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Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

Primary Purpose

Chronic Pelvic Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Sham TENS Stimulation

Sacral TENS Stimulation

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain Syndrome focused on measuring transcutaneous electrical stimulation, chronic pelvic pain, sacral, randomized clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female with chronic pelvic pain for ≥6 months 18-65 years old Visual Numeric Scale of Pain score ≥4/10 Voluntarily participate to the study Exclusion Criteria: 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

Sites / Locations

Istanbul University Istanbul Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Chronic Pelvic Pain Patients with TENS

Chronic Pelvic Pain Patients with Sham Stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Numeric Scale of Pain

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

Secondary Outcome Measures

The Pelvic Pain Impact Questionnaire

Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment

Female Sexual Function Index

Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment

Patient Satisfaction Questionnaire

Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment.

Full Information

NCT ID

NCT06099847

First Posted

October 20, 2023

Last Updated

October 24, 2023

Sponsor

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT06099847

Brief Title

Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

Official Title

Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

August 23, 2023 (Actual)

Study Completion Date

September 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

Our study aiming to test the efficacy of sacral transcutaneous electrical stimulation (TENS) intervention in patients with chronic pelvic pain. We aim to test the efficacy and compare it with sham stimulation therapy in chronic pelvic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pelvic Pain Syndrome

Keywords

transcutaneous electrical stimulation, chronic pelvic pain, sacral, randomized clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.

Masking

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chronic Pelvic Pain Patients with TENS

Arm Type

Experimental

Arm Description

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

Arm Title

Chronic Pelvic Pain Patients with Sham Stimulation

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sham TENS Stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sacral TENS Stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Visual Numeric Scale of Pain

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

The Pelvic Pain Impact Questionnaire

Description

Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment

Time Frame

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

Title

Female Sexual Function Index

Description

Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment

Time Frame

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

Title

Patient Satisfaction Questionnaire

Description

Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment.

Time Frame

Immediately After Treatment and 1 Month After Treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nalan Capan Bolukbas, M.D.

Organizational Affiliation

Istanbul University

Official's Role

Study Director

Facility Information:

Facility Name

Istanbul University Istanbul Faculty of Medicine

City

Fatih

State/Province

Istanbul

ZIP/Postal Code

34640

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32917532

Citation

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.

Results Reference

result

PubMed Identifier

23710833

Citation

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.

Results Reference

result

Links:

URL

https://pubmed.ncbi.nlm.nih.gov/23710833/

Description

Main Reference

Learn more about this trial

Sacral Transcutaneous Electrical Stimulation Efficacy in Chronic Pelvic Pain: A Randomized Clinical Trial

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