Transdermal Neuromodulation for Management of Chronic Pelvic Pain in Women

NCT06080828 | Completed

• 1 other identifier: P.T/WH/2/2023/42e
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chronic pelvic pain (CPP) significantly impacts the 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 aim of the study will be to examine the effect of posterior tibial nerve stimulation on 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. The 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.

Conditions

Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• VAS.

  measurement of pain level using visual analogue scale

  Before treatment and after 4 weeks of treatment

Secondary Outcomes (2)

• EQ-5D-5L

  Before treatment and after 4 weeks of treatment

• serum cortisol

  Before treatment and after 4 weeks of treatment

Study Arms (2)

study group (SG)

EXPERIMENTAL

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.

Device: Percutaneous Posterior Tibial Nerve Stimulation; Behavioral: Home instructions

control group (CG)

PLACEBO COMPARATOR

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.

Device: Placebo Percutaneous Posterior Tibial Nerve Stimulation; Behavioral: Home instructions

Interventions

Percutaneous Posterior Tibial Nerve Stimulation DEVICE

20 minutes of neuromodulation of the posterior tibial nerve of both lower limbs using Physio Go-lite electrical stimulation device (made by ASTAR in Poland, ver 1.0.2 in Poland). Using Transcutaneous Electrical Nerve Stimulation (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 microsecond 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.

study group (SG)

Placebo Percutaneous Posterior Tibial Nerve Stimulation DEVICE

placebo neuromodulation of the posterior tibial nerve in both lower limbs, much as those in the research group.

control group (CG)

Home instructions BEHAVIORAL

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.

control group (CG); study group (SG)

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: indicate if participant eligibility is based on gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparous, with a body mass index not exceeding 30 kg/m2 and complaining of idiopathic chronic pelvic pain syndrome (CPP).

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelshaikh University

Kafr ash Shaykh, 12623, Egypt

Location

Study Officials

• Ahmed M Kadry, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: August 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year from publication
• Access Criteria: Upon request from the principal investigator with appropriate justification

Locations

EG (1)