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Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial

Primary Purpose

Pelvic Pain Syndrome

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutaneous Posterior Tibial Nerve Stimulation
Placebo Percutaneous Posterior Tibial Nerve Stimulation
Home instructions
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain Syndrome

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP). Exclusion Criteria: chronic uterine prolapse, endometriosis, pelvic tumor, any sexual problems, an active genitourinary infection, heart diseases, kidney diseases, cognitive disorders or any physical or psychological condition that might impair the ability to provide written informed consent or adhere to the research procedure

Sites / Locations

  • Kafrelshaikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group (SG)

control group (CG)

Arm Description

they will receive treatment with 20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR, ver 1.0.2 in Poland). Using TENS current in the device, the positive electrode will be placed posterior to the medial ankle malleolus, and the negative electrode will placed ten centimeters away on the leg along the tibial nerve path. The TENS current parameters will be 200 micro second pulse width, 10 Hz frequency, and intensity according to participant tolerance ranging between (10 - 50 mA) that increased gradually until visible movement in the big toe or fanning of toes will be noticed. The therapy sessions will be given three times a week, every other day, for a total of twelve sessions. Alos, they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.

They will receive placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group. Alos, they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.

Outcomes

Primary Outcome Measures

VAS.
measurement of pain level using visual analogue scale

Secondary Outcome Measures

EQ-5D-5L
health survey was used to evaluate health-related QOL
serum cortisol
Early-morning serum cortisol concentration is an important biological marker for adequate pain control

Full Information

First Posted
October 8, 2023
Last Updated
October 8, 2023
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT06080828
Brief Title
Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Official Title
Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Chronic pelvic pain (CPP) significantly impacts quality of life in women. This study investigated the effects of transdermal neuromodulation in females with CPP. Trial Design: Parallel, randomized, single-blind, controlled trial The amies of the study will be to examine the effect of posterior tibial nerve stimulation of women with idiopathic chronic pelvic pain syndrome. Methods: Thirty females with chronic pelvic pain will be randomly allocated 1:1 to receive either transdermal neuromodulation of the posterior tibial nerve (intervention group) or advice to control posture (control group) for 4 weeks at the Outpatient Physical Therapy Clinic at Kafrelsheikh University in Egypt. Primary outcome was pain intensity measured by visual analog scale (VAS). Secondary outcomes were serum cortisol level and quality of life (QOL) score. Assessments will be done at baseline and after 4 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group (SG)
Arm Type
Experimental
Arm Description
they will receive treatment with 20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR, ver 1.0.2 in Poland). Using TENS current in the device, the positive electrode will be placed posterior to the medial ankle malleolus, and the negative electrode will placed ten centimeters away on the leg along the tibial nerve path. The TENS current parameters will be 200 micro second pulse width, 10 Hz frequency, and intensity according to participant tolerance ranging between (10 - 50 mA) that increased gradually until visible movement in the big toe or fanning of toes will be noticed. The therapy sessions will be given three times a week, every other day, for a total of twelve sessions. Alos, they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.
Arm Title
control group (CG)
Arm Type
Placebo Comparator
Arm Description
They will receive placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group. Alos, they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.
Intervention Type
Device
Intervention Name(s)
Percutaneous Posterior Tibial Nerve Stimulation
Intervention Description
20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR, ver 1.0.2 in Poland). Using TENS current in the device, the positive electrode will be placed posterior to the medial ankle malleolus, and the negative electrode will placed ten centimeters away on the leg along the tibial nerve path. The TENS current parameters will be 200 micro second pulse width, 10 Hz frequency, and intensity according to participant tolerance ranging between (10 - 50 mA) that increased gradually until visible movement in the big toe or fanning of toes will be noticed. The therapy sessions will be given three times a week, every other day, for a total of twelve sessions.
Intervention Type
Device
Intervention Name(s)
Placebo Percutaneous Posterior Tibial Nerve Stimulation
Intervention Description
placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group.
Intervention Type
Behavioral
Intervention Name(s)
Home instructions
Intervention Description
they will receive leaflet with information for home instructions on how to properly walk, sleep, maintain good posture, and deal with activities of daily living.
Primary Outcome Measure Information:
Title
VAS.
Description
measurement of pain level using visual analogue scale
Time Frame
Before treatment and after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
EQ-5D-5L
Description
health survey was used to evaluate health-related QOL
Time Frame
Before treatment and after 4 weeks of treatment
Title
serum cortisol
Description
Early-morning serum cortisol concentration is an important biological marker for adequate pain control
Time Frame
Before treatment and after 4 weeks of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
indicate if participant eligibility is based on gender identity.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP). Exclusion Criteria: chronic uterine prolapse, endometriosis, pelvic tumor, any sexual problems, an active genitourinary infection, heart diseases, kidney diseases, cognitive disorders or any physical or psychological condition that might impair the ability to provide written informed consent or adhere to the research procedure
Facility Information:
Facility Name
Kafrelshaikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
12623
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women: A Randomized Controlled Trial

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