Dyspareunia (Female)NCT06730776
Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia
A study testing Topical medication and Transcutaneous electrical acupoint stimulation in people with Dyspareunia (Female), run by Cairo University at 1 site in Egypt.
Trial summary
Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Dyspareunia (Female)
- What is being tested?
- Topical medication and Transcutaneous electrical acupoint stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women complain of secondary dyspareunia, diagnosed and referred by the gynecologist.
- Multiparous women.
- Their ages will range from 25-35 years.
- Their body BMI will be less than 35 kg/m².
- Their pain level on the VAS will be ≥ 4.
- All the women were negative for vaginal infections caused by viruses, bacteria or fungi.
Who cannot join
- Pregnancy
- Malignancy.
- The presence of an intrauterine device, vaginal infection, or skin/mucous lesions.
- Diabetes mellitus.
- Dermatological abnormalities on the skin at acupuncture point.
- Severe uncontrolled cardiac patients or implanted cardiac rhythm devices.
- Dyspareunia with endometriosis.
- Fearing from electricity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Physical Therapy
Giza, Egypt, 12511
Marwa GA Ahmed, 01018637863, marwagamal30594@gmail.com
About this study
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial
Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia.
Patients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.
Read the detailed description
Patients will be divided randomly into two groups equal in number:
Control group (Group A): It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity).
Study group (GroupB): It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). All females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study
- Conditions
- Dyspareunia (Female)
- Being tested
- Topical medication, Transcutaneous electrical acupoint stimulation
- Keywords
- dyspareunia,
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical medicationOther
It will be given to all participants in both groups (A\&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity.
Transcutaneous electrical acupoint stimulationOther
This procedure will be applied for group B only. Before starting the first treatment session, each patient will be instructed briefly about the nature of the treatment to gain the patient's confidence and cooperation. This procedure will be performed by using TENS device on acupoints as the following: The participating woman will be placed in a relaxed comfortable supine position with her back well supported. The surface of the treated skin and the electrodes will be cleaned with alcohol wipe. The TENS protocol consists of a 30-minute weekly. session for 10 weeks of biphasic pulses with modulation 0/10-50 Hz of frequency and 300/100/3000 microseconds of pulse duration (s). The intensity parameter will be adapted individually according to each woman's perception, and modulated so that it is applied without discomfort, ranging between 10 and 100 mA (pulsing sensation) (Dionisi and Senatori ,2011)
| Study group | Role | What they receive |
|---|---|---|
| Control group (group A) | Active comparator | It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity) Receives: Other: Topical medication |
| Study group (group B) | Experimental | It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), topical medication(lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity) Receives: Other: Topical medication; Other: Transcutaneous electrical acupoint stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain intensity
Visual analogue scale (VAS) will be used to measure pain intensity for each female in both groups (A\&B). Each female will be asked to mark the point on the scale that represents her pain level.
Measured: Ten weeks
Assessment of dyspareunia
Marinoff Dyspareunia Scale will be used to evaluate vaginal and vulvar symptoms and pain related to sexual intercourse for both groups (A\& B) before and after the end of the treatment (10 weeks).
Measured: 10 Weeks
Secondary outcomes (2)
Assessment of sexual function
The female sexual function index will be used to evaluate sexual function including (desire, arousal, lubrication, satisfaction, and orgasm) for all women with dyspareunia in both groups (A\& B) before and after the end of the treatment.
Measured: Ten weeks
Assessment of quality of life
Sexual quality of life-female (SQOL-F) questionnaire will be used to evaluate quality of life for all women with dyspareunia in both groups (A\&B) before and after the end of the treatment.
Measured: Ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyspareunia (Female)Studies 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
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa gamal abdelrahman ahmed, Cairo University
- Investigators
- Doaa A Osman, Study chair, Department of Women's Health, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730776
- Sponsor's protocol ID
- P.T.REC/012/005373
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Dyspareunia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06730776
- Acronym / sponsor ID
- P.T.REC/012/005373
- Conditions
- Dyspareunia (Female)
- Keywords
- dyspareunia,
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Dec 2024 (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.
Transcutaneous electrical acupoint stimulation (TEAS)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. Till now there is no previous study that investigates the effect of TEAS on dyspareunia. This study will determine the effect of transcutaneous acupoint stimulation on dyspareunia.
Patients will be divided randomly into two groups equal in number: The control group will receive only topical medication. The study group will receive Acu-TENS and topical medication.
Detailed description
Patients will be divided randomly into two groups equal in number:
Control group (Group A): It will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity).
Study group (GroupB): It will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). All females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (group A) | Active comparator | Other: Topical medicationIt will include 19 women with dyspareunia. They will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity) |
| Study group (group B) | Experimental | Other: Topical medication, Other: Transcutaneous electrical acupoint stimulationIt will include 19 women with dyspareunia. They will receive Acu-TENS (30 minutes per session, once per week for 10 weeks), topical medication(lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity) |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| Topical medicationIt will be given to all participants in both groups (A\&B). The most commonly prescribed topical medication is lidocaine ointment 5% (Xylocaine jelly 2% or ointment 5%; AstraZeneca Pharmaceuticals LP, Wilmington, DE), applied as required for symptoms and for 30 minutes before sexual activity. | Other | Control group (group A), Study group (group B) |
| Transcutaneous electrical acupoint stimulationThis procedure will be applied for group B only. Before starting the first treatment session, each patient will be instructed briefly about the nature of the treatment to gain the patient's confidence and cooperation. This procedure will be performed by using TENS device on acupoints as the following: The participating woman will be placed in a relaxed comfortable supine position with her back well supported. The surface of the treated skin and the electrodes will be cleaned with alcohol wipe. The TENS protocol consists of a 30-minute weekly. session for 10 weeks of biphasic pulses with modulation 0/10-50 Hz of frequency and 300/100/3000 microseconds of pulse duration (s). The intensity parameter will be adapted individually according to each woman's perception, and modulated so that it is applied without discomfort, ranging between 10 and 100 mA (pulsing sensation) (Dionisi and Senatori ,2011) | Other | Study group (group B) |
Primary outcome
Assessment of pain intensity
Time frame: Ten weeks
Visual analogue scale (VAS) will be used to measure pain intensity for each female in both groups (A\&B). Each female will be asked to mark the point on the scale that represents her pain level.
Assessment of dyspareunia
Time frame: 10 Weeks
Marinoff Dyspareunia Scale will be used to evaluate vaginal and vulvar symptoms and pain related to sexual intercourse for both groups (A\& B) before and after the end of the treatment (10 weeks).
2 secondary outcomes
Assessment of sexual function
Time frame: Ten weeks
Assessment of quality of life
Time frame: Ten weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Dyspareunia (Female)
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
RecruitingObservational study
Rigid Hymenal Ring as a Cause for Insertional Dyspareunia
Dyspareunia (Female)
RecruitingPhase 2
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Vulvo Vaginal Atrophy (VVA)
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
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.
Doaa A Osman study chair
Department of Women's Health, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical medication and Transcutaneous electrical acupoint stimulation in people with Dyspareunia (Female), run by Cairo University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 12 Dec 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 Egypt. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa GA Ahmed (01018637863, marwagamal30594@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain intensity (time frame: Ten weeks). 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 12 Dec 2024.