Endometriosis (Diagnosis)NCT06914752
TENS for Endometriosis Pain in Adolescents and Young Adults
A study testing TENS in people with Endometriosis (Diagnosis), run by Boston Children's Hospital at 1 site in United States.
Trial summary
The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis. Read more about this study
- Who is it for?
- Ages 10 to 21 years, women only
- Conditions the study is for
- Endometriosis (Diagnosis)
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2026
- 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 10 to 21 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent girls and young women (13-25)
- Diagnosis of endometriosis,
- Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment.
- Personal smart phone or mobile device
- Speak either English or Spanish.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The goal of this project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.
- Conditions
- Endometriosis (Diagnosis)
- Being tested
- TENS
- Keywords
- endometriosis, TENS, transcutaneous electrical nerve stimulation
- Medical subject headings
- Endometriosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Not described Receives: Device: TENS |
| Delayed Intervention | Experimental | Not described Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain - Visual Acuity Scale
Pain on a scale of 0-10, where a higher score indicates worse pain.
Measured: 6 months
Secondary outcomes (2)
Endometriosis Health Profile 30 (EHP-30)
The Endometriosis Health Profile is a 30 item patient-reported outcome measures designed to assess the health-related quality of life of people living with endometriosis. Scores range from 0 to 100 with higher scores being associated with WORSE health related quality of life.
Measured: 6 months
Missed school/work
Individuals will be asked to track the number of days of missed school/work.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Study not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Single group
- Model description
- Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Boskey, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914752
- Sponsor's protocol ID
- IRB-P00050840
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENS for Endometriosis Pain in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT06914752
- Acronym / sponsor ID
- IRB-P00050840
- Conditions
- Endometriosis (Diagnosis)
- Keywords
- endometriosis, TENS, transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Apr 2025 (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 project is plan to investigate the utility of Transcutaneous Electrical Nerve Stimulators (TENS) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Delayed intervention trial. Individuals will be randomized to immediate or delayed treatment with the intervention.
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Device: TENS |
| Delayed Intervention | Experimental | Device: TENS |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescent girls and young women (13-25)
- Diagnosis of endometriosis,
- Current pelvic pain (score ≥ 3 on Visual Analog Scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment.
- Personal smart phone or mobile device
- Speak either English or Spanish.
Key exclusion criteria (0 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 |
|---|---|---|
| TENStranscutaneous electrical nerve stimulation | Device | Delayed Intervention, Immediate intervention |
Primary outcome
Pain - Visual Acuity Scale
Time frame: 6 months
Pain on a scale of 0-10, where a higher score indicates worse pain.
2 secondary outcomes
Endometriosis Health Profile 30 (EHP-30)
Time frame: 6 months
Missed school/work
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Endometriosis (Diagnosis), run by Boston Children's Hospital at 1 site in United States.
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 0 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: withdrawn, as of the sponsor's last update on 10 Dec 2025. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain - Visual Acuity Scale (time frame: 6 months). 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 10 Dec 2025.