Pelvic PainNCT06982989
Clinical Study on the Treatment of Pelvic Pain With Wearable Dual-band LED Device
A study testing use LED to treat pelvic pain in people with Pelvic Pain, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study is a prospective clinical trial, which intends to prospective include female pelvic pain (dysmenorrhea and chronic pelvic pain), screen suitable cases, wear dual-band LED devices in non-menstrual period, perform low-dose phototherapy on local pelvic area and acupoints, and observe the changes of pelvic pain… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- use LED to treat pelvic pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2028
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pelvic pain
Who cannot join
- Irregular menstrual cycles;
- Inflammatory disease;
- pregnant;
- Light allergy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Unniversity Third Hospital
Beijing, Beijing Municipality, 100191
Zhangxin Wu, 82267518, wzxpku2008@126.com
About this study
This study is a prospective clinical trial, which intends to prospective include female pelvic pain (dysmenorrhea and chronic pelvic pain), screen suitable cases, wear dual-band LED devices in non-menstrual period, perform low-dose phototherapy on local pelvic area and acupoints, and observe the changes of pelvic pain and related serological indicators in clinical practice.
- Conditions
- Pelvic Pain
- Being tested
- use LED to treat pelvic pain
- Keywords
- LED, pelvic pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use LED to treat pelvic painDevice
Use led to treat pelvic pain
| Study group | Role | What they receive |
|---|---|---|
| Use LED to treat pelvic pain | Other | patient choose LED to treat pelvic pain Receives: Device: use LED to treat pelvic pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy that LED release pelvic pain
Use VAS scale to evaluate the pain.The changes in the VAS score of pelvic pain before and after treatment.
Measured: 1 month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982989
- Sponsor's protocol ID
- LED Pelvic pain
- Other IDs
- 2022YFB3604705
- Status last verified
- Mar 2025
- First submitted
- 29 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Pelvic Pain With Wearable Dual-band LED Device
- ClinicalTrials.gov ID
- NCT06982989
- Acronym / sponsor ID
- LED Pelvic pain
- Conditions
- Pelvic Pain
- Keywords
- LED, pelvic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 May 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.
This study is a prospective clinical trial, which intends to prospective include female pelvic pain (dysmenorrhea and chronic pelvic pain), screen suitable cases, wear dual-band LED devices in non-menstrual period, perform low-dose phototherapy on local pelvic area and acupoints, and observe the changes of pelvic pain and related serological indicators in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use LED to treat pelvic pain | Other | Device: use LED to treat pelvic painpatient choose LED to treat pelvic pain |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pelvic pain
Key exclusion criteria (4 listed)
- Irregular menstrual cycles;
- Inflammatory disease;
- pregnant;
- Light allergy;
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 |
|---|---|---|
| use LED to treat pelvic painUse led to treat pelvic pain | Device | Use LED to treat pelvic pain |
Primary outcome
Efficacy that LED release pelvic pain
Time frame: 1 month after the treatment
Use VAS scale to evaluate the pain.The changes in the VAS score of pelvic pain before and after treatment.
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 21 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use LED to treat pelvic pain in people with Pelvic Pain, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 May 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 China. 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 Zhangxin Wu (82267518, wzxpku2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy that LED release pelvic pain (time frame: 1 month after the treatment). 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 21 May 2025.