Chronic Pelvic Pain Syndrome
Conditions
Keywords
transcutaneous electrical stimulation, chronic pelvic pain, sacral, randomized clinical trial
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. Is sacral transcutaneous electrical stimulation (TENS) effective to reduce/relief pain in patients with chronic pelvic pain? 2. 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.
Interventions
DEVICESham TENS Stimulation
Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area.
DEVICESacral TENS Stimulation
Sacral TENS stimulation have been applied to directly the skin of sacral area.
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Intervention model description
We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Numeric Scale of Pain | Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment | Patients with Chronic Pelvic Pain assessed their pain levels before, right after and 1 month after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Pelvic Pain Impact Questionnaire | Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment | Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment |
| Female Sexual Function Index | Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment | Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment |
| Patient Satisfaction Questionnaire | Immediately After Treatment and 1 Month After Treatment | Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment. |
Countries
Turkey (Türkiye)
Outcome results
None listed