NCT06099847

Brief Summary

The goal of this interventional study is to test of efficacy of sacral Transcutaneous Electrical Stimulation (TENS) in patients with chronic pelvic pain. The main questions it aims to answer are:

  1. 1.Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain?
  2. 2.Is the effect of TENS comparable to sham stimulation therapy in patients with chronic pelvic pain?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 20, 2023

Last Update Submit

October 24, 2023

Conditions

Chronic Pelvic Pain Syndrome

Keywords

transcutaneous electrical stimulationchronic pelvic painsacralrandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Visual Numeric Scale of Pain

    Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment

    Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment

Secondary Outcomes (3)

  • The Pelvic Pain Impact Questionnaire

    Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment

  • Female Sexual Function Index

    Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment

  • Patient Satisfaction Questionnaire

    Immediately After Treatment and 1 Month After Treatment

Study Arms (2)

Chronic Pelvic Pain Patients with TENS

EXPERIMENTAL

19 patients with chronic pelvic pain have been received sacral TENS intervention.

Device: Sacral TENS Stimulation

Chronic Pelvic Pain Patients with Sham Stimulation

SHAM COMPARATOR

19 patients with chronic pelvic pain have been received sham stimulation intervention.

Device: Sham TENS Stimulation

Interventions

Sham TENS StimulationDEVICE

Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.

Chronic Pelvic Pain Patients with Sham Stimulation
Sacral TENS StimulationDEVICE

Sacral TENS stimulation have been applied to directly the skin of sacral area.

Chronic Pelvic Pain Patients with TENS

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female with chronic pelvic pain for ≥6 months
  • years old
  • Visual Numeric Scale of Pain score ≥4/10
  • Voluntarily participate to the study

You may not qualify if:

  • Pregnancy
  • Having severe medical and/or psychiatric disorder
  • Malignancy
  • Chronic infection
  • Inflammatory musculoskeletal system disease
  • Skin infection in sacral/pelvic area
  • Having implanted neuromodulatory device (such as pacemaker or defibrillator)
  • Refusing to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Fatih, Istanbul, 34640, Turkey (Türkiye)

Location

Related Publications (2)

  • Arik MI, Kiloatar H, Aslan B, Icelli M. The effect of TENS for pain relief in women with primary dysmenorrhea: A systematic review and meta-analysis. Explore (NY). 2022 Jan-Feb;18(1):108-113. doi: 10.1016/j.explore.2020.08.005. Epub 2020 Aug 29.

    PMID: 32917532RESULT

  • Tirlapur SA, Vlismas A, Ball E, Khan KS. Nerve stimulation for chronic pelvic pain and bladder pain syndrome: a systematic review. Acta Obstet Gynecol Scand. 2013 Aug;92(8):881-7. doi: 10.1111/aogs.12184. Epub 2013 Jun 22.

    PMID: 23710833RESULT

Related Links

Study Officials

  • Nalan Capan Bolukbas, M.D.

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Only participants are blinded for the intervention. Care provider (physiotherapist), investigator (medical doctor, physiatrist) and outcomes assessor (medical doctor, physiatrist) are not blinded and they are know which intervention (TENS or sham stimulation) is provided to the patients.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

February 1, 2023

Primary Completion

August 23, 2023

Study Completion

September 15, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)