NCT06982989

Brief 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 and related serological indicators in clinical practice.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Jan 2023Dec 2028

Study Start

First participant enrolled

January 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6 years

First QC Date

April 29, 2025

Last Update Submit

May 13, 2025

Conditions

Pelvic Pain

Keywords

LEDpelvic pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month after the treatment

Study Arms (1)

Use LED to treat pelvic pain

OTHER

patient choose LED to treat pelvic pain

Device: use LED to treat pelvic pain

Interventions

use LED to treat pelvic painDEVICE

Use led to treat pelvic pain

Use LED to treat pelvic pain

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pelvic pain

You may not qualify if:

  • Irregular menstrual cycles;
  • Inflammatory disease;
  • pregnant;
  • Light allergy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Unniversity Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhangxin Wu

CONTACT

82267518wzxpku2008@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 21, 2025

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 21, 2025

Record last verified: 2025-03

Locations

CN(1)