EndometriosisNCT06537765
Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
A study testing Medical treatment, Therapeutic ultrasound (US) and Transcutaneous electrical nerve stimulation (TENS) in people with Endometriosis, run by Cairo University.
Trial summary
This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Medical treatment, Therapeutic ultrasound (US) and Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 10 Oct 2024
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Forty-five women clinically diagnosed by the gynecologist with endometriosis will be included in the study.
- Abdominal wall endometriosis will be diagnosed via Color Doppler ultrasonography.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
- All patients have reported mild to moderate endometriosis symptoms such as (chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, pain with bowel movements and urination and excessive bleeding) as recorded by Endometriosis Health profile questionnaire (EHP30).
- All patients use continuous hormonal treatment for at least 3 months.
Who cannot join
- Severe endometriosis which is diagnosed by the gynecologist.
- Pregnancy, peacemaker, epilepsy, cardiac arrhythmia, cancer, acute inflammatory pelvic disease.
- Use of injectable hormonal therapy within the previous 6 weeks.
- Patients with contraindication of ultrasound (Patients with reduced sensation to pain and/or heat, local malignancy, local acute infection and over areas of thrombosis or other vascular abnormalities).
- Cognitive deficiency and difficulty to understand instructions or use the instruments.
Trial locations and contacts
No sites are listed yet.
Manal El-Shafei, PhD contact
About this study
This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis.
Read the detailed description
Endometriosis affects 10-15% of reproductive-age women, causing pelvic pain and infertility. While laparoscopy is the primary treatment, it has risks. Medications are also used but often have side effects. Complementary therapies like acupuncture, yoga, and physical therapy modalities show promise. Therapeutic ultrasound has demonstrated effectiveness in managing chronic pain and adhesions associated with endometriosis. Transcutaneous electrical nerve stimulation (TENS) has shown positive results in pain relief and potentially improving uterine conditions for implantation. This study aims to investigate the combined effect of therapeutic ultrasound and TENS on endometriosis-related adhesion and pain, providing valuable information for physical therapists in treating this condition.
- Conditions
- Endometriosis
- Being tested
- Medical treatment, Therapeutic ultrasound (US), Transcutaneous electrical nerve stimulation (TENS)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentDrug
All women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist.
Therapeutic ultrasound (US)Device
Women will be asked to assume supine lying position, and the lower abdomen will be cleaned thoroughly with alcohol and dried well thereafter. Ultrasound gel will be distributed over the lower abdomen .The device will be adjusted to Frequency of 1MHz, Mode: continuous wave, Intensity: 1.5W/cm, duration of treatment: 15 minutes for the treatment site, then the skin will be cleaned again to remove ultrasound gel.
Transcutaneous electrical nerve stimulation (TENS)Device
TENS electrodes will be placed on specific acupuncture points for women in supine position. These points include VB29, ST36, CV6, CV4, LV3, KD3, SP6, and SP9. The treatment aims to improve blood circulation, remove adhesions, regulate menstrual activity and hormones, and prevent new adhesions and menstrual reflux in endometriosis patients.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic ultrasound (US) Group | Experimental | It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, Therapeutic US, 3 sessions, per week for eight weeks. Receives: Drug: Medical treatment; Device: Therapeutic ultrasound (US) |
| Transcutaneous Electrical Nerve Stimulation (TENS) Group | Experimental | It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, TENS therapy, 3 sessions, per week for eight weeks. Receives: Drug: Medical treatment; Device: Transcutaneous electrical nerve stimulation (TENS) |
| US + TENS Group | Experimental | It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks. Receives: Drug: Medical treatment; Device: Therapeutic ultrasound (US); Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adhesion size
New Color Doppler Ultrasound scanner will be used in the study to assess adhesion size for all women with endometriosis in all groups (A, B, \& C) before and after the study, and this procedure will be applied by the gynecologist.
Measured: 8 weeks
The McGill pain questionnaire (MPQ)
The pain intensity for all groups (A, B, \& C) will be assessed using the McGill Pain Questionnaire (MPQ) before and after the treatment program. The MPQ is a comprehensive tool that evaluates various dimensions of a patient's pain experience through three parts. The first part includes an anatomical drawing where the patient marks the location of their pain. The second part is a Verbal Descriptor Scale (VDS) for the patient to indicate the intensity of their current pain. The third part is an inventory of 72 descriptive adjectives to detail the pain further. The MPQ measures three key aspects: (1) the pain rating index, which assigns numerical values to each word descriptor, (2) the number of words chosen, and (3) the present pain intensity on a 1-5 scale (1 for mild, 2 for discomforting, 3 for distressing, 4 for horrible, and 5 for excruciating).
Measured: 8 weeks
The Endometriosis Health profile (EHP30) questionnaire
The Endometriosis Health profile (EHP30) questionnaire will be used to assess symptoms of endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is self-reporting instrument that contains a core questionnaire consisting of 30 items assessing five dimensions. The five dimensions included pain, control and impotence, emotional well-being, social support, and self
-image. Each scale is converted into a score from 0 to 100, with a lower score representing a better quality of life.
Measured: 8 weeks
Secondary outcomes (1)
The Health-related quality of life (HRQOL-36) questionnaire
The Health-related quality of life (HRQOL-36) questionnaire will be used to assess health related quality of life for all women with endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is a reliable and validated disease specific questionnaire with 36 questions that encompass five core scales: pain, control and powerlessness, emotional well-being, social support, and self- image. Questions are asked regarding endometriosis and are answered on a 5-points Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse health-related quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion10 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mohammed Ibrahim Mohammed Derwa, Cairo University
- Investigators
- Soheir El-Kosery, PhD, Study chair, Professor of Physical Therapy for Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537765
- Sponsor's protocol ID
- 012/003874
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
- ClinicalTrials.gov ID
- NCT06537765
- Acronym / sponsor ID
- 012/003874
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 10 Oct 2024 (estimated)
- First posted
- 5 Aug 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.
This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis.
Detailed description
Endometriosis affects 10-15% of reproductive-age women, causing pelvic pain and infertility. While laparoscopy is the primary treatment, it has risks. Medications are also used but often have side effects. Complementary therapies like acupuncture, yoga, and physical therapy modalities show promise. Therapeutic ultrasound has demonstrated effectiveness in managing chronic pain and adhesions associated with endometriosis. Transcutaneous electrical nerve stimulation (TENS) has shown positive results in pain relief and potentially improving uterine conditions for implantation. This study aims to investigate the combined effect of therapeutic ultrasound and TENS on endometriosis-related adhesion and pain, providing valuable information for physical therapists in treating this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Therapeutic ultrasound (US) Group | Experimental | Drug: Medical treatment, Device: Therapeutic ultrasound (US)It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, Therapeutic US, 3 sessions, per week for eight weeks. |
| Transcutaneous Electrical Nerve Stimulation (TENS) Group | Experimental | Drug: Medical treatment, Device: Transcutaneous electrical nerve stimulation (TENS)It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, TENS therapy, 3 sessions, per week for eight weeks. |
| US + TENS Group | Experimental | Drug: Medical treatment, Device: Therapeutic ultrasound (US), Device: Transcutaneous electrical nerve stimulation (TENS)It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Forty-five women clinically diagnosed by the gynecologist with endometriosis will be included in the study.
- Abdominal wall endometriosis will be diagnosed via Color Doppler ultrasonography.
- Their ages will range from 25 to 35 years old.
- Their body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
- All patients have reported mild to moderate endometriosis symptoms such as (chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, pain with bowel movements and urination and excessive bleeding) as recorded by Endometriosis Health profile questionnaire (EHP30).
Key exclusion criteria (5 listed)
- Severe endometriosis which is diagnosed by the gynecologist.
- Pregnancy, peacemaker, epilepsy, cardiac arrhythmia, cancer, acute inflammatory pelvic disease.
- Use of injectable hormonal therapy within the previous 6 weeks.
- Patients with contraindication of ultrasound (Patients with reduced sensation to pain and/or heat, local malignancy, local acute infection and over areas of thrombosis or other vascular abnormalities).
- Cognitive deficiency and difficulty to understand instructions or use the instruments.
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 |
|---|---|---|
| Medical treatmentAll women with endometriosis in all groups (A, B, \& C) will receive their medical treatment as prescribed by the gynecologist. | Drug | Therapeutic ultrasound (US) Group, Transcutaneous Electrical Nerve Stimulation (TENS) Group, US + TENS Group |
| Therapeutic ultrasound (US)Women will be asked to assume supine lying position, and the lower abdomen will be cleaned thoroughly with alcohol and dried well thereafter. Ultrasound gel will be distributed over the lower abdomen .The device will be adjusted to Frequency of 1MHz, Mode: continuous wave, Intensity: 1.5W/cm, duration of treatment: 15 minutes for the treatment site, then the skin will be cleaned again to remove ultrasound gel. | Device | Therapeutic ultrasound (US) Group, US + TENS Group |
| Transcutaneous electrical nerve stimulation (TENS)TENS electrodes will be placed on specific acupuncture points for women in supine position. These points include VB29, ST36, CV6, CV4, LV3, KD3, SP6, and SP9. The treatment aims to improve blood circulation, remove adhesions, regulate menstrual activity and hormones, and prevent new adhesions and menstrual reflux in endometriosis patients. | Device | Transcutaneous Electrical Nerve Stimulation (TENS) Group, US + TENS Group |
Primary outcome
Assessment of adhesion size
Time frame: 8 weeks
New Color Doppler Ultrasound scanner will be used in the study to assess adhesion size for all women with endometriosis in all groups (A, B, \& C) before and after the study, and this procedure will be applied by the gynecologist.
The McGill pain questionnaire (MPQ)
Time frame: 8 weeks
The pain intensity for all groups (A, B, \& C) will be assessed using the McGill Pain Questionnaire (MPQ) before and after the treatment program. The MPQ is a comprehensive tool that evaluates various dimensions of a patient's pain experience through three parts. The first part includes an anatomical drawing where the patient marks the location of their pain. The second part is a Verbal Descriptor Scale (VDS) for the patient to indicate the intensity of their current pain. The third part is an inventory of 72 descriptive adjectives to detail the pain further. The MPQ measures three key aspects: (1) the pain rating index, which assigns numerical values to each word descriptor, (2) the number of words chosen, and (3) the present pain intensity on a 1-5 scale (1 for mild, 2 for discomforting, 3 for distressing, 4 for horrible, and 5 for excruciating).
The Endometriosis Health profile (EHP30) questionnaire
Time frame: 8 weeks
The Endometriosis Health profile (EHP30) questionnaire will be used to assess symptoms of endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is self-reporting instrument that contains a core questionnaire consisting of 30 items assessing five dimensions. The five dimensions included pain, control and impotence, emotional well-being, social support, and self -image. Each scale is converted into a score from 0 to 100, with a lower score representing a better quality of life.
1 secondary outcome
The Health-related quality of life (HRQOL-36) questionnaire
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Manal El-Shafei, PhD contact
Soheir El-Kosery, PhD study chair
Professor of Physical Therapy for Women's Health
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment, Therapeutic ultrasound (US) and Transcutaneous electrical nerve stimulation (TENS) in people with Endometriosis, 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 6 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 6 Aug 2024. 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 Rania Derwa, B.Sc (01017628838, raniaderwa2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adhesion size (time frame: 8 weeks). The study lists 3 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 6 Aug 2024.