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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Pelvic Pain Patients with TENS | Experimental | 19 patients with chronic pelvic pain have been received sacral TENS intervention. |
|
| Chronic Pelvic Pain Patients with Sham Stimulation | Sham Comparator | 19 patients with chronic pelvic pain have been received sham stimulation intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham TENS Stimulation | Device | Sacral TENS device without appropriate electrical stimulation have been applied to directly the skin of sacral area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Pelvic Pain Impact Questionnaire | Patients with Chronic Pelvic Pain assessed pelvic pain impact before, right after and 1 month after treatment | Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment |
| Female Sexual Function Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalan Capan Bolukbas, M.D. | Istanbul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Istanbul Faculty of Medicine | Fatih | Istanbul | 34640 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32917532 | Result | 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. | |
| 23710833 | Result | 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. |
| Label | URL |
|---|---|
| Main Reference | View source |
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We aim to compare sacral TENS in patients with chronic pelvic pain and compare it with sham stimulation therapy.
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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.
| Sacral TENS Stimulation | Device | Sacral TENS stimulation have been applied to directly the skin of sacral area. |
|
Patients with Chronic Pelvic Pain assessed their sexual functions before, right after and 1 month after treatment |
| Baseline (Before Treatment), immediately After Treatment and 1 Month After Treatment |
| Patient Satisfaction Questionnaire | Patients with Chronic Pelvic Pain assessed their satisfaction levels right after and 1 month after treatment. | Immediately After Treatment and 1 Month After Treatment |