Clinical Study on the Treatment of Pelvic Pain With Weara... | NCT06982989

Studies
Clinical Study on the Treatment of Pelvic Pain With Wearable Dual-band LED Device

NCT06982989

Sponsor

Peking University Third Hospital

Status

Recruiting

Last Update Posted

May 21, 2025Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Pelvic Pain

Interventions

use LED to treat pelvic pain

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022YFB3604705	Other Grant/Funding Number	Ministry of Science and Technology of the People's Republic of China

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 29, 2025

First Submission Date that Met QC Criteria

May 13, 2025

First Posted Date

May 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2025

Last Update Posted Date

May 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use LED to treat pelvic pain	Other	patient choose LED to treat pelvic pain	Device: use LED to treat pelvic pain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
use LED to treat pelvic pain	Device	Use led to treat pelvic pain	Use LED to treat pelvic pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pelvic pain

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhangxin Wu	Contact	82267518		wzxpku2008@126.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Unniversity Third Hospital	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 1, 2023	May 8, 2025	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Jan 1, 2023	May 8, 2025	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided