Effect of contact diathermy on pain and quality of life in women with Primary Chronic Pelvic Pain Syndrome: A randomized placebo-controlled trial.

Not Applicable

• Conditions: Primary Chronic Pelvic Pain Syndrome; Anaesthesiology - Pain management

• Registration Number: ACTRN12622000726752
• Lead Sponsor: niversidad de Castilla la Mancha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-20
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

Women diagnosed of CPPS according to the definition by the European Urology Association (EUA).
- Presence of tenderness on palpation of Levator Ani (LA) muscle during vaginal examination.
- Presence of abnormal tension at rest within the PFM as indicated by surface electromyographic (EMG) signal (for the purpose of this study, this is defined as mean PFM EMG resting activity above 5 microV over a minimum period of 100 secs).
- Pharmacological treatment had remained stable for a minimum of 4 weeks prior to initiation of CRet therapy.
- Able and willing to provide informed consent.
- CRet treatment naive.

Exclusion Criteria

- Pregnant or trying to get pregnant.
- Women presenting with an abnormal cell cytology on last smear test.
- Local malignancy/tumours.
- Women with a pace-maker fitted.
- Presence of open wounds in the treatment area.
- Presence of thrombosis/impaired circulation in the treatment area.
- Exposure to X Ray therapy or other ionizing radiations in the previous 6 months.
- Those with impaired/absent sensation in the treatment.
- Those unable to comprehend the physiotherapist’s instructions or who were unable to co-operate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity with 100 mm visual analogue scale (VAS).[Baseline, before each CRet session, one week (primary timepoint) and 6 weeks after intervention is finished.];Pain rating Index (PRI) as measured by the McGill Pain Questionnaire[Baseline, one week (primary timepoint) and 6 weeks after completing treatment protocol.]

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL) using the WHOQOL-BREF questionnaire.[Baseline, one week and 6 weeks after completing study protocol.];Average electromyographic (EMG) activity of pelvic floor muscles (PFM), over a minimum period of 100 seconds will be measured in µV at rest, with participants in a crook lying supine position.[Baseline, one week and 6 weeks after completing study protocol.];Sexual Function as measured by the Female Sexual Function Index (FSFI).[Baseline, one week and 6 weeks after completing study protocol.];Global Response Assessment (GRA), using a 7-item Likert-type scale.[6 weeks after completion of study protocol.]