites are listed yet.
About this study
These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)?
Read the detailed description
Premenstrual syndrome is a collection of emotional, physiological, and behavioral symptoms that develop around the end of the luteal phase and fade away with or after menstruation Due to limited evidence on the efficacy of sustained progesterone and the side effects of antidepressant and anxiolytics, in some cases, alternative therapies are recommended for patients with PMS TEAS may be more effective than other forms of transcutaneous electrical nerve stimulation (TENS) in modulating brain activity because acupoint areas contain relatively denser neural and neuroactive components than non-acupoint areas TEAS has been reported to have similar efficacy as acupuncture, electrical acupuncture, and TENS
- Conditions
- Premenstrual Pain
- Being tested
- Transcutaneous electrical nerve stimulation (TENS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Control group will receive TEAS on sham acupoint daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles Study group will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles
| Study group | Role | What they receive |
|---|---|---|
| sham acupoint | Experimental | Control group: (placebo group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on sham acupoint (the acupoint selection site was 1 inch away from the acupoint selection in the study group) daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Electroacupuncture | Experimental | Study group: (Electroacupuncture group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
The pain intensity will be assessed through visual analogue scale (VAS) for each participant in both groups before and after treatment Each participant will be asked to mark a point on VAS line between the extremes that related to her current pain intensity
Measured: Up to 3 monthes
premenstrual syndrome severity
Participants can differentiate between their experiences of different symptoms during menstrual cycle and they will be assessed before and after treatment using the Menstrual Distress Questionnaire (MDQ) Each participant will be asked to rate their experience of each of the symptoms on the MDQ on a scale ranging from no experience of the symptom to an acute or partially disabling experience of the symptom
Measured: up to 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start10 Jun 2022 (estimated)
- Primary completion10 Sep 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Mohammed Elsayed Abdelaal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395156
- Sponsor's protocol ID
- P.T.REC/012/003688
- Status last verified
- May 2022
- First submitted
- 24 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF TENS ON ACUPOINTS IN PREMENSTRUAL SYNDROME
- ClinicalTrials.gov ID
- NCT05395156
- Acronym / sponsor ID
- P.T.REC/012/003688
- Conditions
- Premenstrual Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 27 May 2022 (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.
These will be no effect of transcutaneous electrical acupoint stimulation on premenstrual syndrome Does transcutaneous electrical acupoint stimulation affect premenstrual syndrome (PMS)?
Detailed description
Premenstrual syndrome is a collection of emotional, physiological, and behavioral symptoms that develop around the end of the luteal phase and fade away with or after menstruation Due to limited evidence on the efficacy of sustained progesterone and the side effects of antidepressant and anxiolytics, in some cases, alternative therapies are recommended for patients with PMS TEAS may be more effective than other forms of transcutaneous electrical nerve stimulation (TENS) in modulating brain activity because acupoint areas contain relatively denser neural and neuroactive components than non-acupoint areas TEAS has been reported to have similar efficacy as acupuncture, electrical acupuncture, and TENS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham acupoint | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Control group: (placebo group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on sham acupoint (the acupoint selection site was 1 inch away from the acupoint selection in the study group) daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months |
| Electroacupuncture | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Study group: (Electroacupuncture group) will be consisted of twenty-five females diagnosed with premenstrual syndrome. They will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles with average of 7 sessions per month for 3 months. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Their age will range from 18 to 25 years.
- The regularity of menstrual cycle is 28-35 days.
- All of them suffering from moderate and sever PMS.
- All participants are virgin.
- Their BMI will range from 25-30 kg\m2.
Key exclusion criteria (5 listed)
- Any pathological findings in the pelvic cavity as PCO, Endometriosis and pelvic inflammatory disease.
- Any history of gynecological intervention.
- Have any condition impedes the use of electrotherapy.
- Receiving sedatives or any medical treatment.
- Having irregular menstruation.
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 electrical nerve stimulation (TENS)Control group will receive TEAS on sham acupoint daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles Study group will receive TEAS on neurogenic acupoints daily from 3 days before menstruation to the 4th day of menstruation for 3 consequent menstrual cycles | Device | Electroacupuncture, sham acupoint |
Primary outcome
pain severity
Time frame: Up to 3 monthes
The pain intensity will be assessed through visual analogue scale (VAS) for each participant in both groups before and after treatment Each participant will be asked to mark a point on VAS line between the extremes that related to her current pain intensity
premenstrual syndrome severity
Time frame: up to 3 monthes
Participants can differentiate between their experiences of different symptoms during menstrual cycle and they will be assessed before and after treatment using the Menstrual Distress Questionnaire (MDQ) Each participant will be asked to rate their experience of each of the symptoms on the MDQ on a scale ranging from no experience of the symptom to an acute or partially disabling experience of the symptom
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Premenstrual Pain, run by Cairo University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azza Barmoud, professor (01008410312, drazzakassab@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity (time frame: Up to 3 monthes). The study lists 2 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 27 May 2022.